3 edition of Value-impact analysis of regulatory options for resolution of generic issue C-8 found in the catalog.
Value-impact analysis of regulatory options for resolution of generic issue C-8
1990 by Division of Safety Issue Resolution, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission in Washington, DC .
Written in English
|Other titles||Value impact analysis of regulatory options for resolution of generic issue C-8.|
|Statement||prepared by J.D. Jamison, T.V. Vo, A.S. Tabatabai.|
|Contributions||Vo, T. V., Tabatabai, A. S., U.S. Nuclear Regulatory Commission. Division of Safety Issue Resolution., Pacific Northwest Laboratory.|
|The Physical Object|
|Pagination||1 v. (various pagings)|
regulatory decision making,including through the testing of alternative approaches and consulting with those affected, regulatory impact analysis seeks to delive r regulations (or other policy solutions) that provide the greatest benefits to the community. The value of regulatory impact analysis processes is accepted by all Australian governments. A regulatory impact analysis or regulatory impact assessment (RIA) is a document created before a new government regulation is introduced. RIAs are produced in many countries, although their scope, content, role and influence on policy making vary. Regulatory Impact Analysis: Frequently Asked Questions (FAQs) February 7, With this document, the Office of Information and Regulatory Affairs (OIRA) is providing answers to frequently asked questions about the regulatory impact analysis that is required by Executive Order and OMB Circular A 1. Social media erupted in September with news of Turing's % markup of pyrimethamine, a year-old drug used to treat toxoplasmosis. Overnight, the company's brash founder and chief executive, Martin Shkreli, became the poster child for industry greed run by: 3.
The Changing Face of Regulatory Reporting: Challenges and Opportunities for Financial Institutions. 4. As enhanced data quality, reporting, and management. requirements gain more prominence and their role in capital management intensifies, the industry would be wise to pay more attention to this key area. In , the BCBS issued guidance File Size: 1MB.
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NUREG/CR, "Value-Impact Analysis of Regulatory Options for Resolution of Generic Issue C MSIV Leakage and LCS Failure," U.S. Nuclear Regulatory Commission, May Memorandum for J. Taylor from E.
Beckjord, "Resolution of Generic Safety Issue C-8," Ma . Value-impact analysis of regulatory options for resolution of generic issue C MSIV leakage and LCS failure. [J D Jamison; T V Vo; A S Tabatabai; U.S.
Nuclear Regulatory Commission. Division of Safety Issue Resolution. These two volumes provide the documentation for industry resolution of the US Nuclear Regulatory Commission (NRC) generic issue B, Degradation and Failure of Bolting in Nuclear Power Plants.
The issue was identified as a consequence of concerns about the structural integrity of component supports circa Cited by: 3.
Imposition was the step in the generic issues program where each affected licensee and/or applicant was required or guided to prepare a schedule for implementing the generic issue resolution consistent with a Rule, Policy, Regulatory Guide, generic letter, bulletin, and/or licensing guidance developed during the resolution stage.
This report presents a summary of the regulatory analysis conducted by the US Nuclear Regulatory Commission staff to evaluate the value/impact of alternatives for the resolution of Unresolved Safety Issue A, ''Safety Implications of Control Systems.''.
Regulatory Analysis for the Resolution of Generic Safety Issue Piping and the Use of Highly Combustible Gases in Vital Areas: NUREG Functional Capability of Piping Systems: NUREG NRC Editorial Style Guide: NUREG Environmental Monitoring of Low-Level Radioactive Waste Disposal Facility: NUREG Regulatory analysis for the resolution of Generic Is ''Beyond design basis accidents in spent fuel pools'' the regulatory analysis for Generic Issue information that can be used.
Regulatory Impact Analysis (RIA) Manual. IntRoDuctIon to RegulatoRy Impact analysIs. What is RIa. Regulatory Impact Assessment (RIA) is a. process. of several steps which aims to analytically and systemically answer the question of. whether a regulatory intervention is needed, and if so.
which of the possible options is the best File Size: 1MB. Regulatory Impact Analysis - Europe Regulatory Environment in the European Generic Pharmaceutical Market Data Exclusivity • Uniform level of data protection of originator products for 10 years • Permits to access data of a generic application but the generic version cannot be launched until the completion of the ten-year period 8+2+1.
Regulatory reform through regulatory impact analysis: The Canadian experience by Apogee Research. 33 Chapter 3. Regulatory compliance cost assessment: UK experience by The Better Regulation Unit. 63 Chapter 4. An assessment of the US regulatory impact analysis programFile Size: 1MB.
Regulatory Impact Analysis: A Tool for Policy Coherence 11 Sept. Regulatory impact analysis (RIA) is a systemic approach to critically assessing the positive and negative effects of proposed and existing regulations and non-regulatory alternatives.
In addition, the cost analysis anticipated that the NRC would issue a bulletin requesting that licensees review their containment sumps and recirculation systems, as outlined in the proposed resolution.
The NRC cost for safety issue resolution (SIR) development was estimated to be $26, for the bulletin and $, for review of licensee. This report presents a summary of the regulatory analysis conducted by the NRC staff to evaluate the value and impact of potential alternatives for the resolution of Unresolved Safety Issue (USI) A, ''Systems Interactions in Nuclear Power Plants.''.
Regulatory Impact Analysis (RIA) is one of the most important regulatory quality tools available to governments. Its aim is to influence policy makers to adopt the most efficient and effective regulatory options, by requiring the use of evidence based techniques to analyse regulatory options.
GSR14 discussion paper Using Regulatory Impact Analysis to handle related issues in order to make the best use of tools such as RIA, and thus increase confidence in regulatory decision‐making.
(CBA), and risk analysis. Options scrutinized always have to. Regulatory Impact Analysis (RIA) is the systematic process of identification and quantification of benefits and costs likely to flow from regulatory or non-regulatory options for a. The Resolution advocates the need to elevate illicit trafficking in cultural objects as an issue of global concern and to identify and close gaps in the current legislation.
The United Nations Security Council (UNSC) has issued several Resolutions 7 supplementing. consequences of policy options and to promote the economic, environmental and social welfare goals that serve the interests of citizens.
The material in this publication can assist countries to improve their governance arrangements for promoting policy coherence through the incorporation of and refinements to systems for regulatory impact analysis. SFST Regulatory Conference, November, Presentation: "Industry Developed Generic Issue Resolution Programs Used Nuclear Fuel Storage and Transportation," Marc Nichol, Nuclear Energy Institute.
Author: ORPUser Created Date: 11/10/ AM. The Pacific Northwest Laboratory, under contract to the US Nuclear Regulatory Commission, has conducted an assessment of the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue ``Availability of Heating, Ventilation, and Air Conditioning (HVAC) and Chilled Water Systems.`` The key objectives of the study were to (a) identify vulnerabilities related to.
Current Developments in Guidance for Regulatory Bioanalysis Dr Gerry McGuire Resolution Analytical Consultancy Ltd Edinburgh, Scotland UK [email protected] 1st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution Amman, Jordan – File Size: KB.
Chapter 11 Presentation of Analysis and Results. An economic analysis of regulatory or policy options should present all identifiable costs.
and benefits that are incremental to the regulation or policy under consideration. These should include directly intended effects and associated costs, as well as ancillary (or co-) benefits and costs.
the analysis of advertising materialы found in health care organizations during the study visits. The evaluation reviewed the key issues of pharmaceutical promotion relevant to public health and healthcare system in Kyrgyzstan. Likewise in many other countries, the pharmaceutical promotion’s role.
Regulatory analysis for the resolution of generic issueenhancement of the reliability of the Westinghouse solid state protection system by D Basdekas (Book). Abstract. At a time when thousands of trade mark applications and registrations 1 for pharmaceuticals populate the world’s trade mark registers, it is becoming increasingly difficult to create, clear and protect pharmaceutical marks on a global basis.
Here we will explore the regulatory issues and legal aspects which impact on the creation of pharmaceutical brands as well as the criteria for Author: Alison Azulay. Overview of Regulatory Impact Analysis.
One of the vital components to developing regulations is to inform Government, stakeholders, and the public about the issue, context/background, options considered, and the impacts, economic and otherwise, as well as their distributional impacts to aid in decision making.
Cases Federal Trade Commission v. American Financial Support Services Inc., et al. Bureau of Consumer Financial Protection, et al.
Consumer Advocacy Center Inc. conceptual issues raised in the Guidelines and suggest how to pro- ceed with the analysis. The goal of regulatory impact analysis is to develop and organize information on benefits, costs, and economic impacts so as to clarify trade-offs among alternative regulatory options.*.
ABSTRACT. Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefits of regulation as well as solutions to current issues to enhance the decision-making process. Previous research suggests that adequate generic prices can be maintained with 4 or more producers.
When the threat of falling below this threshold emerges, CMS could work with the FDA to allow temporary importation of products by manufacturers vetted by stringent regulatory authorities around the by: 3.
through Executive Orderdirect agencies to perform regulatory impact analysis (RIA) on many proposed regulations. 1 Executive agencies must produce an RIA for any regulation the Office of Management and Budget designates as “significant.” 2 Analytical requirements are especially rigorous for.
analytic resources are targeted on those issues that are most important for decision-making. In addition, the analysis must assess related uncertainties. In Step 1, the agency defines the framework for the analysis, explaining the need for the regulatory action and identifying the regulatory and non-regulatory options that will be Size: KB.
Regulatory Impact Analysis: A Primer. With this document, the Office of Information and Regulatory Affairs is providing a primer to assist agencies in developing regulatory impact analyses (RIAs), as required for economically significant rules by Executive OrderExecutive Orderand File Size: KB.
A regulatory impact analysis is always published in the Federal Register. The Federal Register allows the analysis to be viewed by the public in order to determine the regulation's validity.
COVID Resources. Reliable information about the coronavirus (COVID) is available from the World Health Organization (current situation, international travel).Numerous and frequently-updated resource results are available from this ’s WebJunction has pulled together information and resources to assist library staff as they consider how to handle coronavirus.
Regulatory impact analyses (RIAs) apply a well-established and widely-used framework for collecting, organizing, and evaluating data on the anticipated consequences of alternative policies. They help ensure that regulatory actions are justified and necessary to achieve social goals, and that these actions are implemented in the most efficient, least burdensome, and most cost-effective manner.
Cost-benefit statement (template) table 1 note 1 Base Year Final Year Total (PV) table 1 note 2 Annualized Average table 1 note 3; A. Quantified Impacts (in Can$, YYYY table 1 note 4 price level / constant dollars). Table 1 Notes Table 1 Note 1 Indicate in notes below the table the time period (minimum 10 years) as well as the discount rate used for the analysis (real discount rate of 7 per.
Regulatory impact analysis (RIA) is a tool regulators use to help guide them through the decision-making process when promulgating regulations. The goals of an RIA are simple and straightforward: to assess whether a problem exists that is systemic in nature and therefore requires intervention, to define the desired outcome sought through intervention, to describe the various.
In this report, the staff of the US Nuclear Regulatory Commission provides a regulatory analysis for the proposed resolution of Generic Issue (GI), ``Loss of Essential Service Water in LWRS.`` GI deals with the concerns pertaining to the reliability of essential service water (ESW) system and related problems for all light water.
Generics: Bioequivalence is the major regulatory challenge for the development of a new generic 4, 5. According to the regulation a generic should have parameters like area under the concentration (AUC) time curve, the peak concentration (C max), and the time to peak concentration (t max).
One trend is that healthcare manufacturers are taking regulatory affairs issues more seriously and thus the analysis of them is getting more sophisticated. Another is that manufacturers are growing more interested in finding objective measures, from quantitative metrics to benchmarking, to assess regulatory compliance.A logistic binomial model is used to describe the relative odds of full compliance rather than regulatory avoidance by way of partial or creative compliance.
The analysis is based on the accounting policies adopted by internationally listed companies registered in Europe where, despite the harmonising impact of the European company law Cited by: 2.Recent reports have highlighted dramatic price increases for several older generic drugs, including a number of essential products used to treat deadly infectious diseases.
Although most of these medicines have been widely available at reasonable prices for decades, some manufacturers have seized on unique features of the pharmaceutical.