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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development - Institute Of Medicine - Bog - National Academies Press -

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development - Institute Of Medicine - Bog - National Academies Press -

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop. Table of ContentsFront Matter1 Introduction2 The Importance of Innovative Regulatory Science3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce4 Education and Training of a Regulatory Science Workforce5 Career Paths Within Academia and Industry6 International Applications of Regulatory Science7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and PracticeReferencesAppendix A: Workshop AgendaAppendix B: Participant Biographies

DKK 221.00
3

Revisiting Brucellosis in the Greater Yellowstone Area - Board On Agriculture And Natural Resources - Bog - National Academies Press - Plusbog.dk

Revisiting Brucellosis in the Greater Yellowstone Area - Board On Agriculture And Natural Resources - Bog - National Academies Press - Plusbog.dk

Brucellosis is a nationally and internationally regulated disease of livestock with significant consequences for animal health, public health, and international trade. In cattle, the primary cause of brucellosis is Brucella abortus, a zoonotic bacterial pathogen that also affects wildlife, including bison and elk. As a result of the Brucellosis Eradication Program that began in 1934, most of the country is now free of bovine brucellosis. The Greater Yellowstone Area (GYA), where brucellosis is endemic in bison and elk, is the last known B. abortus reservoir in the United States. The GYA is home to more than 5,500 bison that are the genetic descendants of the original free-ranging bison herds that survived in the early 1900s, and home to more than 125,000 elk whose habitats are managed through interagency efforts, including the National Elk Refuge and 22 supplemental winter feedgrounds maintained in Wyoming. In 1998 the National Research Council (NRC) issued a report, Brucellosis in the Greater Yellowstone Area, that reviewed the scientific knowledge regarding B. abortus transmission among wildlife—particularly bison and elk—and cattle in the GYA. Since the release of the 1998 report, brucellosis has re-emerged in domestic cattle and bison herds in that area. Given the scientific and technological advances in two decades since that first report, Revisiting Brucellosis in the Greater Yellowstone Area explores the factors associated with the increased transmission of brucellosis from wildlife to livestock, the recent apparent expansion of brucellosis in non-feedground elk, and the desire to have science inform the course of any future actions in addressing brucellosis in the GYA. Table of ContentsFront MatterSummary1 Introduction2 Geographic Scope of Populations and Disease and Change in Land Use3 Ecology and Epidemiology of Brucella abortusin the Greater Yellowstone Ecosystem4 Scientific Progress and New Research Tools5 Federal, State, and Regional Management Efforts6 Adaptive Management7 Management Options8 Economic Issues in Managing Brucellosis9 Remaining Gaps for Understanding and Controlling Brucellosis10 Overall Findings, Conclusions, and RecommendationsAppendix A: Biographical Sketches of Committee MembersAppendix B: Open Session Meeting Agendas

DKK 396.00
3

The Chemistry of Microbiomes - Board On Chemical Sciences And Technology - Bog - National Academies Press - Plusbog.dk

The Chemistry of Microbiomes - Board On Chemical Sciences And Technology - Bog - National Academies Press - Plusbog.dk

The 21st century has witnessed a complete revolution in the understanding and description of bacteria in eco- systems and microbial assemblages, and how they are regulated by complex interactions among microbes, hosts, and environments. The human organism is no longer considered a monolithic assembly of tissues, but is instead a true ecosystem composed of human cells, bacteria, fungi, algae, and viruses. As such, humans are not unlike other complex ecosystems containing microbial assemblages observed in the marine and earth environments. They all share a basic functional principle: Chemical communication is the universal language that allows such groups to properly function together. These chemical networks regulate interactions like metabolic exchange, antibiosis and symbiosis, and communication. The National Academies of Sciences, Engineering, and Medicine's Chemical Sciences Roundtable organized a series of four seminars in the autumn of 2016 to explore the current advances, opportunities, and challenges toward unveiling this "chemical dark matter" and its role in the regulation and function of different ecosystems. The first three focused on specific ecosystems—earth, marine, and human—and the last on all microbiome systems. This publication summarizes the presentations and discussions from the seminars. Table of ContentsFront Matter1 Introduction2 Illuminating the Microbial Dark Matter Beneath Your Feet: Microbial Catalysis in the Terrestrial Subsurface - Kelly C. Wrighton, Rebecca A. Daly, and Michael J. Wilkins3 Life in High-Temperature Environments: Modern-Day Analogs of Early Earth Still Relevant Today - William P. Inskeep4 Advancing Our Understanding of the Chemistry of Soil Microbiomes - Trent R. Northen, Zheyun Zhang, Jian Gao, Tami Swenson, and Yasuo Yoshikuni5 Envisioning a Chemical Metaproteomics Capability for Biochemical Research and Diagnosis of Global Ocean Microbiomes - Mak A. Saito, Chip Breier, Mike Jakuba, Matthew McIlvin, and Dawn Moran6 Chemical Ecology: The Language of Microbiomes - Mark E. Hay, Deanna S. Beatty, and Frank J. Stewart7 Organic Nutrient Chemistry and the Marine Microbiome - Daniel J. Repeta and Rene M. Boiteau 8 Digitizing the Chemistry Associated with Microbes: Importance, Current Status, and Opportunities - Pieter C. Dorrestein9 Deciphering the Chemistry of the Human Gut Microbiome - Emily P. Balskus10 Engineering the Microbiome for Human Health Applications - Timothy K. Lu, Mark Mimee, Robert J. Citorik, and Karen Pepper11 Talking with Molecules: Marine Bacteria and Microalgae - Mohammad R. Seyedsayamdost12 Genome-Scale Metabolic Modeling and Its Application to Microbial Communities - Jennifer L. Reed13 Epilogue After the Panel DiscussionsAppendix A: Seminars AgendasAppendix B: Biographic Sketches of Seminars Planning Committee and Seminars SpeakersAppendix C: Seminars Attendees

DKK 364.00
3

Views of the U.S. National Academies of Sciences, Engineering, and Medicine on Agenda Items at Issue at the World Radiocommunication Conference 2023 -

Views of the U.S. National Academies of Sciences, Engineering, and Medicine on Agenda Items at Issue at the World Radiocommunication Conference 2023 -

The radio frequency spectrum is a limited resource for which there is an ever-increasing demand from an expansive range of applications - all the way from commercial, such as mobile phones, to scientific, such as hurricane monitoring from space. Since radio waves do not stop at national borders, international regulation is necessary to ensure effective use of the radio spectrum for all parties. Use of the radio spectrum is regulated internationally by the Radio Regulations (RR), an international treaty. The International Telecommunication Union (ITU) has as its mission the facilitation of the efficient and interference-free use of the radio spectrum. Every 2 to 5 years, the ITU convenes a World Radiocommunication Conference (WRC) to review and revise the international RR. Changes to the RR are formulated through proposals to the conference according to Agenda Items, which are agreed on at the previous WRC. At the request of the National Science Foundation and the National Aeronautics and Space Administration, this report provides guidance to U.S. spectrum managers and policymakers as they prepare for the 2023 WRC to protect the scientific exploration of Earth and the universe using the radio spectrum. This report identifies the 2023 agenda items of relevance to U.S. radio astronomers and Earth remote sensing researchers, along with proposed agenda items for the 2027 WRC. Table of ContentsFront Matter1 Introduction2 Views of the U.S. National Academies of Sciences, Engineering, and Medicine on Selected WRC-23 and WRC-27 Agenda ItemsAppendixesAppendix A: Statement of TaskAppendix B: Acronyms and Abbreviations

DKK 292.00
3

Transportation of Laboratory Animals - National Academies Of Sciences Engineering And Medicine - Bog - National Academies Press - Plusbog.dk

Front-of-Package Nutrition Rating Systems and Symbols - Committee On Examination Of Front Of Package Nutrition Rating Systems And Symbols - Bog -

Front-of-Package Nutrition Rating Systems and Symbols - Committee On Examination Of Front Of Package Nutrition Rating Systems And Symbols - Bog -

During the past decade, tremendous growth has occurred in the use of nutrition symbols and rating systems designed to summarize key nutritional aspects and characteristics of food products. These symbols and the systems that underlie them have become known as front-of-package (FOP) nutrition rating systems and symbols, even though the symbols themselves can be found anywhere on the front of a food package or on a retail shelf tag. Though not regulated and inconsistent in format, content, and criteria, FOP systems and symbols have the potential to provide useful guidance to consumers as well as maximize effectiveness. As a result, Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the Institute of Medicine (IOM) to examine and provide recommendations regarding FOP nutrition rating systems and symbols. The study was completed in two phases. Phase I focused primarily on the nutrition criteria underlying FOP systems. Phase II builds on the results of Phase I while focusing on aspects related to consumer understanding and behavior related to the development of a standardized FOP system. Front-of-Package Nutrition Rating Systems and Symbols focuses on Phase II of the study. The report addresses the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration, assesses which icons are most effective with consumer audiences, and considers the systems/icons that best promote health and how to maximize their use.

DKK 292.00
3

Improving the Regulation and Management of Low-Activity Radioactive Wastes - Nuclear And Radiation Studies Board - Bog - National Academies Press -

Improving the Regulation and Management of Low-Activity Radioactive Wastes - Nuclear And Radiation Studies Board - Bog - National Academies Press -

The largest volumes of radioactive wastes in the United States contain only small amounts of radioactive material. These low-activity wastes (LAW) come from hospitals, utilities, research institutions, and defense installations where nuclear material is used. Millions of cubic feet of LAW also arise every year from non-nuclear enterprises such as mining and water treatment. While LAW present much less of a radiation hazard than spent nuclear fuel or high-level radioactive wastes, they can cause health risks if controlled improperly. Improving the Regulation and Management of Low-Activity Radioactive Wastes asserts that LAW should be regulated and managed according to the degree of risk they pose for treatment, storage, and disposal. Current regulations are based primarily on the type of industry that produced the waste--the waste's origin--rather than its risk. In this report, a risk-informed approach for regulating and managing all types of LAW in the United States is proposed. Implemented in a gradual or stepwise fashion, this approach combines scientific risk assessment with public values and perceptions. It focuses on the hazardous properties of the waste in question and how they compare with other waste materials. The approach is based on established principles for risk-informed decision making, current risk-informed initiatives by waste regulators in the United States and abroad, solutions available under current regulatory authorities, and remedies through new legislation when necessary.

DKK 331.00
1

Innovations in Pharmaceutical Manufacturing on the Horizon - Board On Chemical Sciences And Technology - Bog - National Academies Press - Plusbog.dk

Innovations in Pharmaceutical Manufacturing on the Horizon - Board On Chemical Sciences And Technology - Bog - National Academies Press - Plusbog.dk

In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further. At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years. Table of ContentsFront MatterSummary1 Introduction2 Innovations in Manufacturing Drug Substances3 Innovations in Manufacturing Drug Products4 New Control Approaches to Enable Quality Assurance and Process Capability5 Innovations in Integrated, Flexible, and Distributed Manufacturing Networks6 Advancing Innovation: Observations, Challenges, Opportunities, and RecommendationsAppendix A: Biographic Information on the Committee to Identify Innovative Technologies to Advance Pharmaceutical ManufacturingAppendix B: Disclosure of Unavoidable Conflicts of InterestAppendix C: Workshop and Webinar AgendasAppendix D: Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop—in BriefAppendix E: Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop—in Brief

DKK 396.00
1

The Use of Limited Access Privilege Programs in Mixed-Use Fisheries - Ocean Studies Board - Bog - National Academies Press - Plusbog.dk

The Use of Limited Access Privilege Programs in Mixed-Use Fisheries - Ocean Studies Board - Bog - National Academies Press - Plusbog.dk

A central goal of U.S. fisheries management is to control the exploitation of fish populations so that fisheries remain biologically productive, economically valuable, and socially equitable. Although the Magnuson-Stevens Fishery Conservation and Management Act led to many improvements, a number of fish populations remained overfished and some fisheries were considered economically inefficient. In response, Congress amended the Act in 2006 to allow additional management approaches, including Limited Access Privilege Programs (LAPPs) in which individuals receive a permit to harvest a defined portion of the total allowable catch for a particular fish stock. This report examines the impacts of LAPPs on mixed-use fisheries, defined as fisheries where recreational, charter, and commercial fishing sectors target the same species or stocks. The report offers recommendations for NOAA's National Marine Fisheries Service (NMFS) and the Regional Fishery Management Councils (the Councils) who oversee and manage federally regulated fisheries. For each of the five mixed-use fisheries included in the report, the committee examined available fisheries data and analyses and collected testimony from fishery participants, relevant Councils, and NMFS regional experts through a series of public meetings. Table of ContentsFront MatterExecutive SummarySummary1 Introduction2 Individual Quota Systems and LAPPs3 Progress in Meeting Goals of LAPPs and Magnuson-Stevens Fishery Conservation and Management Act as Determined by Program Reviews4 Ecological Impacts of LAPPs in Mixed-Use Fisheries5 Social and Economic Effects for Commercial Participants in Mixed-Use Fisheries6 Social and Economic Effects of LAPPs for Recreational Fishery Stakeholders in Mixed-Use Fisheries7 Broader Community Social and Economic Effects8 Addressing the Impacts of LAPPs in Mixed-Use FisheriesReferencesAppendix: Committee Biographies

DKK 318.00
1

Enhancing the Resilience of the Nation's Electricity System - Board On Energy And Environmental Systems - Bog - National Academies Press - Plusbog.dk

Enhancing the Resilience of the Nation's Electricity System - Board On Energy And Environmental Systems - Bog - National Academies Press - Plusbog.dk

Americans' safety, productivity, comfort, and convenience depend on the reliable supply of electric power. The electric power system is a complex "cyber-physical" system composed of a network of millions of components spread out across the continent. These components are owned, operated, and regulated by thousands of different entities. Power system operators work hard to assure safe and reliable service, but large outages occasionally happen. Given the nature of the system, there is simply no way that outages can be completely avoided, no matter how much time and money is devoted to such an effort. The system's reliability and resilience can be improved but never made perfect. Thus, system owners, operators, and regulators must prioritize their investments based on potential benefits. Enhancing the Resilience of the Nation's Electricity System focuses on identifying, developing, and implementing strategies to increase the power system's resilience in the face of events that can cause large-area, long-duration outages: blackouts that extend over multiple service areas and last several days or longer. Resilience is not just about lessening the likelihood that these outages will occur. It is also about limiting the scope and impact of outages when they do occur, restoring power rapidly afterwards, and learning from these experiences to better deal with events in the future. Table of ContentsFront MatterSummary1 Introduction and Motivation2 Today's Grid and the Evolving System of the Future3 The Many Causes of Grid Failure4 Strategies to Prepare for and Mitigate Large-Area, Long-Duration Blackouts5 Strategies for Reducing the Harmful Consequences from Loss of Grid Power6 Restoring Grid Function After a Major Disruption7 ConclusionsAppendix A: Statement of TaskAppendix B: Committee BiographiesAppendix C: Disclosure of Conflicts of InterestAppendix D: Presentations and Committee MeetingsAppendix E: Examples of Large OutagesAppendix F: Acronyms

DKK 448.00
1

The Global Movement and Tracking of Chemical Manufacturing Equipment - Board On Chemical Sciences And Technology - Bog - National Academies Press -

The Global Movement and Tracking of Chemical Manufacturing Equipment - Board On Chemical Sciences And Technology - Bog - National Academies Press -

Dual-use applications for chemical manufacturing equipment have been recognized as a concern for many years, and export-control regulations worldwide are in place as a result. These regulations, in conjunction with the verification and inspection requirements of Article VI of the Chemical Weapons Convention, are designed to support non-proliferation of manufacturing equipment suitable for production of chemical warfare agents. In recent years, globalization has changed the distribution of chemical manufacturing facilities around the world. This has increased the burden on current inspection regimes, and increased the amount of manufacturing equipment available around the world. Movement of that equipment, both domestically and as part of international trade, has increased to accommodate these market shifts. To better understand the movement and tracking of chemical manufacturing equipment of dual-use concern, the Project on Advanced Systems and Concepts for Countering Weapons of Mass Destruction at the Naval Postgraduate School contracted with the Board on Chemical Sciences and Technology of the National Research Council to hold a workshop on the global movement and tracking of chemical manufacturing equipment. The workshop, held in May 2014, looked at key concerns regarding the availability and movement of equipment for chemical manufacturing, particularly used and decommissioned equipment that is of potential dual-use concern. The workshop examined today's industrial, security, and political contexts in which these materials are being produced, regulated, and transferred. The workshop also facilitated discussions about current practices, including consideration of their congruence with current technologies and security threats in the global chemical industrial system. The Global Movement and Tracking of Chemical Manufacturing Equipment summarizes the presentations and discussion of the event. Table of ContentsFront Matter1 Introduction and Overview2 The Changing Global Landscape3 The Lifetime of Manufacturing Equipment4 The Security Dimension5 The Internet as a Secondary Market6 Final Group DiscussionAppendix A: Statement of TaskAppendix B: Workshop AgendaAppendix C: Biographical Sketches of Workshop Speakers and Organizing Committee MembersAppendix D: Workshop AttendeesAppendix E: The Board on Chemical Sciences and Technology

DKK 266.00
1

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration - Board On Environmental Studies And Toxicology - Bog -

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration - Board On Environmental Studies And Toxicology - Bog -

With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations. Table of ContentsFront MatterA Risk-Characterization Framework for Decision-Making at the Food and Drugh AdministrationSummary1 Introduction2 A Risk-Characterization Framework3 Case Study of a Mitigation-Selection Decision4 Case Study of a Targeting Decision5 Case Study of a Strategic-Investment Decision6 Case Study of a Targeting Decision That Spans Food and Drug Administration Centers7 Conclusions and Future DirectionsAppendix A: Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health RisksAppendix B: Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase IIAppendix C: Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase IIAppendix D: Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase IIAppendix E: Factors Hypothesized as Important in Understanding Risk

DKK 299.00
1

Transforming EPA Science to Meet Today's and Tomorrow's Challenges - Committee On Anticipatory Research For Epa's Research And Development Enterprise

Transforming EPA Science to Meet Today's and Tomorrow's Challenges - Committee On Anticipatory Research For Epa's Research And Development Enterprise

Since its establishment in 1970, the mission of the Environmental Protection Agency is to protect human health and the environment. EPA develops regulations, ensures compliance, and issues policies, in coordination with state, tribal, and local governments. To accomplish its mission, EPA should be equipped to produce and access the highest quality and most advanced science. The Office of Research and Development (ORD) provides the scientific bases for regulatory and public health policies that have broad impacts on the nation's natural resources and quality of human life, and that yield economic benefits and incur compliance costs for the regulated community. In addition, ORD develops the agency core research capabilities, providing tools and methods for meeting current and anticipating future environmental challenges, such as the risks to health and the environment posed by climate change. Because challenges associated with environmental protection today are complex and affected by many interacting factors, the report points to the need for a substantially broader and better integrated approach to environmental protection. This report calls for EPA ORD to pursue all of its scientific aims in a new framework—to apply systems thinking to a One Environment ? One Health approach in all aspects of ORD work. To accomplish this, the report provides actionable recommendations on how ORD might consider incorporating emerging science and systems thinking into the agency research planning, so that ORD can become an increasingly impactful organization. The report identifies a number of high-priority recommendations for ORD to pursue in taking advantage of a broad range of advanced tools, in concert with collaborators in other federal agencies and the broader scientific community. Given the resource constraints, the report recognizes that ORD will have to make decisions about priorities for implementing its recommendations, and that ORD leadership is in the best position to set those priorities as implementation begins. The report concluded by stating that shifting to a systems-thinking approach will require renewed support from science leadership, enhanced strategic planning, investment in new and broader expertise and tools, and a reimagined and inclusive commitment to communication and collaboration. Table of ContentsFront MatterSummary1 Introduction2 ORD's Approach to Providing Forward-Looking Science3 A One EnvironmentOne Health Approach for ORD4 Strengthening the Scientific and Technological Capabilities of the EPA Scientific Enterprise5 Acquiring and Applying Emerging Tools and Methods6 A Path Forward for Science for Environmental ProtectionAppendix A: Committee BiosketchesAppendix B: Open Session AgendasAppendix C: Monitoring for ExposureAppendix D: BiotechnologyAppendix E: Participatory Research ApproachesAppendix F: Data Science and Machine Learning

DKK 286.00
1