WorldWideScience

Sample records for gained regulatory approval

  1. 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.

  2. 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...

  3. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

  4. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-04-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

  5. 75 FR 59771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2010-09-28

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the Proposed Rule.... I. Introduction On July 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k... pertinent distribution-related information from its members in a timely fashion to facilitate its Regulation...

  6. 75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-15

    ... registered capacity, may work in other investment-related industries, such as financial planning, or may seek...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule..., 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...

  7. 75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-01

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

  8. 75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

  9. 30 CFR 906.10 - State regulatory program approval.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false State regulatory program approval. 906.10 Section 906.10 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE COLORADO § 906.10 State...

  10. Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

    Science.gov (United States)

    Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J

    2017-08-01

    We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.

  11. 77 FR 74722 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-12-17

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68401; File No. SR-CME-2012-42] Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule Change Regarding the Valuation of... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

  12. 78 FR 69168 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

    Science.gov (United States)

    2013-11-18

    ... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70848; File No. SR-NSCC-2013-10] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To...

  13. 77 FR 40394 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-07-09

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67333; File No. SR-OCC-2012-07] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Adjustment... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

  14. 77 FR 27529 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of...

    Science.gov (United States)

    2012-05-10

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66922; File No. SR-ICC-2012-05] Self-Regulatory... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... of the Comptroller of the Currency, U.K. Financial Services Authority, or any other regulatory body...

  15. Analysis of time to regulatory and ethical approval of SATVI TB ...

    African Journals Online (AJOL)

    Background. Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product. Aim. Our aim was to ...

  16. 78 FR 28267 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2013-05-14

    ... Trust Company (``DTC'') and maintain accounts to facilitate Delivery Orders (``DOs'') to approved... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... securities transactions and foster cooperation and coordination with persons engaged in the clearance and...

  17. Evaluation of regulatory processes affecting nuclear power plant early site approval and standardization

    International Nuclear Information System (INIS)

    1983-12-01

    This report presents the results of a survey and evaluation of existing federal, state and local regulatory considerations affecting siting approval of power plants in the United States. Those factors that may impede early site approval of nuclear power plants are identified, and findings related to the removal of these impediments and the general improvement of the approval process are presented. A brief evaluation of standardization of nuclear plant design is also presented

  18. 75 FR 1437 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

    Science.gov (United States)

    2010-01-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61274; File No. SR-CBOE-2009-089] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule... announce to members via Regulatory Circular any determination regarding the routing of market stock-option...

  19. 76 FR 78059 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2011-12-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65927; File No. SR-OCC-2011-15] Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Management of..., future regulatory requirements for clearinghouses could impose liquidity requirements that would be...

  20. 77 FR 76319 - Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Minor Rule Violation...

    Science.gov (United States)

    2012-12-27

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68489; File No. 4-655] Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Minor Rule Violation Plan for BOX Options Exchange LLC... \\4\\ requiring that a self-regulatory organization (``SRO'') promptly file notice with the Commission...

  1. 77 FR 40928 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Granting Approval of...

    Science.gov (United States)

    2012-07-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67357; File No. SR-C2-2012-011] Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Granting Approval of Proposed Rule Change To Implement a... and subsequently migrates to the DRF, the regulatory data for the portion of the day that the main...

  2. Considerations, clues and challenges: Gaining Ethical and Trust research approval when using the NHS as a research setting

    Energy Technology Data Exchange (ETDEWEB)

    Jonker, Leon, E-mail: leon.jonker@cumbria.ac.uk [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom); Research and Development Department, North Cumbria University Hospitals NHS Trust, Carlisle CA2 7HY (United Kingdom); Cox, Diane; Marshall, Gill [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom)

    2011-08-15

    Substantial changes have been made in recent years to the process of obtaining ethical and research governance approval for research projects in the NHS. The advent of the Integrated Research Application System (IRAS) has streamlined the process, providing a single point of entry. Ethical approval gained in one part of the country is now valid throughout the UK. The previous process of gaining research governance approval in NHS Trusts was maligned and it has been overhauled with the introduction of the National Institute of Health Research (NIHR) Coordinated System for gaining NHS Permission. In addition to updating the reader about the new processes around gaining ethical and Trust approval for research within an NHS setting, essential research project documentation needed for submission are discussed. The aspects of a proposal that Ethics Committees and Trust R and D Departments consider when reviewing applications are highlighted. The implemented changes to the research approval processes will mostly benefit large multi-centre studies; small scale unfunded studies and student projects are potentially at risk of being marginalised in the quest for a streamlined ethics and NHS Trust research governance approval process. However, researchers' familiarity with the approval system should minimise rejection rates and delays.

  3. Considerations, clues and challenges: Gaining Ethical and Trust research approval when using the NHS as a research setting

    International Nuclear Information System (INIS)

    Jonker, Leon; Cox, Diane; Marshall, Gill

    2011-01-01

    Substantial changes have been made in recent years to the process of obtaining ethical and research governance approval for research projects in the NHS. The advent of the Integrated Research Application System (IRAS) has streamlined the process, providing a single point of entry. Ethical approval gained in one part of the country is now valid throughout the UK. The previous process of gaining research governance approval in NHS Trusts was maligned and it has been overhauled with the introduction of the National Institute of Health Research (NIHR) Coordinated System for gaining NHS Permission. In addition to updating the reader about the new processes around gaining ethical and Trust approval for research within an NHS setting, essential research project documentation needed for submission are discussed. The aspects of a proposal that Ethics Committees and Trust R and D Departments consider when reviewing applications are highlighted. The implemented changes to the research approval processes will mostly benefit large multi-centre studies; small scale unfunded studies and student projects are potentially at risk of being marginalised in the quest for a streamlined ethics and NHS Trust research governance approval process. However, researchers' familiarity with the approval system should minimise rejection rates and delays.

  4. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

    Science.gov (United States)

    Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

    2015-01-01

    Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

  5. 77 FR 4844 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

    Science.gov (United States)

    2012-01-31

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66235; File No. SR-CBOE-2011-114] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Complex Order Processing in Hybrid 3.0 Classes January 25, 2012. I. Introduction On November 29, 2011, the Chicago Board Options...

  6. 77 FR 66196 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-11-02

    ... Accounting Principles (``GAAP''). Canadian clearing members that use Form 1 report the same, and in some... Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Financial... financial reporting by Canadian clearing members to reflect the Investment Industry Regulatory Organization...

  7. 76 FR 2737 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

    Science.gov (United States)

    2011-01-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63668; File No. SR-NSCC-2010-09] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change... Facility January 6, 2011. I. Introduction On August 30, 2010, the National Securities Clearing Corporation...

  8. 77 FR 15432 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-03-15

    ... corporate governance structure of OCC by: (i) Increasing the number of public directors on OCC's Board of... directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds... Directors, OCC stated that the changes would enhance the corporate governance structure at OCC. As such, the...

  9. 75 FR 2915 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2010-01-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61317; File No. SR-ISE-2009-103] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Market Data Fees January 8, 2010. I. Introduction On November 25, 2009, the International...

  10. 76 FR 64980 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2011-10-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65548; File No. SR-ISE-2011-39] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Complex Orders October 13, 2011. I. Introduction On July 1, 2011, the International Securities Exchange...

  11. 77 FR 4852 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2012-01-31

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66234; File No. SR-ISE-2011-82] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Legging Orders January 25, 2012. I. Introduction On November 29, 2011, the International Securities...

  12. 77 FR 4605 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2012-01-30

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66231; File No. SR-EDGA-2011-40] Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Granting Approval of Proposed Rule Change Amending EDGA Rule 11.9 January 24, 2012. On December 2, 2011, EDGA Exchange, Inc. (``Exchange'' or ``EDGA'') filed...

  13. 75 FR 30095 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Amending Its...

    Science.gov (United States)

    2010-05-28

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62157; File No. SR-NYSEArca-2010-28] Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Amending Its Schedule of Fees May 24, 2010. On April 12, 2010, NYSE Arca, Inc. (``NYSE Arca'') filed with the Securities and Exchange...

  14. 30 CFR 906.15 - Approval of Colorado regulatory program amendments.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Colorado regulatory program amendments. 906.15 Section 906.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE COLORADO...

  15. IRT‑Sofia, HEU to LEU conversion: regulatory approval tasks solution overview

    International Nuclear Information System (INIS)

    Mitev, Mladen; Belousov, Sergey; Dimitrov, Dobromir

    2014-01-01

    The HEU to LEU conversion of the IRT–Sofia research reactor of the Institute for Nuclear Research and Nuclear Energy of the Bulgarian Academy of Sciences was jointly studied with the Argonne National Laboratory as a part of the RERTR Programme. The main purpose of the collaboration consisted in accomplishment of safety analyses and preparation of documents used for regulatory approval tasks solution. The main steps and results which are fundamental for the preparation of IRT–Sofia Safety Analyses Report including Operating Limits and Conditions are presented in this paper. The documents prepared by INRNE in accordance with the European nuclear safety requirements and IAEA recommendations were submitted for approval to the Bulgarian Nuclear Regulatory Agency at the end of 2010. Key words: research reactor, safety analyses report, Nuclear Regulatory Agency

  16. 76 FR 78706 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2011-12-19

    ... incorporated NYSE Rule 2A (Jurisdiction) as part of the process of developing a consolidated rulebook..., among other things, rulemaking, examinations, disciplinary actions, and listing applications. NYSE Rule... executives, employees and approved persons in connection with their conduct of the business of member...

  17. Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape.

    Science.gov (United States)

    Benda, Norbert; Brandt, Andreas

    2018-01-01

    Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.

  18. Requirements for US regulatory approval of the International Thermonuclear Experimental Reactor (ITER)

    International Nuclear Information System (INIS)

    Petti, D.A.; Haire, J.C.

    1993-12-01

    The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project

  19. A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

    Science.gov (United States)

    DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

    2015-11-01

    We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  20. Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan.

    Science.gov (United States)

    Nakayama, Hiroki; Tsukamoto, Katsura

    2018-04-17

    The approval of orphan anticancer drugs has increased, with the number exceeding that of non-orphan drugs in Japan in recent years. Although orphan anticancer drugs may have unique characteristics due to their rarity, these have not been fully characterized. We investigated anticancer drugs approved in Japan between April 2004 and November 2017 to reveal the characteristics of regulatory approval and pivotal studies on orphan anticancer drugs compared to non-orphan drugs. The median regulatory review time and number of patients in pivotal studies on orphan anticancer drugs (281.0 days [interquartile range, 263.3-336.0]; 222.5 patients [66.0-454.3]) were significantly lower than those on non-orphan drugs (353.0 days [277.0-535.5]; 521.0 patients [303.5-814.5], respectively) (P < 0.001). Phase II, non-randomized and non-controlled designs were more frequently used in pivotal studies on orphan anticancer drugs (45.9%, 41.9% and 43.2%) than non-orphan drugs (17.2%, 14.1% and 14.1%, respectively). Response rate was more commonly used as a primary endpoint in pivotal studies on orphan anticancer drugs (48.6%) than non-orphan drugs (17.2%). Indications limited by molecular features, second or later treatment line, and accelerated approval in the United States were associated with the use of response rate in orphan anticancer drug studies. In conclusion, we demonstrated that orphan anticancer drugs in Japan have unique characteristics compared to non-orphan drugs: shorter regulatory review and pivotal studies frequently using phase II, non-randomized, or non-controlled designs and response rate as a primary endpoint, with fewer patients.

  1. Approaches to safety, environment and regulatory approval for the International Thermonuclear Experimental Reactor

    International Nuclear Information System (INIS)

    Saji, G.; Bartels, H.W.; Chuyanov, V.; Holland, D.; Kashirski, A.V.; Morozov, S.I.; Piet, S.J.; Poucet, A.; Raeder, J.; Rebut, P.H.; Topilski, L.N.

    1995-01-01

    International Thermonuclear Experimental Reactor (ITER) Engineering Design Activities (EDA) in safety and environment are approaching the point where conceptual safety design, topic studies and research will give way to project oriented engineering design activities. The Joint Central Team (JCT) is promoting safety design and analysis necessary for siting and regulatory approval. Scoping studies are underway at the general level, in terms of laying out the safety and environmental design framework for ITER. ITER must follow the nuclear regulations of the host country as the future construction site of ITER. That is, regulatory approval is required before construction of ITER. Thus, during the EDA, some preparations are necessary for the future application for regulatory approval. Notwithstanding the future host country's jurisdictional framework of nuclear regulations, the primary responsibility for safety and reliability of ITER rests with the legally responsible body which will operate ITER. Since scientific utilization of ITER and protection of the large investment depends on safe and reliable operation of ITER, we are highly motivated to achieve maximum levels of operability, maintainability, and safety. ITER will be the first fusion facility in which overall 'nuclear safety' provisions need to be integrated into the facility. For example, it will be the first fusion facility with significant decay heat and structural radiational damage. Since ITER is an experimental facility, it is also important that necessary experiments can be performed within some safety design limits without requiring extensive regulatory procedures. ITER will be designed with such a robust safety envelope compatible with the fusion power and the energy inventories. The basic approach to safety will be realized by 'defense-in-depth'. (orig.)

  2. Regulatory approvals in a large multinational clinical trial: the ESPRIT experience.

    Science.gov (United States)

    McNay, Laura A; Tavel, Jorge A; Oseekey, Karen; McDermott, Cathy M; Mollerup, David; Bebchuk, Judith D

    2002-02-01

    While accepted as serving an important function to safeguard human subjects, the process of obtaining regulatory approvals to conduct clinical trials is generally regarded as cumbersome and time-consuming. For large multinational trials, U.S. federally sponsored human subject research abroad involves specific U.S. regulatory requirements, in addition to those of the host country, that act as further hurdles. These requirements may include obtaining an Assurance of Protection for Human Subjects from the Office of Human Research Protection of the U.S. Department of Health and Human Services, maintaining specific Ethics Committee/Institutional Review Board (EC/IRB) composition, and incorporating mandated elements in informed consents, all of which may differ from local policies and guidelines. Specific examples of issues that led to delays in regulatory approvals for sites participating in the multinational clinical trial entitled Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) are presented here. While the goal of these requirements is to protect the rights and welfare of human subjects, they may create substantial delays and engender resentment over the notion of lack of respect for individual country sovereignty. Substudies within ESPRIT have been undertaken to obtain feedback from EC/IRB chairpersons, site personnel responsible for processing the required assurances, ESPRIT investigators, and study participants regarding aspects of current U.S. regulatory requirements related to human subject protection and ethical issues in multinational research. The purpose of these substudies is to compare the attitudes and experiences across countries regarding important ethical issues associated with conducting ESPRIT. One objective of the substudies is to gather additional insight to the impact of U.S. regulatory processes. Another is to help to inform the debate about how to best maximize the rights and welfare of clinical trial

  3. 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...

  4. 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...

  5. 75 FR 2899 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-01-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61333; File No. SR-NYSE-2009-117] Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Amending Its... regulatory program. III. Discussion and Commission's Findings After careful review, the Commission finds that...

  6. 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)

  7. Changing innovation into a registered product: From concept to regulatory approval.

    Science.gov (United States)

    Rhodes, Linda

    2018-05-01

    Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples. The regulatory path is discussed, with a review of the various oversight agencies, and the categories of data required to be submitted, including safety, efficacy, manufacturing, environmental impact and human food safety. In conclusion, the cost, development time, and barriers to innovation in veterinary medical pharmaceuticals are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Gender-specific Regulatory Challenges to Product Approval: a panel discussion.

    Science.gov (United States)

    McGregor, Alyson J; Barr, Helen; Greenberg, Marna R; Safdar, Basmah; Wildgoose, Peter; Wright, David W; Hollander, Judd E

    2014-12-01

    On May 13, 2014, a 1-hour panel discussion session titled "Gender-specific Regulatory Challenges to Product Approval" was held during the Academic Emergency Medicine consensus conference, "Gender-specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes." The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and students engaged in research and clinical practice. A panel was convened involving a representative from the Office of Women's Health of the U.S. Food and Drug Administration, two pharmaceutical executives, and a clinical EM researcher. The moderated discussion also involved audience members who contributed significantly to the dialogue. Historical background leading up to the session along with the main themes of the discussion are reproduced in this article. These revolve around sex- and gender-specific research, statistical analysis of sex and gender, clinical practice, financial costs associated with pharmaceutical development, adaptive design, and specific recommendations on the regulatory process as it affects the specialty of EM. © 2014 by the Society for Academic Emergency Medicine.

  9. 78 FR 15394 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2013-03-11

    ...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Adopting... paragraph (d) it contains a provision establishing how the transition period from NYSE Rule 477 will work... to announce the effective date of the new rules at least 30 days in advance in an Information...

  10. 76 FR 45308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2011-07-28

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... change should provide NOM Participants assistance in effectively managing their quotations. \\6\\ 15 U.S.C...,\\2\\ a proposed rule change to adopt a new risk monitor mechanism. The proposed rule change was...

  11. 77 FR 48570 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2012-08-14

    ... Underlying Securities) of the NASDAQ Options Market rules.\\11\\ Additionally, the Target Component's and the...\\ Additionally, the Target Component's and the Benchmark Component's trading volume (in all markets in which the...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change Relating to the...

  12. 76 FR 67238 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS...

    Science.gov (United States)

    2011-10-31

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65619, File No. SR-BATS-2011-032] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS Exchange, Inc. To Adopt Rules Applicable to Auctions Conducted by the Exchange for Exchange-Listed Securities October 25, 2011. I. Introduction On August 22, 2011,...

  13. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

    Science.gov (United States)

    Meyskens, Frank L; Curt, Gregory A; Brenner, Dean E; Gordon, Gary; Herberman, Ronald B; Finn, Olivera; Kelloff, Gary J; Khleif, Samir N; Sigman, Caroline C; Szabo, Eva

    2011-03-01

    This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

  14. 78 FR 62814 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2013-10-22

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Assume... Authority and Supervision September 30, 2013. On July 31, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or...) Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

  15. 76 FR 21085 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2011-04-14

    ...-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To Amend The NASDAQ OMX Group, Inc. By- Laws April 8, 2011. I. Introduction On February 8, 2011, The NASDAQ Stock Market... vote cast either ``for'' or ``against'' that director's election. In its filing, NASDAQ noted that...

  16. 77 FR 35455 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2012-06-13

    ...-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed Rule Change Amending NYSE Rule 107B To Add a Class of Supplemental Liquidity Providers That Are Registered as Market... proposed rule change to amend NYSE Rule 107B to add a class of Supplemental Liquidity Providers (``SLP...

  17. 77 FR 65237 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2012-10-25

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...Tree Trust October 19, 2012. I. Introduction On August 15, 2012, The NASDAQ Stock Market LLC (``Nasdaq... temporary defensive strategies that are inconsistent with its investment strategies, the Fund's ability to...

  18. 77 FR 47472 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-08-08

    ... proposed rule change to make certain amendments that, in part, clarified the operation of the new Market... equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change, as Modified by...

  19. 77 FR 38879 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2012-06-29

    ... marketable non-displayed interest, the Market Maker would be required to re-enter a quotation for purposes of...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Adding New... Securities Exchange Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to add new...

  20. 77 FR 49034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2012-08-15

    ... entering new orders at inferior prices. This occurs because the current process directs the order to NASDAQ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Amend Rule... June 14, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange''), filed with the Securities and...

  1. 76 FR 55148 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt...

    Science.gov (United States)

    2011-09-06

    ...-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt Rules for the...-4 thereunder,\\2\\ a proposed rule change to adopt rules for the qualification, listing, and delisting... the Proposal The Exchange proposes rules to adopt a program for the qualification, listing, and...

  2. 78 FR 62834 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2013-10-22

    ... Fund of First Trust Exchange-Traded Fund VII October 9, 2013. I. Introduction On August 16, 2013, The... for the provision of custody, transfer agency, and accounting agent services with the same or with...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...

  3. 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...

  4. 75 FR 1438 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2010-01-11

    ...)(iv). Finally, because DMMs no longer act as agent for orders on the Display Book under the rules of... the Policy would not be in violation the Order Display rule \\8\\ and/or the Firm Quote rule \\9\\ under...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change Rescinding...

  5. 75 FR 1439 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding...

    Science.gov (United States)

    2010-01-11

    ...(a)(iv). Finally, because DMMs no longer act as agent for orders on the Display Book under the rules... fails to follow the Policy would not be in violation the Order Display rule \\8\\ and/or the Firm Quote...-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding NYSE Information...

  6. 75 FR 65541 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To...

    Science.gov (United States)

    2010-10-25

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63132; File No. SR-Phlx-2010-118] Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To Expand the $.50 Strike Price Program October 19, 2010. On August 25, 2010, NASDAQ OMX PHLX, Inc. (``Phlx'' or ``Exchange...

  7. 78 FR 75437 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2013-12-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71004; File No. SR-Phlx-2013-101] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Regarding the Short Term Options Program December 6, 2013. I. Introduction On October 3, 2013, NASDAQ OMX PHLX LLC...

  8. 77 FR 67851 - Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2012-11-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68177; File No. SR-BOX-2012-003] Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To Amend the Price Improvement Period November 7, 2012. I. Introduction On July 25, 2012, BOX Options Exchange LLC (``Exchange...

  9. 75 FR 12590 - Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule...

    Science.gov (United States)

    2010-03-16

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61680; File No. SR-CHX-2009-18] Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule Change To Amend Its Co-Location Fees March 10, 2010. I. Introduction On December 22, 2009, the Chicago Stock Exchange, Inc. (``CHX'' or...

  10. 76 FR 8793 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2011-02-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63875; File No. SR-Phlx-2010-183] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Expanding Its Short Term Option Program February 9, 2011. I. Introduction On December 15, 2010, NASDAQ OMX PHLX LLC...

  11. 75 FR 38585 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To...

    Science.gov (United States)

    2010-07-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62396; File No. SR-BX-2010-012] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange...

  12. 75 FR 69491 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange...

    Science.gov (United States)

    2010-11-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63266; File No. SR-NYSE-2010-67] Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange LLC Changing the NYBX Order Execution Sequence November 5, 2010. I. Introduction On September 9, 2010, the New York...

  13. 75 FR 9988 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2010-03-04

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61590; File No. SR-Phlx-2009-113] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule Change Relating to Index Option Position Limits February 25, 2010. On December 29, 2009, NASDAQ OMX PHLX, Inc. (``Phlx'' or...

  14. 75 FR 38584 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To...

    Science.gov (United States)

    2010-07-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62395; File No. SR-Phlx-2010-18] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX PHLX (``Phlx'' or...

  15. 75 FR 80553 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to...

    Science.gov (United States)

    2010-12-22

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63558; File No. SR-NYSEAmex-2010-100] Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to Complex Orders December 16, 2010. I. Introduction On October 20, 2010, NYSE Amex LLC (``NYSE Amex'' or the ``Exchange...

  16. 76 FR 2182 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2011-01-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63654; File No. SR-Phlx-2010-158] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Establishing a $5 Strike Price Program January 6, 2011. I. Introduction On November 12, 2010, NASDAQ OMX PHLX LLC...

  17. The expanding regulatory universe of p53 in gastrointestinal cancer [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Andrew Fesler

    2016-04-01

    Full Text Available Tumor suppresser gene TP53 is one of the most frequently deleted or mutated genes in gastrointestinal cancers. As a transcription factor, p53 regulates a number of important protein coding genes to control cell cycle, cell death, DNA damage/repair, stemness, differentiation and other key cellular functions. In addition, p53 is also able to activate the expression of a number of small non-coding microRNAs (miRNAs through direct binding to the promoter region of these miRNAs.  Many miRNAs have been identified to be potential tumor suppressors by regulating key effecter target mRNAs. Our understanding of the regulatory network of p53 has recently expanded to include long non-coding RNAs (lncRNAs. Like miRNA, lncRNAs have been found to play important roles in cancer biology.  With our increased understanding of the important functions of these non-coding RNAs and their relationship with p53, we are gaining exciting new insights into the biology and function of cells in response to various growth environment changes. In this review we summarize the current understanding of the ever expanding involvement of non-coding RNAs in the p53 regulatory network and its implications for our understanding of gastrointestinal cancer.

  18. Gaining acceptance for the use of in vitro toxicity assays and QIVIVE in regulatory risk assessment.

    Science.gov (United States)

    Meek, M E Bette; Lipscomb, John C

    2015-06-05

    Testing strategies are anticipated to increasingly rely on in vitro data as a basis to characterize early steps or key events in toxicity at relevant dose levels in human tissues. Such strategies require quantitative in vitro to in vivo extrapolation to characterize dose-response as a basis for comparison with exposure to estimate risk. Current experience in the incorporation of mechanistic and in vitro data in risk assessment is considered here in the context of identified principles to increase the potential for timely acceptance of more progressive and tailored testing strategies by the regulatory community. These principles are outlined as transitioning in a familiar context, tiering to acquire experience and increase confidence, contextual knowledge transfer to facilitate interpretation and communication, coordination and development of expertise and continuing challenge. A proposed pragmatic tiered data driven framework which includes increasing reliance on in vitro data and quantitative in vitro to in vivo extrapolation is considered in the context of these principles. Based on this analysis, possible additional steps that might facilitate timely evolution and potentially, uptake are identified. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines.

    Science.gov (United States)

    Gold, Laura S; Klein, Gregory; Carr, Lauren; Kessler, Larry; Sullivan, Sean D

    2012-01-25

    In this article, we trace the chronology of developments in breast imaging technologies that are used for diagnosis and staging of breast cancer, including mammography, ultrasonography, magnetic resonance imaging, computed tomography, and positron emission tomography. We explore factors that affected clinical acceptance and utilization of these technologies from discovery to clinical use, including milestones in peer-reviewed publication, US Food and Drug Administration approval, reimbursement by payers, and adoption into clinical guidelines. The factors driving utilization of new imaging technologies are mainly driven by regulatory approval and reimbursement by payers rather than evidence that they provide benefits to patients. Comparative effectiveness research can serve as a useful tool to investigate whether these imaging modalities provide information that improves patient outcomes in real-world settings.

  20. Regulatory Approval Decisions in the Presence of Market Externalities: The Case of Genetically Modified Wheat

    OpenAIRE

    Furtan, William Hartley; Gray, Richard S.; Holzman, J.J.

    2005-01-01

    This study examines the optimal approval strategy for genetically modified (GM) wheat varieties in Canada and the United States. Without an affordable segregation system, the introduction of GM wheat will create a market for "lemons" that will result in the loss of important export markets. Using a differentiated product trade model for spring wheat, with endogenous technology pricing, a payoff matrix is generated for the possible approval outcomes. Results show that the existence of the mark...

  1. Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

    Science.gov (United States)

    Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

    Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory

  2. 75 FR 22673 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of a...

    Science.gov (United States)

    2010-04-29

    ... remove any potential cloud on the jurisdictional status of options or security futures on ETFS Palladium... that are affected by this approval order are essentially the same as the options and security futures... securities transactions and derivative transactions.\\6\\ By amending its By-Laws to help clarify that options...

  3. 77 FR 3531 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-01-24

    ... Organizations; The Depository Trust Company; Order Approving Proposed Rule Change To Enhance Risk Management.... Description The rule change will enhance the risk management controls associated with DTC's Receiver... Participant's net debit cap is placed on a pending (recycling) queue until another transaction creates...

  4. 76 FR 5417 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

    Science.gov (United States)

    2011-01-31

    ... consisting of amendments to Rule A-3, on membership on the Board, in order to establish a Nominating... Independent Public Finance Advisors to discuss the proposed rule change among other matters. See Memorandum... to the creation of the Nominating Committee of the MSRB. On September 30, 2010, the SEC approved MSRB...

  5. 78 FR 24257 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2013-04-24

    ... positions are in-the- money or out-of-the-money. Volume, like open interest, is a measure of a Clearing... demands on OCC's services and facilities that are not captured by the current methodology. IV. Conclusion... Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change To Implement a Revised...

  6. 75 FR 82119 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

    Science.gov (United States)

    2010-12-29

    ..., the Board's basic fair practice rule, to apply the rules to municipal advisors. The proposed rule... Independent Public Finance Advisors, dated December 9, 2010. This order approves the proposed rule change. II... of which may have a substantial impact on the finances of those municipal entities. In other cases...

  7. 76 FR 51075 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval to...

    Science.gov (United States)

    2011-08-17

    ... Organizations; International Securities Exchange, LLC; Order Granting Approval to a Proposed Rule Change Relating to Appointments to Competitive Market Makers August 11, 2011. I. Introduction On June 10, 2011, the International Securities Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the Securities...

  8. 76 FR 37867 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

    Science.gov (United States)

    2011-06-28

    ..., as Modified by Amendment No. 1, to Reduce the Minimum Size of the Nominating and Governance Committee... proposed rule change to reduce the minimum size of the Nominating and Governance Committee (``NGC'') from... the original proposed rule change, it had not yet obtained formal approval from its Board of Directors...

  9. 76 FR 38231 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Approving Proposed Rule...

    Science.gov (United States)

    2011-06-29

    ... No. 1, To Reduce the Minimum Size of the Nominating and Governance Committee June 22, 2011. I... size of the Nominating and Governance Committee (``NGC'') from seven to five. On May 18, 2011, the..., it had not yet obtained formal approval from its Board of Directors for the specific Bylaw changes...

  10. 76 FR 19173 - Self-Regulatory Organizations; the Options Clearing Corporation; Order Granting Approval of...

    Science.gov (United States)

    2011-04-06

    ... to list and trade options on the CBOE Gold ETF Volatility Index.\\6\\ The March 2011 Supplement amends... on the CBOE Gold ETF Volatility Index and similarly structured equity-based volatility indexes that...) (order approving CBOE's proposed rules to list and trade CBOE Gold ETF Volatility Index options). \\7\\ For...

  11. 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...

  12. 78 FR 20156 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

    Science.gov (United States)

    2013-04-03

    ... execution of an engagement letter; (2) the execution of a bond purchase agreement; or (3) the receipt of... response to circumstances suggesting corruption and unfair dealing in gaining employment and participating...

  13. 78 FR 63263 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2013-10-23

    ... internet service providers.\\5\\ \\5\\ Securities Exchange Act Release No. 53980 (June 14, 2006), 71 FR 36155... other things, promote the prompt and accurate clearance and settlement of securities transactions. \\8... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70704; File No. SR-OCC-2013-10] Self-Regulatory...

  14. 77 FR 74043 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Science.gov (United States)

    2012-12-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68368; File No. SR-ODD-2012-02] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Adjustments for... (``November 2012 Supplement'') to amend the options disclosure document (``ODD'') to reflect certain changes...

  15. 76 FR 3684 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Science.gov (United States)

    2011-01-20

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63711; File No. SR-ODD-2011-01] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Credit Default Options in, and Making Certain Technical Amendments to, the June 2007 Supplement to the Options Disclosure...

  16. 77 FR 3828 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Science.gov (United States)

    2012-01-25

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66193; File No. SR-ODD-2012-01] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Relative... disclosure document (``ODD'') to reflect certain changes to disclosure regarding relative performance options...

  17. 77 FR 61033 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

    Science.gov (United States)

    2012-10-05

    ...) NSCC's automated ACATS-Fund/SERV interface, for eligible mutual fund assets; (iii) NSCC's ACATS-IPS... customer account asset data. \\4\\ ACATS complements Financial Industry Regulatory Authority (``FINRA'') Rule... positions and available securities are allocated by book entry. This allocation of securities is...

  18. 75 FR 51866 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-08-23

    ... Transfer Service of National Securities Clearing Corporation August 16, 2010. I. Introduction On June 4... complements a Financial Industry Regulatory Authority (``FINRA'') rule requiring FINRA members to use... specified time frames. \\5\\ CNS is an ongoing accounting system which nets today's Settling Trades with...

  19. 77 FR 32704 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

    Science.gov (United States)

    2012-06-01

    ... securities owned or under management by the institutional customer. The MSRB stated that FINRA Rule 2111....19b-4. \\3\\ The implementation date for Financial Industry Regulatory Authority (``FINRA'') Rule 2111... General Counsel, Securities Industry and Financial Markets Association, dated May 4, 2012 (``SIFMA Letter...

  20. 30 CFR 948.15 - Approval of West Virginia regulatory program amendments.

    Science.gov (United States)

    2010-07-01

    ..., 2008 CSR 38-2-2.39 (deletion of cumulative impact definition).CSR 38-2-3.22.e (approval of material... Legislative Rules at title 38, Series 2. June 29, 1990 October 4, 1991 CSR 38-2 §§ 2, 3, 5, 6, 9, 11 through 14, 17, 20, 22. July 12, 1991 November 19, 1991 CSR 38-2-20.5, .6, .7. July 30, 1993 August 16, 1995...

  1. 76 FR 12144 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Order Granting Approval of a...

    Science.gov (United States)

    2011-03-04

    ..., which should provide a clearer picture of its risk exposure and generally facilitate better risk... organizations' respective ``stand-alone'' margin requirements--in other words, an amount reflecting the ratio of... clearing organization had a net loss (``worse- off party''), and the other had a net gain (``better-off...

  2. Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

    Science.gov (United States)

    Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

    2015-01-01

    The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs. Copyright © 2014 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  3. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.

    Science.gov (United States)

    Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V

    2017-01-01

    The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

  4. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics

    Directory of Open Access Journals (Sweden)

    J. Javier Hernandez

    2017-11-01

    Full Text Available The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

  5. FERC approves process for Lake Erie link: Project meets significant regulatory milestone

    International Nuclear Information System (INIS)

    Anon

    2002-01-01

    The Federal Electric Regulatory Commission (FERC) of the United States has issued an order to TransEnergie US Ltd., and Hydro One Inc., authorizing the sale of transmission rights for the proposed Lake Erie link. This project will consists of bi-directional high voltage direct current facilities connecting the transmission grids of Ontario, Canada and the United States. The sale is authorized to proceed via a non-discriminatory 'open season' process. The project will consist of buried underwater cables under Lake Erie connecting the transmission systems near Simcoe, Ontario with those in the US at either, or both, of Springfield, Pennsylvania, and Ashtabula, Ohio. The project will provide an increase in transmission capability of up to 975 MW between the electric control areas of the Ontario Independent Electricity Market Operator, the East Central Area Reliability Coordination Agreement in Ohio and the Pennsylvania-New Jersey-Maryland Interconnection. The Lake Erie Link will be financially supported by those consumers who see value in the associated transmission rights, rather than through the regulated rates paid by transmission customers in general. The article provides an overview of the background of the Lake Erie Link, the cable system, the converter station, and the potential economic benefits

  6. 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.

  7. Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.

    Science.gov (United States)

    Woolacott, Nerys; Corbett, Mark; Jones-Diette, Julie; Hodgson, Robert

    2017-10-01

    Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from nonrandomized studies, from small single-arm trials, or from single-center trials; and using surrogate end points. We examined these methodological challenges through a pragmatic review of the available literature. Methods to adjust nonrandomized studies for confounding are imperfect. The relative treatment effect generated from single-arm trials is uncertain and may be optimistic. Single-center trial results may not be generalizable. Surrogate end points, on average, overestimate treatment effects. Current methods for analyzing such data are limited, and effectiveness claims based on these suboptimal forms of evidence are likely to be subject to significant uncertainty. Assessments of cost-effectiveness, based on the modeling of such data, are likely to be subject to considerable uncertainty. This uncertainty must not be underestimated by decision makers: methods for its quantification are required and schemes to protect payers from the cost of uncertainty should be implemented. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  8. 76 FR 13442 - Joint Industry Plan; Order Approving Amendment No. 25 to the Joint Self-Regulatory Organization...

    Science.gov (United States)

    2011-03-11

    ..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and...

  9. 78 FR 66788 - Joint Industry Plan; Order Approving Amendment No. 30 to the Joint Self-Regulatory Organization...

    Science.gov (United States)

    2013-11-06

    ..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and...

  10. 75 FR 64771 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for BATS Y-Exchange, Inc.

    Science.gov (United States)

    2010-10-20

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63113; File No. 4-616] Self-Regulatory... provisions of Rule 19d-1(c)(1) of the Act \\4\\ requiring that a self-regulatory organization promptly file... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs...

  11. Decree 328/003. Is approve the organizational structure reformulation project of the regulatory unit of Unit 006 Energy and water services of subsection 02 Presidency of the Republic

    International Nuclear Information System (INIS)

    2003-01-01

    This decree approve the organizational structure project of The regulatory energy and water services ( URSEA). This unit is responsible for monitoring the activities related to electricity, gas, drinking water, sanitation and oil, fuel and other hydrocarbon derivatives

  12. 75 FR 53727 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving Proposed Rule Change, as...

    Science.gov (United States)

    2010-09-01

    ... underwritings; (ii) supervision of market making commitments; (iii) final approval of advertisements as these... designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable...

  13. 75 FR 26827 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGA Exchange, Inc.

    Science.gov (United States)

    2010-05-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62037; File No. 4-595] Self-Regulatory... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... would not be subject to the provisions of Rule 19d-1(c)(1) under the Act\\4\\ requiring that a self...

  14. 75 FR 26822 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGX Exchange, Inc.

    Science.gov (United States)

    2010-05-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62036; File No. 4-594] Self-Regulatory... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... would not be subject to the provisions of Rule 19d-1(c)(1) under the Act \\4\\ requiring that a self...

  15. Development approach on usage of radiation and inspection of QA according to the change of approval procedure of safety regulatory guides

    International Nuclear Information System (INIS)

    Oh, B. J.; Ahn, H. Z.; Kim, S. W.; Yoo, S. O.; Kang, S. C.; Yang, S. H.; Han, S. J.; Kim, H. S.; Kim, H. J.

    2002-01-01

    In accordance with 2001 amendment of the Atomic Energy Act(AEA), KINS also amended its internal 'Regulation on Implementation of Entrusted AEA-related Work'. Up to now the nuclear safety-specialized institute has used its internally developed guidelines in the safety regulation. From now on, however, the institute will enhance the objectivity and transparency by having the instruments approved by the Ministry of Science ad Technology. In this paper, we introduced the major points and directions to be considered to the development of the safety regulatory guides on Inspection for the quality assurance of the nuclear reactor facilities and the use of radioisotopes, and review and inspection for dosimeter reading

  16. 77 FR 57630 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change Amending...

    Science.gov (United States)

    2012-09-18

    ... change was published for comment in the Federal Register on July 30, 2012.\\3\\ The Commission received no comment letters regarding the proposed rule change. This order approves the proposed rule change. \\1\\ 15 U...

  17. 77 FR 25003 - Self-Regulatory Organizations; NASDAQ OMX Phlx LLC; Order Approving Proposed Rule Change To Amend...

    Science.gov (United States)

    2012-04-26

    ...; review and endorsement of customer orders; final approval of advertising or sales literature for use by... and qualified, given the importance and complexity of the rules governing financial responsibility for...

  18. 77 FR 42349 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Defining a...

    Science.gov (United States)

    2012-07-18

    ... ATP Holders via Regulatory Bulletin regarding the rule change. The Exchange plans to issue notice....\\7\\ \\7\\ See Notice, supra note 3, at 32158. III. Discussion The Commission finds that the proposed...

  19. 77 FR 27255 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2012-05-09

    ... Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To Reduce the Current Level of Risk Mutualization Among Clearing Participants and To Modify the Initial Margin Risk Model So That It Is Easier for... modifications to its risk model for clearing credit default swaps (``CDS'') contracts. For the first...

  20. 75 FR 19436 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-04-14

    ..., the Commission is not publishing it for comment.\\4\\ This order approves the proposed rule change, as... NASDAQ OMX Corporate Governance Guidelines, however, provide a different standard for uncontested... contained in the Corporate Governance Guidelines; contested elections would remain subject to the plurality...

  1. 75 FR 500 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2010-01-05

    .... 61043 (November 20, 2009), 74 FR 62612. On January 22, 2009, the Commission approved the formation of... wholly-owned subsidiary, NYSE Market, Inc., owns less than 9% of the aggregate limited partnership... proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f). \\12\\ 15 U.S...

  2. Deliberation by the French Energy Regulatory Commission of 13 July 2017 relating to the report on the implementation of GRTgaz's investment programme for 2016 and approving its amended investment programme for 2017. Deliberation by the French Energy Regulatory Commission of 13 July 2017 concerning the report on the implementation of TIGF's investment programme for 2016 and approving its amended investment programme for 2017

    International Nuclear Information System (INIS)

    Carenco, Jean-Francois; Chauvet, Christine; Edwige, Catherine; Gassin, Helene; Lastelle, Jean-Laurent

    2017-01-01

    Pursuant to the provisions of 2 of Article L.134-3 and of II of Article L.431-6 of the French Energy code, gas transmission system operators (TSOs) must transmit their annual investment programmes to the French Energy Regulatory Commission (CRE) for approval. Within this framework, CRE 'ensures that the investments required for the proper development of the networks, and for transparent and non-discriminatory access to them are made'. With regard to the investment programme for the year 2016: - in the deliberation of 17 December 2015, CRE approved GRTgaz's and TIGF's investment programmes for 2016; - in the deliberation of 15 December 2016, CRE approved the update of GRTgaz's and TIGF's 2016 investment programmes, and requested the operators to present, for mid-2017, the definitive report on the implementation of their 2016 investment programme. With regard to the investment programme for the year 2017: - in the deliberation of 15 December 2016, CRE approved GRTgaz's and TIGF's 2017 investment programmes, and requested the operators to present, for mid-2017, a report on the implementation mid-year of the investment programme for the year 2017. On 31 May 2017, GRTgaz's and TIGF's forwarded their amended investment programme for 2017 and were interviewed by CRE's Board on 6 July 2017. GRTgaz's and TIGF's presented the differences observed between the investment levels approved and the actual investments made for 2016 on the one hand, and the updated forecasts for 2017 on the other hand

  3. 75 FR 36136 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change To Amend...

    Science.gov (United States)

    2010-06-24

    ... is the practice of NYSE Euronext's Global Risk and Audit Services Department (``RAS''), which...) and Section 401(a) of the Exchange's Bylaws To Eliminate the Exchange's Audit Committee, Compensation... eliminate the Exchange's Audit Committee, Compensation Committee, and Regulatory Oversight Committee. The...

  4. 76 FR 79729 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2011-12-22

    ... plc as signatories. II. Self-Regulatory Organization's Statement of the Terms of Substance of the... is the recognition that CDS contracts cleared by ICC referencing broad-based securities indices are... would, among other things, decompose CDS contracts referencing broad-based [[Page 79730

  5. Developmental gene regulatory networks in sea urchins and what we can learn from them [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Megan L. Martik

    2016-02-01

    Full Text Available Sea urchin embryos begin zygotic transcription shortly after the egg is fertilized.  Throughout the cleavage stages a series of transcription factors are activated and, along with signaling through a number of pathways, at least 15 different cell types are specified by the beginning of gastrulation.  Experimentally, perturbation of contributing transcription factors, signals and receptors and their molecular consequences enabled the assembly of an extensive gene regulatory network model.  That effort, pioneered and led by Eric Davidson and his laboratory, with many additional insights provided by other laboratories, provided the sea urchin community with a valuable resource.  Here we describe the approaches used to enable the assembly of an advanced gene regulatory network model describing molecular diversification during early development.  We then provide examples to show how a relatively advanced authenticated network can be used as a tool for discovery of how diverse developmental mechanisms are controlled and work.

  6. 78 FR 23601 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2013-04-19

    ... greatly restricts gains from the manipulation of any one underlying stock.\\44\\ The commenter provides... volatile U.S. stocks that also have market capitalization of at least $5 billion. In seeking to replicate... securities (i.e., those which convert into the underlying stock), the down-and-in put options written by the...

  7. First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan - Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.

    Science.gov (United States)

    Konishi, Akihide; Ho, Mami; Shirai, Yuko; Shirato, Haruki

    2018-05-25

    A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.

  8. Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants.

    Science.gov (United States)

    Ma, Julian K-C; Drossard, Jürgen; Lewis, David; Altmann, Friedrich; Boyle, Julia; Christou, Paul; Cole, Tom; Dale, Philip; van Dolleweerd, Craig J; Isitt, Valerie; Katinger, Dietmar; Lobedan, Martin; Mertens, Hubert; Paul, Mathew J; Rademacher, Thomas; Sack, Markus; Hundleby, Penelope A C; Stiegler, Gabriela; Stoger, Eva; Twyman, Richard M; Vcelar, Brigitta; Fischer, Rainer

    2015-10-01

    Although plant biotechnology has been widely investigated for the production of clinical-grade monoclonal antibodies, no antibody products derived from transgenic plants have yet been approved by pharmaceutical regulators for clinical testing. In the Pharma-Planta project, the HIV-neutralizing human monoclonal antibody 2G12 was expressed in transgenic tobacco (Nicotiana tabacum). The scientific, technical and regulatory demands of good manufacturing practice (GMP) were addressed by comprehensive molecular characterization of the transgene locus, confirmation of genetic and phenotypic stability over several generations of transgenic plants, and by establishing standard operating procedures for the creation of a master seed bank, plant cultivation, harvest, initial processing, downstream processing and purification. The project developed specifications for the plant-derived antibody (P2G12) as an active pharmaceutical ingredient (API) based on (i) the guidelines for the manufacture of monoclonal antibodies in cell culture systems; (ii) the draft European Medicines Agency Points to Consider document on quality requirements for APIs produced in transgenic plants; and (iii) de novo guidelines developed with European national regulators. From the resulting process, a GMP manufacturing authorization was issued by the competent authority in Germany for transgenic plant-derived monoclonal antibodies for use in a phase I clinical evaluation. Following preclinical evaluation and ethical approval, a clinical trial application was accepted by the UK national pharmaceutical regulator. A first-in-human, double-blind, placebo-controlled, randomized, dose-escalation phase I safety study of a single vaginal administration of P2G12 was carried out in healthy female subjects. The successful completion of the clinical trial marks a significant milestone in the commercial development of plant-derived pharmaceutical proteins. © 2015 Society for Experimental Biology, Association of

  9. A drug's life: the pathway to drug approval.

    Science.gov (United States)

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  10. Regulatory and institutional issues impending cleanup at US Department of Energy sites: Perspectives gained from an office of environmental restoration workshop

    Energy Technology Data Exchange (ETDEWEB)

    Fallon, W E; Gephart, J M; Gephart, R E; Quinn, R D; Stevenson, L A

    1991-05-01

    The US Department of Energy's (DOE) nuclear weapons and energy operations are conducted across a nation-wide industrial complex engaged in a variety of manufacturing, processing, testing, and research and development activities. The overall mission of DOE Office of Environmental Restoration and Waste Management (EM) is to protect workers, the public, and the environment from waste materials generated by past, current, and future DOE activities and to bring the DOE complex into compliance with all applicable laws, regulations, and agreements related to health, safety, and the environment. EM addresses this broad mandate through related and interdependent programs that include corrective actions, waste operations, environmental restoration, and technology development. The EM Office of Environmental Restoration (EM-40) recognizes the importance of implementing a complex-wide process to identify and resolve those issues that may impede progress towards site cleanup. As a first step in this process, FM-40 sponsored an exercise to identify and characterize major regulatory and institutional issues and to formulate integrated action steps towards their resolution. This report is the first product of that exercise. It is intended that the exercise described here will mark the beginning of an ongoing process of issue identification, tracking, and resolution that will benefit cleanup activities across the DOE complex.

  11. Gain, loss and divergence in primate zinc-finger genes: a rich resource for evolution of gene regulatory differences between species.

    Directory of Open Access Journals (Sweden)

    Katja Nowick

    Full Text Available The molecular changes underlying major phenotypic differences between humans and other primates are not well understood, but alterations in gene regulation are likely to play a major role. Here we performed a thorough evolutionary analysis of the largest family of primate transcription factors, the Krüppel-type zinc finger (KZNF gene family. We identified and curated gene and pseudogene models for KZNFs in three primate species, chimpanzee, orangutan and rhesus macaque, to allow for a comparison with the curated set of human KZNFs. We show that the recent evolutionary history of primate KZNFs has been complex, including many lineage-specific duplications and deletions. We found 213 species-specific KZNFs, among them 7 human-specific and 23 chimpanzee-specific genes. Two human-specific genes were validated experimentally. Ten genes have been lost in humans and 13 in chimpanzees, either through deletion or pseudogenization. We also identified 30 KZNF orthologs with human-specific and 42 with chimpanzee-specific sequence changes that are predicted to affect DNA binding properties of the proteins. Eleven of these genes show signatures of accelerated evolution, suggesting positive selection between humans and chimpanzees. During primate evolution the most extensive re-shaping of the KZNF repertoire, including most gene additions, pseudogenizations, and structural changes occurred within the subfamily homininae. Using zinc finger (ZNF binding predictions, we suggest potential impact these changes have had on human gene regulatory networks. The large species differences in this family of TFs stands in stark contrast to the overall high conservation of primate genomes and potentially represents a potent driver of primate evolution.

  12. 7 CFR 1735.90 - Preliminary approvals.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Requirements for... franchises, licenses, and permits; (4) All required regulatory body approvals; (5) All required corporate...

  13. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.

  14. Regulatory considerations for computational requirements for nuclear criticality safety

    International Nuclear Information System (INIS)

    Bidinger, G.H.

    1995-01-01

    As part of its safety mission, the U.S. Nuclear Regulatory Commission (NRC) approves the use of computational methods as part of the demonstration of nuclear criticality safety. While each NRC office has different criteria for accepting computational methods for nuclear criticality safety results, the Office of Nuclear Materials Safety and Safeguards (NMSS) approves the use of specific computational methods and methodologies for nuclear criticality safety analyses by specific companies (licensees or consultants). By contrast, the Office of Nuclear Reactor Regulation approves codes for general use. Historically, computational methods progressed from empirical methods to one-dimensional diffusion and discrete ordinates transport calculations and then to three-dimensional Monte Carlo transport calculations. With the advent of faster computational ability, three-dimensional diffusion and discrete ordinates transport calculations are gaining favor. With the proper user controls, NMSS has accepted any and all of these methods for demonstrations of nuclear criticality safety

  15. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  16. 76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-19

    ... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...

  17. Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of 111In-BzDTPA-pertuzumab

    International Nuclear Information System (INIS)

    Lam, Karen; Chan, Conrad; Done, Susan J.; Levine, Mark N.; Reilly, Raymond M.

    2015-01-01

    Introduction: 111 In-BzDTPA-pertuzumab is a novel imaging probe for detecting changes in HER2 expression in breast cancer (BC) caused by treatment with trastuzumab (Herceptin). Our aim was to evaluate the pharmacokinetics, normal tissue biodistribution, radiation dosimetry and acute toxicity of 111 In-BzDTPA-pertuzumab in non-tumor bearing mice in order to obtain regulatory approval to advance this agent to a first-in-humans Phase I/II clinical trial. Methods: Biodistribution and pharmacokinetic studies were performed in non-tumor bearing Balb/c mice injected i.v. with 111 In-BzDTPA-pertuzumab (2.5 MBq; 2 μg). The cumulative number of disintegrations per source organ derived from the biodistribution data was used to predict the radiation absorbed doses in humans using OLINDA/EXM software. Acute toxicity was studied at two weeks post-injection of 111 In-BzDTPA-pertuzumab (1.0 MBq, 20 μg) with comparison to control mice injected with unlabeled BzDTPA-pertuzumab (20 μg) or Sodium Chloride Injection USP. The dose of 111 In-BzDTPA-pertuzumab corresponded to 23-times the human radioactivity dose and 10-times the protein dose on a MBq/kg and mg/kg basis, respectively. Toxicity was assessed by monitoring body mass, complete blood cell count (CBC), hematocrit (Hct), hemoglobin (Hb), serum creatinine (SCr) and alanine aminotransferease (ALT) and by histopathological examination of tissues at necropsy. Results: 111 In-BzDTPA-pertuzumab exhibited a biphasic elimination from the blood with a distribution half-life (t 1/2 α) of 3.8 h and an elimination half-life (t 1/2 β) of 228.2 h. The radiopharmaceutical was distributed mainly in the blood, heart, lungs, liver, kidneys and spleen. The projected whole-body radiation absorbed dose in humans was 0.05 mSv/MBq corresponding to a total of 16.8 mSv for three separate administrations of 111 In-BzDTPA-pertuzumab (111 MBq) planned for the Phase I/II trial. There were slight changes in Hb and SCr levels associated with

  18. Avelumab: First Global Approval.

    Science.gov (United States)

    Kim, Esther S

    2017-05-01

    Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

  19. Should I Gain Weight?

    Science.gov (United States)

    ... Videos for Educators Search English Español Should I Gain Weight? KidsHealth / For Teens / Should I Gain Weight? ... something about it. Why Do People Want to Gain Weight? Some of the reasons people give for ...

  20. Regulatory requirements for designing PET-CT facility in India

    International Nuclear Information System (INIS)

    Tandon, Pankaj

    2010-01-01

    In India, cyclotron-produced radionuclides are gaining importance in molecular imaging in Nuclear Medicine (NM) departments. The importance of this modality among others is due to the fact that it provides valuable clinical information, which was lacking in other available modalities. Presently, every well-established hospital would like to procure Medical Cyclotron or positron emission tomography-computed tomography (PET-CT) facility in their NM department. Because cyclotron-produced radionuclides have higher energy than the other routinely used radionuclides for diagnosis, it becomes essential for the user to know about the regulatory requirement and radiation safety precautions that one has to take for the installation of this new modality in their premises. The various stages of approval of PET-CT facility by the Atomic Energy Regulatory Board (AERB) and important steps that one has to know/follow before planning for this new facility are summarized

  1. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  2. Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs

    Science.gov (United States)

    McGettigan, Patricia; Roderick, Peter; Mahajan, Rushikesh; Kadam, Abhay; Pollock, Allyson M.

    2015-01-01

    Background In 2012, an Indian parliamentary committee reported that manufacturing licenses for large numbers of fixed dose combination (FDC) drugs had been issued by state authorities without prior approval of the Central Drugs Standard Control Organization (CDSCO) in violation of rules, and considered that some ambiguity until 1 May 2002 about states’ powers might have contributed. To our knowledge, no systematic enquiry has been undertaken to determine if evidence existed to support these findings. We investigated CDSCO approvals for and availability of oral FDC drugs in four therapeutic areas: analgesia (non-steroidal anti-inflammatory drugs [NSAIDs]), diabetes (metformin), depression/anxiety (anti-depressants/benzodiazepines), and psychosis (anti-psychotics). Methods and Findings This was an ecologic study with a time-trend analysis of FDC sales volumes (2007–2012) and a cross-sectional examination of 2011–2012 data to establish the numbers of formulations on the market with and without a record of CDSCO approval (“approved” and “unapproved”), their branded products, and sales volumes. Data from the CDSCO on approved FDC formulations were compared with sales data from PharmaTrac, a database of national drug sales. We determined the proportions of FDC sales volumes (2011–2012) arising from centrally approved and unapproved formulations and from formulations including drugs banned/restricted internationally. We also determined the proportions of centrally approved and unapproved formulations marketed before and after 1 May 2002, when amendments were made to the drug rules. FDC approvals in India, the United Kingdom (UK), and United States of America (US) were compared. For NSAID FDCs, 124 formulations were marketed, of which 34 (27%) were centrally approved and 90 (73%) were unapproved; metformin: 25 formulations, 20 (80%) approved, five (20%) unapproved; anti-depressants/benzodiazepines: 16 formulations, three (19%) approved, 13 (81%) unapproved

  3. Weight Gain during Pregnancy

    Science.gov (United States)

    ... Global Map Premature Birth Report Cards Careers Archives Pregnancy Before or between pregnancies Nutrition, weight & fitness Prenatal ... fitness > Weight gain during pregnancy Weight gain during pregnancy E-mail to a friend Please fill in ...

  4. Preventing Weight Gain

    Science.gov (United States)

    ... Local Programs Related Topics Diabetes Nutrition Preventing Weight Gain Language: English (US) Español (Spanish) Recommend on Facebook ... cancer. Choosing an Eating Plan to Prevent Weight Gain So, how do you choose a healthful eating ...

  5. The regulatory framework in the UK

    International Nuclear Information System (INIS)

    O'Sullivan, R.

    1984-01-01

    The subject is covered in sections, headed: basic regulatory requirements covering the transport of radioactive material in the UK; responsibility for safety (competent authority; provision of regulations; implementation of regulations (international and national); design of transport flask; safety case; testing; assessment; approval certificate; compliance assurance; administration); advice and information on the regulatory safety standards. (U.K.)

  6. Data Management in a Regulatory Context

    Directory of Open Access Journals (Sweden)

    Niels Grønning

    2017-07-01

    Full Text Available With the implementation of Article 57(2 in 2012 the European Medicines Agency (EMA embarked on a digitalization journey that foreseeably would ensure greater product oversight and interoperability across the community. This initiative has subsequently led to additional focus from the agency with respect to the utilization and harmonization of data as part of the regulatory process. Driven by both internal and external factors, the EMA have through the European Union telematics strategy laid the foundation for the regulatory-driven services that may be expected from the community the coming years. Supported by standardization initiatives (e.g., ISO Identification of Medicinal Products, the EMA is gradually building an information management-driven approach to data utilization and exploitation within drug evaluation and approval. Primarily driven by the increasing demand for signal detection, the EMA is additionally hoping to leverage the establishment of defined information models and supporting controlled terms to safeguard future activities within the community. Collectively, the overall community may seek to gain from the overall digitalization roadmap proposed by the EMA and interesting opportunities may be sought as part of the transition. Already now pharmaceutical companies are gradually adapting to this new paradigm and actively seeking to explore how they may leverage the future EMA operating model to serve internal business requirements. If successful, the collective efforts from industry and regulators may lead to an unprecedented product oversight and offer regulators the opportunity to proactively drive corrective actions and, therefore, improve patient safety.

  7. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

    In 2001, the IAEA published TECDOC 1254, which examined the way in which the recognized functions of a regulatory body for nuclear facilities results in competence needs. Using the systematic approach to training (SAT), TECDOC 1254 provided a framework for regulatory bodies for managing training and developing and their maintaining their competence. It has been successfully used by many regulators. The IAEA has also introduced a methodology and an assessment tool - Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) - which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2009, the IAEA established a steering committee (supported by a bureau) with the mission to advise the IAEA on how it could best assist Member States to develop suitable competence management systems for their regulatory bodies. The committee recommended the development of a safety report on managing staff competence as an integral part of a regulatory body's management system. This Safety Report was developed in response to this request. It supersedes TECDOC 1254, broadens its application to regulatory bodies for all facilities and activities, and builds upon the experience gained through the application of TECDOC 1254 and SARCoN and the feedback received from Member States. This Safety Report applies to the management of adequate competence as needs change, and as such is equally applicable to the needs of States 'embarking' on a nuclear power programme. It also deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an 'embarking' State's regulatory system

  8. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  9. The Political Economy of Regulatory Risk

    OpenAIRE

    Strausz, Roland

    2009-01-01

    I investigate the argument that, in a two–party system with different regulatory objectives, political uncertainty generates regulatory risk. I show that this risk has a fluctuation effect that hurts both parties and an output–expansion effect that benefits one party. Consequently, at least one party dislikes regulatory risk. Moreover, both political parties gain from eliminating regulatory risk when political divergence is small or the winning probability of the regulatory–risk–averse party ...

  10. Gains of integrating sector-wise pollution regulation

    DEFF Research Database (Denmark)

    Jacobsen, Lars Bo; Nielsen, Max; Nielsen, Rasmus

    2016-01-01

    This paper extends the Orani-G Computable General Equilibrium model with an externality market. The externality market is modelled with a limited number of pollution permits that are traded between representative firms in different sectors. The model is applied to identify the gains of a common...... of introducing more coherent regulatory frameworks that include all polluters under the same regulatory system....

  11. Gestational weight gain.

    Science.gov (United States)

    Kominiarek, Michelle A; Peaceman, Alan M

    2017-12-01

    Prenatal care providers are advised to evaluate maternal weight at each regularly scheduled prenatal visit, monitor progress toward meeting weight gain goals, and provide individualized counseling if significant deviations from a woman's goals occur. Today, nearly 50% of women exceed their weight gain goals with overweight and obese women having the highest prevalence of excessive weight gain. Risks of inadequate weight gain include low birthweight and failure to initiate breast-feeding whereas the risks of excessive weight gain include cesarean deliveries and postpartum weight retention for the mother and large-for-gestational-age infants, macrosomia, and childhood overweight or obesity for the offspring. Prenatal care providers have many resources and tools to incorporate weight and other health behavior counseling into routine prenatal practices. Because many women are motivated to improve health behaviors, pregnancy is often considered the optimal time to intervene for issues related to eating habits and physical activity to prevent excessive weight gain. Gestational weight gain is a potentially modifiable risk factor for a number of adverse maternal and neonatal outcomes and meta-analyses of randomized controlled trials report that diet or exercise interventions during pregnancy can help reduce excessive weight gain. However, health behavior interventions for gestational weight gain have not significantly improved other maternal and neonatal outcomes and have limited effectiveness in overweight and obese women. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Global Regulatory Differences for Gene- and Cell-Based Therapies

    DEFF Research Database (Denmark)

    Coppens, Delphi G M; De Bruin, Marie L; Leufkens, Hubert G M

    2017-01-01

    Gene- and cell-based therapies (GCTs) offer potential new treatment options for unmet medical needs. However, the use of conventional regulatory requirements for medicinal products to approve GCTs may impede patient access and therapeutic innovation. Furthermore, requirements differ between...... jurisdictions, complicating the global regulatory landscape. We provide a comparative overview of regulatory requirements for GCT approval in five jurisdictions and hypothesize on the consequences of the observed global differences on patient access and therapeutic innovation....

  13. Basic regulatory requirements for carrying out investigations, reasoning and the approving of the disposal of radioactive and other industrial waste in geological formations in the U.S.S.R

    International Nuclear Information System (INIS)

    Pimenov, M.K.

    1980-01-01

    Legislation and other regulatory standards in force or in preparation in the USSR relating to the disposal and storage of radioactive and other industrial wastes in underground formations are discussed in the report. A tentative outline of the basic operations involved in the disposal of radioactive and other industrial wastes into geological formations is given. Supervision, control and penalties provided by law are also discussed. Conclusions are made that the comparison of national legislative instruments and regulatory documents and procedures relating to underground disposal of radioactive and industrial wastes into geological formations is timely and urgent. (author)

  14. 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

  15. 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.

  16. What's the Regulatory Value of a Target Product Profile?

    Science.gov (United States)

    Breder, Christopher D; Du, Wenny; Tyndall, Adria

    2017-07-01

    Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog. Published by Elsevier Ltd.

  17. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

    The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

  18. 9 CFR 317.4 - Labeling approval.

    Science.gov (United States)

    2010-01-01

    ... undue economic hardship; and (iv) An unfair competitive advantage would not result from the granting of... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and...

  19. GAIN Technology Workshops Summary Report

    Energy Technology Data Exchange (ETDEWEB)

    Braase, Lori Ann [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-08-01

    National and global demand for nuclear energy is increasing and United States (U.S.) global leadership is eroding. There is a sense of urgency with respect to the deployment of the innovative nuclear energy technologies. The Gateway for Accelerated Innovation in Nuclear (GAIN) initiative is based on the simultaneous achievement of three strategic goals. The first is maintaining global technology leadership within the U.S. Department of Energy (DOE). The second is enabling global industrial leadership for nuclear vendors and suppliers. The third is focused on utility optimization of nuclear energy within the clean energy portfolio. An effective public-private partnership is required to achieve these goals. DOEs recognizes the recent sense of urgency new developers and investors have in getting their concepts to market. They know that time to market for nuclear technology takes too long and the facilities needed to conduct the necessary research, development and demonstration (RD&D) activities are very expensive to develop and maintain. Early technologies, in the lower technology readiness levels (TRL) need materials testing, analysis, modeling, code development, etc., most of which currently exists in the DOE national laboratory system. However, mature technologies typically need large component testing and demonstration facilities, which are expensive and long-lead efforts. By understanding the needs of advanced nuclear technology developers, GAIN will connect DOE national laboratory capabilities (e.g., facilities, expertise, materials, and data) with industry RD&D needs. In addition, GAIN is working with the Nuclear Regulatory Commission (NRC) to streamline processes and increase understanding of the licensing requirements for advanced reactors.

  20. GAIN Technology Workshops Summary Report

    International Nuclear Information System (INIS)

    Braase, Lori Ann

    2016-01-01

    National and global demand for nuclear energy is increasing and United States (U.S.) global leadership is eroding. There is a sense of urgency with respect to the deployment of the innovative nuclear energy technologies. The Gateway for Accelerated Innovation in Nuclear (GAIN) initiative is based on the simultaneous achievement of three strategic goals. The first is maintaining global technology leadership within the U.S. Department of Energy (DOE). The second is enabling global industrial leadership for nuclear vendors and suppliers. The third is focused on utility optimization of nuclear energy within the clean energy portfolio. An effective public-private partnership is required to achieve these goals. DOEs recognizes the recent sense of urgency new developers and investors have in getting their concepts to market. They know that time to market for nuclear technology takes too long and the facilities needed to conduct the necessary research, development and demonstration (RD&D) activities are very expensive to develop and maintain. Early technologies, in the lower technology readiness levels (TRL) need materials testing, analysis, modeling, code development, etc., most of which currently exists in the DOE national laboratory system. However, mature technologies typically need large component testing and demonstration facilities, which are expensive and long-lead efforts. By understanding the needs of advanced nuclear technology developers, GAIN will connect DOE national laboratory capabilities (e.g., facilities, expertise, materials, and data) with industry RD&D needs. In addition, GAIN is working with the Nuclear Regulatory Commission (NRC) to streamline processes and increase understanding of the licensing requirements for advanced reactors.

  1. Antidepressants and Weight Gain

    Science.gov (United States)

    ... 2015;37:46. Blumenthal SR, et al. An electronic health records study of long-term weight gain following antidepressant ... your agreement to the Terms and Conditions and Privacy Policy linked below. Terms and Conditions Privacy Policy ...

  2. Weight gain - unintentional

    Science.gov (United States)

    ... diabetes Hormone changes or medical problems can also cause unintentional weight gain. This may be due to: Cushing syndrome Underactive thyroid, or low thyroid (hypothyroidism) Polycystic ovary syndrome Menopause Pregnancy Bloating, or swelling ...

  3. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    1999-06-01

    The IAEA directed extensive efforts during the years 1991 to 1995 to the integral revision of all NUSS quality assurance publications, which were approved and issued as Safety Series No.50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations (1996). When these quality assurance publications were developed, their prime focus was on requirements against which work performed by the licensees could be measured and assessed by the regulatory bodies. In this way, they only helped to facilitate the functions of regulators. No requirements or recommendations were provided on how the regulators should ensure the effective implementation of their own activities. The present publication is a first attempt to collect, integrate and offer available experience to directly support performance of regulatory activities. It presents a comprehensive compilation on the application of quality assurance principles and methods by regulatory bodies to their activities. The aim is consistent good performance of regulatory activities through a systematic approach

  4. Specific problems and practical experience of regulatory inspection during commissioning in the United Kingdom

    International Nuclear Information System (INIS)

    Lewis, G.

    1977-01-01

    The commissioning of nine Magnox and two Advanced Gas-cooled Reactor Nuclear Power Plants in the United Kingdom during the last sixteen years under the regulatory control of the Nuclear Installations Inspectorate of the Health and Safety Executive has been based on a Stage Approval Philosophy starting with proof-testing of the primary gas circuit and concluding with tests on the reactor at full power. The practical experience gained during this period has enabled the Nuclear Installations Inspectorate to rationalise the procedures and test requirements without comporomising safety standards. The Operating Rules and Maintenance Schedules are approved for commissioning and during this period are reviewed for their adequacy for future power operation of the plant. The organisation, documentation, test procedures and the commissioning programme used for the Advanced Gas-cooled Reactors are briefly explained. (author)

  5. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

    In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

  6. Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved packages

    International Nuclear Information System (INIS)

    1987-11-01

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1). This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volume 1

  7. 13 CFR 108.380 - Final approval as a NMVC Company.

    Science.gov (United States)

    2010-01-01

    ... VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.380 Final approval as a... amount of Regulatory Capital set forth in its application, pursuant to § 108.310(a)(1); and (B) The... at least 30 percent of its Regulatory Capital if the Conditionally Approved NMVC Company— (i) Already...

  8. 77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

    Science.gov (United States)

    2012-02-28

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

  9. Receiver gain function: the actual NMR receiver gain

    OpenAIRE

    Mo, Huaping; Harwood, John S.; Raftery, Daniel

    2010-01-01

    The observed NMR signal size depends on the receiver gain parameter. We propose a receiver gain function to characterize how much the raw FID is amplified by the receiver as a function of the receiver gain setting. Although the receiver is linear for a fixed gain setting, the actual gain of the receiver may differ from what the gain setting suggests. Nevertheless, for a given receiver, we demonstrate that the receiver gain function can be calibrated. Such a calibration enables accurate compar...

  10. Glycoconjugate Vaccines: The Regulatory Framework.

    Science.gov (United States)

    Jones, Christopher

    2015-01-01

    Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

  11. 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.

  12. Receiver Gain Modulation Circuit

    Science.gov (United States)

    Jones, Hollis; Racette, Paul; Walker, David; Gu, Dazhen

    2011-01-01

    A receiver gain modulation circuit (RGMC) was developed that modulates the power gain of the output of a radiometer receiver with a test signal. As the radiometer receiver switches between calibration noise references, the test signal is mixed with the calibrated noise and thus produces an ensemble set of measurements from which ensemble statistical analysis can be used to extract statistical information about the test signal. The RGMC is an enabling technology of the ensemble detector. As a key component for achieving ensemble detection and analysis, the RGMC has broad aeronautical and space applications. The RGMC can be used to test and develop new calibration algorithms, for example, to detect gain anomalies, and/or correct for slow drifts that affect climate-quality measurements over an accelerated time scale. A generalized approach to analyzing radiometer system designs yields a mathematical treatment of noise reference measurements in calibration algorithms. By treating the measurements from the different noise references as ensemble samples of the receiver state, i.e. receiver gain, a quantitative description of the non-stationary properties of the underlying receiver fluctuations can be derived. Excellent agreement has been obtained between model calculations and radiometric measurements. The mathematical formulation is equivalent to modulating the gain of a stable receiver with an externally generated signal and is the basis for ensemble detection and analysis (EDA). The concept of generating ensemble data sets using an ensemble detector is similar to the ensemble data sets generated as part of ensemble empirical mode decomposition (EEMD) with exception of a key distinguishing factor. EEMD adds noise to the signal under study whereas EDA mixes the signal with calibrated noise. It is mixing with calibrated noise that permits the measurement of temporal-functional variability of uncertainty in the underlying process. The RGMC permits the evaluation of EDA by

  13. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

    Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

  14. Photomultiplier gain stabilisation

    International Nuclear Information System (INIS)

    Le Baud, P.; Sautiez, B.

    1958-07-01

    By the control and adjustment of magnetic deflection applied to the electron beam of a photomultiplier it has proved possible to flatten the gain curve, forming plateaux at levels dependent upon the voltage at intake. It should be possible to add this simple device to most photomultipliers on the market today. (author) [fr

  15. Safety analysis - current and future regulatory challenges

    Energy Technology Data Exchange (ETDEWEB)

    Jamieson, T., E-mail: Terry.Jamieson@cnsc-ccsn.gc.ca [Canadian Nuclear Safety Commission, Ottawa, ON (Canada)

    2015-07-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  16. Safety analysis - current and future regulatory challenges

    International Nuclear Information System (INIS)

    Jamieson, T.

    2015-01-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  17. 7 CFR 1425.4 - Approval.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS COOPERATIVE MARKETING ASSOCIATIONS § 1425.4 Approval. (a) For a cooperative to gain CMA status to participate in a marketing assistance loan or Loan deficiency... prepared in accordance with generally accepted accounting principles; (3) A copy of the articles of...

  18. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  19. 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

  20. Learn and gain

    CERN Document Server

    Al-Alami, Suhair Eyad Jamal

    2013-01-01

    Initiating the slogan ""love it, live it"", Learn and Gain includes eight short stories, chosen to illustrate various modes of narration, as well as to provoke reflection and discussion on a range of issues. All texts utilized here illustrate how great writers can, with their insight and gift for words, help us to see the world we live in, in new probing and exciting ways. What characterises the book, the author believes, is the integration of the skills of literary competence, communicative c...

  1. A flexible regulatory framework

    International Nuclear Information System (INIS)

    Silvennoinen, T.

    2000-01-01

    Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

  2. 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

  3. Strengthening of the nuclear safety regulatory body. Field evaluation review

    International Nuclear Information System (INIS)

    1996-10-01

    As a result of a request from the Preparation Committee of the Nuclear Regulatory Authority (NRA) in 1992, and as recommended by the CEC/RAMG (Commission of European Communities/Regulatory Assistance Management Group) and the Agency mission in July 1993 to the Slovak Republic, the project SLR/9/005 was approved in 1993 as a model project for the period 1994-1996. Current budge is $401,340 and disbursements to date amount to $312,873. The project time schedule has been extended to 1997. The major conclusions of this evaluation are as follows: The project responded to an urgent national need, as well as to a statutory mandate of the Agency, and was adequately co-ordinated with other international assistance programmes to NRA. The project was designed as a structured programme of assistance by means of expert missions, scientific visits and a limited amount of equipment, acting upon several key areas of NRA regulatory responsibilities. Agency assistance was provided in a timely manner. A high concentration of expert missions was noticed at the initial stages of the project, which posed some managements problems. This was corrected to some extent in the course of implementation. Additionally, some overlapping of expert mission recommendations suggests that improvements are needed in the design of such missions. The exposure to international regulatory practice and expertise has resulted in substantial developments of NRA, both in organizational and operational terms. The project can claim to have contributed to NRA having gained governmental and international confidence. NRA's role in the safety assessment of Bohunice V1 reconstruction, as well as in Bohunice V2 safety review, Bohunice A1 decommissioning and in informing the public, also points at the success achieved by the project. The institutional and financial support of the Government contributed decisively to the project achievements. (author). Figs, tabs

  4. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, le...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  5. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...... by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh....

  6. Gains from quota trade

    DEFF Research Database (Denmark)

    Andersen, Jesper Levring; Bogetoft, Peter

    2007-01-01

    We provide a framework for evaluating potential effects of introducing tradable quotas to a sector. The effects depend on the economies of scale and scope of the production technology, and on firms' ability and willingness to learn best practice methods (catching up) and to change their input...... and output composition (mix). To illustrate our approach, data from the Danish fishery are used to calculate the potential gains from introducing individually transferable fishing quotas. Data envelopment analysis is used to model the production technology. We find that pure reallocation is as important...

  7. Gaining Relational Competitive Advantages

    DEFF Research Database (Denmark)

    Hu, Yimei; Zhang, Si; Li, Jizhen

    2015-01-01

    Establishing strategic technological partnerships (STPs) with foreign partners is an increasingly studied topic within the innovation management literature. Partnering firms can jointly create sources of relational competitive advantage. Chinese firms often lack research and development (R......&D) capabilities but are increasingly becoming preferred technological partners for transnational corporations. We investigate an STP between a Scandinavian and a Chinese firm and try to explore how to gain relational competitive advantage by focusing on its two essential stages: relational rent generation...... and appropriation. Based on an explorative case study, we develop a conceptual framework that consists of process, organizational alliance factors, and coordination modes that we propose lead to relational competitive advantage....

  8. Regulatory Aspects of Sabin Type 2 Withdrawal From Trivalent Oral Poliovirus Vaccine: Process and Lessons Learned.

    Science.gov (United States)

    Decina, Daniela; Fournier-Caruana, Jacqueline; Takane, Marina; Ostad Ali Dehaghi, Razieh; Sutter, Roland

    2017-07-01

    Withdrawal of type 2 oral poliovirus vaccine (OPV) in OPV-using countries required regulatory approval for use of inactivated poliovirus vaccine and bivalent OPV in routine immunization. Worldwide, a variety of mechanisms were used by member states, with some differences in approach observed between inactivated poliovirus vaccine and bivalent OPV. These included acceptance for use of World Health Organization (WHO) prequalified vaccines, registration and licensure pathways, participation in WHO-convened joint reviews of licensing dossiers, as well as pragmatic application of alternatively available mechanisms, when appropriate. Simple but effective tools were used to monitor progress and to record, authenticate, and share information. Essential to achievement of regulatory targets was ongoing communication with key stakeholders, including switch-country national regulatory authorities, vaccine manufacturers, partner organizations, and relevant units within WHO. Understanding of the regulatory environment gained through the OPV switch can be helpful in supporting further stages of the polio end game and other time-sensitive vaccine introduction programs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  9. 76 FR 28102 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-05-13

    ... Analysis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555... qualitative, traditional or probabilistic), data, and criteria for considering risk are appropriate for making... 10 CFR part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants.'' Other types of...

  10. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2015-01-01

    This section treats of the following National legislative and regulatory activities: 1 - Australia: General legislation - Bill to amend the Australian Radiation Protection and Nuclear Safety Act 1998; 2 - France: General legislation - Law No. 2015-992 of 17 August 2015 on the energy transition for green growth; ASN Report on the state of nuclear safety and radiation protection in France in 2014; 3 - Germany: Radioactive waste management - First Ordinance to amend the 2005 Gorleben Development Freeze Ordinance (2015); 4 - Greece: Radioactive waste management - Joint Ministerial Decision establishing the national policy on the management of spent fuel and radioactive waste; 5 - Lithuania: Nuclear safety and radiological protection - Revised requirements for modifications, Plan for enhancement of nuclear safety, New requirements for the commissioning of nuclear power plants, Revised requirements regulating the provision of information on abnormal events; Radioactive waste management - Revised requirements for acceptance criteria for near surface repository; Nuclear security - Revised requirements for physical protection; 6 - Romania: Licensing and regulatory infrastructure - Government Decision No. 600/2014 for approval of National Nuclear Safety and Security; International co-operation - Government Decision No. 525/2014 for approval of the Co-operation Agreement on the radioactive waste management between the French National Radioactive Waste Management Agency (ANDRA) and Nuclear Agency and Radioactive Waste (ANDR) Strategy; Memorandum of Understanding for Co-operation and Exchange of Information in Nuclear Regulatory Matters between the National Commission for Nuclear Activities Control (CNCAN) of Romania and the President of National Atomic Energy Agency (PAA) of Poland; Government Decision No. 540/2015 for approval of the Agreement between the Government of Romania and the Government of the People's Republic of China regarding co-operation in the peaceful

  11. Regulatory requirements related to maintenance and compliance monitoring

    International Nuclear Information System (INIS)

    Ling, A.K.H.

    1997-01-01

    The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

  12. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

    The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

  13. Acting to gain information

    Science.gov (United States)

    Rosenchein, Stanley J.; Burns, J. Brian; Chapman, David; Kaelbling, Leslie P.; Kahn, Philip; Nishihara, H. Keith; Turk, Matthew

    1993-01-01

    This report is concerned with agents that act to gain information. In previous work, we developed agent models combining qualitative modeling with real-time control. That work, however, focused primarily on actions that affect physical states of the environment. The current study extends that work by explicitly considering problems of active information-gathering and by exploring specialized aspects of information-gathering in computational perception, learning, and language. In our theoretical investigations, we analyzed agents into their perceptual and action components and identified these with elements of a state-machine model of control. The mathematical properties of each was developed in isolation and interactions were then studied. We considered the complexity dimension and the uncertainty dimension and related these to intelligent-agent design issues. We also explored active information gathering in visual processing. Working within the active vision paradigm, we developed a concept of 'minimal meaningful measurements' suitable for demand-driven vision. We then developed and tested an architecture for ongoing recognition and interpretation of visual information. In the area of information gathering through learning, we explored techniques for coping with combinatorial complexity. We also explored information gathering through explicit linguistic action by considering the nature of conversational rules, coordination, and situated communication behavior.

  14. Regulatory aspects of emergency planning

    International Nuclear Information System (INIS)

    Jamgochian, M.T.

    1986-01-01

    The paper discusses the advances that have been made in the USA in the field of emergency planning over the past several years and considers regulatory changes that may be on the horizon. The paper examines the importance of severe accident source terms and their relationship to emergency preparedness, recent research results of work on source terms, and the experience gained from evaluation of licensee performance during annual emergency preparedness exercises. (author)

  15. Leading Gainful Employment Metric Reporting

    Science.gov (United States)

    Powers, Kristina; MacPherson, Derek

    2016-01-01

    This chapter will address the importance of intercampus involvement in reporting of gainful employment student-level data that will be used in the calculation of gainful employment metrics by the U.S. Department of Education. The authors will discuss why building relationships within the institution is critical for effective gainful employment…

  16. 78 FR 57319 - Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines...

    Science.gov (United States)

    2013-09-18

    ...-AB20 Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; kidSAFE... proposed self-regulatory guidelines submitted by the kidSAFE Seal Program (``kidSAFE''), owned and operated... enabling industry groups or others to submit to the Commission for approval self-regulatory guidelines that...

  17. 17 CFR 1.52 - Self-regulatory organization adoption and surveillance of minimum financial requirements.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements. (a) Each self-regulatory organization must adopt, and submit for Commission approval, rules...

  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. Croatian energy regulatory council - independent Croatian regulatory body

    International Nuclear Information System (INIS)

    Klepo, M.

    2002-01-01

    By means of approving five energy laws, the Republic of Croatia established an appropriate legislative framework for energy sector regulation. A series of sub-law acts is presently being elaborated as well as some additional documents in order to bring about transparent and non-discriminatory provisions for the establishment of electric energy, gas, oil/oil derivatives and thermal energy markets, i.e. for the introduction and management of market activities and public services. A considerable share of these activities relates to the definition of transparent regulatory mechanisms that would guarantee the implementation of regulation rules based on the law, and be carried out by the independent regulatory body - Croatian Energy Regulatory Council. The Council's rights and obligations include firm executive functions, which present obligations to every energy entity. A dissatisfied party may set in motion a settlement of dispute, if it maintains that the decisions are not based on the law or reveal a flaw in the procedure. Therefore, it is the Council's priority to always make careful and law-abiding decisions. This paper gives insight into the regulatory framework elements based on the laws including the Council's organisational structure and non-profit entities that will prepare act proposals for the Council and perform other professional activities. (author)

  20. Regulatory Physiology

    Science.gov (United States)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  1. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of bench-marking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  2. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of benchmarking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  3. Regulatory frameworks for mobile medical applications.

    Science.gov (United States)

    Censi, Federica; Mattei, Eugenio; Triventi, Michele; Calcagnini, Giovanni

    2015-05-01

    A mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.

  4. 75 FR 15470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-03-29

    ...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is proposing... (Disclosure of Price and Concessions in Selling Agreements) and the deletion of NASD Rule 2770 (Disclosure of Price in Selling Agreements). FINRA Rule 5160 was approved by the Commission on January 25, 2010 \\5\\ and...

  5. 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 ...

  6. 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 ...

  7. Regulatory control of radiation sources in Slovakia

    International Nuclear Information System (INIS)

    Auxtova, L.

    2001-01-01

    In Slovakia, there are two regulatory authorities. Regulatory control of the utilization of nuclear energy, based on the Slovak National Council's law No. 130/1998 on the peaceful uses of nuclear energy, is exercised by the Nuclear Regulatory Authority of the Slovak Republic. The second regulatory authority - the Ministry of Health - is empowered by law No. 72/1994 on the protection of human health to license radiation sources and is responsible for radiation protection supervision (there are nearly 3000 establishments with sealed sources, radiation generators and unsealed sources in Slovakia). Pursuant to a new radiation protection regulation based on international standards, radiation sources are to be categorized in six classes according to the associated exposure and contamination hazards. A national strategy for improving the safety of radiation sources over their life-cycle and for the management of disused and orphan sources is being prepared for governmental approval. (author)

  8. Pharmacovigilance of biologicals : dynamics in post-approval safety learning

    NARCIS (Netherlands)

    Vermeer, N.S.

    2015-01-01

    Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict

  9. 18 CFR 300.10 - Application for confirmation and approval.

    Science.gov (United States)

    2010-04-01

    ... REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS FOR FEDERAL POWER MARKETING ADMINISTRATIONS CONFIRMATION AND APPROVAL OF THE RATES OF FEDERAL POWER MARKETING ADMINISTRATIONS Filing Requirements § 300.10... with applicable laws and that it is the lowest possible rate consistent with sound business principles...

  10. 48 CFR 2052.215-77 - Travel approvals and reimbursement.

    Science.gov (United States)

    2010-10-01

    ... reimbursement. 2052.215-77 Section 2052.215-77 Federal Acquisition Regulations System NUCLEAR REGULATORY....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

  11. 76 FR 41154 - Review and Approval of Projects

    Science.gov (United States)

    2011-07-13

    ..., production fluids, tophole water, and unconventional natural gas development. In order to encourage the reuse... techniques. The ``gallon one'' regulatory threshold currently applicable under the regulations to gas well... rulemaking; provide for administrative approval of interbasin transfers of flowback and production fluids...

  12. 78 FR 16601 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-03-18

    ... Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule... (MAGNASTOR[supreg]) System listing within the ``List of Approved Spent Fuel Storage Casks'' to include... for the MAGNASTOR[supreg] System cask design within the list of approved spent fuel storage casks that...

  13. 78 FR 32077 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-05-29

    ... Fuel Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear Regulatory Commission. ACTION: Direct... All-purpose Storage (MAGNASTOR[supreg]) System listing within the ``List of Approved Spent Fuel... CoC No. 1031, MAGNASTOR[supreg] System listing within the ``List of Approved Spent Fuel Storage Casks...

  14. 77 FR 56241 - Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000

    Science.gov (United States)

    2012-09-12

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0131] Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000 By letter dated December 10, 2010, Westinghouse Electric... final design approval (FDA) for the Advanced Passive 1000 (AP1000) design upon the completion of...

  15. 75 FR 51437 - Notice of Request for Extension of a Currently Approved Information Collection (Advanced Meat...

    Science.gov (United States)

    2010-08-20

    ... Request for Extension of a Currently Approved Information Collection (Advanced Meat Recovery) AGENCY: Food... information collection regarding the regulatory requirements associated with the production of meat from Advanced Meat Recovery systems because the OMB approval will expire on January 31, 2011. DATES: Comments on...

  16. 78 FR 45112 - Approval and Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available...

    Science.gov (United States)

    2013-07-26

    ... description of the VOC rule that is proposed for approval in this action is provided below. 10 CSR 10-5.455... to approve a revision to Missouri's VOC rule 10 CSR 10-5.455 into Missouri's SIP, as EPA believes... regulatory action'' subject to review by the Office of Management and Budget under Executive Order 12866 (58...

  17. 78 FR 11639 - Houston Pipe Line Company LP; Notice of Petition for Rate Approval

    Science.gov (United States)

    2013-02-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR13-31-000] Houston Pipe Line Company LP; Notice of Petition for Rate Approval Take notice that on February 1, 2013, Houston Pipe Line Company LP (HPL) filed for approval of rates for transportation service pursuant to section...

  18. 77 FR 63311 - Acacia Natural Gas Corporation; Notice of Petition for Rate Approval

    Science.gov (United States)

    2012-10-16

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR13-1-000] Acacia Natural Gas Corporation; Notice of Petition for Rate Approval Take notice that on October 9, 2012, Acacia Natural Gas Corporation (Acacia) filed a Petition for Rate Approval pursuant to 284.123(b)(2) of the...

  19. Operational gain : measuring the capture of genetic gain ...

    African Journals Online (AJOL)

    The concept of operational gain is more than the weighted average of the genetic quality of planted hectares, and encompasses tree breeding efficiencies, propagation efficiencies, matching of species and genotype to site, plant use efficiency and early measures of stand density and growth. To test the operational gain ...

  20. 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

  1. 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

  2. Poet North Manchester 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

  3. 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

  4. 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

  5. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. Drugs Approved for Leukemia

    Science.gov (United States)

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  7. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  8. 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...

  9. 30 CFR 902.10 - State regulatory program approval.

    Science.gov (United States)

    2010-07-01

    ... Mining and Water Management, 3601 C Street, Suite 800, Anchorage, AK 99503-5925, Telephone: (907) 762... Section 902.10 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE ALASKA § 902.10 State...

  10. RESEARCH Analysis of time to regulatory and ethical approval of ...

    African Journals Online (AJOL)

    against TB.5-7 As a result of this work, the SATVI clinical research site in Worcester, Western ... TB vaccine in 2004 were included in this analysis. ..... Bollyky TJ, Cockburn IM, Berndt E. Bridging the gap: improving clinical development and the.

  11. Regulatory practices of radiation safety of SNF transportation in Russia

    International Nuclear Information System (INIS)

    Kuryndina, Lidia; Kuryndin, Anton; Stroganov, Anatoly

    2008-01-01

    This paper overviews current regulatory practices for the assurance of nuclear and radiation safety during railway transportation of SNF on the territory of Russian Federation from NPPs to longterm-storage of reprocessing sites. The legal and regulatory requirements (mostly compliant with IAEA ST-1), licensing procedure for NM transportation are discussed. The current procedure does not require a regulatory approval for each particular shipment if the SNF fully comply with the Rosatom's branch standard and is transported in approved casks. It has been demonstrated that SNF packages compliant with the branch standard, which is knowingly provide sufficient safety margin, will conform to the federal level regulations. The regulatory approval is required if a particular shipment does not comply with the branch standard. In this case, the shipment can be approved only after regulatory review of Applicant's documents to demonstrate that the shipment still conformant to the higher level (federal) regulations. The regulatory review frequently needs a full calculation test of the radiation safety assurance. This test can take a lot of time. That's why the special calculation tools were created in SEC NRS. These tools aimed for precision calculation of the radiation safety parameters by SNF transportation use preliminary calculated Green's functions. Such approach allows quickly simulate any source distribution and optimize spent fuel assemblies placement in cask due to the transport equation property of linearity relatively the source. The short description of calculation tools are presented. Also, the paper discusses foreseen implications related to transportation of mixed-oxide SNF. (author)

  12. High Gain Advanced GPS Receiver

    National Research Council Canada - National Science Library

    Brown, Alison; Zhang, Gengsheng

    2006-01-01

    NAVSYS High Gain Advanced GPS Receiver (HAGR) uses a digital beam-steering antenna array to enable up to eight GPS satellites to be tracked, each with up to 10 dBi of additional antenna gain over a conventional receiver solution...

  13. LBB evaluation for a typical Japanese PWR primary loop by using the US NRC approved methods

    Energy Technology Data Exchange (ETDEWEB)

    Swamy, S.A.; Bhowmick, D.C.; Prager, D.E. [Westinghouse Nuclear Technology Division, Pittsburgh, PA (United States)

    1997-04-01

    The regulatory requirements for postulated pipe ruptures have changed significantly since the first nuclear plants were designed. The Leak-Before-Break (LBB) methodology is now accepted as a technically justifiable approach for eliminating postulation of double-ended guillotine breaks (DEGB) in high energy piping systems. The previous pipe rupture design requirements for nuclear power plant applications are responsible for all the numerous and massive pipe whip restraints and jet shields installed for each plant. This results in significant plant congestion, increased labor costs and radiation dosage for normal maintenance and inspection. Also the restraints increase the probability of interference between the piping and supporting structures during plant heatup, thereby potentially impacting overall plant reliability. The LBB approach to eliminate postulating ruptures in high energy piping systems is a significant improvement to former regulatory methodologies, and therefore, the LBB approach to design is gaining worldwide acceptance. However, the methods and criteria for LBB evaluation depend upon the policy of individual country and significant effort continues towards accomplishing uniformity on a global basis. In this paper the historical development of the U.S. LBB criteria will be traced and the results of an LBB evaluation for a typical Japanese PWR primary loop applying U.S. NRC approved methods will be presented. In addition, another approach using the Japanese LBB criteria will be shown and compared with the U.S. criteria. The comparison will be highlighted in this paper with detailed discussion.

  14. Experiences gained in implementing a broad-based risk-informed application

    International Nuclear Information System (INIS)

    Schinzel, G.E.

    2004-01-01

    The South Texas Project was granted a first-of-kind exemption from special treatment requirements contained in 10-CFR Parts 21, 50, and 100 in August 2001. Since that time, South Texas has pursued a cautious, deliberate approach to implement these risk-informed exemption allowances. Over the past two years, South Texas has gained a unique insight into the challenges and benefits that exist in pursuing a broad-based risk-informed application. The American nuclear industry is currently pursuing similar capabilities through proposed rule 10-CFR 50.69 which is scheduled for NRC final review and approval in the July, 2004 time-frame. This proposed rule closely resembles the approach taken by South Texas in the exemption process and the allowances granted. For nuclear utilities that wish to pursue a similar broad-based risk-informed application, a well-conceived strategic approach is needed to prioritize the implementation activities as well as engage stake-holders in the implementation process. Cultural and communication challenges exist which must be addressed and effectively overcome. The goal of this paper is to communicate these challenges to the attendees, inform attendees of the safety and economic benefits to be recognized through this risk-informed approach, and to provide insight into continuing application opportunities that were not readily apparent when the broad-based exemption was originally conceived. This paper and presentation will be beneficial for both domestic and international attendees, as well as for personnel with utility or regulatory backgrounds. (author)

  15. Regulatory challenges

    International Nuclear Information System (INIS)

    Austvik, Ole Gunnar

    2003-01-01

    The problem for policy makers wanting to liberalize natural gas markets is that its concentrated structure may also be the socially most efficient one. Because of scale economies, more firms operating in the market may incur higher transportation costs unless the market grows sufficiently in each geographic segment. This argument goes for product extension through vertical (or horizontal) integration and the exploitation of economies of scope as well. Thus, the challenge for governments is to intervene in a way that preserves a market structure that has the potential to minimize cost, and at the same lime change its behavior in order to avoid possible lax cost control and exploitation of market power. The existence of scope advantages indicates that liberalization of the market should open for the possibility to bundle services in competition with provision of unbundled services. If operations are unbundled and there exist economies of scope, the gain from increased competition should be weighed against the losses of less efficient operations of each firm. Thus, with the growth in the European market, gradually more arguments support the idea of unbundling. The significant scale economy in trunk pipelines, sunk investments and capital immobility, possible economies of scope in vertical integration and companies' bundling of services influences vertical and horizontal ownership relations and contractual terms in the European gas market. In specific segments of the markets, these relationships may promote efficient investments and pricing without public interference, but the strong concentration of market power indicates that this is rather the exception than the rule. In order to design an efficient and welfare maximizing way of regulating the market one needs a closer identification of the actual goal of the regulation. Microeconomic theory is often used for this purpose. The author discusses the alternatives of laissez-faire, nationalization or regulation for the

  16. State regulatory issues in acid rain compliance

    International Nuclear Information System (INIS)

    Solomon, B.D.; Brick, S.

    1992-01-01

    This article discusses the results of a US EPA workshop for state regulators and commission staff on acid rain compliance concerns. The topics of the article include the results of market-based emissions control, how emissions trading is expected to reduce emissions, public utility commissions approval of compliance plans, the purposes of the workshop, market information, accounting issues, regulatory process and utility planning, multi-state compliance planning, and relationship to other compliance issues

  17. 76 FR 2425 - Draft Regulatory Guide: Reissuance and Availability

    Science.gov (United States)

    2011-01-13

    ... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a..., the public can gain entry into ADAMS, which provides text and image files of NRC's public [email protected] . The Regulatory Analysis is available electronically under ADAMS Accession Number...

  18. 76 FR 32878 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2011-06-07

    ...: Mekonen [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The U.S. Nuclear Regulatory..., the public can gain entry into ADAMS, which provides text and image files of the NRC's [email protected] . The Regulatory Analysis is available electronically under ADAMS Accession Number...

  19. 76 FR 5215 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2011-01-28

    ... . SUPPLEMENTARY INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public... . From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's... [email protected] . The Regulatory Analysis is available electronically under ADAMS Accession...

  20. Regulatory issues resolved through design certification on the System 80+trademark standard plant design

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.; Brinkman, C.B.

    1996-01-01

    The US Nuclear Regulatory Commission (NRC) has completed its review of the System 80+trademark Standard Plant Design, approving advanced design features and closing severe accident licensing issues. Final Design Approval was granted in July 1994. The NRC review was extensive, requiring written responses to over 4,950 questions and formal printing of over 50,000 Safety Analysis Report pages. New safety issues never before addressed in a regulatory atmosphere had to be resolved with detailed analysis and evaluation of design features. the System 80+ review demonstrated that regulatory issues can be firmly resolved only through presentation of a detailed design and completion of a comprehensive regulatory review

  1. 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.

  2. Developmental gains in visuospatial memory predict gains in mathematics achievement.

    Science.gov (United States)

    Li, Yaoran; Geary, David C

    2013-01-01

    Visuospatial competencies are related to performance in mathematical domains in adulthood, but are not consistently related to mathematics achievement in children. We confirmed the latter for first graders and demonstrated that children who show above average first-to-fifth grade gains in visuospatial memory have an advantage over other children in mathematics. The study involved the assessment of the mathematics and reading achievement of 177 children in kindergarten to fifth grade, inclusive, and their working memory capacity and processing speed in first and fifth grade. Intelligence was assessed in first grade and their second to fourth grade teachers reported on their in-class attentive behavior. Developmental gains in visuospatial memory span (d = 2.4) were larger than gains in the capacity of the central executive (d = 1.6) that in turn were larger than gains in phonological memory span (d = 1.1). First to fifth grade gains in visuospatial memory and in speed of numeral processing predicted end of fifth grade mathematics achievement, as did first grade central executive scores, intelligence, and in-class attentive behavior. The results suggest there are important individual differences in the rate of growth of visuospatial memory during childhood and that these differences become increasingly important for mathematics learning.

  3. Developmental gains in visuospatial memory predict gains in mathematics achievement.

    Directory of Open Access Journals (Sweden)

    Yaoran Li

    Full Text Available Visuospatial competencies are related to performance in mathematical domains in adulthood, but are not consistently related to mathematics achievement in children. We confirmed the latter for first graders and demonstrated that children who show above average first-to-fifth grade gains in visuospatial memory have an advantage over other children in mathematics. The study involved the assessment of the mathematics and reading achievement of 177 children in kindergarten to fifth grade, inclusive, and their working memory capacity and processing speed in first and fifth grade. Intelligence was assessed in first grade and their second to fourth grade teachers reported on their in-class attentive behavior. Developmental gains in visuospatial memory span (d = 2.4 were larger than gains in the capacity of the central executive (d = 1.6 that in turn were larger than gains in phonological memory span (d = 1.1. First to fifth grade gains in visuospatial memory and in speed of numeral processing predicted end of fifth grade mathematics achievement, as did first grade central executive scores, intelligence, and in-class attentive behavior. The results suggest there are important individual differences in the rate of growth of visuospatial memory during childhood and that these differences become increasingly important for mathematics learning.

  4. Developmental Gains in Visuospatial Memory Predict Gains in Mathematics Achievement

    Science.gov (United States)

    Li, Yaoran; Geary, David C.

    2013-01-01

    Visuospatial competencies are related to performance in mathematical domains in adulthood, but are not consistently related to mathematics achievement in children. We confirmed the latter for first graders and demonstrated that children who show above average first-to-fifth grade gains in visuospatial memory have an advantage over other children in mathematics. The study involved the assessment of the mathematics and reading achievement of 177 children in kindergarten to fifth grade, inclusive, and their working memory capacity and processing speed in first and fifth grade. Intelligence was assessed in first grade and their second to fourth grade teachers reported on their in-class attentive behavior. Developmental gains in visuospatial memory span (d = 2.4) were larger than gains in the capacity of the central executive (d = 1.6) that in turn were larger than gains in phonological memory span (d = 1.1). First to fifth grade gains in visuospatial memory and in speed of numeral processing predicted end of fifth grade mathematics achievement, as did first grade central executive scores, intelligence, and in-class attentive behavior. The results suggest there are important individual differences in the rate of growth of visuospatial memory during childhood and that these differences become increasingly important for mathematics learning. PMID:23936154

  5. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

    The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

  6. 77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

    Science.gov (United States)

    2012-05-02

    ... approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period... asthma is not well controlled [[Page 26017

  7. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    Science.gov (United States)

    2012-05-03

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... chronic gout in adult patients refractory to conventional therapy. Subsequent to this approval, the Patent...

  8. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Science.gov (United States)

    2010-12-06

    ..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... or systemic therapy. Subsequent to this approval, the Patent and Trademark Office received a patent...

  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. 75 FR 1734 - Children’s Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; i-SAFE...

    Science.gov (United States)

    2010-01-13

    ... Proposed Self-Regulatory Guidelines; i-SAFE, Inc. Application for Safe Harbor AGENCY: Federal Trade... for public comment concerning proposed self-regulatory guidelines submitted by i-SAFE, Inc. under the... approval self-regulatory guidelines that would implement the Rule's protections.\\3\\ \\1\\ 64 FR 59888 (1999...

  11. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC approved packages

    International Nuclear Information System (INIS)

    1988-12-01

    This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  12. Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved packages

    International Nuclear Information System (INIS)

    1983-01-01

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  13. Directory of certificates of compliance for radioactive materials packages, Report of NRC approved packages

    International Nuclear Information System (INIS)

    1990-10-01

    This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  14. CORN, LP Goldfield Approval

    Science.gov (United States)

    This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

  15. 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)

  16. Poet Lake Crystal Approval

    Science.gov (United States)

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

  17. 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

  18. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

  19. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Packages

    International Nuclear Information System (INIS)

    1993-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  20. Specification of merger gains in the Norwegian electricity distribution industry

    International Nuclear Information System (INIS)

    Saastamoinen, Antti; Bjørndal, Endre; Bjørndal, Mette

    2017-01-01

    Electricity distribution often exhibits economies of scale. In Norway, a number of smaller distribution system operators exist and thus there is potential to restructure the industry, possibly through mergers. However, the revenue cap regulatory model in Norway does not incentivize firms to merge as merging leads to a stricter revenue cap for the merged company. Thus the regulator compensates the firms in order to create such incentives. The amount of compensation is based on the potential gains of the merger estimated using a data envelopment analysis (DEA) based frontier approach introduced by Bogetoft and Wang (2005). DEA is however only one of many possible frontier estimators that can be used in estimation. Furthermore, the returns to scale assumption, the operating environment of firms and the presence of stochastic noise and outlier observations are all known to affect to the estimation of production technology. In this paper we explore how varying assumptions under two alternative frontier estimators shape the distribution of merger gains within the Norwegian distribution industry. Our results reveal that the restructuring policies of the industry may be significantly altered depending how potential gains from the mergers are estimated. - Highlights: • The merger gains of Norwegian electricity distribution firm are investigated. • Different estimators and model specifications are applied. • Results show that the gains are significantly affected by the model choice. • Incentives to merge may be shaped through the estimation of gains.

  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. Biosimilars: a regulatory perspective from America.

    Science.gov (United States)

    Kay, Jonathan

    2011-05-12

    Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.

  3. 77 FR 1524 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-01-10

    ... initiating and adjudicating various types of actions, including disciplinary, eligibility, expedited, and... also may review the decision. Oral Argument in Review of Proceedings FINRA Rule 9341(a) establishes the procedure for a party requesting an oral argument before the Subcommittee or, if applicable, the Extended...

  4. 75 FR 8771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-25

    ... information relative to such member's financial condition as disclosed in its most recent balance sheet... an alternative means of satisfying the requirement that members make balance sheet information... financial condition as disclosed in its most recent balance sheet * * *.'' FINRA proposed providing members...

  5. 75 FR 32525 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-08

    ...., Associate Clinical Professor of Law, Cornell Law School, and Director, Cornell Securities Law Clinic, and Lennie Sliwinski, Cornell Law School class of 2011, dated May 15, 2010; and Scott R. Shewan, President... arbitration award to a customer. FINRA Rule 9554 allows FINRA to bring expedited actions to address failures...

  6. 77 FR 55519 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-09-10

    ... option, derivative, security-based swap, or other financial instrument overlying a security that is the... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67774; File No. SR-FINRA-2012-025] Self... National Association of Securities Dealers, Inc. (``NASD'')) filed with the Securities and Exchange...

  7. 75 FR 8772 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-25

    ... broker-customer relationship; or (5) the lending arrangement is based on a business relationship outside of the broker-customer relationship. In addition, with the exception of lending arrangements between... for a loan that is not the product of the broker- customer relationship would not vitiate the idea...

  8. 75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-10-06

    ...-ROM, DVD, portable hard drive, laptop computer, disc, diskette, or any other portable device for... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63016; File No. SR-FINRA-2010-021] Self... to Amend FINRA Rule 8210 to Require Information Provided via Portable Media Device be Encrypted...

  9. 75 FR 11972 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-03-12

    ... Business Member's Web site may not reflect 100 percent of that member's volume for that ATS dark pool...' Web sites to see the total volume for any given ATS dark pool, and the TRF Business Members will make... they receive for each ATS dark pool on their Web site and must prominently disclose that the Web site...

  10. 75 FR 56608 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-09-16

    ... Counsel, Secretary, Chief Compliance Officer, Accenture plc to Elizabeth M. Murphy, Secretary, Commission..., Accenture plc to Elizabeth M. Murphy, Secretary, Commission, dated June 3, 2010; and Letter from Karrie... criticized various aspects of the application of the proposed rule change to ETPs. One commenter described...

  11. 77 FR 15824 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-03-16

    ... provides that a claim alleging employment discrimination, including sexual harassment, in violation of a... proposed rule change, the Commission has considered the rule's impact on efficiency, competition, and...

  12. 78 FR 57916 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-09-20

    ... McLarty, President, American Association for Justice, dated July 11, 2013 (``AAJ Letter''); Katrina M... and General Counsel, Financial Services Institute, dated July 11, 2013 (``FSI Letter''); Glenn S... are not limited to the documents enumerated in the Lists. It would also stress that the Customer Code...

  13. 75 FR 3270 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-01-20

    ... fingerprinting requirements of SEA Rule 17f-2 for purposes of a criminal background check. The Commission finds..., competition, and capital formation. 15 U.S.C. 78c(f). \\9\\ 15 U.S.C. 78o-3(b)(6). It is therefore ordered...

  14. 76 FR 81551 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-12-28

    ... the member to qualify for the No-Knowledge Exception in Supplementary Material .02 to FINRA Rule 5320... from trading that security on the same side of the market for its own proprietary account at a price... order up to the size and at a price that is the same as, or better, than the price at which the member...

  15. 75 FR 39603 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-09

    ... related to fraud or securities laws violations; \\10\\ (4) a government authority or regulator has provided... related to fraud or securities laws violations; \\14\\ (4) a government authority or regulator has provided... potentially violating an anti-fraud rule of the Federal securities laws and stated that where it has actual...

  16. 75 FR 44033 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2010-07-27

    ... the allowance for research in straightforward and streamlined fashion. Proposed FINRA Rule 5141.03 is... NASD provisions in more straightforward and streamlined fashion and accordingly render them obsolete... and reports concerning issuers, industries, securities, economic factors and trends, portfolio...

  17. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-01

    ... reflect the corporate name change and other similar matters. The proposed amendments to the NASD Dispute... Name and Other Technical Changes FINRA proposed to implement certain other non-substantive changes to....'' FINRA also proposed to amend Article II, section 2.1 to change the name and address of the registered...

  18. 77 FR 67038 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-11-08

    ... of Functions by FINRA to Subsidiaries (``Delegation Plan''), the NAMC has the power and authority... such other powers and authority as is necessary to effectuate the purposes of FINRA's Rules.\\7\\ The... knowledge. [T]hen the situation could be deemed a legal case.'' The Commission believes that the commenter...

  19. 78 FR 58580 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-09-24

    ..., dated July 10, 2013 (``Speyer Letter''); and Leonard Steiner, Attorney, dated July 10, 2013 (``Steiner..., Neuman Letter, Sanders Letter, Speyer Letter, St. John's Law Letter, and Steiner Letter. \\13\\ See... Letter, and Steiner Letter. See also Pace Law Letter. \\15\\ See Bakhtiari Letter and Sanders Letter. \\16...

  20. 78 FR 21449 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-04-10

    ... & Kantas, dated Feb. 7, 2013 (``Shepherd Letter''); letter from Leonard Steiner, Beverly Hills, California, dated Feb. 7, 2013 (``Steiner Letter''); letter from Joseph Fogel, Fogel & Associates, dated Feb. 7...

  1. 77 FR 27262 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-05-09

    ... University Law School, and Director, Cornell Securities Law Clinic, and Brenda Beauchamp, Cornell Law School... letter from Jill I. Gross, Director, Edward Pekarek, Assistant Director, and Genavieve Shingle, Student..., scheduling, and traveling to hearings; (3) it would provide an alternative for customers who are unable to...

  2. 76 FR 70190 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-11-10

    ... October 20, 2011 (``Shatto Letter''); letter from Naphtali M. Hamlet, Investor, dated October 21, 2011 (``Hamlet Letter''); letter from Daniel Zinn, General Counsel, OTC Markets Group Inc., dated October 20... reported for public dissemination. \\12\\ See Shatto Letter; Hamlet Letter. \\13\\ See Shatto Letter. \\14\\ See...

  3. 76 FR 10629 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2011-02-25

    ... through the eligibility proceedings as ``contrary to the most basic ideals of constitutional due process..., Section 3(b) of the FINRA By-Laws provides that no person shall be associated with a member, continue to... Article III, Section 4 of the FINRA By- Laws, a person is subject to a ``disqualification'' with respect...

  4. 78 FR 29190 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2013-05-17

    ... able to manually input and verify trade data within 10 seconds.\\18\\ One commenter asserted that the... balance between promoting the goals of increased automation and efficiency in the marketplace and... trades with a large number of securities.\\28\\ \\28\\ See FIF Letter and SIFMA Letter. FINRA responded that...

  5. 78 FR 72951 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-12-04

    ... regarding the risks and financial impact associated with the customer's loan of securities, and requires... the introducing member that has a customer relationship with the lender in making the determination... securities, and the risks and financial impact associated with the customer's loan of securities. Proposed...

  6. 76 FR 5850 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2011-02-02

    ... certain information relating to customer accounts, including, among other things, the signature of the registered representative introducing the account and signature of the member, partner, officer or manager... clarify that members maintain the signature of the partner, officer or manager denoting that the account...

  7. 78 FR 38771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-06-27

    ... information that raises significant identity theft, personal safety, or privacy concerns that are not... raises personal safety or privacy concerns is released to the public when considering whether to release... customer information or information that raises identity theft, personal safety or privacy concerns that do...

  8. 75 FR 51147 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2010-08-18

    ... ``participation in a public offering'' means for purposes of the Rule and suggested an alternative definition... understood and that the alternative definition suggested by the commenter would be an inappropriate narrowing... underwriter'' under the Rule. FINRA recognized the issue raised by the commenter and stated their intention to...

  9. 75 FR 41562 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-16

    ... SEC Rule 15c3-3) in the Consolidated FINRA Rulebook July 12, 2010. I. Introduction On May 14, 2010... arrangements) that when computing charges against net capital for transactions in securities covered by FINRA... computed using the applicable special maintenance margin requirements pursuant to other provisions of the...

  10. 75 FR 37488 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-06-29

    ... restrictions on sub-penny pricing in theory, it stated that the minimum quoting increments for shares priced... institutional investors looking to take sizeable positions in thinly traded stocks, as the displaying of a...

  11. 76 FR 11542 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-03-02

    ... Surety Association of America. Under NYSE Rule 319(a), the Stockbrokers Partnership Bond and the Brokers... disadvantage to underwriters that do not offer this type of coverage.\\26\\ The commenter further stated that...

  12. 78 FR 60982 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2013-10-02

    ... becomes ``systemic as well as intentional or willful.'' In response, FINRA noted that inclusion of a rule... the rules of a Registered Securities Association enforce compliance with, and provide appropriate... FINRA should only consider a member's activity a rule violation if the violation becomes systemic as...

  13. Linaclotide: first global approval.

    Science.gov (United States)

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  14. Neratinib: First Global Approval.

    Science.gov (United States)

    Deeks, Emma D

    2017-10-01

    Neratinib (Nerlynx™) is an oral, irreversible inhibitor of the human epidermal growth factor receptors HER1 (EGFR), HER2 and HER4. The drug originally arose from research by Wyeth (now Pfizer) and is now being developed by Puma Biotechnology primarily for the treatment of HER2-positive (HER+) breast cancer. Neratinib is approved in the USA for the extended adjuvant treatment of patients with HER2+ early-stage breast cancer who have been previously treated with a trastuzumab-based adjuvant regimen, and is in the preregistration phase for this indication in the EU. Neratinib, as monotherapy and/or combination therapy, is also in phase 3 development for metastatic breast cancer and in phase 1/2 development for advanced breast cancer and other solid tumours, including non-small cell lung cancer, colorectal cancer and glioblastoma. This article summarizes the milestones in the development of neratinib leading to this first approval for breast cancer.

  15. Professional and Regulatory Search

    Science.gov (United States)

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

  16. Regulation for continuous improvements - the new regulatory strategy of SKI

    International Nuclear Information System (INIS)

    Hoegberg, L.; Svensson, G.; Viktorsson, C.

    1998-01-01

    This paper describes the new regulatory objectives and strategy of the Swedish Nuclear Power Inspectorate. Factors that have influenced the development of the regulatory strategy, including an international peer review, are discussed. In addition to general technical requirements for a defence in depth, the new strategy strongly focuses on the quality of plant safety management processes, to be monitored by process-oriented inspections. Also, quality assurance of regulatory activities is stressed. Experience gained so far shows that the regulatory approach chosen in Sweden promotes utility self assessment, quality of safety management and ownership of safety work within the utility staff. (author)

  17. Regulatory control, nuclear safety regulation and waste management in Spain

    International Nuclear Information System (INIS)

    Martin, A.

    2000-01-01

    This article presents the challenges that faces the spanish regulatory authority. The deregulation of electricity industry imposes severe changes in nuclear power economics and forces nuclear power to compete with other sources of electricity. A pressure is perceived for regulatory effectiveness primarily since the cost of regulation is a component of the cost of the product. This effectiveness gain in regulatory control will be reached through systematic strategic analysis, formulation and implementation. The regulatory aspects of plant life extension and of waste management are examined

  18. Developmental Gains in Visuospatial Memory Predict Gains in Mathematics Achievement

    OpenAIRE

    Li, Yaoran; Geary, David C.

    2013-01-01

    Visuospatial competencies are related to performance in mathematical domains in adulthood, but are not consistently related to mathematics achievement in children. We confirmed the latter for first graders and demonstrated that children who show above average first-to-fifth grade gains in visuospatial memory have an advantage over other children in mathematics. The study involved the assessment of the mathematics and reading achievement of 177 children in kindergarten to fifth grade, inclusiv...

  19. Future nuclear regulatory challenges

    International Nuclear Information System (INIS)

    Royen, J.

    1998-01-01

    In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

  20. Directory of certificates of compliance for radioactive materials packages. Volume 1. Summary report of NRC approved packages. Revision 6

    International Nuclear Information System (INIS)

    1983-09-01

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective September 14, 1983

  1. Directory of certificates of compliance for radioactive materials packages. Volume 1. Summary report of NRC approved packages

    International Nuclear Information System (INIS)

    1977-12-01

    Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. This volume contains a summary report of NRC-approved packages for radioactive material packages effective Nov. 30, 1977

  2. 10 CFR 76.119 - Security facility approval and safeguarding of National Security Information and Restricted Data.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Security facility approval and safeguarding of National Security Information and Restricted Data. 76.119 Section 76.119 Energy NUCLEAR REGULATORY COMMISSION... approval and safeguarding of National Security Information and Restricted Data. The requirements for...

  3. Drug lag and key regulatory barriers in the emerging markets

    Directory of Open Access Journals (Sweden)

    Harriet Wileman

    2010-01-01

    This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; ′Western Approval′, local clinical development (LCD, Certificate of Pharmaceutical Product (CPP, Good Manufacturing Practice (GMP, pricing approval, document authentication and harmonisation.

  4. Trainees' Perceived Knowledge Gain Unrelated to the Training Domain: The Joint Action of Impression Management and Motives

    Science.gov (United States)

    Chiaburu, Dan S.; Huang, Jason L.; Hutchins, Holly M.; Gardner, Richard G.

    2014-01-01

    Trainees' knowledge gains represent an important outcome in human resource development. In this research, we tested a model examining the joint influence of social desirability (impression management, self-deception) and motives (need for power, need for approval) on trainees' self-reported knowledge gain. We conducted a study with…

  5. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Science.gov (United States)

    2012-05-02

    ... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

  6. The PREEV project of the Latin American Forum.Regulatory practices on aging and life extension

    International Nuclear Information System (INIS)

    Figueras, J. M.

    2011-01-01

    The American Forum Plenary approved in 2008 the PREEV project, Regulatory Practices in Aging and Life Extension, whose main objective is to improve the regulatory action with regard to the management programs of life and long-term operation of nuclear power plants in the countries of the region Latin American.

  7. 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

  8. Regulatory activities; Actividades regulatorias

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information.

  9. 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

  10. Optomechanical transistor with mechanical gain

    Science.gov (United States)

    Zhang, X. Z.; Tian, Lin; Li, Yong

    2018-04-01

    We study an optomechanical transistor, where an input field can be transferred and amplified unidirectionally in a cyclic three-mode optomechanical system. In this system, the mechanical resonator is coupled simultaneously to two cavity modes. We show that it only requires a finite mechanical gain to achieve the nonreciprocal amplification. Here the nonreciprocity is caused by the phase difference between the linearized optomechanical couplings that breaks the time-reversal symmetry of this system. The amplification arises from the mechanical gain, which provides an effective phonon bath that pumps the mechanical mode coherently. This effect is analogous to the stimulated emission of atoms, where the probe field can be amplified when its frequency is in resonance with that of the anti-Stokes transition. We show that by choosing optimal parameters, this optomechanical transistor can reach perfect unidirectionality accompanied with strong amplification. In addition, the presence of the mechanical gain can result in ultralong delay in the phase of the probe field, which provides an alternative to controlling light transport in optomechanical systems.

  11. The Pro-Cyclical Impact of Basel III Regulatory Capital on Bank Capital Risk

    OpenAIRE

    Song, Guoxiang

    2014-01-01

    To raise the quality of regulatory capital, Basel III capital rules recognize unrealized gains and losses on all available-for-sale (AFS) securities in Common Equity Tier 1 Capital (CET1). However, by examining the correlations between U.S. GDP growth rate, interest rates and regulatory capital ratios computed using Basel III regulatory capital definition for six U.S. global systemically important banks (G-SIBs) since 2007, this chapter finds that Basel III regulatory capital will enhance the...

  12. Supercollider: Footprint approved

    International Nuclear Information System (INIS)

    Anon.

    1990-01-01

    With the 'footprint' - the precise location of the 87-kilometre US Superconducting Supercollider, SSC, and its ancillary buildings - now approved, teams of specialists commissioned by the State of Texas swing into action to procure the 17,000 acres (69 million square metres) of land covered by the project. With the SSC Laboratory in Ellis County and the US Department of Energy (DoE, the overseeing government agency) both hiring manpower for this project to collide 20 TeV (20,000 GeV) proton beams before the end of the century, the host State of Texas is providing a helping hand

  13. Challenges in orphan drug development and regulatory policy in China.

    Science.gov (United States)

    Cheng, Alice; Xie, Zhi

    2017-01-18

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

  14. Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved quality assurance programs for radioactive material packages

    International Nuclear Information System (INIS)

    1987-11-01

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1987. This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  15. Commutated automatic gain control system

    Science.gov (United States)

    Yost, S. R.

    1982-01-01

    A commutated automatic gain control (AGC) system was designed and built for a prototype Loran C receiver. The receiver uses a microcomputer to control a memory aided phase-locked loop (MAPLL). The microcomputer also controls the input/output, latitude/longitude conversion, and the recently added AGC system. The circuit designed for the AGC is described, and bench and flight test results are presented. The AGC circuit described actually samples starting at a point 40 microseconds after a zero crossing determined by the software lock pulse ultimately generated by a 30 microsecond delay and add network in the receiver front end envelope detector.

  16. [Fast food promotes weight gain].

    Science.gov (United States)

    Stender, Steen; Dyerberg, Jørn; Astrup, Arne V

    2007-05-07

    The total amounts of fat in a fast food menu consisting of French fries and fried Chicken Nuggets from McDonald's and KFC, respectively, bought in 35 different countries vary from 41 to 71 gram. In most countries the menu contained unacceptably high amounts of industrially-produced trans fat which contributes to an increased risk of ischaemic heart disease, weight gain, abdominal fat accumulation and type 2 diabetes. The quality of the ingredients in fast food ought to be better and the size of the portions smaller and less energy-dense so that frequent fast food meals do not increase the risk of obesity and diseases among customers.

  17. Insights gained from aging research

    International Nuclear Information System (INIS)

    Blahnik, D.E.; Casada, D.A.; Edson, J.L.; Fineman, D.L.; Gunther, W.E.; Haynes, H.D.; Hoopingarner, K.R.; Jacobus, M.J.; Jarrell, D.B.; Kryter, R.C.; Magelby, H.L.; Murphy, G.A.; Subudhi, M.M.

    1992-03-01

    The US NRC Office of Nuclear Regulatory Research has implemented hardware-oriented engineering research programs to identify and resolve technical issues related to the aging of systems, structures, and components (SSCs) in operating nuclear power plants. This report provides a summary of those research results which have been compiled and published in NUREGS and related technical reports. The systems, components and structures that have been studied are organized by alphabetical order. The research results summary on the SSCs is followed by an assessment guide to emphasize inspection techniques which may be useful for detecting aging degradation in nuclear power plants. This report will be updated periodically to reflect new research results on these or other SSCs

  18. Insights gained from aging research

    Energy Technology Data Exchange (ETDEWEB)

    Blahnik, D.E.; Casada, D.A.; Edson, J.L.; Fineman, D.L.; Gunther, W.E.; Haynes, H.D.; Hoopingarner, K.R.; Jacobus, M.J.; Jarrell, D.B.; Kryter, R.C.; Magelby, H.L.; Murphy, G.A.; Subudhi, M.M.

    1992-03-01

    The US NRC Office of Nuclear Regulatory Research has implemented hardware-oriented engineering research programs to identify and resolve technical issues related to the aging of systems, structures, and components (SSCs) in operating nuclear power plants. This report provides a summary of those research results which have been compiled and published in NUREGS and related technical reports. The systems, components and structures that have been studied are organized by alphabetical order. The research results summary on the SSCs is followed by an assessment guide to emphasize inspection techniques which may be useful for detecting aging degradation in nuclear power plants. This report will be updated periodically to reflect new research results on these or other SSCs.

  19. Factors related to drug approvals: predictors of outcome?

    Science.gov (United States)

    Liberti, Lawrence; Breckenridge, Alasdair; Hoekman, Jarno; McAuslane, Neil; Stolk, Pieter; Leufkens, Hubert

    2017-06-01

    There is growing interest in characterising factors associated with positive regulatory outcomes for drug marketing authorisations. We assessed empirical studies published over the past 15 years seeking to identify predictive factors. Factors were classified to one of four 'factor clusters': evidentiary support; product or indication characteristics; company experience or strategy; social and regulatory factors. We observed a heterogeneous mix of technical factors (e.g., study designs, clinical evidence of efficacy) and less studied social factors (e.g., company-regulator interactions). We confirmed factors known to be of relevance to drug approval decisions (imperative) and a cohort of less understood (compensatory) social factors. Having robust supportive clinical evidence, addressing rare or serious illness, following scientific advice and prior company experience were associated with positive outcomes, which illustrated the multifactorial nature of regulatory decision making and factors need to be considered holistically while having varying, context-dependent importance. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Ethical and regulatory problems of molecular imaging

    International Nuclear Information System (INIS)

    Jeong, Jae Min

    2004-01-01

    As a molecular imaging is the most up-to-date technology in nuclear medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. For clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology

  1. 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)

  2. Can Beta Blockers Cause Weight Gain?

    Science.gov (United States)

    ... cause weight gain? Can beta blockers cause weight gain? Answers from Sheldon G. Sheps, M.D. Yes. Weight gain can occur as a side effect of some ... and metoprolol (Lopressor, Toprol-XL). The average weight gain is about 2.6 pounds (about 1.2 ...

  3. A gain-coefficient switched Alexandrite laser

    International Nuclear Information System (INIS)

    Lee, Chris J; Van der Slot, Peter J M; Boller, Klaus-J

    2013-01-01

    We report on a gain-coefficient switched Alexandrite laser. An electro-optic modulator is used to switch between high and low gain states by making use of the polarization dependent gain of Alexandrite. In gain-coefficient switched mode, the laser produces 85 ns pulses with a pulse energy of 240 mJ at a repetition rate of 5 Hz.

  4. Organization of nuclear regulatory activities

    International Nuclear Information System (INIS)

    Blidaru, Valentin

    2008-01-01

    The paper presents the structure, missions and organizational aspects of the CNCAN, the National Commission for the control of nuclear activities in Romania. The paper addresses the following main issues: 1.General aspects; 2.Organizational structure of the NRA in Romania; 3.General description of the Division for Nuclear Safety Assessments; 4.Specific activities; 5.Regulatory approaches and practices. Under the title of 'General aspects' the following three basic statements are highlighted: 1.CNCAN is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and the licensing of nuclear facilities; 2.CNCAN is the national authority competent in exercising the regulatory activity, authorization and control in the nuclear field provided by the law No. 111/ 1996 republished in 1998; 3.The Commission exercises its functions independently of the ministries and other authorities of the public control administration being subordinated to the Romanian Government. The organizational structure is as follows: - President, the Managerial Council and the Advisory Council coordinating the four General Divisions that are responsible for: - Nuclear Safety with Division of Nuclear Safety Assessment and Division of Nuclear Objectives Surveillance; - Radiological Safety with Division of Radiological Safety Assessment and Division of Operational Radiation Protection; - Surveillance of Environmental Radioactivity with Division of Assessment and Analysis and Division of National Network; - Development and Resource with the Division of Economy and Division of Human Resources. In addition under direct coordination of the President operate the Division of Radiation Protection, Transport and Radioactive Waste and the Division of International Cooperation and Communication. Specific activities are listed describing among others the issues of: - Safety of nuclear installation; - Evaluation relating to licensing of nuclear

  5. Regulatory Commission of Alaska

    Science.gov (United States)

    Map Help Regulatory Commission of Alaska Login Forgot Password Arrow Image Forgot password? View Cart login Procedures for Requesting Login For Consumers General Information Telephone Electric Natural Gas

  6. Regulation No. 56/2006 Coll. of the Nuclear Regulatory Authority of the Slovak Republic dated as of January 12, 2006 on details concerning requirements for quality system documentation of authorisation holder, as well as details concerning quality requirements for nuclear installations, details concerning quality requirements for classified equipment and details concerning the scope of their approval

    International Nuclear Information System (INIS)

    2006-01-01

    This Regulation provides details of the requirements for quality system documentation holder, details of the quality requirements for nuclear installations, details concerning quality requirements for classified equipment and details of the scope of their approval. This Regulation came into force on March 1, 2006.

  7. Estimating the potential gains from mergers

    DEFF Research Database (Denmark)

    Bogetoft, Peter; Wang, Dexiang

    2005-01-01

    We introduce simple production economic models to estimate the potential gains from mergers. We decompose the gains into technical ef¿ciency, size (scale) and harmony (mix) gains, and we discuss alternative ways to capture these gains. We propose to approximate the production processes using...... the non-parametric. Data Envelopment Analysis (DEA) approach, and we use the resulting operational approach to estimate the potential gains from merging agricultural extension of¿ces in Denmark....

  8. Nuclear energy's future: lifting the regulatory cloud

    International Nuclear Information System (INIS)

    Walske, C.

    1983-01-01

    Nuclear energy provides 13% of US and 10% of world electricity, with an exemplary safety record and less insult to the environment than any other power source. Walske argues that nuclear power is 15% cheaper than coal despite the high capital and regulatory costs, but regulatory delays in the construction and licensing periods have increased 70% to 10 to 14 years, more than twice the lead time in France and Japan. The long lead time exaggerates the difficulty in forecasting demand, and allows interruptions for fundamental design changes after construction has begun. Walske outlines new legislation for site pre-approval, plant standardization, combined construction and operating licenses, and hybrid procedures for public hearings that would make regulation less uncertain

  9. Miracle drug: Brazil approves never-tested cancer medicine.

    Science.gov (United States)

    Kuchenbecker, Ricardo S; Mota, Daniel M

    2017-07-01

    Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.

  10. Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive material packages

    International Nuclear Information System (INIS)

    1988-12-01

    This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  11. Heritability of gestational weight gain

    DEFF Research Database (Denmark)

    Andersson, Elina Scheers; Silventoinen, Karri; Tynelius, Per

    2015-01-01

    Gestational weight gain (GWG) is a complex trait involving intrauterine environmental, maternal environmental, and genetic factors. However, the extent to which these factors contribute to the total variation in GWG is unclear. We therefore examined the genetic and environmental influences...... on the variation in GWG in the first and second pregnancy in monozygotic (MZ) and dizygotic (DZ) twin mother-pairs. Further, we explored if any co-variance existed between factors influencing the variation in GWG of the mothers’ first and second pregnancies. By using Swedish nationwide record-linkage data, we...... identified 694 twin mother-pairs with complete data on their first pregnancy and 465 twin mother-pairs with complete data on their second pregnancy during 1982–2010. For a subanalysis, 143 twin mother-pairs had complete data on two consecutive pregnancies during the study period. We used structural equation...

  12. Unidirectional high gain brake stop

    Science.gov (United States)

    Lang, David J. (Inventor)

    1987-01-01

    This invention relates to a unidirectional high gain brake arrangement that includes in combination a shaft mounted for rotation within a housing. The shaft is rotatable in either direction. A brake is selectively releasably coupled to the housing and to the shaft. The brake has a first member. An intermittent motion device is respectively coupled through the first member to the housing and through a one-way clutch to the shaft. The brake also has a second member that is mechanically coupled to the first brake member and to the housing. The intermittent motion device causes the brake to be activated by movement imparted to the first brake member after a preset number of revolutions of the shaft in one direction. The brake is released by rotation of the shaft in an opposite direction whereby torque transmitted through the one-way clutch to the first brake member is removed.

  13. Boesmanland gains from nuclear wastes

    International Nuclear Information System (INIS)

    Smit, I.

    1984-01-01

    It is being claimed that the geobotany of the Boesmanland will gain from the use of the farm Vaalputs for radioactive waste disposal from the Koeberg nuclear power station. Only 1 km 2 of the 10 000 ha that was bought for the purpose will be used for the disposal of low-level radioactive wastes and 2 m 3 to 3 m 3 per year will be used for the storage of high-level radioactive wastes. The rest of the area, Nucor plans to develop as a nature reserve, restoring the natural botany and ecology. Before Vaalputs was selected as site for radioactive waste disposal, a regional analysis was done. According to this there is more or less 500 people staying within a radius of 25km from the farm. Geological surveys showed no mineral deposits of economic value. During the past 100 million years the area was also free from seismic activity

  14. Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market.

    Science.gov (United States)

    Patriarca, Peter A; Van Auken, R Michael; Kebschull, Scott A

    2018-01-01

    Benefit-risk evaluations of drugs have been conducted since the introduction of modern regulatory systems more than 50 years ago. Such judgments are typically made on the basis of qualitative or semiquantitative approaches, often without the aid of quantitative assessment methods, the latter having often been applied asymmetrically to place emphasis on benefit more so than harm. In an effort to preliminarily evaluate the utility of lives lost or saved, or quality-adjusted life-years (QALY) lost and gained as a means of quantitatively assessing the potential benefits and risks of a new chemical entity, we focused our attention on the unique scenario in which a drug was initially approved based on one set of data, but later withdrawn from the market based on a second set of data. In this analysis, a dimensionless risk to benefit ratio was calculated in each instance, based on the risk and benefit quantified in similar units. The results indicated that FDA decisions to approve the drug corresponded to risk to benefit ratios less than or equal to 0.136, and that decisions to withdraw the drug from the US market corresponded to risk to benefit ratios greater than or equal to 0.092. The probability of FDA approval was then estimated using logistic regression analysis. The results of this analysis indicated that there was a 50% probability of FDA approval if the risk to benefit ratio was 0.121, and that the probability approaches 100% for values much less than 0.121, and the probability approaches 0% for values much greater than 0.121. The large uncertainty in these estimates due to the small sample size and overlapping data may be addressed in the future by applying the methodology to other drugs.

  15. Overcoming regulatory and economic challenges facing pharmacogenomics.

    Science.gov (United States)

    Cohen, Joshua P

    2012-09-15

    The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

  16. 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…

  17. 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.

  18. Grandfathering of competent authority approved packages

    International Nuclear Information System (INIS)

    Osgood, N.L.

    2004-01-01

    International Atomic Energy Agency transportation regulations are reviewed and revised on a periodic basis as new technical and scientific information becomes available. The 1996 Edition of the Regulations for the Safe Transport of Radioactive Materials in TS-R-1 includes provisions for the use of package designs approved to previous editions of the regulations. This assures that there is no disruption of transport when the regulations are updated and revised. The revision of package design standards may make certain designs obsolete, though not necessarily unsafe. The U.S. Nuclear Regulatory Commission is the agency in the United States that certifies transportation packages for Type B and fissile materials. NRC regulations include grandfathering provisions that are comparable to and compatible with the IAEA standards. NRC staff is promoting a new system that would eliminate the need to grandfather package designs. Under the new method, any new or revised provision of the regulations that affects package standards would include its own transitional arrangements. In this way, each change would be evaluated for its safety importance. Changes in the package standards that are important to safety would be implemented immediately upon the regulations coming into force. Other changes, that do not significantly affect safety, would have longer implementation periods. In this way, all packages in use would be compatible with the regulations in force, and no specific grandfathering provisions for older designs would be needed. NRC staff has concluded that the package design standards are mature and have been shown to be protective over the past 40 years of shipping experience. We predict that future changes in package design standards will not be substantive in terms of resulting in significant changes in physical performance of a package in transport, including actual transportation accidents. The benefits of the new system would be a more predictable regulatory structure

  19. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-10-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  20. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  1. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-01-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  2. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1991-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  3. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-08-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  4. Trust in regulatory regimes

    NARCIS (Netherlands)

    Six, Frédérique; Verhoest, Koen

    2017-01-01

    Within political and administrative sciences generally, trust as a concept is contested, especially in the field of regulatory governance. This groundbreaking book is the first to systematically explore the role and dynamics of trust within regulatory regimes. Conceptualizing, mapping and analyzing

  5. Nuclear Regulatory legislation

    International Nuclear Information System (INIS)

    1984-06-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 97th Congress, 2nd Session, has been prepared by the Office of the Executive Legal Director, U.S. Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document

  6. Gain attenuation of gated framing camera

    International Nuclear Information System (INIS)

    Xiao Shali; Liu Shenye; Cao Zhurong; Li Hang; Zhang Haiying; Yuan Zheng; Wang Liwei

    2009-01-01

    The theoretic model of framing camera's gain attenuation is analyzed. The exponential attenuation curve of the gain along the pulse propagation time is simulated. An experiment to measure the coefficient of gain attenuation based on the gain attenuation theory is designed. Experiment result shows that the gain follows an exponential attenuation rule with a quotient of 0.0249 nm -1 , the attenuation coefficient of the pulse is 0.00356 mm -1 . The loss of the pulse propagation along the MCP stripline is the leading reason of gain attenuation. But in the figure of a single stripline, the gain dose not follow the rule of exponential attenuation completely, instead, there is a gain increase at the stripline bottom. That is caused by the reflection of the pulse. The reflectance is about 24.2%. Combining the experiment and theory, which design of the stripline MCP can improved the gain attenuation. (authors)

  7. Use of risk information in regulatory reviews

    International Nuclear Information System (INIS)

    Sagar, B.; Benke, R.; Mohanty, S.

    2004-01-01

    The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

  8. 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,...

  9. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  10. The regulatory mechanism in the U.S. lessons learned

    International Nuclear Information System (INIS)

    Roberts, T.M.

    1987-01-01

    The U.S. Nuclear Regulatory Commission is responsible for the regulation of the commercial uses of nuclear power in the United States in order to protect the public health and safety. The NRC has undertaken a number of initiatives to incorporate the experience gained from the over 25 years of commercial nuclear power plant operation. These initiatives are aimed at improving the regulatory structure currently in place by providing for a more predictable and stable regulatory environment and by more efficiently and effectively focusing the activities of utilities on the safe operation of their facilities. (author)

  11. Audit of Gaining Early Awareness and Readiness for Undergraduate Programs. Final Audit Report.

    Science.gov (United States)

    Office of Inspector General (ED), Washington, DC.

    An audit was conducted to determine whether the U.S. Department of Education had implemented adequate management controls to administer the Gaining Early Awareness and Readiness for Undergraduate Programs (GEAR UP) in accordance with legislative, regulatory, and internal administrative requirements. The focus was on the fiscal year 2000 grant…

  12. Preliminary perspectives gaines from individual plant examination of external events (IPEEE) seismic and fire submittal review

    International Nuclear Information System (INIS)

    Chen, J.T.; Connell, E.; Chokshi, N.

    1997-01-01

    As a result of the U.S. Nuclear Regulatory Commission (USNRC) initiated Individual plant Examination of External Events (IPEEE) program, every operating nuclear power reactor in the United States has performed an assessment of severe accident due to external events. This paper provides a summary of the preliminary insights gained through the review of 24 IPEEE submittals

  13. Review of High Gain FELs

    International Nuclear Information System (INIS)

    Shintake, Tsumoru

    2007-01-01

    For understanding on basic radiation mechanism of the high-gain FEL based on SASE, the author presents electron-crystal interpretation of FEL radiation. In the electron-crystal, electrons are localized at regularly spaced multi-layers, which represents micro-bunching, whose spacing is equal to the radiation wavelength, and the multi-layers are perpendicular to beam axis, thus, diffracted wave creates Bragg's spots in forward and backward directions. Due to the Doppler's effect, frequency of the back-scattered wave is up-converted, generates forwardly focused X-ray. The Bragg's effect contributes focusing the X-ray beam into a spot, thus peak power becomes extremely higher by factor of typically 107. This is the FEL radiation. As well known, the total numbers of scattered photons in Bragg's spots is equal to the total elastic scattering photons from the atoms contained in the crystal. Therefore, total power in the FEL laser is same as the spontaneous radiation power from the undulator for the same beam parameter. The FEL radiation phenomenon is simple interference effect. In today's presentations, we use the laser pointer, and we frequently experience difficulty in pointing precisely or steadily in one place on the screen, since the laser spot is very small and does not spread. Exactly same to this, X-ray FEL is a highly focused beam, and pointing stability dominates productivity of experiment, thus we need special care on beam stability from linear accelerator

  14. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  15. 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 ( ...

  16. 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

  17. Gain scheduling using the Youla parameterization

    DEFF Research Database (Denmark)

    Niemann, Hans Henrik; Stoustrup, Jakob

    1999-01-01

    Gain scheduling controllers are considered in this paper. The gain scheduling problem where the scheduling parameter vector cannot be measured directly, but needs to be estimated is considered. An estimation of the scheduling vector has been derived by using the Youla parameterization. The use...... in connection with H_inf gain scheduling controllers....

  18. Determination of the STIS CCD Gain

    Science.gov (United States)

    Riley, Allyssa; Monroe, TalaWanda; Lockwood, Sean

    2016-09-01

    This report summarizes the analysis and absolute gain results of the STIS Cycle 23 special calibration program 14424 that was designed to measure the gain of amplifiers A, C and D at nominal gain settings of 1 and 4 e-/DN. We used the mean-variance technique and the results indicate a mean-variance technique.

  19. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2016-01-01

    - Poland: Organisation and structure; 7 - Slovak Republic: International co-operation, Nuclear security (Entry into force of the Amendment to the Convention on the Physical Protection of Nuclear Material; Act No. 91/2016 Coll. on Criminal Responsibility of Legal Persons), Liability and compensation (Newly adopted Civil Procedural Code); 8 - Slovenia: Nuclear safety and radiological protection - including nuclear emergency planning (Decree on the program of the systematic monitoring of working and living environments and raising awareness about measures to reduce public exposure to natural radiation sources; Rules on authorised experts for radiation and nuclear safety); 9 - United States: General legislation, regulations and instruments (Nuclear Regulatory Commission approved a final rule amending licensing, inspection and annual fee regulations to establish a variable annual fee structure for light-water small modular reactors)

  20. 77 FR 24585 - List of Approved Spent Fuel Storage Casks: HI-STORM 100, Revision 8

    Science.gov (United States)

    2012-04-25

    ... Storage Casks: HI-STORM 100, Revision 8 AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule... revising the Holtec International HI-STORM 100 System listing within the ``List of Approved Spent Fuel...) 72.214, by revising the Holtec International HI-STORM 100 System listing within the ``List of...

  1. 76 FR 2243 - List of Approved Spent Fuel Storage Casks: NUHOMS ® HD System Revision 1

    Science.gov (United States)

    2011-01-13

    ... Storage Casks: NUHOMS [supreg] HD System Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION: Direct... fuel storage regulations by revising the Transnuclear, Inc. (TN) NUHOMS [supreg] HD System listing... NUHOMS [supreg] HD System cask design listed in Sec. 72.214 (List of approved spent fuel storage casks...

  2. 77 FR 4203 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System, Revision 2

    Science.gov (United States)

    2012-01-27

    ... Storage Casks: MAGNASTOR[supreg] System, Revision 2 AGENCY: Nuclear Regulatory Commission. ACTION: Direct... storage regulations by revising the NAC International, Inc. (NAC) MAGNASTOR[supreg] System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 2 to Certificate of...

  3. 75 FR 24786 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

    Science.gov (United States)

    2010-05-06

    ... Fuel Storage Casks: NUHOMS[supreg] HD System Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION... storage regulations by revising the Transnuclear, Inc. (TN) NUHOMS[supreg] HD System listing within the... System cask design within the list of approved spent fuel storage casks that power reactor licensees can...

  4. 75 FR 33736 - List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 1

    Science.gov (United States)

    2010-06-15

    ... Fuel Storage Casks: MAGNASTOR System, Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION... storage cask regulations by revising the NAC International, Inc. (NAC), MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1 to Certificate of...

  5. 78 FR 78693 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

    Science.gov (United States)

    2013-12-27

    ... Storage Casks: Transnuclear, Inc. Standardized NUHOMS[supreg] Cask System AGENCY: Nuclear Regulatory... storage regulations by revising the Transnuclear, Inc. Standardized NUHOMS[supreg] Cask System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 11 to Certificate of...

  6. 76 FR 70331 - List of Approved Spent Fuel Storage Casks: MAGNASTOR ® System, Revision 2

    Science.gov (United States)

    2011-11-14

    ... Fuel Storage Casks: MAGNASTOR [supreg] System, Revision 2 AGENCY: Nuclear Regulatory Commission. ACTION... its spent fuel storage regulations by revising the NAC International, Inc. (NAC) MAGNASTOR [supreg] System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 2 to...

  7. 76 FR 2277 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

    Science.gov (United States)

    2011-01-13

    ... Fuel Storage Casks: NUHOMS[supreg] HD System Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION... System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1 to... the NUHOMS[supreg] HD Horizontal Modular Storage System for Irradiated Nuclear Fuel. [[Page 2279...

  8. 75 FR 19645 - Enterprise Texas Pipeline LLC; Notice of Petition for Rate Approval

    Science.gov (United States)

    2010-04-15

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-14-000] Enterprise..., 2010, Enterprise Texas Pipeline LLC (Enterprise Texas) filed a petition for rate approval pursuant to section 284.123(b)(2) of the Commission's regulations. Enterprise Texas proposes rates of $0.6090 per...

  9. 75 FR 27340 - Enterprise Alabama Intrastate, LLC; Notice of Petition for Rate Approval

    Science.gov (United States)

    2010-05-14

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-21-000] Enterprise..., Enterprise Alabama Intrastate, LLC (Enterprise Alabama) filed a petition for rate approval pursuant to section 284.123(b)(2) of the Commission's regulations. Enterprise Alabama states it is filing to justify...

  10. 76 FR 44583 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-07-26

    ... designated method are manufactured in an ISO 9001-registered facility. Also, an applicant must submit a minor... of Management and Budget (OMB) for review and approval. This is a request to renew an existing... and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725...

  11. Trends in approval times for genetically engineered crops in the United States and the European Unio

    NARCIS (Netherlands)

    Smart, Richard D.; Blum, Matthias; Wesseler, J.H.H.

    2017-01-01

    Genetically engineered (GE) crops are subject to regulatory oversight to Ensure their safety for humans and the environment. Their approval in the European Union (EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political

  12. 75 FR 41855 - Enogex L.L.C.; Notice of Petition for Rate Approval

    Science.gov (United States)

    2010-07-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-52-000] Enogex L.L.C.; Notice of Petition for Rate Approval July 13, 2010. Take notice that on July 1, 2010, Enogex L.L.C. (Enogex) filed pursuant to section 284.123(b)(2) of the Commission's regulations, filed a petition...

  13. 77 FR 59679 - Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving...

    Science.gov (United States)

    2012-09-28

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0044; Docket No. 50-423] Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving Application Regarding Corporate Restructuring and Conforming Amendment I Dominion Nuclear Connecticut, Inc. (DNC), Central Vermont Public Service...

  14. 77 FR 28375 - Eagle Rock Desoto Pipeline, L.P.; Notice of Petition for Rate Approval

    Science.gov (United States)

    2012-05-14

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR12-25-000] Eagle Rock Desoto Pipeline, L.P.; Notice of Petition for Rate Approval Take notice that on May 1, 2012, Eagle Rock Desoto Pipeline, L.P. (Desoto) filed a Rate Election pursuant to 284.123(b)(1) of the Commissions...

  15. 76 FR 30832 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Permits for...

    Science.gov (United States)

    2011-05-27

    ... not a ``significant regulatory action'' subject to review by the Office of Management and Budget under... 0 2. In Sec. 52.2520, the table in paragraph (c) is amended by revising the entries for [45 CSR.../subject effective EPA approval date explanation/citation 45 CSR] date at 40 CFR 52.2565 * * * * * * * [45...

  16. 78 FR 22020 - Agency Information Collection Activities: Requests for Comments; Clearance of New Approval of...

    Science.gov (United States)

    2013-04-12

    ... about our intention to request the Office of Management and Budget (OMB) approval for a new information... will define what a propeller critical part is, require the identification of propeller critical parts... information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget...

  17. 75 FR 39932 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-07-13

    ...; Comment Request; Recognition Application for Sustainable Water Leadership Program (Renewal) AGENCY... Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval... to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention...

  18. 76 FR 46322 - Agency Information Collection Activities Under OMB Review; Renewal of a Currently Approved...

    Science.gov (United States)

    2011-08-02

    ... has forwarded the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval: Recreation Visitor Use Surveys. The ICR describes the nature of the... Department of the Interior at the Office of Management and Budget, Office of Information and Regulatory...

  19. Protection of third parties by collateral clauses of plan approvals or licenses

    International Nuclear Information System (INIS)

    Badura, P.

    1989-01-01

    This contribution discusses the regulatory functions of collateral clauses of plan approvals or licences, the legal protection of the constitutional and other rights of third parties in connection with the licensing of installations or similar projects, infringements of such rights and means of defence, and protection of neighbours under public law against noise. (RST) [de

  20. 78 FR 41846 - Approval and Promulgation of Implementation Plans; New York State Ozone Implementation Plan Revision

    Science.gov (United States)

    2013-07-12

    ... Pavement and Asphalt Based Surface Coating,'' (see 77 FR 13974). It is important to note that EPA is... approved regulations'' in 40 CFR 52.1670 for the Part 241, ``Asphalt Pavement and Asphalt Based Surface..., this action: Is not a ``significant regulatory action'' subject to review by the Office of Management...

  1. 75 FR 5786 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-02-04

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Steel Plants: Electric Arc... [email protected] , or by mail to: EPA Docket Center (EPA/DC), Environmental Protection Agency...., Washington, DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and...

  2. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

    Markman, D.W.

    1999-01-01

    Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

  3. 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...

  4. Nuclear regulatory regime in Lithuania

    International Nuclear Information System (INIS)

    Kutas, S.

    1999-01-01

    The Law on Nuclear Energy establishes the legal basis for nuclear safety in the Republic of Lithuania. It assigns the responsibility for safety to the operating organization of a nuclear facility and outlines the tasks of the operator and the regulatory authority. According to this Law, the Nuclear Power Safety Inspectorate (VATESI) shall implement state regulation of nuclear safety. Standards and rules, guides and regulations of nuclear safety and radiation protection approved by the Government or by the institutions authorised. It is mandatory for all public and local authorities, enterprises, institutions, organisations, their associations, the officials and other persons whose activities are related to the operation of nuclear facilities, to the use and management of nuclear and radioactive materials therein. Safety guarantee in nuclear energy based on the requirements of the laws and regulations of the Republic of Lithuania, on the requirements of the international treaties to which the Republic of Lithuania is a party, also on the recommendations of the IAEA and other international organisations and authorities

  5. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  6. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-04-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  7. Through the regulatory hoop

    International Nuclear Information System (INIS)

    Kirner, N.P.

    1985-01-01

    There are many regulatory hoops through which waste generators, brokers, and disposal site operators must jump to dispose of waste safely. As the proposed exclusionary date of January 1, 1986, approaches, these regulatory hoops have the distinct possibility of multiplying or at least changing shape. The state of Washington, in its role as an Agreement State with the US Nuclear Regulatory Commission, licenses and inspects the commercial operator of the Northwest Compact's low-level radioactive waste disposal site on the Hanford Reservation. Washington has received as much as 53%, or 1.4 million cubic feet per year, of the nation's total volume of waste disposed. To control such a large volume of waste, a regulatory program involving six agencies has developed over the years in Washington

  8. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Liver Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  10. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  12. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  13. Drugs Approved for Skin Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  15. Drugs Approved for Wilms Tumor

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  16. Drugs Approved for Lung Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  17. Drugs Approved for Bone Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  18. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  19. Drugs Approved for Penile Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  20. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  1. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  2. Is It Really FDA Approved?

    Science.gov (United States)

    ... satisfaction before companies can market them in interstate commerce. Some examples of biologics that require approval are ... it means the agency has determined that the benefits of the product outweigh the known risks for ...

  3. Electronic Voucher Approval - Financial Management

    Data.gov (United States)

    US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...

  4. The limits of evidence in drug approval and availability: a case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication.

    Science.gov (United States)

    Hong, Haeyeon; Mackey, William C

    2014-08-01

    Despite numerous efforts to develop effective medications for the treatment of intermittent claudication (IC) over the past 4 decades, a gold standard medical management option has yet to be defined. Although not life-threatening, IC interferes with mobility and activities of daily living, significantly impairing quality of life and potentially causing depression. Cilostazol, the leading pharmacologic agent for IC in the United States, was approved by the US Food and Drug Administration (FDA) in 1999 based on controversial data. Meanwhile, naftidrofuryl, the first-line pharmacologic agent for IC in the United Kingdom and Europe, has never been approved by the FDA and therefore is not available in the United States. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect impossible. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted, because the manufacturers of these agents have much to lose and little to gain from such a study. This article provides an overview of the pharmacology of cilostazol and naftidrofuryl, and the clinical studies leading to their approval and clinical acceptance. It further explores the possible sources of bias in analyzing these clinical trials, some of which have been brought to light by the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom in its technology appraisal guidance. It also speculates the ways in which economic incentives may affect drug-marketing decisions. A literature review of pharmacology and clinical trials for cilostazol and naftidrofuryl was performed in PubMed. The majority of included clinical trials were initially identified through the most recent Cochrane review articles as well as the FDA's approval packet for cilostazol. The

  5. Current regulatory and licensing status for byproduct sources, facilities and applications

    International Nuclear Information System (INIS)

    Tingey, G.L.; Jensen, G.A.; Hazelton, R.F.

    1985-02-01

    Public use of nuclear byproducts, especially radioactive isotopes, will require approval by various regulatory agencies. Use of cesium-137 as an irradiation source for sterilizing medical products will require US Nuclear Regulatory Commission (NRC) approval. Two applications have been filed with NRC, and approval is expected soon. Widespread use of irradiation for food products depends on a favorable ruling by the Food and Drug Administration (FDA). A ruling is pending that would permit irradiation of fruits and vegetables up to 100 krad. NRC also controls the use of isotopes in remote power generators, but little regulatory action has been required in recent years. Recent development of radioluminescent (RL) lighting for runway lights has led to interest by commercial manufacturers. At the present time, a license has been issued to at least one manufacturer for sale of tritium-powered runway lights. 28 refs., 1 fig

  6. Energy Projects, Social Licence, Public Acceptance and Regulatory Systems in Canada: A White Paper

    Directory of Open Access Journals (Sweden)

    John Colton

    2016-05-01

    recommendations include: 1. Governmental Coordination. Greater coordination of regulatory processes between the federal and provincial governments is required and should be directed towards enhancing beneficial outcomes for all affected stakeholders (Section 6.1. 2. Stakeholder Engagement. A consistent, transparent and rigorous system for identifying and reaching out to stakeholders is essential to regulatory efficiency and efficacy (Section 6.2. 3. Social Licence as a Concept. When it comes to energy development, the term “social licence” needs to be further analyzed, and, if used, used with care (Section 6.3. 4. First Nations. The federal and provincial governments should take ownership of this duty to consult and ensure that it is done in a comprehensive manner that has been set out by both domestic and international law (Section 6.4. 5. Changes to the NEB Act. An independent review of the changes to the NEB Act regarding time to consult and the list of those who can be consulted should be undertaken to ensure the NEB is unconstrained in its ability to regulate appropriately and has public confidence in its mandate and decisions (Section 6.5. 6. Make Broader Use of Information Gained during Assessment Processes. Energy regulators should consider mechanisms to report recurring concerns that are outside of the scope of their mandate (Section 6.6. 7. Compliance after Project Approval. There is a need for publicly available, timely and relevant data relating to the compliance and post-approval status of projects. Data should be placed on a government portal to increase accessibility to stakeholders (Section 6.7. 8. Cross-Examination in Regulatory Hearings. The extensiveness of permitted cross-examination, and indeed the entire regulatory proceeding, needs to be proportionate to the magnitude of the impacts of the ultimate decision (Section 6.8.

  7. 76 FR 11288 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2011-03-01

    ..., telephone: 301-492- 3303 or e-mail; [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The U..., the public can gain entry into ADAMS, which provides text and image files of NRC's public documents... analysis may be found in ADAMS under Accession No. ML102350573. Regulatory guides are not copyrighted, and...

  8. 76 FR 10917 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2011-02-28

    ..., telephone: 301-251- 7627 or e-mail: [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The... . From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's....nrc.gov/reading-rm/doc-collections/ . The regulatory analysis may be found in ADAMS under Accession No...

  9. Legislative and regulatory framework of radioactive waste management in Romania

    International Nuclear Information System (INIS)

    Cutoiu, D.

    2000-01-01

    The paper intent is to present an update on the Romanian legislative and regulatory framework in the area of radioactive waste management. Based on the experiences gained by the National Commission for Nuclear Activities Control in the past years, the recent legislative initiatives related to the coherent radwaste management policy at the national level are presented. (author)

  10. Transportation of Large Wind Components: A Permitting and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron [National Renewable Energy Lab. (NREL), Golden, CO (United States); Cook, Jeff [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2016-09-01

    This report summarizes permitting and regulatory issues associated with transporting wind turbine blades, towers, and nacelles as well as large transformers (wind components). These wind components are commonly categorized as oversized and overweight (OSOW) and require specific permit approvals from state and local jurisdictions. The report was developed based on a Quadrennial Energy Review (QER) recommendation on logistical requirements for the transportation of 'oversized or high-consequence energy materials, equipment, and components.'

  11. Regulatory Promotion of Emergent CCS Technology

    Energy Technology Data Exchange (ETDEWEB)

    Davies, Lincoln; Uchitel, Kirsten; Johnson, David

    2014-01-01

    Despite the growing inevitability of climate change and the attendant need for mitigation strategies, carbon capture and sequestration (CCS) has yet to gain much traction in the United States. Recent regulatory proposals by the U.S. Environmental Protection Agency (EPA), limited in scope to new-build power plants, represent the only significant policy initiative intended to mandate diffusion of CCS technology. Phase I of this Project assessed barriers to CCS deployment as prioritized by the CCS community. That research concluded that there were four primary barriers: (1) cost, (2) lack of a carbon price, (3) liability, and (4) lack of a comprehensive regulatory regime. Phase II of this Project, as presented in this Report, assesses potential regulatory models for CCS and examines where those models address the hurdles to diffusing CCS technology identified in Phase I. It concludes (1) that a CCS-specific but flexible standard, such as a technology performance standard or a very particular type of market-based regulation, likely will promote CCS diffusion, and (2) that these policies cannot work alone, but rather, should be combined with other measures, such as liability limits and a comprehensive CCS regulatory regime.

  12. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

    Ms. Ruusaliisa Leinonen and Mr. Magnus Halin from Fortum gave a joint presentation on industry perceptions of regulatory oversight of LMfS/SC. It was concluded that an open culture of discussion exists between the regulator (STUK) and the licensee, based on the common goal of nuclear safety. An example was provided of on how regulatory interventions helped foster improvements to individual and collective dose rate trends, which had remained static. Regulatory interventions included discussions on the ALARA concept to reinforce the requirement to continuously strive for improvements in safety performance. Safety culture has also been built into regulatory inspections in recent years. Training days have also been organised by the regulatory body to help develop a shared understanding of safety culture between licensee and regulatory personnel. Fortum has also developed their own training for managers and supervisors. Training and ongoing discussion on LMfS/SC safety culture is considered particularly important because both Fortum and the regulatory body are experiencing an influx of new staff due to the demographic profile of their organisations. It was noted that further work is needed to reach a common understanding of safety culture on a practical level (e.g., for a mechanic setting to work), and in relation to the inspection criteria used by the regulator. The challenges associated with companies with a mix of energy types were also discussed. This can make it more difficult to understand responsibilities and decision making processes, including the role of the parent body organisation. It also makes communication more challenging due to increased complexity and a larger number of stakeholders

  13. Influences of finite gain bandwidth on pulse propagation in parabolic fiber amplifiers with distributed gain profiles

    International Nuclear Information System (INIS)

    Zhao Jia-Sheng; Li Pan; Chen Xiao-Dong; Feng Su-Juan; Mao Qing-He

    2012-01-01

    The evolutions of the pulses propagating in decreasing and increasing gain distributed fiber amplifiers with finite gain bandwidths are investigated by simulations with the nonlinear Schrödinger equation. The results show that the parabolic pulse propagations in both the decreasing and the increasing gain amplifiers are restricted by the finite gain bandwidth. For a given input pulse, by choosing a small initial gain coefficient and gain variation rate, the whole gain for the pulse amplification limited by the gain bandwidth may be higher, which is helpful for the enhancement of the output linearly chirped pulse energy. Compared to the decreasing gain distributed fiber amplifier, the increasing gain distributed amplifier may be more conducive to suppress the pulse spectral broadening and increase the critical amplifier length for achieving a larger output linearly chirped pulse energy

  14. Energy Gaining Windows for Residental Buildings

    DEFF Research Database (Denmark)

    Kragh, Jesper; Laustsen, Jacob Birck; Svendsen, Svend

    2008-01-01

    This paper presents some of the research done during the last 8 years at the Technical University of Denmark developing improved low-energy window solutions. The focus has been on maximizing the net energy gain of windows for residential buildings. The net energy gain of windows is the solar gain...... minus the heat loss integrated over the heating season. It is assumed that in northern cold climates all of the solar gain during the heating season can be utilized for space heating. Problems with overheating in the summer period must be solved with overhang or moveable solar shading devices. Two...... and longer durability of the window. The glazing in these fiber reinforced polyester windows is both unsealed and sealed triple glazing units. To increase the net energy gain slim frame profiles have been developed to increase the glazing area and thereby the solar gain. The challenge when developing slim...

  15. ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

    Energy Technology Data Exchange (ETDEWEB)

    Hope Morgan; Richard A. Varela; Deborah LaHood; Susan Cisco; Mary Ann Benavides; Donna Burks

    2002-11-01

    The Texas Railroad Commission (RRC), working in partnership with the United States Department of Energy and the oil and gas industry it regulates, is implementing a strategy for improving efficiency in regulations and significantly reducing administrative operating costs through the Electronic Compliance and Approval Process (ECAP). The project will streamline regulatory compliance and reporting by providing the ability to electronically submit, process, and query oil and gas applications and reports through the Internet-based ECAP system. Implementation of an ECAP drilling permit pilot project began September 1999 after funding resources were secured--a $700,000 grant from the U.S. Department of Energy and an appropriation of $1.4 million from the Texas Legislature. The pilot project involves creating the ability to file, review, and approve a well's drilling permit application through a completely electronic process. The pilot project solution will ultimately provide the infrastructure, technology, and electronic modules to enable the filing of all compliance permits and performance reports through the internet from a desktop computer. The pilot project was conducted in three phases. The first phase, implemented May 2000, provided the infrastructure that allows the electronic filing and approval of simple drilling permit applications, associated fees, and attachments. The official ''roll-out'' of ECAP and the first electronically filed drilling permit application occurred on May 11, 2000 in Dallas in conjunction with an Internet Workshop sponsored by the Petroleum Technology Transfer Council. After the completion of Phase I, the ECAP team conducted an extensive review of progress to date and analyzed requirements and opportunities for future steps. The technical team identified core infrastructure modifications that would facilitate and better support future development and expansion of the ECAP system and work began on database structure

  16. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    Wieland, Patricia; Almeida, Ivan Pedro Salati de

    2011-01-01

    The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

  17. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    2005-01-01

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)

  18. Russian Experience in the Regulatory Supervision of the Uranium Legacy Sites - 12441

    Energy Technology Data Exchange (ETDEWEB)

    Kiselev, M.F.; Romanov, V.V. [Federal Medical Biological Agency, Moscow (Russian Federation); Shandala, N.K.; Titov, A.V.; Kiselev, S.M.; Seregin, V.A.; Metlyaev, E.G.; Novikova, N. [Burnasyan Federal Medical Biophysical Centre, Moscow (Russian Federation); Khokhlova, E.A. [Regional Management-107 under FMBA of Russia, Krasnokamensk (Russian Federation)

    2012-07-01

    Management of the uranium legacy is accompanied with environmental impact intensity of which depends on the amount of the waste generated, the extent of that waste localization and environmental spreading. The question is: how hazardous is such impact on the environment and human health? The criterion for safety assurance is adequate regulation of the uranium legacy. Since the establishment of the uranium industry, the well done regulatory system operates in the FMBA of Russia. Such system covers inter alia, the uranium legacy. This system includes the extent laboratory network of independent control and supervision, scientific researches, regulative practices. The current Russian normative and legal basis of the regulation and its application practice has a number of problems relating to the uranium legacy, connected firstly with the environmental remediation. To improve the regulatory system, the urgent tasks are: -To introduce the existing exposure situation into the national laws and standards in compliance with the ICRP system. - To develop criteria for site remediation and return, by stages, to uncontrolled uses. The similar criteria have been developed within the Russian-Norwegian cooperation for the purpose of remediation of the sites for temporary storage of SNF and RW. - To consider possibilities and methods of optimization for the remediation strategies under development. - To separate the special category - RW resulted from uranium ore mining and dressing. The current Russian RW classification is based on the waste subdivision in terms of the specific activities. Having in mind the new RW-specific law, we receive the opportunity to separate some special category - RW originated from the uranium mining and milling. Introduction of such category can simplify significantly the situation with management of waste of uranium mining and milling processes. Such approach is implemented in many countries and approved by IAEA. The category of 'RW originated

  19. Measurement of Antenna Bore-Sight Gain

    Science.gov (United States)

    Fortinberry, Jarrod; Shumpert, Thomas H.

    2016-01-01

    The absolute or free-field gain of a simple antenna can be approximated using standard antenna theory formulae or for a more accurate prediction, numerical methods may be employed to solve for antenna parameters including gain. Both of these methods will result in relatively reasonable estimates but in practice antenna gain is usually verified and documented via measurements and calibration. In this paper, a relatively simple and low-cost, yet effective means of determining the bore-sight free-field gain of a VHF/UHF antenna is proposed by using the Brewster angle relationship.

  20. The US regulatory framework

    International Nuclear Information System (INIS)

    MacDonald, C.E.

    1984-01-01

    The chapter discusses the following: a brief account is given of the regulations covering the transportation of radioactive materials in the USA; departmental responsibilities; design of casks; packaging; approval of routes for transport of spent fuel; physical protection against theft or sabotage; inspection; safety standards. (U.K.)

  1. Needs of research for regulatory purposes

    International Nuclear Information System (INIS)

    Wanner, H.

    2010-01-01

    Hans Wanner, Swiss Federal Nuclear Safety Inspectorate (ENSI), presented a general overview of regulatory research at the international level based on a preliminary input from international colleagues and observed that the question of active involvement of nuclear regulatory and supervisory bodies in R and D projects has become a topic of increasing interest in recent years even if the way in which research is included in regulatory activities varies from country to country. The range spans from countries with no regulatory R and D activities to countries with extensive activities that are often carried out by independent research organisations acting on behalf of the regulatory body. In a few countries, the regulator and implementer have their research carried out by the same research institutes. As an example H. Wanner explained the organisation of R and D work in Switzerland. He presented the potential merits of R and D work carried out by the regulator and introduced a number of questions that would gain from being addressed at an international level. He stressed that the R and D work performed by the implementer must be comprehensive and there should be, in principle, no need for complementary work by the regulatory body. Nevertheless, R and D work of the regulator has still several merits. It improves the regulator's necessary competence to review the safety case allowing it to rely on the scientific community. It provides the regulator's independence, allowing a different view on the safety case from the implementer's view. By bringing to the fore the scientific and technical ability of the regulator, R and D work by the regulator provides additional confidence to the stakeholders in the credibility of the regulator. There may exist further motivations for the regulator to carry out its own R and D projects, among which is the verification of key safety issues or the investigation of topics not addressed by the implementer, i.e., to fill scientific gaps. The

  2. Humanitarian Use Device and Humanitarian Device Exemption regulatory programs: pros and cons.

    Science.gov (United States)

    Bernad, Daniel Maxwell

    2009-03-01

    The US FDA established the Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) program to encourage medical device firms to address rare diseases. Despite being in existence for over a decade, there has only been one peer-reviewed publication examining this field. The objective of this report is to investigate how the HUD/HDE program differs from the standard regulatory system, discuss its potential advantages and disadvantages, and to speculate which humanitarian devices will be brought to market within the next 5 years. A total of 40 semistructured interviews with stakeholders, representing approximately half (n = 20, 49%) of the firms that have successfully obtained HDE-approved products, were performed in order to acquire the primary data for this paper. There appear to be short-term gains and long-term drains associated with launching humanitarian devices to market. This report aims to provide sponsors with information that may allow them to make better decisions during their product development of humanitarian devices and may, hopefully, also play a role in encouraging other sponsors to take the necessary steps forward in helping to find treatments for patients with rare diseases.

  3. Nuclear Regulatory Legislation

    International Nuclear Information System (INIS)

    1989-08-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 100th Congress, 2nd Session, has been prepared by the Office of the General Counsel, US Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document. Persons using this document are placed on notice that it may not be used as an authoritative citation in lieu of the primary legislative sources. Furthermore, while every effort has been made to ensure the completeness and accuracy of this material, neither the United States Government, the Nuclear Regulatory Commission, nor any of their employees makes any expressed or implied warranty or assumes liability for the accuracy or completeness of the material presented in this compilation

  4. Regulatory compliance guide for DOT-7A type A packaging design

    International Nuclear Information System (INIS)

    Kelly, D.L.

    1996-01-01

    The purpose of this guide is to provide instruction for assuring that the regulatory design requirements for a DOT-7A Type A packaging are met. This guide also supports the testing and evaluation activities that are performed on new packaging designs by a DOE-approved test facility through the DOE's DOT-7A Test Program. This Guide was updated to incorporate regulatory changes implemented by HM-169A (49 CFR, 'Transportation')

  5. Efficiency Gains and Myopic Antitrust Authority in a Dynamic Merger Game

    OpenAIRE

    MOTTA, Massimo; VASCONCELOS, Helder

    2003-01-01

    This Paper models a sequential merger formation game with endogenous efficiency gains in which every merger has to be submitted for approval to the Antitrust Authority (AA). Two different types of AA are studied: first, a myopic AA, which judges a given merger without considering that subsequent mergers may occur; and, second, a forward-looking AA, which anticipates the ultimate market structure a given merger will lead to. By contrasting the decisions of these two types of AA, merger policy ...

  6. 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

  7. Prediction of regulatory elements

    DEFF Research Database (Denmark)

    Sandelin, Albin

    2008-01-01

    Finding the regulatory mechanisms responsible for gene expression remains one of the most important challenges for biomedical research. A major focus in cellular biology is to find functional transcription factor binding sites (TFBS) responsible for the regulation of a downstream gene. As wet......-lab methods are time consuming and expensive, it is not realistic to identify TFBS for all uncharacterized genes in the genome by purely experimental means. Computational methods aimed at predicting potential regulatory regions can increase the efficiency of wet-lab experiments significantly. Here, methods...

  8. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

    Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  9. Weight gain following treatment of hyperthyroidism.

    Science.gov (United States)

    Dale, J; Daykin, J; Holder, R; Sheppard, M C; Franklyn, J A

    2001-08-01

    Patients frequently express concern that treating hyperthyroidism will lead to excessive weight gain. This study aimed to determine the extent of, and risk factors for, weight gain in an unselected group of hyperthyroid patients. We investigated 162 consecutive hyperthyroid patients followed for at least 6 months. Height, weight, clinical features, biochemistry and management were recorded at each clinic visit. Documented weight gain was 5.42 +/- 0.46 kg (mean +/- SE) and increase in BMI was 8.49 +/- 0.71%, over a mean 24.2 +/- 1.6 months. Pre-existing obesity, Graves' disease causing hyperthyroidism, weight loss before presentation and length of follow-up each independently predicted weight gain. Patients treated with thionamides or radioiodine gained a similar amount of weight (thionamides, n = 87, 5.16 +/- 0.63 kg vs. radioiodine, n = 62, 4.75 +/- 0.57 kg, P = 0.645), but patients who underwent thyroidectomy (n = 13) gained more weight (10.27 +/- 2.56 kg vs. others, P = 0.007). Development of hypothyroidism (even transiently) was associated with weight gain (never hypothyroid, n = 102, 4.57 +/- 0.52 kg, transiently hypothyroid, n = 29, 5.37 +/- 0.85 kg, on T4, n = 31, 8.06 +/- 1.42 kg, P = 0.014). This difference remained after correcting for length of follow-up. In the whole cohort, weight increased by 3.95 +/- 0.40 kg at 1 year (n = 144) to 9.91 +/- 1.62 kg after 4 years (n = 27) (P = 0.008), representing a mean weight gain of 3.66 +/- 0.44 kg/year. We have demonstrated marked weight gain after treatment of hyperthyroidism. Pre-existing obesity, a diagnosis of Graves' disease and prior weight loss independently predicted weight gain and weight continued to rise with time. Patients who became hypothyroid, despite T4 replacement, gained most weight.

  10. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2001-01-01

    These columns treat of the legislative and regulatory activities of different OECD countries: Australia (environment protection and biodiversity conservation act and regulations, 1999-2000); Bulgaria (basic standards for radiation protection, 2000); France (decree on the standard tax charged on polluting activities due from operators of installations classified for environmental protection purposes, 2000; amendment of the orders on the transport of dangerous goods by road and by rail, 2000); Georgia (law on nuclear and radiation safety, 1998); Germany (amendments to nuclear legislation implementing EURATOM directives, 2000; amendment to the nuclear third party liability provisions of the atomic energy act, 2001; amendment to the foreign trade ordinance, 2000; ordinance on the treatment of foodstuffs with radiation, 2000; general administrative regulations on radioactivity limits in food and feeds); Ireland (European communities regulations on foodstuffs treated with ionizing radiations, 2000); Japan (law for nuclear sitting area development, 2000; Republic of Korea (amendments to the act on compensation for nuclear damage, 2001); Latvia (act on radiation safety and nuclear safety, 2000); Lithuania (resolution approving the decommissioning program for Unit 1, Ignalina NPP, 2001); Luxembourg (grand-ducal regulations on the protection of the public against the risks resulting from ionizing radiation, 2000; grand-ducal regulations relating to foods and food ingredients treated with ionizing radiation, 2000); Mexico (norm regarding selection, qualification and training requirements for staff of a NPP, 2000; norm regarding solid residue as radioactive waste, 2000); Mongolia (law on nuclear weapons free status and its implementing resolution, 2000); Netherlands (amendment to the nuclear energy act, 2000); Norway (act on radiation and use of radiation, 2000); Pakistan (nuclear authority ordinance, 2001); Poland (atomic energy act, 2000); Spain (royal decree on activities

  11. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2013-01-01

    This section reviews the recent National legislative and regulatory activities: Algeria (Establishment of a nuclear security centre); Armenia (Amendment to the Law of the Republic of Armenia on the Safe Utilization of Atomic Energy for Peaceful Purposes); Brazil (creation of a Support Centre for Safety and Radiation Protection - Centro de Apoio a Seguranca Fisica Nuclear e Radiologica - CENASF); Canada (enacting of the Nuclear Terrorism Act,4 which amends the Criminal Code, creating four new Criminal Code offences related to nuclear terrorism; proposal to replace the existing Nuclear Liability Act with the increase of the amount of compensation available to address civil nuclear damage); France (National plan for the management of radioactive materials and waste - PNGMDR; Law No.2013-580 of 4 July 2013 authorising approval of the agreement between France and Monaco on the management of Monegasque radioactive waste in the French territory; Decree No.2013-675 of 25 July 2013 publishing an agreement of co-operation between France and Saudi Arabia for the development of nuclear energy for peaceful purposes); Germany (Act for retrieving radioactive waste from and decommissioning the Asse II Mine); Greece (Decree transposing Council Directive 2011/70/Euratom); Ireland (Adoption of European Communities Regulations on Carriage of Dangerous Goods by Road and Use of Transportable Pressure Equipment); Luxembourg (Transposition of Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste); Poland (New requirements for employees concerning radiological protection; New detailed requirements for nuclear facility siting, design, commissioning and operation, organisational unit commissioning, periodical safety assessment, decommissioning and fund contributions; New regulation on subsidies related to nuclear safety and radiological protection; New requirements on transparency of

  12. Top-level regulatory criteria for the standard MHTGR

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1986-10-15

    The Licensing Plan for the Standard MHTGR (Ref. 1) describes a program to support a U.S. Nuclear Regulatory Commission (NRC) design review and approval. The Plan calls for the submittal of Top-Level Regulatory Criteria to the NRC for concurrence with their completeness and acceptability for the MHTGR program. The Top-Level Regulatory Criteria are defined as the standards for judging licensability that directly specify acceptable limits for protection of the public health and safety and the environment. The criteria proposed herein are for normal plant operation and a broad spectrum of anticipated events, including accidents. The approach taken is to define a set of criteria which are general as opposed to being design specific. Specifically, it is recommended that criteria be met which: 1. Are less prescriptive than current regulation, thereby encouraging maximum flexibility in design approaches. 2. Are measurable. 3. Are not more strict than the criteria for current power plants.

  13. The persuasive effects of framing messages on fruit and vegetable consumption according to regulatory focus theory

    NARCIS (Netherlands)

    Dijkstra, Arie; Rothman, Alexander; Pietersma, Suzanne

    2011-01-01

    According to Regulatory Focus theory (RFT), outcomes in persuasive messages can be framed in four different ways, as gains, non-gains, losses or non-losses. In study 1, the persuasiveness of all four frames was compared and the presence/absence effect that was expected on the basis of the

  14. Recent FDA Regulatory Measures

    NARCIS (Netherlands)

    Grossman, M.R.

    2014-01-01

    The use of antimicrobial drugs (antibiotics) in animal feed or drinking water helps animals to gain weight more efficiently, but also contributes to antimicrobial resistance, which makes important antibiotics less effective and threatens public health.

  15. Environmental approvals in New Brunswick : economic considerations

    Energy Technology Data Exchange (ETDEWEB)

    Marrack, C.; Maitland, R. [Suez Renewable Energy North America, Houston, TX (United States)

    2008-07-01

    This presentation provided a timeline of economic considerations related to New Brunswick's regulatory approval process for wind power developments. The economics of wind power projects require careful consideration during the initial planning phases, as it is not yet known if projects are viable. Spending in the early stages of a project should therefore be limited to items that focus on components of the environmental impact assessment (EIA) process that include establishing a relationship with First Nations groups in the area, and conducting seasonal bird studies. Economic considerations change when project viability is confirmed, and developers can then progress to conducting traditional knowledge studies and further seasonal bird studies. Baseline information studies should be reviewed, and biophysical surveys should involve the identification of any wetlands, sensitive areas, and rare plants. Archaeology studies are also required by the provincial government, as well as bat studies to determine if the site has a resident population of bats. Public and stakeholder consultations and open houses should then be held with an adequate time-frame for the submission of questions and concerns and the development of mitigation strategies. Project viability should be confirmed before power purchase agreements (PPAs) are signed. After PPAs are signed, the largest economic consideration is the schedule-related risk associated with legal and financial problems. It was concluded that noise impact, visual impact, and socioeconomic assessments and studies can be conducted after the PPA is secured. tabs., figs.

  16. Some Numbers behind Canada's Decision to Adopt an Orphan Drug Policy: US Orphan Drug Approvals in Canada, 1997-2012.

    Science.gov (United States)

    Herder, Matthew; Krahn, Timothy Mark

    2016-05-01

    We examined whether access to US-approved orphan drugs in Canada has changed between 1997 (when Canada chose not to adopt an orphan drug policy) and 2012 (when Canada reversed its policy decision). Specifically, we looked at two dimensions of access to US-approved orphan drugs in Canada: (1) regulatory access; and (2) temporal access. Whereas only 63% of US-approved orphan drugs were granted regulatory approval in 1997, we found that regulatory access to US-approved orphan drugs in Canada increased to 74% between 1997 and 2012. However, temporal access to orphan drugs is slower in Canada: in a head-on comparison of 40 matched drugs, only two were submitted and four were approved first in Canada; moreover, the mean review time in Canada (423 days) was longer than that in the US (mean = 341 days), a statistically significant difference (t[39] = 2.04, p = 0.048). These results raise questions about what motivated Canada's apparent shift in orphan drug policy. Copyright © 2016 Longwoods Publishing.

  17. Maximum gain of Yagi-Uda arrays

    DEFF Research Database (Denmark)

    Bojsen, J.H.; Schjær-Jacobsen, Hans; Nilsson, E.

    1971-01-01

    Numerical optimisation techniques have been used to find the maximum gain of some specific parasitic arrays. The gain of an array of infinitely thin, equispaced dipoles loaded with arbitrary reactances has been optimised. The results show that standard travelling-wave design methods are not optimum....... Yagi–Uda arrays with equal and unequal spacing have also been optimised with experimental verification....

  18. Gain Shift Corrections at Chi-Nu

    Energy Technology Data Exchange (ETDEWEB)

    Brown, Tristan Brooks [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Univ. of Massachusetts, Lowell, MA (United States). Dept. of Physics and Applied Physics; Devlin, Matthew James [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-08-30

    Ambient conditions have the potential to cause changes in liquid scintillator detector gain that vary with time and temperature. These gain shifts can lead to poor resolution in both energy as well as pulse shape discrimination. In order to correct for these shifts in the Chi-Nu high energy array, a laser system has been developed for calibration of the pulse height signals.

  19. Nonunity gain minimal-disturbance measurement

    DEFF Research Database (Denmark)

    Sabuncu, Metin; Mišta, L.; Fiurášek, J.

    2007-01-01

    We propose and experimentally demonstrate an optimal nonunity gain Gaussian scheme for partial measurement of an unknown coherent state that causes minimal disturbance of the state. The information gain and the state disturbance are quantified by the noise added to the measurement outcomes...

  20. Efficiency gains, bounds, and risk in finance

    NARCIS (Netherlands)

    Sarisoy, Cisil

    2015-01-01

    This thesis consists of three chapters. The first chapter analyzes efficiency gains in the estimation of expected returns based on asset pricing models and examines the economic implications of such gains in portfolio allocation exercises. The second chapter provides nonparametric efficiency bounds

  1. Evaluating realized genetic gains from tree improvement.

    Science.gov (United States)

    J.B. St. Clair

    1993-01-01

    Tree improvement has become an essential part of the management of forest lands for wood production, and predicting yields and realized gains from forests planted with genetically-improved trees will become increasingly important. This paper discusses concepts of tree improvement and genetic gain important to growth and yield modeling, and reviews previous studies of...

  2. Regulatory activities in gaining assurance of training program effectiveness in Canada

    International Nuclear Information System (INIS)

    Legare, Michele

    2003-01-01

    This presentation shows the regulator's point of view on evaluating a training program effectiveness. The mission of the Training Program Evaluation Section of the Canadian Atomic Energy Control Board is to obtain and document assurance that the training of NPP operators is effective in providing them with the knowledge and skills needed to become and remain competent. Proposals are made to be considered when drafting the IAEA guideline on evaluation of training program effectiveness

  3. Management by regulatory inspection authorities of experience gained from safety related occurrences in nuclear power plants

    International Nuclear Information System (INIS)

    Tore, E.; Nilsson, R.

    1977-01-01

    A short description is given of the system used by the Swedish Nuclear Power Inspectorate to collect information of events occurring in nuclear power plants. The standard forms used by the utilities when reporting the events are described and a motivation given to their lay-out. The evaluation routine is defined and statistics given of events which occurred during the period July 1 1974 to December 31 1976. (author)

  4. Gain control mechanisms in spinal motoneurons

    Directory of Open Access Journals (Sweden)

    Michael David Johnson

    2014-07-01

    Full Text Available Motoneurons provide the only conduit for motor commands to reach muscles. For many years, motoneurons were in fact considered to be little more than passive wires. Systematic studies in the past 25 years however have clearly demonstrated that the intrinsic electrical properties of motoneurons are under strong neuromodulatory control via multiple sources. The discovery of potent neuromodulation from the brainstem and its ability to change the gain of motoneurons shows that the passive view of the motor output stage is no longer tenable. A mechanism for gain control at the motor output stage makes good functional sense considering our capability of generating an enormous range of forces, from very delicate (e.g. putting in a contact lens to highly forceful (emergency reactions. Just as sensory systems need gain control to deal with a wide dynamic range of inputs, so to might motor output need gain control to deal with the wide dynamic range of the normal movement repertoire. Two problems emerge from the potential use of the brainstem monoaminergic projection to motoneurons for gain control. First, the projection is highly diffuse anatomically, so that independent control of the gains of different motor pools is not feasible. In fact, the system is so diffuse that gain for all the motor pools in a limb likely increases in concert. Second, if there is a system that increases gain, probably a system to reduce gain is also needed. In this review, we summarize recent studies that show local inhibitory circuits within the spinal cord, especially reciprocal and recurrent inhibition, have the potential to solve both of these problems as well as constitute another source of gain modulation.

  5. Developing regulatory approaches

    International Nuclear Information System (INIS)

    Axelsson, Lars

    2012-01-01

    Lars Axelsson presented SSM progress on oversight of LMfS/SC since the Chester 1 Workshop in 2007. Current SSM approaches for safety culture oversight include targeted safety management and safety culture inspections, compliance inspections which cover aspects of safety management/safety culture and multi-disciplinary team inspections. Examples of themes for targeted inspections include management of ambiguous operational situations or other weak signals, understanding of and attitudes to Human Performance tools, the Safety Department's role and authority and Leadership for safety. All regulatory activities provide inputs for the SSM yearly safety evaluation of each licensee. A form has been developed to capture safety culture observations from inspections and other interactions with licensees. Analysis will be performed to identify patterns and provide information to support planning of specific Safety Culture activities. Training has been developed for regulatory staff to enhance the quality of regulatory interventions on safety culture. This includes a half-day seminar to provide an overview of safety culture, and a workshop which provides more in-depth discussion on cultural issues and how to capture those during regulatory activities. Future plans include guidance for inspectors, and informal seminars on safety culture with licensees

  6. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1992-07-01

    This document compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rule making which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  7. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-02-01

    This document is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considered action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  8. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1989-07-01

    This document is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  9. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1992-11-01

    This document provides a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  10. Comments on regulatory reform

    International Nuclear Information System (INIS)

    Hendrie, J.M.

    1982-01-01

    Nuclear regulatory reform is divided into two parts. The first part contains all those matters for which new legislation is required. The second part concerns all those matters that are within the power of the Commission under existing statutes. Recommendations are presented

  11. Comments on regulatory reform

    Energy Technology Data Exchange (ETDEWEB)

    Hendrie, J.M.

    1982-01-01

    Nuclear regulatory reform is divided into two parts. The first part contains all those matters for which new legislation is required. The second part concerns all those matters that are within the power of the Commission under existing statutes. Recommendations are presented.

  12. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  13. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  14. Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved quality assurance programs for radioactive material packages

    International Nuclear Information System (INIS)

    1983-01-01

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  15. 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.

  16. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  17. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  18. Drugs Approved for Testicular Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  19. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  20. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  1. Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-10-01

    The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date.

  2. Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages

    International Nuclear Information System (INIS)

    1990-10-01

    The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  3. Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages

    International Nuclear Information System (INIS)

    1989-10-01

    The purpose of this directory is to make available a convenient source of information on packaging which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  4. Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

    International Nuclear Information System (INIS)

    1995-10-01

    The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

  5. Respirator studies for the Nuclear Regulatory Commission. Protection factors for supplied-air respirators. Progress report, October 1, 1976--September 30, 1977

    International Nuclear Information System (INIS)

    Hack, A.; Bradley, O.D.; Trujillo, A.

    1977-12-01

    This report describes the work performed during FY 1977 for the Nuclear Regulatory Commission. The Protection Factors (efficiency) provided by 25 NIOSH approved supplied-air respirators were determined while the devices were worn by a panel of anthropometrically selected test subjects. The major recommendation was that demand-type respirators should neither be used nor approved

  6. 77 FR 22789 - Withdrawal of Approval of Part of a New Animal Drug Application; Tiamulin

    Science.gov (United States)

    2012-04-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0262... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of... to the production indications for use of increased rate of weight gain and improved feed efficiency...

  7. Optimal weight gain in triplet pregnancies.

    Science.gov (United States)

    Johnston, Robert C; Erfani, Hadi; Shamshirsaz, Amir A; Spiel, Melissa; Ravangard, Sam F; Shaman, Majid; Allaf, M Baraa; Shamshirsaz, Alireza A; Haeri, Sina

    2017-08-01

    To identify appropriate weight gain in triplet gestations, which may aid in reducing the risk of perinatal morbidity within this high-risk cohort. This retrospective cohort study evaluated all non-anomalous triplet pregnancies between 23 and 40 weeks' gestation resulting in live births at five tertiary-care medical centers between 1991 and 2011. Subjects were divided by pre-pregnancy BMI into underweight, normal-weight, overweight, and obese groups, and then stratified by low (gain (≥1.5 lbs/week). Primary outcomes included spontaneous preterm birth and preeclampsia. We included 116 mothers and 348 corresponding neonates for final analysis. The incidence of preeclampsia and preterm delivery less than 32 weeks' gestation was 37% and 41%, respectively. The incidence of preeclampsia increased with weight gain per week, but was not statistically different from subjects who gained less weight. We found no statistical correlation between weight gain per week and preterm delivery. We found no association between preeclampsia or preterm delivery and increasing weight gain in triplet pregnancies. The association with increased risk for preeclampsia was predominantly due to BMI effect. Based on the current study, recommendations for optimal weight gain in mothers with triplet gestations could not be defined.

  8. Personality type influence the gestational weight gain.

    Science.gov (United States)

    Franik, Grzegorz; Lipka, Nela; Kopyto, Katarzyna; Kopocińska, Joanna; Owczarek, Aleksander; Sikora, Jerzy; Madej, Paweł; Chudek, Jerzy; Olszanecka-Glinianowicz, Magdalena

    2017-08-01

    Pregnancy is frequently followed by the development of obesity. Aside from psychological factors, hormonal changes influence weight gain in pregnant women. We attempted to assess the potential association between personality type and the extent of gestational weight gain. The study group involved 773 women after term delivery (age 26.3 ± 3.9 years, body mass before pregnancy 61.2 ± 11.1 kg). Weight gain during pregnancy was calculated by using self-reported body mass prior to and during the 38th week of pregnancy. Personality type was assessed using the Polish version of the Framingham Type A Behavior Patterns Questionnaire (adapted by Juczynski). Two hundred forty-six (31.8%) study subjects represented type A personalities, 272 (35.2%) type B and 255 (33.0%) an indirect type. Gestational weight gain was related to the behavior patterns questionnaire score and age. In women gain was higher than in women with type B behavior of the same age. In women >30, the gestational weight gain was larger for type B personalities. Type A personality and increased urgency in younger pregnant women increases the risk of developing obesity during pregnancy in women below 30 years old. A higher level of competitiveness demonstrates a risk factor of excessive weight gain during pregnancy regardless of age.

  9. Controlling gain one photon at a time

    Science.gov (United States)

    Schwartz, Gregory W; Rieke, Fred

    2013-01-01

    Adaptation is a salient property of sensory processing. All adaptational or gain control mechanisms face the challenge of obtaining a reliable estimate of the property of the input to be adapted to and obtaining this estimate sufficiently rapidly to be useful. Here, we explore how the primate retina balances the need to change gain rapidly and reliably when photons arrive rarely at individual rod photoreceptors. We find that the weakest backgrounds that decrease the gain of the retinal output signals are similar to those that increase human behavioral threshold, and identify a novel site of gain control in the retinal circuitry. Thus, surprisingly, the gain of retinal signals begins to decrease essentially as soon as background lights are detectable; under these conditions, gain control does not rely on a highly averaged estimate of the photon count, but instead signals from individual photon absorptions trigger changes in gain. DOI: http://dx.doi.org/10.7554/eLife.00467.001 PMID:23682314

  10. Intrinsic gain modulation and adaptive neural coding.

    Directory of Open Access Journals (Sweden)

    Sungho Hong

    2008-07-01

    Full Text Available In many cases, the computation of a neural system can be reduced to a receptive field, or a set of linear filters, and a thresholding function, or gain curve, which determines the firing probability; this is known as a linear/nonlinear model. In some forms of sensory adaptation, these linear filters and gain curve adjust very rapidly to changes in the variance of a randomly varying driving input. An apparently similar but previously unrelated issue is the observation of gain control by background noise in cortical neurons: the slope of the firing rate versus current (f-I curve changes with the variance of background random input. Here, we show a direct correspondence between these two observations by relating variance-dependent changes in the gain of f-I curves to characteristics of the changing empirical linear/nonlinear model obtained by sampling. In the case that the underlying system is fixed, we derive relationships relating the change of the gain with respect to both mean and variance with the receptive fields derived from reverse correlation on a white noise stimulus. Using two conductance-based model neurons that display distinct gain modulation properties through a simple change in parameters, we show that coding properties of both these models quantitatively satisfy the predicted relationships. Our results describe how both variance-dependent gain modulation and adaptive neural computation result from intrinsic nonlinearity.

  11. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2013-01-01

    This section compiles the presentations of the following texts sorted by country. Armenia - Licensing and regulatory infrastructure: New design safety requirements adopted, New seismic hazard assessment guidelines adopted; France - Licensing and regulatory infrastructure: Decree No. 2012-1248 of 9 November 2012 authorising the ITER Organisation to create the 'ITER' basic nuclear installation in Saint-Paul-lez-Durance (Bouches-du-Rhone); - Nuclear security: Law No. 2012-1473 of 28 December 2012 authorizing the approval of the Amendment to the Convention on the Physical Protection of Nuclear Material; - Nuclear safety and radiological protection: Complementary safety assessments. Follow-up of the stress tests carried out on French nuclear power plants. Action Plan of the French Nuclear Safety Authority (ASN) - December 2012; - International cooperation: Decree No. 2012-1178 of 22 October 2012 publishing the Cooperation Agreement between the government of the French Republic and the government of the Republic of Tunisia for the development of peaceful uses of nuclear energy, signed in Tunis on 23 April 2009; Decree No. 2012-1180 of 22 October 2012 publishing the Cooperation Agreement between the government of the French Republic and the government of Mongolia in the field of nuclear energy (with annex), signed in Ulaanbaatar on 14 October 2010; Germany - General legislation: Bill to amend the Atomic Energy Act to expedite the retrieval of radioactive waste from and to decommission the Asse II Mine (2013); Act to amend the Act on Environmental Legal Remedies and other environmental provisions (2013); - Radiation protection: General administrative rules on Section 47 of the Radiation Protection Ordinance (2012); - Nuclear Safety: Safety requirements for nuclear power plants (2012); - Transport of radioactive material: International Transport of Dangerous Goods by Road (2010, 2012); - Regulations on nuclear trade (including non-proliferation): Export List (2013); Greece

  12. Directory of certificates of compliance for radioactive materials packages. Volume 1, Revision 17: Report of NRC approved packages

    International Nuclear Information System (INIS)

    1994-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  13. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages

    International Nuclear Information System (INIS)

    1993-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  14. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance

    Science.gov (United States)

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2010-01-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus. PMID:20495689

  15. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance.

    Science.gov (United States)

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2008-08-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus.

  16. Point Information Gain and Multidimensional Data Analysis

    Directory of Open Access Journals (Sweden)

    Renata Rychtáriková

    2016-10-01

    Full Text Available We generalize the point information gain (PIG and derived quantities, i.e., point information gain entropy (PIE and point information gain entropy density (PIED, for the case of the Rényi entropy and simulate the behavior of PIG for typical distributions. We also use these methods for the analysis of multidimensional datasets. We demonstrate the main properties of PIE/PIED spectra for the real data with the examples of several images and discuss further possible utilizations in other fields of data processing.

  17. TCAD simulation of Low Gain Avalanche Detectors

    Science.gov (United States)

    Dalal, Ranjeet; Jain, Geetika; Bhardwaj, Ashutosh; Ranjan, Kirti

    2016-11-01

    In the present work, detailed simulation using Technology Computer Aided Design (TCAD) tool, Silvaco for non-irradiated and irradiated LGAD (Low Gain Avalanche Detector) devices has been carried out. The effects of different design parameters and proton irradiation on LGAD operation are discussed in detail. An already published effective two trap bulk damage model is used to simulate the radiation damage without implementing any acceptor removal term. The TCAD simulation for irradiated LGAD devices produce decreasing gain with increasing fluence, similar to the measurement results. The space charge density and electric field distribution are used to illustrate the possible reasons for the degradation of gain of the irradiated LGAD devices.

  18. TCAD simulation of Low Gain Avalanche Detectors

    Energy Technology Data Exchange (ETDEWEB)

    Dalal, Ranjeet; Jain, Geetika; Bhardwaj, Ashutosh, E-mail: ashutosh.bhardwaj@cern.ch; Ranjan, Kirti

    2016-11-11

    In the present work, detailed simulation using Technology Computer Aided Design (TCAD) tool, Silvaco for non-irradiated and irradiated LGAD (Low Gain Avalanche Detector) devices has been carried out. The effects of different design parameters and proton irradiation on LGAD operation are discussed in detail. An already published effective two trap bulk damage model is used to simulate the radiation damage without implementing any acceptor removal term. The TCAD simulation for irradiated LGAD devices produce decreasing gain with increasing fluence, similar to the measurement results. The space charge density and electric field distribution are used to illustrate the possible reasons for the degradation of gain of the irradiated LGAD devices.

  19. TCAD simulation of Low Gain Avalanche Detectors

    International Nuclear Information System (INIS)

    Dalal, Ranjeet; Jain, Geetika; Bhardwaj, Ashutosh; Ranjan, Kirti

    2016-01-01

    In the present work, detailed simulation using Technology Computer Aided Design (TCAD) tool, Silvaco for non-irradiated and irradiated LGAD (Low Gain Avalanche Detector) devices has been carried out. The effects of different design parameters and proton irradiation on LGAD operation are discussed in detail. An already published effective two trap bulk damage model is used to simulate the radiation damage without implementing any acceptor removal term. The TCAD simulation for irradiated LGAD devices produce decreasing gain with increasing fluence, similar to the measurement results. The space charge density and electric field distribution are used to illustrate the possible reasons for the degradation of gain of the irradiated LGAD devices.

  20. Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

    Science.gov (United States)

    Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

    2017-12-01

    Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

  1. Active rc filter permits easy trade-off of amplifier gain and sensitivity to gain

    Science.gov (United States)

    Kerwin, W. J.; Shaffer, C. V.

    1968-01-01

    Passive RC network was designed with zeros of transmission in the right half of the complex frequency plane in the feedback loop of a simple negative-gain amplifier. The proper positioning provides any desired trade-off between amplifier gain and sensitivity to amplifier gain.

  2. MOS current gain cells with electronically variable gain and constant bandwidth

    NARCIS (Netherlands)

    Klumperink, Eric A.M.; Seevinck, Evert

    1989-01-01

    Two MOS current gain cells are proposed that provide linear amplification of currents supplied by several linear MOS V-I converters. The gain is electronically variable by a voltage or a current and can be made insensitive to temperature and IC processing. The gain cells have a constant

  3. Detective quantum efficiency gains compared with speed gains for hypersensitized astronomical plates

    International Nuclear Information System (INIS)

    Kaye, A.L.

    1977-01-01

    It is reasonable to assume that gains in detective quantum efficiency (DQE) are far better criteria for assessing the performance of hypersensitizing techniques than gains in speed. It is shown here that gains in speed can be misleading, for some methods of hypersensitization give plates of increased speed but reduced detective quantum efficiency. (author)

  4. Nuclear Regulatory Commission information digest

    International Nuclear Information System (INIS)

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide

  5. Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages

    International Nuclear Information System (INIS)

    1979-10-01

    This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory

  6. Digital mammography. Why hasn't it been approved for U.S. hospitals?

    Science.gov (United States)

    2000-01-01

    Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

  7. Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages

    Energy Technology Data Exchange (ETDEWEB)

    None

    1979-10-01

    This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory.

  8. Regulatory experience in nuclear power station decommissioning

    International Nuclear Information System (INIS)

    Ross, W.M.; Waters, R.E.; Taylor, F.E.; Burrows, P.I.

    1995-01-01

    In the UK, decommissioning on a licensed nuclear site is regulated and controlled by HM Nuclear Installations Inspectorate on behalf of the Health and Safety Executive. The same legislative framework used for operating nuclear power stations is also applied to decommissioning activities and provides a continuous but flexible safety regime until there is no danger from ionising radiations. The regulatory strategy is discussed, taking into account Government policy and international guidance for decommissioning and the implications of the recent white paper reviewing radioactive waste management policy. Although each site is treated on a case by case basis as regulatory experience is gained from decommissioning commercial nuclear power stations in the UK, generic issues have been identified and current regulatory thinking on them is indicated. Overall it is concluded that decommissioning is an evolving process where dismantling and waste disposal should be carried out as soon as reasonably practicable. Waste stored on site should, where it is practical and cost effective, be in a state of passive safety. (Author)

  9. Food irradiation—US regulatory considerations

    Science.gov (United States)

    Morehouse, Kim M.

    2002-03-01

    The use of ionizing radiation in food processing has received increased interest as a means of reducing the level of foodborne pathogens. This overview discusses the regulatory issues connected with the use of this technology in the United States. Several recent changes in the FDA's review process are discussed. These include the current policy that utilizes an expedited review process for petitions seeking approval of additives and technologies intended to reduce pathogen levels in food, and the recent USDA rule that eliminates the need for a separate rulemaking process by USDA for irradiation of meat and poultry. Recently promulgated rules and pending petitions before the FDA associated with the use of ionizing radiation for the treatment of foods are also discussed along with the current FDA labeling requirements for irradiated foods and the 1999 advanced notice of proposed rule on labeling. Another issue that is presented is the current status of the approval of packaging materials intended for food contact during irradiation treatment of foods.

  10. Food irradiation--US regulatory considerations

    International Nuclear Information System (INIS)

    Morehouse, Kim M.

    2002-01-01

    The use of ionizing radiation in food processing has received increased interest as a means of reducing the level of foodborne pathogens. This overview discusses the regulatory issues connected with the use of this technology in the United States. Several recent changes in the FDA's review process are discussed. These include the current policy that utilizes an expedited review process for petitions seeking approval of additives and technologies intended to reduce pathogen levels in food, and the recent USDA rule that eliminates the need for a separate rulemaking process by USDA for irradiation of meat and poultry. Recently promulgated rules and pending petitions before the FDA associated with the use of ionizing radiation for the treatment of foods are also discussed along with the current FDA labeling requirements for irradiated foods and the 1999 advanced notice of proposed rule on labeling. Another issue that is presented is the current status of the approval of packaging materials intended for food contact during irradiation treatment of foods

  11. Value Assessment in the Regulatory Context.

    Science.gov (United States)

    Miller, Kathleen L; Woodcock, Janet

    2017-02-01

    Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable. To assist with these benefit-risk value assessments, CDER has two ongoing initiatives: the Patient-Focused Drug Development Initiative that aims to substantially increase the role of patient voice in the regulatory process, and a transparency initiative that focuses on creating a structured framework for benefit-risk assessment. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  12. Optical properties of nanowire metamaterials with gain

    DEFF Research Database (Denmark)

    Isidio de Lima, Joaquim Junior; Adam, Jost; Rego, Davi

    2016-01-01

    The transmittance, reflectance and absorption of a nanowire metamaterial with optical gain are numerically simulated and investigated. It is assumed that the metamaterial is represented by aligned silver nanowires embedded into a semiconductor matrix, made of either silicon or gallium phosphide....... The gain in the matrix is modeled by adding a negative imaginary part to the dielectric function of the semiconductor. It is found that the optical coefficients of the metamaterial depend on the gain magnitude in a non-trivial way: they can both increase and decrease with gain depending on the lattice...... constant of the metamaterial. This peculiar behavior is explained by the field redistribution between the lossy metal nanowires and the amplifying matrix material. These findings are significant for a proper design of nanowire metamaterials with low optical losses for diverse applications....

  13. Active Microwave Metamaterials Incorporating Ideal Gain Devices

    Directory of Open Access Journals (Sweden)

    Hao Xin

    2010-12-01

    Full Text Available Incorporation of active devices/media such as transistors for microwave and gain media for optics may be very attractive for enabling desired low loss and broadband metamaterials. Such metamaterials can even have gain which may very well lead to new and exciting physical phenomena. We investigate microwave composite right/left-handed transmission lines (CRLH-TL incorporating ideal gain devices such as constant negative resistance. With realistic lumped element values, we have shown that the negative phase constant of this kind of transmission lines is maintained (i.e., left-handedness kept while gain can be obtained (negative attenuation constant of transmission line simultaneously. Possible implementation and challenging issues of the proposed active CRLH-TL are also discussed.

  14. Transient optical gain in germanium quantum wells

    Energy Technology Data Exchange (ETDEWEB)

    Chatterjee, Sangam; Lange, Christoph; Koester, Niko S.; Schaefer, Martin; Kira, Mackillo; Koch, Stephan W. [Faculty of Physics and Materials Sciences Center, Philipps-Universitaet Marburg (Germany); Chrastina, Daniel; Isella, Giovanni; Kaenel, Hans von [CNISM, Como (Italy); L-NESS, Dipartimento di Fisica del Politecnico di Milano, Como (Italy); Sigg, Hans [Laboratory for Micro and Nanotecnology, Paul Scherrer Institut, Villigen PSI (Switzerland)

    2010-07-01

    One of today's most-sought goals in semiconductor technology is the monolithic integration of microelectronics and photonics on Si. Optical gain is, in general, not expected for Si and Ge or its alloys due to the indirect nature of the band gap in this material system. Here, we show that Ge/SiGe QWs show transient optical gain and may thus be used as an optically-pumped amplifier at room temperature. Further, the nonequilibrium effects which govern the relaxation dynamics of the optically injected carrier distributions in this material were observed and analyzed using a microscopic many-body theory. Strong non-equilibrium gain was obtained on a sub-100 fs time scale. Long-lived gain arising from {gamma}-point transitions is overcompensated by a process bearing the character of free carrier absorption.

  15. Characteristics of regulatory regimes

    Directory of Open Access Journals (Sweden)

    Noralv Veggeland

    2013-03-01

    Full Text Available The overarching theme of this paper is institutional analysis of basic characteristics of regulatory regimes. The concepts of path dependence and administrative traditions are used throughout. Self-reinforcing or positive feedback processes in political systems represent a basic framework. The empirical point of departure is the EU public procurement directive linked to OECD data concerning use of outsourcing among member states. The question is asked: What has caused the Nordic countries, traditionally not belonging to the Anglo-Saxon market-centred administrative tradition, to be placed so high on the ranking as users of the Market-Type Mechanism (MTM of outsourcing in the public sector vs. in-house provision of services? A thesis is that the reason may be complex, but might be found in an innovative Scandinavian regulatory approach rooted in the Nordic model.

  16. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-07-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter. The rules on which final action has been taken since March 31, 1993 are: Repeal of NRC standards of conduct; Fitness-for-duty requirements for licensees who possess, use, or transport Category I material; Training and qualification of nuclear power plant personnel; Monitoring the effectiveness of maintenance at nuclear power plants; Licensing requirements for land disposal of radioactive wastes; and Licensees' announcements of safeguards inspections

  17. 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.

  18. Renyi information gain on quantum key

    International Nuclear Information System (INIS)

    Brandt, Howard E

    2007-01-01

    The concept of maximum Renyi information gain from quantum key is important in eavesdropping and security analyses of quantum key distribution. It is particularly useful in the design optimization of eavesdropping probes. The present work reviews the quantitative measure of Renyi information gain, its optimization, and application to the design of eavesdropping probes in which single-photon probe states become optimally entangled with the signal states on their way between the legitimate transmitter and receiver

  19. Enhanced Gain in Photonic Crystal Amplifiers

    DEFF Research Database (Denmark)

    Ek, Sara; Semenova, Elizaveta; Hansen, Per Lunnemann

    2012-01-01

    We experimentally demonstrate enhanced gain in the slow-light regime of quantum well photonic crystal amplifiers. A strong gain enhancement is observed with the increase of the group refractive index, due to light slow-down. The slow light enhancement is shown in a amplified spontaneous emission....... These results are promising for short and efficient semiconductor optical amplifiers. This effect will also benefit other devices, such as mode locked lasers....

  20. 77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

    Science.gov (United States)

    2012-05-07

    ... postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the Patent and..., FDA-2010-E-0660, and FDA-2010-E-0659] Determination of Regulatory Review Period for Purposes of Patent... the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which...