E-Rulemaking

2011 ◽  
pp. 713-717
Author(s):  
C. Coglianese
Keyword(s):  
Decision Making ◽  
Information Technology ◽  
The United States ◽  
Public Access ◽  
United States Government ◽  
Regulatory Agencies ◽  
Complex Nature ◽  
Regulatory Decision ◽  
The World ◽  
Regulatory Proposals

Throughout the world, governments use regulation to combat monopoly power, protect consumers, and reduce health, safety, and environmental risks. Regulation promotes the safety of transportation, the cleanliness of the air, and the quality of their food and drugs. Today, nearly every major aspect of contemporary public life is significantly affected by rules made by regulatory agencies, ministries, or bureaus (Kerwin, 2003). Given the consequential and complex nature of regulatory decision-making, crafting rules presents government agencies with significant informational challenges. Government regulators must collect information to understand the causes of regulatory problems, identify available regulatory options, and predict the effects of each alternative (Coglianese, Zeckhauser, & Parson, 2004). To develop a new rule, regulators must often undertake extensive studies and analyses and respond to comments from industry groups and other interested organizations. E-rulemaking—or the use of information technology in government rulemaking—promises to help regulatory agencies make rules more efficiently and with better quality (Brandon & Carlitz, 2002; Johnson, 1998). E-rulemaking may also help expand public access to and participation in government decision making. Despite the significance of regulatory decisions, they have often been made in relative obscurity, with organized business lobbies sometimes having disproportionate influence over policymaking. Information technology may facilitate greater transparency and democratic accountability in the rulemaking process. Already, regulatory agencies are making use of information technology to create Websites containing notices of new regulatory proposals and various background documents. They have also begun to allow citizens to use the Internet to share comments on new regulatory policies or engage in online dialogues (Beierle, 2003; Brandon & Carlitz, 2002). In early 2003, for example, the United States government launched a new Web portal called Regulations.Gov that allows the public to locate and comment on all new regulatory proposals announced by hundreds of federal regulatory agencies (Skrzycki, 2003). In addition, American officials are currently at work developing a government-wide, online docket system that will make available all the extensive information contained in each agency’s rulemaking files (Skrzycki, 2004). Efforts such as these are likely to continue and can be expected in other regulatory jurisdictions around the world.

E-Rulemaking

2011 ◽  
pp. 2769-2775
Author(s):  
Cary Coglianese
Keyword(s):  
Decision Making ◽  
Information Technology ◽  
The United States ◽  
Public Access ◽  
United States Government ◽  
Regulatory Agencies ◽  
Complex Nature ◽  
Regulatory Decision ◽  
The World ◽  
Regulatory Proposals

Throughout the world, governments use regulation to combat monopoly power, protect consumers, and reduce health, safety, and environmental risks. Regulation promotes the safety of transportation, the cleanliness of the air, and the quality of their food and drugs. Today, nearly every major aspect of contemporary public life is significantly affected by rules made by regulatory agencies, ministries, or bureaus (Kerwin, 2003). Given the consequential and complex nature of regulatory decision-making, crafting rules presents government agencies with significant informational challenges. Government regulators must collect information to understand the causes of regulatory problems, identify available regulatory options, and predict the effects of each alternative (Coglianese, Zeckhauser, & Parson, 2004). To develop a new rule, regulators must often undertake extensive studies and analyses and respond to comments from industry groups and other interested organizations. E-rulemaking—or the use of information technology in government rulemaking—promises to help regulatory agencies make rules more efficiently and with better quality (Brandon & Carlitz, 2002; Johnson, 1998). E-rulemaking may also help expand public access to and participation in government decision making. Despite the significance of regulatory decisions, they have often been made in relative obscurity, with organized business lobbies sometimes having disproportionate influence over policymaking. Information technology may facilitate greater transparency and democratic accountability in the rulemaking process. Already, regulatory agencies are making use of information technology to create Websites containing notices of new regulatory proposals and various background documents. They have also begun to allow citizens to use the Internet to share comments on new regulatory policies or engage in online dialogues (Beierle, 2003; Brandon & Carlitz, 2002). In early 2003, for example, the United States government launched a new Web portal called Regulations.Gov that allows the public to locate and comment on all new regulatory proposals announced by hundreds of federal regulatory agencies (Skrzycki, 2003). In addition, American officials are currently at work developing a government-wide, online docket system that will make available all the extensive information contained in each agency’s rulemaking files (Skrzycki, 2004). Efforts such as these are likely to continue and can be expected in other regulatory jurisdictions around the world.

“Little Plants in the Country”: Henry Ford's Village Industries and the Beginning of Decentralized Technology in Modern America

Prospects ◽  
1988 ◽  
Vol 13 ◽  
pp. 181-223 ◽  
Author(s):  
Howard P. Segal
Keyword(s):  
United States ◽  
Decision Making ◽  
New York ◽  
Information Processing ◽  
Real Estate ◽  
New York Times ◽  
The United States ◽  
Physical Proximity ◽  
The World ◽  
Word Processors

“Technology Spurs Decentralization Across the Country.” So reads a 1984 New York Times article on real-estate trends in the United States. The contemporary revolution in information processing and transmittal now allows large businesses and other institutions to disperse their offices and other facilities across the country, even across the world, without loss of the policy- and decision-making abilities formerly requiring regular physical proximity. Thanks to computers, word processors, and the like, decentralization has become a fact of life in America and other highly technological societies.

Security Council

1963 ◽  
Vol 17 (1) ◽  
pp. 226-230
Keyword(s):  
United States ◽  
Soviet Union ◽  
International Law ◽  
Security Council ◽  
The United States ◽  
United States Government ◽  
The Soviet Union ◽  
The World ◽  
Peace And Security ◽  
States Government

The Security Council discussed this question at its 1022nd–1025th meetings, on October 23–25, 1962. It had before it a letter dated October 22, 1962, from the permanent representative of the United States, in which it was stated that the establishment of missile bases in Cuba constituted a grave threat to the peace and security of the world; a letter of the same date from the permanent representative of Cuba, claiming that the United States naval blockade of Cuba constituted an act of war; and a letter also dated October 22 from the deputy permanent representative of the Soviet Union, emphasizing that Soviet assistance to Cuba was exclusively designed to improve Cuba's defensive capacity and that the United States government had committed a provocative act and an unprecedented violation of international law in its blockade.

Enhancing Regulatory Decision Making for Postmarket Drug Safety

2021 ◽  
Author(s):  
Vishal Ahuja ◽  
Carlos A. Alvarez ◽  
John R. Birge ◽  
Chad Syverson
Keyword(s):  
Decision Making ◽  
Operations Management ◽  
The United States ◽  
Pharmaceutical Products ◽  
Unintended Consequences ◽  
Surveillance Systems ◽  
Veterans Health ◽  
Health Administration ◽  
Regulatory Decision ◽  
Increased Risk

The U.S. Food and Drug Administration (FDA) regulates the approval and safe public use of pharmaceutical products in the United States. The FDA uses postmarket surveillance systems to monitor drugs already on the market; a drug found to be associated with an increased risk of adverse events (ADEs) is subject to a recall or a warning. A flawed postmarket decision-making process can have unintended consequences for patients, create uncertainty among providers and affect their prescribing practices, and subject the FDA to unfavorable public scrutiny. The FDA’s current pharmacovigilance process suffers from several shortcomings (e.g., a high underreporting rate), often resulting in incorrect or untimely decisions. Thus, there is a need for robust, data-driven approaches to support and enhance regulatory decision making in the context of postmarket pharmacovigilance. We propose such an approach that has several appealing features—it employs large, reliable, and relevant longitudinal databases; it uses methods firmly established in literature; and it addresses selection bias and endogeneity concerns. Our approach can be used to both (i) independently validate existing safety concerns relating to a drug, such as those emanating from existing surveillance systems, and (ii) perform a holistic safety assessment by evaluating a drug’s association with other ADEs to which the users may be susceptible. We illustrate the utility of our approach by applying it retrospectively to a highly publicized FDA black box warning (BBW) for rosiglitazone, a diabetes drug. Using comprehensive data from the Veterans Health Administration on more than 320,000 diabetes patients over an eight-year period, we find that the drug was not associated with the two ADEs that led to the BBW, a conclusion that the FDA evidently reached, as it retracted the warning six years after issuing it. We demonstrate the generalizability of our approach by retroactively evaluating two additional warnings, those related to statins and atenolol, which we found to be valid. This paper was accepted by Vishal Gaur, operations management.

scholarly journals HYDRAULIC ASPECTS OF WETLAND DESIGN

1988 ◽  
Vol 1 (21) ◽  
pp. 198
Author(s):  
James R. Walker ◽  
Andrea Bertolotti ◽  
Reinhard E. Flick ◽  
C. Robert Feldmeth
Keyword(s):  
The United States ◽  
Coastal Development ◽  
Regulatory Agencies ◽  
Tidal Wetlands ◽  
Basic Principles ◽  
Wetland Functions ◽  
Biological Features ◽  
The World ◽  
Key Features ◽  
Wetland Design

Tidal wetland preservation, restoration and creation have become requisites for coastal development projects in the United States. A basic approach to design of tidal wetlands is presented, stressing cooperation between regulatory agencies, biologists, engineers, and developers. Basic principles of wetland functions are explained and presented as criteria for engineering design. A description of wetlands is given to identify biological features relevant to design. Also, some key features of tides are summarized as they affect wetland design. A numerical model was used to demonstrate how tidal wetlands may be designed to conform with criteria developed by the agencies and biologists. This approach has been used on wetland designs in California, but the approach may be applicable to other areas of the world.

Regulatory Decision-Making and Economic Analysis

2017 ◽  
Author(s):  
Mariano-Florentino Cuéllar ◽  
Jerry L. Mashaw
Keyword(s):  
Public Health ◽  
United States ◽  
Decision Making ◽  
Economic Analysis ◽  
National Security ◽  
Technology Policy ◽  
The United States ◽  
Regulatory Activity ◽  
Regulatory Decision ◽  
Over Time

The economic analysis of regulation is a broad topic, with implications for environmental protection, communications and technology policy, public health, immigration, national security, and other areas affecting risk and welfare in society. This chapter covers only a portion of the relevant ground, focusing on the following essential topics: First, what do we mean by “economic analysis” and what do we mean by “regulation”? Second, why has this topic become an important one, not only the United States, but in most advanced democracies? Third, why is economic analysis and regulation a contested, even contentious, aspect of modern regulatory activity? Finally, and most important, how is economic analysis structured into regulatory decision-making, and how might existing arrangements evolve over time?

Are economists Kings? Economic evidence and discretionary assessments at the UK utility regulatory agencies

2020 ◽  
Author(s):  
Despoina Mantzari
Keyword(s):  
Decision Making ◽  
Electricity Markets ◽  
Political Action ◽  
Competition Law ◽  
Regulatory Agencies ◽  
Economic Regulation ◽  
Economic Evidence ◽  
Regulatory Decision ◽  
Trade Offs ◽  
The Impact

Abstract UK sectoral regulatory authorities are hybrid communities of, among others, lawyers and economists. Since the liberalization of essential services, expert economists enjoy broad discretionary powers in advancing the agencies’ broad statutory objectives. Yet, despite the significant societal impact of economic regulation, existing scholarship in the fields of competition law and regulation and public law has, with very few exceptions, disregarded these actors and the very essence of their work. This article aims to address this gap in the literature by blending theoretical with empirical insights deriving from 14 semi-structured elite interviews with regulatory economists in the regulatory agencies for energy (Office for Gas and Electricity Markets), telecoms (Office for Communications), and water (Office of Water Services). It explores the increased reliance on economics in the regulatory decision-making process and the impact this has had on the authorities’ decision-making and discretion, when making complex trade-offs between the various goals of the regulatory enterprise. In doing so, it puts forward a theoretical framework inspired by Craig Parsons’ typology of political action so as to identify and examine the nature and scope of the constraints that inform and shape the influence of economics in the exercise of regulatory discretion. This endeavour is significant in the sense that it is the first of its kind and, in that it provides a normative framework of analysis that can be applied in other areas of regulation heavily infused with and influenced by economic evidence and analysis, such as ‘pure’ competition law enforcement by both sectoral and competition authorities.

scholarly journals Worldwide Regulatory Guidance Values Applied to Direct Contact Surface Soil Pesticide Contamination: Part I—Carcinogenic Pesticides

2017 ◽  
Vol 10 ◽  
pp. 117862211771193 ◽  
Author(s):  
Aaron A Jennings ◽  
Zijian Li
Keyword(s):  
Surface Soil ◽  
Risk Model ◽  
The United States ◽  
Regulatory Agencies ◽  
Pesticide Contamination ◽  
Regulatory Guidance ◽  
Bounded Set ◽  
The World ◽  
Incidence Risk ◽  
Model Coefficient

Regulatory agencies worldwide have developed regulatory guidance values (RGVs) for nearly 800 pesticides. Analysis of the residential surface soil guidance values applied to the most frequently regulated current-use agriculture, home, and garden pesticides is presented. Part I concentrates on values applied to atrazine, simazine, and trifluralin. These are unique among commonly used pesticides because they are generally considered to be human carcinogens. Their use has been banned in much of the world, but they are commonly used in the United States. Regulatory guidance values applied to these 3 pesticides vary by 8.6, 5.5, and 5.1 orders of magnitude. Risk model coefficient–bounded set uncertainty analysis is applied to help analyze this variability. Cancer risk model uncertainty bounds appear to contain 36.3%, 43.0%, and 49.5% of the RGVs. Most of the remaining values appear to exceed a lifetime cancer incidence risk of 1 × 10−6 and may not be adequately protective of human health.

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