Examining The Use Of Agency Regulatory Guidance

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Examining the Use of Agency Regulatory Guidance

Author : United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs. Subcommittee on Regulatory Affairs and Federal Management
Publisher : Unknown
Page : 164 pages
File Size : 46,7 Mb
Release : 2016
Category : Administrative agencies
ISBN : IND:30000153896505

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Examining the Use of Agency Regulatory Guidance by United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs. Subcommittee on Regulatory Affairs and Federal Management Pdf

Optimizing the Nation's Investment in Academic Research

Author : National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century
Publisher : National Academies Press
Page : 283 pages
File Size : 50,7 Mb
Release : 2016-06-29
Category : Science
ISBN : 9780309379519

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Optimizing the Nation's Investment in Academic Research by National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century Pdf

Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

Legislative Calendar

Author : United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs
Publisher : Unknown
Page : 204 pages
File Size : 42,9 Mb
Release : 2015
Category : Electronic
ISBN : PURD:32754085747081

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Legislative Calendar by United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs Pdf

Rare Diseases and Orphan Products

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Page : 442 pages
File Size : 48,7 Mb
Release : 2011-04-03
Category : Medical
ISBN : 9780309158060

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Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Dietary Supplements

Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher : Unknown
Page : 32 pages
File Size : 41,6 Mb
Release : 1998
Category : Advertising
ISBN : UIUC:30112004816200

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Dietary Supplements by United States. Federal Trade Commission. Bureau of Consumer Protection Pdf

A Guide to the Making of Federal Acts and Regulations

Author : Canada. Department of Justice. Legislative Services Branch,Canada. Legislation and House Planning Secretariat
Publisher : Department of Justice Canada
Page : 420 pages
File Size : 40,5 Mb
Release : 1996
Category : Administrative agencies
ISBN : UCBK:C055931002

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A Guide to the Making of Federal Acts and Regulations by Canada. Department of Justice. Legislative Services Branch,Canada. Legislation and House Planning Secretariat Pdf

Acts and regulations are among a government's most powerful tools for fulfilling its democratic mandate. The steps involved in making them have evolved over centuries and reflect the attention and care required to ensure that they operate effectively and fairly. This guide provides a comprehensive description of how Acts are made at the federal level in Canada and answers questions about particular aspects of how they are made and the people involved. It also outlines the main steps involved in making federal regulations.

Intentional Human Dosing Studies for EPA Regulatory Purposes

Author : National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants
Publisher : National Academies Press
Page : 226 pages
File Size : 54,5 Mb
Release : 2004-06-04
Category : Science
ISBN : 9780309166416

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Intentional Human Dosing Studies for EPA Regulatory Purposes by National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants Pdf

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

Ethical Conduct of Clinical Research Involving Children

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 47,6 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Government Auditing Standards - 2018 Revision

Author : United States Government Accountability Office
Publisher : Lulu.com
Page : 234 pages
File Size : 43,9 Mb
Release : 2019-03-24
Category : Reference
ISBN : 9780359536399

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Government Auditing Standards - 2018 Revision by United States Government Accountability Office Pdf

Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.

Examining the Current State of Cosmetics

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 540 pages
File Size : 42,5 Mb
Release : 2013
Category : Cosmetics
ISBN : MINN:31951D03673401M

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Examining the Current State of Cosmetics by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Pdf

Examining Proposals to Enhance the Regulation of Credit Rating Agencies

Author : United States. Congress. Senate. Committee on Banking, Housing, and Urban Affairs
Publisher : Unknown
Page : 140 pages
File Size : 47,5 Mb
Release : 2010
Category : Business & Economics
ISBN : UOM:39015090376826

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Examining Proposals to Enhance the Regulation of Credit Rating Agencies by United States. Congress. Senate. Committee on Banking, Housing, and Urban Affairs Pdf

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

Author : Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publisher : National Academies Press
Page : 88 pages
File Size : 43,7 Mb
Release : 1999-07-27
Category : Medical
ISBN : 9780309172806

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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices Pdf

In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Examining the Federal Advisory Committee Act

Author : United States. Congress. House. Committee on Oversight and Government Reform. Subcommittee on Information Policy, Census, and National Archives
Publisher : Unknown
Page : 96 pages
File Size : 49,8 Mb
Release : 2008
Category : Business & Economics
ISBN : PSU:000065510780

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Examining the Federal Advisory Committee Act by United States. Congress. House. Committee on Oversight and Government Reform. Subcommittee on Information Policy, Census, and National Archives Pdf

Model Rules of Professional Conduct

Author : American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association)
Publisher : American Bar Association
Page : 216 pages
File Size : 54,5 Mb
Release : 2007
Category : Law
ISBN : 1590318730

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Model Rules of Professional Conduct by American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association) Pdf

The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.