Involvement of Individuals in the Development of Technical Solutions and Rules of Management for Building Renovation Projects: A Case Study of Latvia

NASA Astrophysics Data System (ADS)

Pukite, I.; Grekis, A.; Geipele, I.; Zeltins, N.

2017-08-01

In March 2016, the Latvian government approved a new support program for increasing energy efficiency in residential apartment buildings. For the support of renovation of apartment buildings in the period from 2016 to 2023, 166 470 588 EUR will be available. Different persons, such as energy auditors, designers, architects, project managers and builders, will be involved in the process of planning, development and implementation of building renovation. At the development stage of the building renovation project, special attention should be devoted to the first stage - energy audit and technical project development. The problem arises due to the fact that each of these individuals, during the development of technical building documentation, does not work as a completely unified system. The implementation of construction project planning and organisational management system is one of the most important factors to guarantee that the quality of building renovation project is ensured in accordance with the laws and regulatory standards. The paper studies mutual cooperation, professionalism and the role of information feedback of personnel involved in the planning stage of building renovation, which is an essential prerequisite for the renovation process in order to achieve high quality of work and reduce the energy performance indicator. The present research includes the analysis of different technical solutions and their impact on energy efficiency. Mutual harmonisation of technical specifications is also investigated.

Edge usage, motifs, and regulatory logic for cell cycling genetic networks

NASA Astrophysics Data System (ADS)

Zagorski, M.; Krzywicki, A.; Martin, O. C.

2013-01-01

The cell cycle is a tightly controlled process, yet it shows marked differences across species. Which of its structural features follow solely from the ability to control gene expression? We tackle this question in silico by examining the ensemble of all regulatory networks which satisfy the constraint of producing a given sequence of gene expressions. We focus on three cell cycle profiles coming from baker's yeast, fission yeast, and mammals. First, we show that the networks in each of the ensembles use just a few interactions that are repeatedly reused as building blocks. Second, we find an enrichment in network motifs that is similar in the two yeast cell cycle systems investigated. These motifs do not have autonomous functions, yet they reveal a regulatory logic for cell cycling based on a feed-forward cascade of activating interactions.

Establishing Policy Foundations and Regulatory Systems to Enhance Nursing Practice in the United Arab Emirates.

PubMed

Brownie, Sharon M; Hunter, Lyndal H; Aqtash, Salah; Day, Gary E

2015-01-01

In 2009, the United Arab Emirates (UAE) established a Nursing and Midwifery Council with a mandate to develop standards for the registration and regulation of nursing and midwifery and to strengthen the nursing and midwifery workforce. Priorities included workforce Emiratization and the development of regulatory standards to support advanced and speciality nursing practice and new models of care-particularly for the management of noncommunicable diseases. This article provides background, context for, and best practice inputs to the effort to provide one unified framework of nursing regulation and licensure across the whole of the UAE. This article is intended for nurse leaders, policy makers, and regulators who are reviewing or developing nursing regulatory processes and advancing nursing workforce capacity building activities; and nurse educators and nurses wishing to work in the UAE. © The Author(s) 2015.

Establishing Policy Foundations and Regulatory Systems to Enhance Nursing Practice in the United Arab Emirates

PubMed Central

Hunter, Lyndal H.; Aqtash, Salah; Day, Gary E.

2015-01-01

In 2009, the United Arab Emirates (UAE) established a Nursing and Midwifery Council with a mandate to develop standards for the registration and regulation of nursing and midwifery and to strengthen the nursing and midwifery workforce. Priorities included workforce Emiratization and the development of regulatory standards to support advanced and speciality nursing practice and new models of care—particularly for the management of noncommunicable diseases. This article provides background, context for, and best practice inputs to the effort to provide one unified framework of nursing regulation and licensure across the whole of the UAE. This article is intended for nurse leaders, policy makers, and regulators who are reviewing or developing nursing regulatory processes and advancing nursing workforce capacity building activities; and nurse educators and nurses wishing to work in the UAE. PMID:25944674

7 CFR 4274.337 - Other regulatory requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... with the seismic provisions of one of the following model building codes or the latest edition of that...) Uniform Building Code; (ii) 1993 Building Officials and Code Administrators International, Inc. (BOCA) National Building Code; or (iii) 1992 Amendments to the Southern Building Code Congress International...

7 CFR 4274.337 - Other regulatory requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... with the seismic provisions of one of the following model building codes or the latest edition of that...) Uniform Building Code; (ii) 1993 Building Officials and Code Administrators International, Inc. (BOCA) National Building Code; or (iii) 1992 Amendments to the Southern Building Code Congress International...

7 CFR 4274.337 - Other regulatory requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... with the seismic provisions of one of the following model building codes or the latest edition of that...) Uniform Building Code; (ii) 1993 Building Officials and Code Administrators International, Inc. (BOCA) National Building Code; or (iii) 1992 Amendments to the Southern Building Code Congress International...

Safety of plant-made pharmaceuticals: product development and regulatory considerations based on case studies of two autologous human cancer vaccines.

PubMed

Tusé, Daniel

2011-03-01

Guidelines issued by regulatory agencies for the development of plant-made pharmaceutical (PMP) products provide criteria for product manufacturing and characterization, safety determination, containment and mitigation of environmental risks. Features of plant-made products do not always enable an easy fit within the criteria subscribed to by regulators. The unconventional nature of plant-based manufacturing processes and peculiarities of plant biology relative to that of traditional biological production systems have led to special considerations in the regulatory scrutiny of PMP. Presented in this review are case studies of two plant-made autologous (patient-specific) cancer vaccines, the nature of which introduced challenges to conventional and standardized development and preclinical evaluation routes. The rationale presented to FDA by the sponsors of each vaccine to build consensus and obtain variances to existing guidelines is discussed. While development of many plant-made biologics can be accomplished within the existing regulatory framework, the development of specialized products can be defended with rational arguments based on strong science.

Effects-based chemical category approach for prioritization of low affinity estrogenic chemicals.

PubMed

Hornung, M W; Tapper, M A; Denny, J S; Kolanczyk, R C; Sheedy, B R; Hartig, P C; Aladjov, H; Henry, T R; Schmieder, P K

2014-01-01

Regulatory agencies are charged with addressing the endocrine disrupting potential of large numbers of chemicals for which there is often little or no data on which to make decisions. Prioritizing the chemicals of greatest concern for further screening for potential hazard to humans and wildlife is an initial step in the process. This paper presents the collection of in vitro data using assays optimized to detect low affinity estrogen receptor (ER) binding chemicals and the use of that data to build effects-based chemical categories following QSAR approaches and principles pioneered by Gilman Veith and colleagues for application to environmental regulatory challenges. Effects-based chemical categories were built using these QSAR principles focused on the types of chemicals in the specific regulatory domain of concern, i.e. non-steroidal industrial chemicals, and based upon a mechanistic hypothesis of how these non-steroidal chemicals of seemingly dissimilar structure to 17ß-estradiol (E2) could interact with the ER via two distinct binding types. Chemicals were also tested to solubility thereby minimizing false negatives and providing confidence in determination of chemicals as inactive. The high-quality data collected in this manner were used to build an ER expert system for chemical prioritization described in a companion article in this journal.

Regulatory and policy issues for reuse and remanufacture of wood materials coated with lead-based paint

Treesearch

Thomas R. Napier; Robert H. Falk; George B. Guy; Susan Drodz

2005-01-01

At present, there is no regulatory or policy guidance at the Federal level that permits, prohibits, or qualifies practice for salvaging and reusing building materials coated with lead-based paint (LBP). This paper describes the current regulations and standards relative to LBP in buildings (in particular LBP on lumber and timber products), LBP mitigation, and disposal...

RegNetwork: an integrated database of transcriptional and post-transcriptional regulatory networks in human and mouse

PubMed Central

Liu, Zhi-Ping; Wu, Canglin; Miao, Hongyu; Wu, Hulin

2015-01-01

Transcriptional and post-transcriptional regulation of gene expression is of fundamental importance to numerous biological processes. Nowadays, an increasing amount of gene regulatory relationships have been documented in various databases and literature. However, to more efficiently exploit such knowledge for biomedical research and applications, it is necessary to construct a genome-wide regulatory network database to integrate the information on gene regulatory relationships that are widely scattered in many different places. Therefore, in this work, we build a knowledge-based database, named ‘RegNetwork’, of gene regulatory networks for human and mouse by collecting and integrating the documented regulatory interactions among transcription factors (TFs), microRNAs (miRNAs) and target genes from 25 selected databases. Moreover, we also inferred and incorporated potential regulatory relationships based on transcription factor binding site (TFBS) motifs into RegNetwork. As a result, RegNetwork contains a comprehensive set of experimentally observed or predicted transcriptional and post-transcriptional regulatory relationships, and the database framework is flexibly designed for potential extensions to include gene regulatory networks for other organisms in the future. Based on RegNetwork, we characterized the statistical and topological properties of genome-wide regulatory networks for human and mouse, we also extracted and interpreted simple yet important network motifs that involve the interplays between TF-miRNA and their targets. In summary, RegNetwork provides an integrated resource on the prior information for gene regulatory relationships, and it enables us to further investigate context-specific transcriptional and post-transcriptional regulatory interactions based on domain-specific experimental data. Database URL: http://www.regnetworkweb.org PMID:26424082

Engineering Synthetic Gene Circuits in Living Cells with CRISPR Technology.

PubMed

Jusiak, Barbara; Cleto, Sara; Perez-Piñera, Pablo; Lu, Timothy K

2016-07-01

One of the goals of synthetic biology is to build regulatory circuits that control cell behavior, for both basic research purposes and biomedical applications. The ability to build transcriptional regulatory devices depends on the availability of programmable, sequence-specific, and effective synthetic transcription factors (TFs). The prokaryotic clustered regularly interspaced short palindromic repeat (CRISPR) system, recently harnessed for transcriptional regulation in various heterologous host cells, offers unprecedented ease in designing synthetic TFs. We review how CRISPR can be used to build synthetic gene circuits and discuss recent advances in CRISPR-mediated gene regulation that offer the potential to build increasingly complex, programmable, and efficient gene circuits in the future. Copyright © 2016. Published by Elsevier Ltd.

Working with Policy and Regulatory Factors to Implement Universal Design in the Built Environment: The Australian Experience.

PubMed

Larkin, Helen; Hitch, Danielle; Watchorn, Valerie; Ang, Susan

2015-07-15

Built environments that are usable by all provide opportunities for engagement in meaningful occupations. However, enabling them in day to day design processes and practice is problematic for relevant professions. The purpose of this phenomenological study was to gain greater understanding of the policy and regulatory influences that promote or hinder the uptake of universal design in built environments, to inform better future design. Focus groups or telephone interviews were undertaken with 28 key building industry and disability stakeholders in Australia. Four themes were identified: the difficulties of definition; the push or pull of regulations and policy; the role of formal standards; and, shifting the focus of design thinking. The findings highlight the complexity of working within policy and regulatory contexts when implementing universal design. Occupational therapists working with colleagues from other professions must be aware of these influences, and develop the skills to work with them for successful practice.

Medical waste management plan.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lane, Todd W.; VanderNoot, Victoria A.

2004-12-01

This plan describes the process for managing research generated medical waste at Sandia National Laboratories/California. It applies to operations at the Chemical and Radiation Detection Laboratory (CRDL), Building 968, and other biosafety level 1 or 2 activities at the site. It addresses the accumulation, storage, treatment and disposal of medical waste and sharps waste. It also describes the procedures to comply with regulatory requirements and SNL policies applicable to medical waste.

RCRA, superfund and EPCRA hotline training module. Introduction to: Containment buildings (40 cfr parts 264/265, subpart dd) updated July 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1996-07-01

The module outlines the regulatory history and purpose of containment buildings. It disucsses the relationship between LDR and containment buildings. It summarizes the design and operating standard applicable to containment buildings and describes the relationship between generator accumulation standards and containment buildings.

Normative and economic foundations of high-rise construction in the city of Samara

NASA Astrophysics Data System (ADS)

Didkovskaya, Olga V.; Bocharov, Aleksey Y.; Ilyina, Marina V.; Mamaeva, Olga A.

2018-03-01

Every year the number of free land plots for construction of buildings is steadily decreasing in cities. In this regard, the participants in the investment and construction process are increasingly seeking to maximize the use of land. A logical way for this is to use high-rise construction. However, until recently, builders encountered serious obstacles in the form of lack of special norms and rules for the design of high-rise buildings. It led to the need for individual coordination of each high-rise facility, the development and approval of special technical conditions, the passage of numerous administrative approvals. Thus, investment activity regarding the construction of high-rise buildings in the Russian Federation is reduced. In 2016, there were regulatory changes that substantially alleviated these difficulties. In this article, the authors analyze the features of the town-planning normative-legal field of high-rise construction and its development, track the interrelations between the regulatory regulation of the construction of similar facilities, with the real need, the technical feasibility and economic feasibility of their construction in the urban district of Samara. Conclusions and suggestions are also based on the analysis of the norms of urban zoning, the residential real estate market and the value of land plots.

30 CFR 906.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Natural Resources, Division of Minerals and Geology, Centennial Building, room 215, 1313 Sherman Street..., the Colorado Department of Natural Resources was deemed the regulatory authority in Colorado for...

Facility Decontamination and Decommissioning Program Surveillance and Maintenance Plan, Revision 2

DOE Office of Scientific and Technical Information (OSTI.GOV)

Poderis, Reed J.; King, Rebecca A.

This Surveillance and Maintenance (S&M) Plan describes the activities performed between deactivation and final decommissioning of the following facilities located on the Nevada National Security Site, as documented in the Federal Facility Agreement and Consent Order under the Industrial Sites program as decontamination and decommissioning sites: ? Engine Maintenance, Assembly, and Disassembly (EMAD) Facility: o EMAD Building (Building 25-3900) o Locomotive Storage Shed (Building 25-3901) ? Test Cell C (TCC) Facility: o Equipment Building (Building 25-3220) o Motor Drive Building (Building 25-3230) o Pump Shop (Building 25-3231) o Cryogenic Lab (Building 25-3232) o Ancillary Structures (e.g., dewars, water tower, piping,more » tanks) These facilities have been declared excess and are in various stages of deactivation (low-risk, long-term stewardship disposition state). This S&M Plan establishes and implements a solid, cost-effective, and balanced S&M program consistent with federal, state, and regulatory requirements. A graded approach is used to plan and conduct S&M activities. The goal is to maintain the facilities in a safe condition in a cost-effective manner until their final end state is achieved. This plan accomplishes the following: ? Establishes S&M objectives and framework ? Identifies programmatic guidance for S&M activities to be conducted by National Security Technologies, LLC, for the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) ? Provides present facility condition information and identifies hazards ? Identifies facility-specific S&M activities to be performed and their frequency ? Identifies regulatory drivers, NNSA/NFO policies and procedures, and best management practices that necessitate implementation of S&M activities ? Provides criteria and frequencies for revisions and updates ? Establishes the process for identifying and dispositioning a condition that has not been previously identified or documented ? Provides instructions for implementing annual S&M inspections and activities The following facilities that were included in Revision 1 of this plan have reached final disposition and are no longer in the S&M program: ? Reactor Maintenance, Assembly, and Disassembly Facility, Building 25-3110 ? Test Cell A Facility, Building 25-3113 ? TCC Facility, Building 25-3210 ? Pluto Disassembly Facility, Building 26-2201 ? Super Kukla Facility, Building 27-5400« less

Universal Design as a Booster for Housing Quality and Architectural Practice.

PubMed

Denizou, Karine

2016-01-01

Norwegian central government has for the last decade increasingly focused on universal design. Fundamental changes in the Norwegian building code and corresponding regulations in 2010 give an apparently clear framework for the implementation of accessibility and universal design. However, it seems that neither increased awareness of accessibility requirements and universal design, nor compliance with the building code guarantees improvement of housing quality and usability. The Norwegian regulations have gone further in the direction of performance requirements than most other countries. This applies to all types of requirements, including requirements for usability, functionality and accessibility. Hardly any specifications are to be found in the regulations. Ideally, this lack of specifications should give designers the opportunity to develop innovative answers and hence to respond to different contexts and needs. Still, many architects and builders ask for clear specifications, in order to simplify and speed up design processes and make control of solutions easier. Many architects understand guidelines as minimum requirements, and are thus reproducing the identical solutions without considering the context and the needs of the users. They see accessibility as another regulatory pressure and requirements as restrictions rather than positive incentives. However, there are examples of designers who have internalised the regulatory framework and thus are able to create and integrate inclusive design in their daily work. Based on recent research conducted by SINTEF Building and Infrastructure and financed by the Norwegian State Housing Bank, this paper presents examples of practice where dwellings have been developed within a framework of universal design. Focus of the research has been on the approach of the design team and their understanding and use of the regulatory framework in order to create better homes in dialogue with the building authorities. Main objectives are to: - Contribute to better understanding of universal design as a tool and a method to improve housing quality and usability - Investigate the conditions for developing dwellings with innovative and functional solutions in compliance with the building code - Discuss challenges in interpreting the requirements and in taking the needs of various resident groups into account.

From molecule to market access: drug regulatory science as an upcoming discipline.

PubMed

Gispen-de Wied, Christine C; Leufkens, Hubertus G M

2013-11-05

Regulatory science as a discipline has evolved over the past years with the object to boost and promote scientific rationale behind benefit/risk and decision making by regulatory authorities. The European Medicines Agency, EMA, the Food and Drug Administration, FDA, and the Japanese Pharmaceutical and Medical Devices Agency, PMDA, highlighted in their distinct ways the importance of regulatory science as a basis of good quality assessment in their strategic plans. The Medicines Evaluation Board, MEB, states: 'regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making'. Through analysis of regulatory frameworks itself and their effectiveness, however, regulatory science can also advance knowledge of these systems in general. The comprehensive guidance that is issued to complete an application dossier for regulatory product approval has seldomly been scrutinized for its efficiency. Since it is the task of regulatory authorities to protect and promote public health, it is understood that they take a cautious approach in regulating drugs prior to market access. In general, the authorities are among the first to be blamed if dangerous or useless drugs were allowed to the market. Yet, building a regulatory framework that is not challenged continuously in terms of deliverables for public health and cost-effectiveness, might be counterproductive in the end. Regulatory science and research can help understand how and why regulatory decisions are made, and where renewed discussions may be warranted. The MEB supports regulatory science as an R&D activity to fuel primary regulatory processes on product evaluation and vigilance, but also invests in a 'looking into the mirror' approach. Along the line of the drug life-cycle, publicly available data are reviewed and their regulatory impact highlighted. If made explicit, regulatory research can open the door to evidence based regulatory practice and serve the regulator's contribution to innovative drug licensing today. Copyright © 2013 Elsevier B.V. All rights reserved.

30 CFR 935.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

...: (a) Ohio Department of Natural Resources, Division of Reclamation, Building H-2, 1855 Fountain Square..., the Department of Natural Resources shall be deemed the regulatory authority in Ohio for all surface...

DEACTIVATION AND DECOMMISSIONING ENVIRONMENTAL STRATEGY FOR THE PLUTONIUM FINISHING PLANT COMPLEX, HANFORD NUCLEAR RESERVATION

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hopkins, A.M.; Heineman, R.; Norton, S.

Maintaining compliance with environmental regulatory requirements is a significant priority in successful completion of the Plutonium Finishing Plant (PFP) Nuclear Material Stabilization (NMS) Project. To ensure regulatory compliance throughout the deactivation and decommissioning of the PFP complex, an environmental regulatory strategy was developed. The overall goal of this strategy is to comply with all applicable environmental laws and regulations and/or compliance agreements during PFP stabilization, deactivation, and eventual dismantlement. Significant environmental drivers for the PFP Nuclear Material Stabilization Project include the Tri-Party Agreement; the Resource Conservation and Recovery Act of 1976 (RCRA); the Comprehensive Environmental Response, Compensation and Liability Actmore » of 1980 (CERCLA); the National Environmental Policy Act of 1969 (NEPA); the National Historic Preservation Act (NHPA); the Clean Air Act (CAA), and the Clean Water Act (CWA). Recent TPA negotiation s with Ecology and EPA have resulted in milestones that support the use of CERCLA as the primary statutory framework for decommissioning PFP. Milestones have been negotiated to support the preparation of Engineering Evaluations/Cost Analyses for decommissioning major PFP buildings. Specifically, CERCLA EE/CA(s) are anticipated for the following scopes of work: Settling Tank 241-Z-361, the 232-Z Incinerator, , the process facilities (eg, 234-5Z, 242, 236) and the process facility support buildings. These CERCLA EE/CA(s) are for the purpose of analyzing the appropriateness of the slab-on-grade endpoint Additionally, agreement was reached on performing an evaluation of actions necessary to address below-grade structures or other structures remaining after completion of the decommissioning of PFP. Remaining CERCLA actions will be integrated with other Central Plateau activities at the Hanford site.« less

Potential Impact of Risk and Loss Aversion on the Process of Accepting Kidneys for Transplantation.

PubMed

Heilman, Raymond L; Green, Ellen P; Reddy, Kunam S; Moss, Adyr; Kaplan, Bruce

2017-07-01

Behavioral economic theory suggests that people make decisions based on maximizing perceived value; however, this may be influenced more by the risk of loss rather than of potential gain. Additionally, individuals may seek certainty over uncertainty. These are termed loss aversion and risk aversion, respectively. Loss aversion is particularly sensitive to how the decision is "framed." Thus, labeling a kidney as high Kidney Donor Profile Index results in higher discard rates because this creates a nonlinearity in perceived risk. There is also evidence that the perceived loss due to regulatory sanction results in increased organ discard rates. This may be due to the overuse of terminology that stresses regulatory sanctions and thus perpetuates fear of loss through a form of nudging. Our goal is to point out how these concepts of behavioral economics may negatively influence the decision process to accept these suboptimal organs. We hope to make the community more aware of these powerful psychological influences and thus potentially increase the utilization of these suboptimal organs. Further, we would urge regulatory bodies to avoid utilizing strategies that frame outcomes in terms of loss due to flagging and build models that are less prone to uncertain expected versus observed outcomes.

The synergy of the whole: building a global system for clinical trials to accelerate medicines development.

PubMed

Koski, Greg; Tobin, Mary F; Whalen, Matthew

2014-10-01

The pharmaceutical industry, once highly respected, productive, and profitable, is in the throes of major change driven by many forces, including economics, science, regulation, and ethics. A variety of initiatives and partnerships have been launched to improve efficiency and productivity but without significant effect because they have failed to consider the process as a system. Addressing the challenges facing this complex endeavor requires more than modifications of individual processes; it requires a fully integrated application of systems thinking and an understanding of the desired goals and complex interactions among essential components and stakeholders of the whole. A multistakeholder collaborative effort, led by the Alliance for Clinical Research Excellence and Safety (ACRES), a global nonprofit organization operating in the public interest, is now under way to build a shared global system for clinical research. Its systems approach focuses on the interconnection of stakeholders at critical points of interaction within 4 operational domains: site development and support, quality management, information technology, and safety. The ACRES initiatives, Site Accreditation and Standards, Product Safety Culture, Global Ethical Review and Regulatory Innovation, and Quality Assurance and Safety, focus on building and implementing systems solutions. Underpinning these initiatives is an open, shared, integrated technology (site and optics and quality informatics initiative). We describe the rationale, challenges, progress, and successes of this effort to date and lessons learned. The complexity and fragmentation of the intensely proprietary ecosystem of drug development, challenging regulatory climate, and magnitude of the endeavor itself pose significant challenges, but the economic, social, and scientific rewards will more than justify the effort. An effective alliance model requires a willingness of multiple stakeholders to work together to build a shared system within a noncompetitive space that will have major benefits for all, including better access to medicines, better health, and more productive lives. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Homeland security challenges in nursing practice.

PubMed

Boatright, Connie; McGlown, K Joanne

2005-09-01

Nurses need a comprehensive knowledge of doctrine, laws, regulations,programs, and processes that build the operational framework for health care preparedness. Key components of this knowledge base reside in the areas of: evolution of homeland security: laws and mandates affecting health care and compliance and regulatory issues for health care organizations. This article addresses primary components in both of these areas, after first assessing the status of nursing's involvement (in homeland security), as portrayed in the professional literature.

Working with Policy and Regulatory Factors to Implement Universal Design in the Built Environment: The Australian Experience

PubMed Central

Larkin, Helen; Hitch, Danielle; Watchorn, Valerie; Ang, Susan

2015-01-01

Built environments that are usable by all provide opportunities for engagement in meaningful occupations. However, enabling them in day to day design processes and practice is problematic for relevant professions. The purpose of this phenomenological study was to gain greater understanding of the policy and regulatory influences that promote or hinder the uptake of universal design in built environments, to inform better future design. Focus groups or telephone interviews were undertaken with 28 key building industry and disability stakeholders in Australia. Four themes were identified: the difficulties of definition; the push or pull of regulations and policy; the role of formal standards; and, shifting the focus of design thinking. The findings highlight the complexity of working within policy and regulatory contexts when implementing universal design. Occupational therapists working with colleagues from other professions must be aware of these influences, and develop the skills to work with them for successful practice. PMID:26184278

Modeling gene regulatory networks: A network simplification algorithm

NASA Astrophysics Data System (ADS)

Ferreira, Luiz Henrique O.; de Castro, Maria Clicia S.; da Silva, Fabricio A. B.

2016-12-01

Boolean networks have been used for some time to model Gene Regulatory Networks (GRNs), which describe cell functions. Those models can help biologists to make predictions, prognosis and even specialized treatment when some disturb on the GRN lead to a sick condition. However, the amount of information related to a GRN can be huge, making the task of inferring its boolean network representation quite a challenge. The method shown here takes into account information about the interactome to build a network, where each node represents a protein, and uses the entropy of each node as a key to reduce the size of the network, allowing the further inferring process to focus only on the main protein hubs, the ones with most potential to interfere in overall network behavior.

77 FR 56239 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... Draft Final Revision 1 to Regulatory Guide 1.163, ``Performance-Based Containment Leak-Test Program... inconvenience. If attending this meeting, please enter through the One White Flint North building, 11555...

77 FR 68162 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... Water Reactors,'' Revision 2, and Regulatory Guide 1.79.1, ``Initial Test Program of Emergency Core... White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please...

Self-eating and self-defense: autophagy controls innate immunity and adaptive immunity.

PubMed

Liu, Guangwei; Bi, Yujing; Wang, Ruoning; Wang, Xianghui

2013-04-01

Autophagy (macroautophagy; "self-eating") is a degradation process, in which cytoplasmic content is engulfed and degraded by the lysosome. And, immunity is an important mechanism of the "self-defense" system. Autophagy has long been recognized as a stress response to nutrient deprivation. This will provide energy and anabolic building blocks to maintain cellular bioenergetic homeostasis. Thus, autophagy plays critical roles in regulating a wide variety of pathophysiological processes, including tumorigenesis, embryo development, tissue remodeling, and most recently, immunity. The latter shows that a self-eating (autophagy) process could regulate a self-defense (immune) system. In this review, we summarize the recent findings regarding the regulatory and mechanistic insights of the autophagy pathway in immunity.

CoryneRegNet: an ontology-based data warehouse of corynebacterial transcription factors and regulatory networks.

PubMed

Baumbach, Jan; Brinkrolf, Karina; Czaja, Lisa F; Rahmann, Sven; Tauch, Andreas

2006-02-14

The application of DNA microarray technology in post-genomic analysis of bacterial genome sequences has allowed the generation of huge amounts of data related to regulatory networks. This data along with literature-derived knowledge on regulation of gene expression has opened the way for genome-wide reconstruction of transcriptional regulatory networks. These large-scale reconstructions can be converted into in silico models of bacterial cells that allow a systematic analysis of network behavior in response to changing environmental conditions. CoryneRegNet was designed to facilitate the genome-wide reconstruction of transcriptional regulatory networks of corynebacteria relevant in biotechnology and human medicine. During the import and integration process of data derived from experimental studies or literature knowledge CoryneRegNet generates links to genome annotations, to identified transcription factors and to the corresponding cis-regulatory elements. CoryneRegNet is based on a multi-layered, hierarchical and modular concept of transcriptional regulation and was implemented by using the relational database management system MySQL and an ontology-based data structure. Reconstructed regulatory networks can be visualized by using the yFiles JAVA graph library. As an application example of CoryneRegNet, we have reconstructed the global transcriptional regulation of a cellular module involved in SOS and stress response of corynebacteria. CoryneRegNet is an ontology-based data warehouse that allows a pertinent data management of regulatory interactions along with the genome-scale reconstruction of transcriptional regulatory networks. These models can further be combined with metabolic networks to build integrated models of cellular function including both metabolism and its transcriptional regulation.

Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.

PubMed

Sousa, Varley Dias; Ramalho, Pedro I; Silveira, Dâmaris

2016-05-01

Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

75 FR 3743 - Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-22

... will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we... Building, the Hubert H. Humphrey Building, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. To gain access to the building...

Assessing decision making and dispute resolution in environmental policy: Regulatory negotiations at the Environmental Protection Agency

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lyons, E.A.

This dissertation is an evaluation of the use of negotiations in the rule-making context at the US Environmental Protection Agency (EPA). The goal is to assess the benefits and the limitations of negotiation as a policy process, and to make explicit the values which are expected from a negotiation process as well as the conditions which must be met in order for those values to be realized. Three distinct values are expected of negotiation processes: (1) negotiation is promoted as an efficient process that can save time and money in public decision making by avoiding protracted and expensive legal actions;more » (2) it is expected that a negotiation process which provides a mechanism for reaching accommodation among all competing perspectives can yield good policy outcomes; face-to-face interactions among parties with competing interests should provide opportunities for building better relationships among individuals and also for building community. The usefulness of negotiation as a policy tool is limited by the fact that negotiation is only appropriate in a few select cases in which the issues are mature and the parties affected by the issues are prepared for negotiation.« less

Radiotherapy and Nuclear Medicine Project for an Integral Oncology Center at the Oaxaca High Specialization Regional Hospital

NASA Astrophysics Data System (ADS)

De Jesús, M.; Trujillo-Zamudio, F. E.

2010-12-01

A building project of Radiotherapy & Nuclear Medicine services (diagnostic and therapy), within an Integral Oncology Center (IOC), requires interdisciplinary participation of architects, biomedical engineers, radiation oncologists and medical physicists. This report focus on the medical physicist role in designing, building and commissioning stages, for the final clinical use of an IOC at the Oaxaca High Specialization Regional Hospital (HRAEO). As a first step, during design stage, the medical physicist participates in discussions about radiation safety and regulatory requirements for the National Regulatory Agency (called CNSNS in Mexico). Medical physicists propose solutions to clinical needs and take decisions about installing medical equipment, in order to fulfill technical and medical requirements. As a second step, during the construction stage, medical physicists keep an eye on building materials and structural specifications. Meanwhile, regulatory documentation must be sent to CNSNS. This documentation compiles information about medical equipment, radioactivity facility, radiation workers and nuclear material data, in order to obtain the license for the linear accelerator, brachytherapy and nuclear medicine facilities. As a final step, after equipment installation, the commissioning stage takes place. As the conclusion, we show that medical physicists are essentials in order to fulfill with Mexican regulatory requirements in medical facilities.

The Dangerous Mix of Adolescents and Dietary Supplements for Weight Loss and Muscle Building: Legal Strategies for State Action.

PubMed

Pomeranz, Jennifer L; Barbosa, Grant; Killian, Caroline; Austin, S Bryn

2015-01-01

Adolescents use dietary supplements marketed for weight loss or muscle building, but these are not recommended by physicians. These products are often ineffective, adulterated, mislabeled, or have unclear dosing recommendations, and consumers have suffered injury and death as a consequence. When Congress passed the Dietary Supplement Health and Education Act, it stripped the Food and Drug Administration of its premarket authority, rendering regulatory controls too weak to adequately protect consumers. State government intervention is thus warranted. This article reviews studies reporting on Americans' use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements.

Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moe, Wayne L.

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moe, Wayne Leland

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

On the design of high-rise buildings with a specified level of reliability

NASA Astrophysics Data System (ADS)

Dolganov, Andrey; Kagan, Pavel

2018-03-01

High-rise buildings have a specificity, which significantly distinguishes them from traditional buildings of high-rise and multi-storey buildings. Steel structures in high-rise buildings are advisable to be used in earthquake-proof regions, since steel, due to its plasticity, provides damping of the kinetic energy of seismic impacts. These aspects should be taken into account when choosing a structural scheme of a high-rise building and designing load-bearing structures. Currently, modern regulatory documents do not quantify the reliability of structures. Although the problem of assigning an optimal level of reliability has existed for a long time. The article shows the possibility of designing metal structures of high-rise buildings with specified reliability. Currently, modern regulatory documents do not quantify the reliability of high-rise buildings. Although the problem of assigning an optimal level of reliability has existed for a long time. It is proposed to establish the value of reliability 0.99865 (3σ) for constructions of buildings and structures of a normal level of responsibility in calculations for the first group of limiting states. For increased (construction of high-rise buildings) and reduced levels of responsibility for the provision of load-bearing capacity, it is proposed to assign respectively 0.99997 (4σ) and 0.97725 (2σ). The coefficients of the use of the cross section of a metal beam for different levels of security are given.

Bottom-up GGM algorithm for constructing multiple layered hierarchical gene regulatory networks

USDA-ARS?s Scientific Manuscript database

Multilayered hierarchical gene regulatory networks (ML-hGRNs) are very important for understanding genetics regulation of biological pathways. However, there are currently no computational algorithms available for directly building ML-hGRNs that regulate biological pathways. A bottom-up graphic Gaus...

Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

PubMed

Johnson, F Reed; Zhou, Mo

Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

CoryneRegNet: An ontology-based data warehouse of corynebacterial transcription factors and regulatory networks

PubMed Central

Baumbach, Jan; Brinkrolf, Karina; Czaja, Lisa F; Rahmann, Sven; Tauch, Andreas

2006-01-01

Background The application of DNA microarray technology in post-genomic analysis of bacterial genome sequences has allowed the generation of huge amounts of data related to regulatory networks. This data along with literature-derived knowledge on regulation of gene expression has opened the way for genome-wide reconstruction of transcriptional regulatory networks. These large-scale reconstructions can be converted into in silico models of bacterial cells that allow a systematic analysis of network behavior in response to changing environmental conditions. Description CoryneRegNet was designed to facilitate the genome-wide reconstruction of transcriptional regulatory networks of corynebacteria relevant in biotechnology and human medicine. During the import and integration process of data derived from experimental studies or literature knowledge CoryneRegNet generates links to genome annotations, to identified transcription factors and to the corresponding cis-regulatory elements. CoryneRegNet is based on a multi-layered, hierarchical and modular concept of transcriptional regulation and was implemented by using the relational database management system MySQL and an ontology-based data structure. Reconstructed regulatory networks can be visualized by using the yFiles JAVA graph library. As an application example of CoryneRegNet, we have reconstructed the global transcriptional regulation of a cellular module involved in SOS and stress response of corynebacteria. Conclusion CoryneRegNet is an ontology-based data warehouse that allows a pertinent data management of regulatory interactions along with the genome-scale reconstruction of transcriptional regulatory networks. These models can further be combined with metabolic networks to build integrated models of cellular function including both metabolism and its transcriptional regulation. PMID:16478536

Data Integrity-A Study of Current Regulatory Thinking and Action.

PubMed

Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

2015-01-01

In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce occurrences of data integrity problems. © PDA, Inc. 2015.

Federal New Buildings Handbook for Net Zero Energy, Water, and Waste

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

In 2015, the U.S. Department of Energy’s Office of Energy Efficiency and Renewable Energy (EERE) defined zero energy buildings as "an energy-efficient building where, on a source energy basis, the actual annual delivered energy is less than or equal to the on-site renewable exported energy." This document is focused on applying EERE’s definition of zero energy buildings to federal sector new buildings. However, it is not intended to replace, substitute, or modify any statutory or regulatory requirements and mandates.

NUCLEAR NEW BUILD-INTEGRATING CULTURAL DIFFERENCES IN RADIATION PROTECTION.

PubMed

Haemmerli, Valentin; Bryant, Peter A; Cole, Peter

2017-04-01

Across the world, we are seeing a resurgence in Nuclear New Build. In the UK alone, plans are under way for the construction of 10 new reactors, using 4 different reactor designs all of which are to be provided by foreign vendors, and operated by 3 newly formed licensees within the UK. As these new licensees embark on the task of establishing themselves and progressing the design and build of these reactors, there are challenges faced in integrating the Radiation Protection Requirements and Culture from the various Foreign Investors and Vendors into the UK 'Context'. The following paper identifies the origin of the Radiation Protection Requirements within the UK and foreign investor/vendor countries, in an attempt to integrate them into the UK licensing and approval process. Thus, allowing due credit to be taken for the regulatory regime of the foreign countries where these reactors originate. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Data-driven integration of genome-scale regulatory and metabolic network models

DOE Office of Scientific and Technical Information (OSTI.GOV)

Imam, Saheed; Schauble, Sascha; Brooks, Aaron N.

Microbes are diverse and extremely versatile organisms that play vital roles in all ecological niches. Understanding and harnessing microbial systems will be key to the sustainability of our planet. One approach to improving our knowledge of microbial processes is through data-driven and mechanism-informed computational modeling. Individual models of biological networks (such as metabolism, transcription, and signaling) have played pivotal roles in driving microbial research through the years. These networks, however, are highly interconnected and function in concert a fact that has led to the development of a variety of approaches aimed at simulating the integrated functions of two or moremore » network types. Though the task of integrating these different models is fraught with new challenges, the large amounts of high-throughput data sets being generated, and algorithms being developed, means that the time is at hand for concerted efforts to build integrated regulatory-metabolic networks in a data-driven fashion. Lastly, in this perspective, we review current approaches for constructing integrated regulatory-metabolic models and outline new strategies for future development of these network models for any microbial system.« less

Data-driven integration of genome-scale regulatory and metabolic network models

DOE PAGES

Imam, Saheed; Schauble, Sascha; Brooks, Aaron N.; ...

2015-05-05

Microbes are diverse and extremely versatile organisms that play vital roles in all ecological niches. Understanding and harnessing microbial systems will be key to the sustainability of our planet. One approach to improving our knowledge of microbial processes is through data-driven and mechanism-informed computational modeling. Individual models of biological networks (such as metabolism, transcription, and signaling) have played pivotal roles in driving microbial research through the years. These networks, however, are highly interconnected and function in concert a fact that has led to the development of a variety of approaches aimed at simulating the integrated functions of two or moremore » network types. Though the task of integrating these different models is fraught with new challenges, the large amounts of high-throughput data sets being generated, and algorithms being developed, means that the time is at hand for concerted efforts to build integrated regulatory-metabolic networks in a data-driven fashion. Lastly, in this perspective, we review current approaches for constructing integrated regulatory-metabolic models and outline new strategies for future development of these network models for any microbial system.« less

SATRAT: Staphylococcus aureus transcript regulatory network analysis tool.

PubMed

Gopal, Tamilselvi; Nagarajan, Vijayaraj; Elasri, Mohamed O

2015-01-01

Staphylococcus aureus is a commensal organism that primarily colonizes the nose of healthy individuals. S. aureus causes a spectrum of infections that range from skin and soft-tissue infections to fatal invasive diseases. S. aureus uses a large number of virulence factors that are regulated in a coordinated fashion. The complex regulatory mechanisms have been investigated in numerous high-throughput experiments. Access to this data is critical to studying this pathogen. Previously, we developed a compilation of microarray experimental data to enable researchers to search, browse, compare, and contrast transcript profiles. We have substantially updated this database and have built a novel exploratory tool-SATRAT-the S. aureus transcript regulatory network analysis tool, based on the updated database. This tool is capable of performing deep searches using a query and generating an interactive regulatory network based on associations among the regulators of any query gene. We believe this integrated regulatory network analysis tool would help researchers explore the missing links and identify novel pathways that regulate virulence in S. aureus. Also, the data model and the network generation code used to build this resource is open sourced, enabling researchers to build similar resources for other bacterial systems.

PRELIMINARY RESULTS: EVALUATIONS OF THE ALTERNATIVE ASBESTOS CONTROL METHOD FOR BUILDING DEMOLITION

EPA Science Inventory

This presentation describes the preliminary results of the evaluations of the alternative asbestos control method for demolishing buildings containing asbestos, and are covered under the regulatory requirements of the Asbestos NESHAP. This abstract and presentation are based, at ...

76 FR 40738 - Agency Information Collection Activities: Proposed Collection; Comment Request; Standard Flood...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

... Community Development and Regulatory Improvement Act of 1994 was signed into law. Section 303 (a) of this... requirement for federally regulated lending institutions to determine whether a building or mobile home... Regulatory Improvement Act of 1994. The establishment of the Standard Flood Hazard Determination form has...

Developing non-testing IATA informed by mechanistic insights: Case studies in building scientific confidence (ASCCT meeting)

EPA Science Inventory

Non-testing approaches encompassing (Q)SARs, chemical categories and read-across have enjoyed a revival in recent years following changes in the global regulatory landscape. Whilst the uptake of these non-testing approaches for regulatory purposes is very encouraging, their pract...

Regulating smokeless tobacco and processed areca nut in South-East Asia region: The journey so far and the road ahead.

PubMed

Kaur, Jagdish; Thamarangsi, Thaksaphon; Rinkoo, Arvind Vashishta

2017-09-01

South-East Asia Region (SEAR) has more smokeless tobacco users as compared to smokers. The growing prevalence and cultural acceptance of consumption of flavored areca nut and related products, for example, supari and pan masala in many countries are confounding the scenario. The prevalence of a variety of tobacco products makes regulation a challenge which gets more complicated in view of weak enforcement of regulatory policies aggressive marketing of such products by the tobacco industry. Some countries have attempted to regulate smokeless tobacco and related products by enforcing bans. However, limited evidence base along with lack of technical and regulatory capacities have restricted the SEAR countries to effectively implement product regulation in respect of smokeless tobacco and related products. This paper lays out specific priorities for research and need to enhance regulatory capacity for smokeless tobacco and processed areca nut in the SEAR countries. A systematic and comprehensive search was conducted to identify all original published literature related to regulating smokeless tobacco and processed areca nut. Studies reporting on the same were obtained through searches in relevant academic databases. Relevant World Health Organization (WHO) documents and reports on tobacco products regulation were consulted. Generating the right evidence along with the need to build the capacity of the countries to test the smokeless tobacco and processed areca nut products by establishing testing facilities and providing practical guidelines is of paramount importance. The countries of the SEAR need to prioritize the implementation of Articles 9 and 10 of the WHO Framework Convention on Tobacco Control to strengthen the regulation of smokeless tobacco and processed areca nut products.

Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis.

PubMed

Tupasi, Thelma; Gupta, Rajesh; Danilovits, Manfred; Cirule, Andra; Sanchez-Garavito, Epifanio; Xiao, Heping; Cabrera-Rivero, Jose L; Vargas-Vasquez, Dante E; Gao, Mengqiu; Awad, Mohamed; Gentry, Leesa M; Geiter, Lawrence J; Wells, Charles D

2016-02-01

New drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities. We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization - Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues. Trials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials. Extensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services. Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial.

A Legislative Reform for the Food Safety System of China: A Regulatory Paradigm Shift and Collaborative Governance.

PubMed

Han, Yonghong

2015-01-01

After describing the historical development of China's food safety system from the perspectives of legislation and administration, this article discusses progress in its food law (The Draft Amendments to Food Safety Law). As a further legislative reform for China's food safety system, the Draft Amendments to the Food Safety Law contain innovative institutional designs and manifest a regulatory paradigm shift from government-centered governance to collaborative governance. However, the Draft Amendments face challenges in their implementation. This article argues that developing collaborative governance for food safety in China can be a solution to these challenges. Based on theoretical and empirical studies of collaborative governance, this article proposes that the institutional design of collaborative governance should focus on providing obligations for administrative agencies in the process of food safety rule-making and standard-setting, increasing the independence of nongovernmental organizations, and building two-way electronic platforms for public participation.

Recognizing and engineering digital-like logic gates and switches in gene regulatory networks.

PubMed

Bradley, Robert W; Buck, Martin; Wang, Baojun

2016-10-01

A central aim of synthetic biology is to build organisms that can perform useful activities in response to specified conditions. The digital computing paradigm which has proved so successful in electrical engineering is being mapped to synthetic biological systems to allow them to make such decisions. However, stochastic molecular processes have graded input-output functions, thus, bioengineers must select those with desirable characteristics and refine their transfer functions to build logic gates with digital-like switching behaviour. Recent efforts in genome mining and the development of programmable RNA-based switches, especially CRISPRi, have greatly increased the number of parts available to synthetic biologists. Improvements to the digital characteristics of these parts are required to enable robust predictable design of deeply layered logic circuits. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Federal Existing Buildings Handbook for Net Zero Energy, Water, and Waste

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

In 2015, the U.S. Department of Energy’s Office of Energy Efficiency and Renewable Energy (EERE) defined zero energy buildings as "an energy-efficient building where, on a source energy basis, the actual annual delivered energy is less than or equal to the on-site renewable exported energy." This handbook is focused on applying the EERE definition of zero energy buildings to existing buildings in the federal sector. However, it is not intended to replace, substitute, or modify any statutory or regulatory requirements and mandates.

32 CFR 644.133 - Responsibilities.

Code of Federal Regulations, 2011 CFR

2011-07-01

... responsible for acquiring space in buildings, or land, or both land and buildings, under its own authority or... Army and Air Force; Department of the Navy, including the Marine Corps, for recruiting and main stations; Department of Energy and the Nuclear Regulatory Commission, excluding space in GSA urban centers...

32 CFR 644.133 - Responsibilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... responsible for acquiring space in buildings, or land, or both land and buildings, under its own authority or... Army and Air Force; Department of the Navy, including the Marine Corps, for recruiting and main stations; Department of Energy and the Nuclear Regulatory Commission, excluding space in GSA urban centers...

Water Quality Standards for Coral Reef Protection | Science ...

EPA Pesticide Factsheets

The U.S. Clean Water Act provides a legal framework to protect coastal biological resources such as coral reefs, mangrove forests, and seagrass meadows from the damaging effects of human activities. Even though many resources are protected under this authority, water quality standards have not been effectively applied to coral reefs. The Environmental Protection Agency is promoting biocriteria and other water quality standards through collaborative development of bioassessment procedures, indicators and monitoring strategies. To support regulatory action, bioassessment indicators must be biologically meaningful, relevant to management, responsive to human disturbance, and relatively immune to natural variability. A rapid bioassessment protocol for reef-building stony corals was developed and tested for regulatory applicability. Preliminary testing in the Florida Keys found indicators had sufficient precision and provided information relevant to coral reef management. Sensitivity to human disturbance was demonstrated in the U.S. Virgin Islands for five of eight indicators tested. Once established, monitoring programs using these indicators can provide valuable, long-term records of coral condition and regulatory compliance. Development of a rapid bioassement protocol for reef-building stony corals was tested for regulatory applicability.

Building hospital capacity planning mechanisms in Poland: The impact of 2016/2017 regulatory changes.

PubMed

Dubas-Jakóbczyk, Katarzyna; Sowada, Christoph; Domagała, Alicja; Więckowska, Barbara

2018-02-07

Capacity planning is a crucial component of modern health care governance. The aim of this paper is to analyze the requirements that need to be met to build effective hospital capacity planning mechanisms in Poland. In this context, the recent regulatory changes strongly influencing hospital sector functioning, including introduction of health care needs maps, capital investment assessment, and hospital network regulations, are analyzed. Some possible ways forward, based on review of international experiences in hospital capacity planning, are discussed. Applied methods include literature review and analysis of statistical data as well as desk analysis of key national regulations related to hospital sector. Results indicate that at the system level, the process of capacity planning involves 4 elements: capital investment in facilities, equipment, and technology; service delivery; allocation of staff; and financial resources. For hospital capacity planning to be effective, the strategic decision at the macrolevel must be complemented by appropriate management of individual hospitals. The major challenge of building hospital capacity planning mechanism in Poland is imbedding it into the overall health system strategy. Because of the lack of such a strategy, the practical implementation of the ad hoc changes, which have been introduced, shows some inconsistencies. The regulations implemented between 2016 and 2017 provided a basis for hospital capacity planning, yet still need evaluation and adjustments. Also, including a mechanism for human resources planning is of crucial importance. The regulations should provide incentives for reducing oversized hospital infrastructure with simultaneous development of the long-term and coordinated care models. Copyright © 2018 John Wiley & Sons, Ltd.

Biosafety, biosecurity and internationally mandated regulatory regimes: compliance mechanisms for education and global health security

PubMed Central

Sture, Judi; Whitby, Simon; Perkins, Dana

2015-01-01

This paper highlights the biosafety and biosecurity training obligations that three international regulatory regimes place upon states parties. The duty to report upon the existence of such provisions as evidence of compliance is discussed in relation to each regime. We argue that such mechanisms can be regarded as building blocks for the development and delivery of complementary biosafety and biosecurity teaching and training materials. We show that such building blocks represent foundations upon which life and associated scientists – through greater awareness of biosecurity concerns – can better fulfil their responsibilities to guard their work from misuse in the future. PMID:24494580

Deciphering the transcriptional cis-regulatory code.

PubMed

Yáñez-Cuna, J Omar; Kvon, Evgeny Z; Stark, Alexander

2013-01-01

Information about developmental gene expression resides in defined regulatory elements, called enhancers, in the non-coding part of the genome. Although cells reliably utilize enhancers to orchestrate gene expression, a cis-regulatory code that would allow their interpretation has remained one of the greatest challenges of modern biology. In this review, we summarize studies from the past three decades that describe progress towards revealing the properties of enhancers and discuss how recent approaches are providing unprecedented insights into regulatory elements in animal genomes. Over the next years, we believe that the functional characterization of regulatory sequences in entire genomes, combined with recent computational methods, will provide a comprehensive view of genomic regulatory elements and their building blocks and will enable researchers to begin to understand the sequence basis of the cis-regulatory code. Copyright © 2012 Elsevier Ltd. All rights reserved.

75 FR 54961 - Final Supplemental Environmental Impact Statement, Single Nuclear Unit at the Bellefonte Plant...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

... facility, a wind farm, a methane- gas cofiring facility, and several small solar photovoltaic facilities... maintenance of select plant systems and other regulatory compliance activities. Major buildings and plant... the plant cooling towers and the reactor, auxiliary, control, turbine, office, and service buildings...

78 FR 65605 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-01

..., Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, Washington, DC; New Executive Office Building, 725 17th Street NW., Washington, DC 20503... brokers buying or selling fruit and or vegetables in interstate or foreign commerce to be licensed. The...

78 FR 65639 - Questar Pipeline Company; Notice of Request Under Blanket Authorization

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-01

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP14-6-000] Questar Pipeline... appurtenant facilities located in Moffat County, Colorado. Specifically, Questar proposes to abandon one Solar Saturn 1200 compressor, a compressor building, two generators and a generator building, a liquids storage...

77 FR 32962 - Gulf Coast LNG Export, LLC; Application for Long-Term Authorization To Export Domestically...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-04

...: Office of Fossil Energy, DOE. ACTION: Notice of application. SUMMARY: The Office of Fossil Energy (FE) of... Regulatory Activities, Office of Fossil Energy, P.O. Box 44375, Washington, DC 20026-4375. Hand Delivery or... Gas Regulatory Activities, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence...

Disrupting incrementalism in health care innovation.

PubMed

Soleimani, Farzad; Zenios, Stefanos

2011-08-01

To build enabling innovation frameworks for health care entrepreneurs to better identify, evaluate, and pursue entrepreneurial opportunities. Powerful frameworks have been developed to enable entrepreneurs and investors identify which opportunity areas are worth pursuing and which start-up ideas have the potential to succeed. These frameworks, however, have not been clearly defined and interpreted for innovations in health care. Having a better understanding of the process of innovation in health care allows physician entrepreneurs to innovate more successfully. A review of academic literature was conducted. Concepts and frameworks related to technology innovation were analyzed. A new set of health care specific frameworks was developed. These frameworks were then applied to innovations in various health care subsectors. Health care entrepreneurs would greatly benefit from distinguishing between incremental and disruptive innovations. The US regulatory and reimbursement systems favor incrementalism with a greater chance of success for established players. Small companies and individual groups, however, are more likely to thrive if they adopt a disruptive strategy. Disruption in health care occurs through various mechanisms as detailed in this article. While the main mechanism of disruption might vary across different health care subsectors, it is shown that disruptive innovations consistently require a component of contrarian interpretation to guarantee considerable payoff. If health care entrepreneurs choose to adopt an incrementalist approach, they need to build the risk of disruption into their models and also ascertain that they have a very strong intellectual property (IP) position to weather competition from established players. On the contrary, if they choose to pursue disruption in the market, albeit the competition will be less severe, they need to recognize that the regulatory and reimbursement hurdles are going to be very high. Thus, they would benefit from seeking market opportunities that are large enough to warrant greater regulatory and reimbursement risks.

WHO expert committee on specifications for pharmaceutical preparations.

PubMed

2013-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

Sticking together: building a biofilm the Bacillus subtilis way

PubMed Central

Vlamakis, Hera; Chai, Yunrong; Beauregard, Pascale; Losick, Richard; Kolter, Roberto

2014-01-01

Preface Biofilms are ubiquitous communities of tightly associated bacteria encased in an extracellular matrix. Bacillus subtilis has long-served as a robust model organism to examine the molecular mechanisms of biofilm formation and a number of studies have revealed that this process is subject to a number of integrated regulatory pathways. In this Review, we focus on the molecular mechanisms controlling biofilm assembly and briefly summarize the current state of knowledge regarding their disassembly. We also discuss recent progress that has expanded our understanding of biofilm formation on plant roots, which are a natural habitat for this soil bacterium. PMID:23353768

The impact of plant biotechnology on food allergy.

PubMed

Herman, Eliot M; Burks, A Wesley

2011-04-01

Concerns about food allergy and its societal growth are intertwined with the growing advances in plant biotechnology. The knowledge of plant genes and protein structures provides the key foundation to understanding biochemical processes that produce food allergy. Biotechnology offers the prospect of producing low-allergen or allergen null plants that could mitigate the allergic response. Modified low-IgE binding variants of allergens could be used as a vaccine to build immunotolerance in sensitive individuals. The potential to introduce new allergens into the food supply by biotechnology products is a regulatory concern. Copyright © 2010 Elsevier Ltd. All rights reserved.

Confronting Regulatory Cost and Quality Expectations. An Exploration of Technical Change in Minimum Efficiency Performance Standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Taylor, Margaret; Spurlock, C. Anna; Yang, Hung-Chia

The dual purpose of this project was to contribute to basic knowledge about the interaction between regulation and innovation and to inform the cost and benefit expectations related to technical change which are embedded in the rulemaking process of an important area of national regulation. The area of regulation focused on here is minimum efficiency performance standards (MEPS) for appliances and other energy-using products. Relevant both to U.S. climate policy and energy policy for buildings, MEPS remove certain product models from the market that do not meet specified efficiency thresholds.

19th International Seapower Symposium

DTIC Science & Technology

2010-07-01

are the inter- national agreements, partnerships, and constructs that we are going to need to build to make sure that we’re dealing with all facets...expect to meet in the future. Way Forward Key Performance Areas (Ends) 1. Capabilities and capacity building (DEBEX 27 Nov 08) 2. Engage: The whole...Strengthen regulatory boundaries 7. Build up the African sea powers These are the key performance areas we have so far identified and we believe that

Military Base Off-Taker Opportunities for Tribal Renewable Energy Projects

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nangle, J.

This white paper surveys DOD installations that could have an increased potential interest in the purchase of energy from renewable energy projects on tribal lands. Identification of likely purchasers of renewable energy is a first step in the energy project development process, and this paper aims to identify likely electricity customers that tribal commercial-scale projects could serve. This white paper builds on a geospatial analysis completed in November 2012 identifying 53 reservations within 10 miles of military bases (DOE 2012). This analysis builds on those findings by further refining the list of potential opportunity sites to 15 reservations (Table ES-1),more » based on five additional factors: 1) The potential renewable resources required to meet the installation energy loads; 2) Proximity to transmission lines; 3) Military installation energy demand; 4) State electricity prices; 5) Local policy and regulatory environment.« less

78 FR 47426 - Virgil C. Summer Nuclear Station, Units 2 and 3; South Carolina Electric and Gas; Change to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... Additional Electrical Penetration Assemblies AGENCY: Nuclear Regulatory Commission. ACTION: Exemption and... requested adding four electrical penetration assemblies to the containment vessel and shield building in... assemblies to containment and the shield building. As part of this request, the licensee needed to change...

Functional annotation of regulatory pathways.

PubMed

Pandey, Jayesh; Koyutürk, Mehmet; Kim, Yohan; Szpankowski, Wojciech; Subramaniam, Shankar; Grama, Ananth

2007-07-01

Standardized annotations of biomolecules in interaction networks (e.g. Gene Ontology) provide comprehensive understanding of the function of individual molecules. Extending such annotations to pathways is a critical component of functional characterization of cellular signaling at the systems level. We propose a framework for projecting gene regulatory networks onto the space of functional attributes using multigraph models, with the objective of deriving statistically significant pathway annotations. We first demonstrate that annotations of pairwise interactions do not generalize to indirect relationships between processes. Motivated by this result, we formalize the problem of identifying statistically overrepresented pathways of functional attributes. We establish the hardness of this problem by demonstrating the non-monotonicity of common statistical significance measures. We propose a statistical model that emphasizes the modularity of a pathway, evaluating its significance based on the coupling of its building blocks. We complement the statistical model by an efficient algorithm and software, Narada, for computing significant pathways in large regulatory networks. Comprehensive results from our methods applied to the Escherichia coli transcription network demonstrate that our approach is effective in identifying known, as well as novel biological pathway annotations. Narada is implemented in Java and is available at http://www.cs.purdue.edu/homes/jpandey/narada/.

Tiered Approach to Resilience Assessment.

PubMed

Linkov, Igor; Fox-Lent, Cate; Read, Laura; Allen, Craig R; Arnott, James C; Bellini, Emanuele; Coaffee, Jon; Florin, Marie-Valentine; Hatfield, Kirk; Hyde, Iain; Hynes, William; Jovanovic, Aleksandar; Kasperson, Roger; Katzenberger, John; Keys, Patrick W; Lambert, James H; Moss, Richard; Murdoch, Peter S; Palma-Oliveira, Jose; Pulwarty, Roger S; Sands, Dale; Thomas, Edward A; Tye, Mari R; Woods, David

2018-04-25

Regulatory agencies have long adopted a three-tier framework for risk assessment. We build on this structure to propose a tiered approach for resilience assessment that can be integrated into the existing regulatory processes. Comprehensive approaches to assessing resilience at appropriate and operational scales, reconciling analytical complexity as needed with stakeholder needs and resources available, and ultimately creating actionable recommendations to enhance resilience are still lacking. Our proposed framework consists of tiers by which analysts can select resilience assessment and decision support tools to inform associated management actions relative to the scope and urgency of the risk and the capacity of resource managers to improve system resilience. The resilience management framework proposed is not intended to supplant either risk management or the many existing efforts of resilience quantification method development, but instead provide a guide to selecting tools that are appropriate for the given analytic need. The goal of this tiered approach is to intentionally parallel the tiered approach used in regulatory contexts so that resilience assessment might be more easily and quickly integrated into existing structures and with existing policies. Published 2018. This article is a U.S. government work and is in the public domain in the USA.

A New Algorithm for Identifying Cis-Regulatory Modules Based on Hidden Markov Model

PubMed Central

2017-01-01

The discovery of cis-regulatory modules (CRMs) is the key to understanding mechanisms of transcription regulation. Since CRMs have specific regulatory structures that are the basis for the regulation of gene expression, how to model the regulatory structure of CRMs has a considerable impact on the performance of CRM identification. The paper proposes a CRM discovery algorithm called ComSPS. ComSPS builds a regulatory structure model of CRMs based on HMM by exploring the rules of CRM transcriptional grammar that governs the internal motif site arrangement of CRMs. We test ComSPS on three benchmark datasets and compare it with five existing methods. Experimental results show that ComSPS performs better than them. PMID:28497059

E3Net: a system for exploring E3-mediated regulatory networks of cellular functions.

PubMed

Han, Youngwoong; Lee, Hodong; Park, Jong C; Yi, Gwan-Su

2012-04-01

Ubiquitin-protein ligase (E3) is a key enzyme targeting specific substrates in diverse cellular processes for ubiquitination and degradation. The existing findings of substrate specificity of E3 are, however, scattered over a number of resources, making it difficult to study them together with an integrative view. Here we present E3Net, a web-based system that provides a comprehensive collection of available E3-substrate specificities and a systematic framework for the analysis of E3-mediated regulatory networks of diverse cellular functions. Currently, E3Net contains 2201 E3s and 4896 substrates in 427 organisms and 1671 E3-substrate specific relations between 493 E3s and 1277 substrates in 42 organisms, extracted mainly from MEDLINE abstracts and UniProt comments with an automatic text mining method and additional manual inspection and partly from high throughput experiment data and public ubiquitination databases. The significant functions and pathways of the extracted E3-specific substrate groups were identified from a functional enrichment analysis with 12 functional category resources for molecular functions, protein families, protein complexes, pathways, cellular processes, cellular localization, and diseases. E3Net includes interactive analysis and navigation tools that make it possible to build an integrative view of E3-substrate networks and their correlated functions with graphical illustrations and summarized descriptions. As a result, E3Net provides a comprehensive resource of E3s, substrates, and their functional implications summarized from the regulatory network structures of E3-specific substrate groups and their correlated functions. This resource will facilitate further in-depth investigation of ubiquitination-dependent regulatory mechanisms. E3Net is freely available online at http://pnet.kaist.ac.kr/e3net.

To recognize the use of international standards for making harmonized regulation of medical devices in Asia-pacific.

PubMed

Anand, K; Saini, Ks; Chopra, Y; Binod, Sk

2010-07-01

'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards, such as, basic standards, group standards, and product standards, are a tool for harmonizing regulatory processes, to assure the safety, quality, and performance of medical devices. Standards represent the opinion of experts from all interested parties, including industry, regulators, users, and others.

"It's all about trust": reflections of researchers on the complexity and controversy surrounding biobanking in South Africa.

PubMed

Moodley, Keymanthri; Singh, Shenuka

2016-10-10

Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented. In-depth qualitative interviews were conducted with a purposive sample of 21 researchers - 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40-60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors. Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements (MTAs) were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust. Building trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa.

Building Blocks of the Nexin-Dynein Regulatory Complex in Chlamydomonas Flagella*

PubMed Central

Lin, Jianfeng; Tritschler, Douglas; Song, Kangkang; Barber, Cynthia F.; Cobb, Jennifer S.; Porter, Mary E.; Nicastro, Daniela

2011-01-01

The directional flow generated by motile cilia and flagella is critical for many processes, including human development and organ function. Normal beating requires the control and coordination of thousands of dynein motors, and the nexin-dynein regulatory complex (N-DRC) has been identified as an important regulatory node for orchestrating dynein activity. The nexin link appears to be critical for the transformation of dynein-driven, linear microtubule sliding to flagellar bending, yet the molecular composition and mechanism of the N-DRC remain largely unknown. Here, we used proteomics with special attention to protein phosphorylation to analyze the composition of the N-DRC and to determine which subunits may be important for signal transduction. Two-dimensional electrophoresis and MALDI-TOF mass spectrometry of WT and mutant flagellar axonemes from Chlamydomonas identified 12 N-DRC-associated proteins, including all seven previously observed N-DRC components. Sequence and PCR analyses identified the mutation responsible for the phenotype of the sup-pf-4 strain, and biochemical comparison with a radial spoke mutant revealed two components that may link the N-DRC and the radial spokes. Phosphoproteomics revealed eight proteins with phosphorylated isoforms for which the isoform patterns changed with the genotype as well as two components that may play pivotal roles in N-DRC function through their phosphorylation status. These data were assembled into a model of the N-DRC that explains aspects of its regulatory function. PMID:21700706

Critical review of the building downwash algorithms in AERMOD.

PubMed

Petersen, Ron L; Guerra, Sergio A; Bova, Anthony S

2017-08-01

The only documentation on the building downwash algorithm in AERMOD (American Meteorological Society/U.S. Environmental Protection Agency Regulatory Model), referred to as PRIME (Plume Rise Model Enhancements), is found in the 2000 A&WMA journal article by Schulman, Strimaitis and Scire. Recent field and wind tunnel studies have shown that AERMOD can overpredict concentrations by factors of 2 to 8 for certain building configurations. While a wind tunnel equivalent building dimension study (EBD) can be conducted to approximately correct the overprediction bias, past field and wind tunnel studies indicate that there are notable flaws in the PRIME building downwash theory. A detailed review of the theory supported by CFD (Computational Fluid Dynamics) and wind tunnel simulations of flow over simple rectangular buildings revealed the following serious theoretical flaws: enhanced turbulence in the building wake starting at the wrong longitudinal location; constant enhanced turbulence extending up to the wake height; constant initial enhanced turbulence in the building wake (does not vary with roughness or stability); discontinuities in the streamline calculations; and no method to account for streamlined or porous structures. This paper documents theoretical and other problems in PRIME along with CFD simulations and wind tunnel observations that support these findings. Although AERMOD/PRIME may provide accurate and unbiased estimates (within a factor of 2) for some building configurations, a major review and update is needed so that accurate estimates can be obtained for other building configurations where significant overpredictions or underpredictions are common due to downwash effects. This will ensure that regulatory evaluations subject to dispersion modeling requirements can be based on an accurate model. Thus, it is imperative that the downwash theory in PRIME is corrected to improve model performance and ensure that the model better represents reality.

AP1 Keeps Chromatin Poised for Action | Center for Cancer Research

Cancer.gov

The human genome harbors gene-encoding DNA, the blueprint for building proteins that regulate cellular function. Embedded across the genome, in non-coding regions, are DNA elements to which regulatory factors bind. The interaction of regulatory factors with DNA at these sites modifies gene expression to modulate cell activity. In cells, DNA exists in a complex with proteins

Adverse Outcome Pathways: From Research to Regulation ...

EPA Pesticide Factsheets

An adverse outcome pathway (AOP) organizes existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify knowledge gaps where more research is needed to understand the underlying mechanisms, aid in chemical hazard characterization, and guide the development of new testing approaches that use fewer or no animals. A September 2014 workshop co-sponsored by NICEATM and PCRM considered how the AOP concept could improve regulatory assessments of chemical toxicity. Scientists from 21 countries, representing industry, academia, regulatory agencies, and special interest groups, attended the workshop, titled Adverse Outcome Pathways: From Research to Regulation. Workshop plenary presentations were followed by breakout sessions that considered regulatory acceptance of AOPs and AOP-based tools, criteria for building confidence in an AOP for regulatory use, and requirements to build quantitative AOPs and AOP networks. Discussions during the closing session emphasized a need to increase transparent and inclusive collaboration, especially with disciplines outside of toxicology. Additionally, to increase impact, working groups should be established to systematically prioritize and develop AOPs. Multiple collaborative projects and follow-up activities resulted from the workshop. This manuscript provides a

Sri Lanka's national assessment on innovation and intellectual property for access to medical products.

PubMed

Beneragama, Hemantha; Shridhar, Manisha; Ranasinghe, Thushara; Dissanayake, Vajira Hw

2016-09-01

In 2008, the Global strategy and plan of action on public health, innovation and intellectual property (GSPA-PHI) was launched by the World Health Organization, to stimulate fresh thinking on innovation in, and access to, medicines and to build sustainable research on diseases disproportionately affecting low- and middle-income countries. As part of the activities of the GSPA-PHI, Sri Lanka has been the first country to date to assess the national environment for medical technology and innovation. This year-long, multistakeholder, participative analysis facilitated identification of clear and implementable policy recommendations, for the government to increase its effectiveness in promoting innovation in health products through institutional development, investment and coordination among all areas relevant to public health. The assessment also highlighted areas for priority action, including closing the technology gap in development of health products, facilitating technology transfer, and building the health-research and allied workforces. The Sri Lankan experience will inform the ongoing independent external evaluation of the GSPA-PHI worldwide. The assessment process coincided with the passing of the National Medicines Regulatory Authority Act in 2015. In addition, there is growing recognition that regional cooperation will be critical to improving access to medical products in the future. Sri Lanka is therefore actively promoting cooperation to establish a regional regulatory affairs network. Lessons learnt from the Sri Lankan assessment may also benefit other countries embarking on a national GSPA-PHI assessment.

Transuranic Waste Processing Center (TWPC) Legacy Tank RH-TRU Sludge Processing and Compliance Strategy - 13255

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rogers, Ben C.; Heacker, Fred K.; Shannon, Christopher

2013-07-01

The U.S. Department of Energy (DOE) needs to safely and efficiently treat its 'legacy' transuranic (TRU) waste and mixed low-level waste (LLW) from past research and defense activities at the Oak Ridge National Laboratory (ORNL) so that the waste is prepared for safe and secure disposal. The TWPC operates an Environmental Management (EM) waste processing facility on the Oak Ridge Reservation (ORR). The TWPC is classified as a Hazard Category 2, non-reactor nuclear facility. This facility receives, treats, and packages low-level waste and TRU waste stored at various facilities on the ORR for eventual off-site disposal at various DOE sitesmore » and commercial facilities. The Remote Handled TRU Waste Sludge held in the Melton Valley Storage Tanks (MVSTs) was produced as a result of the collection, treatment, and storage of liquid radioactive waste originating from the ORNL radiochemical processing and radioisotope production programs. The MVSTs contain most of the associated waste from the Gunite and Associated Tanks (GAAT) in the ORNL's Tank Farms in Bethel Valley and the sludge (SL) and associated waste from the Old Hydro-fracture Facility tanks and other Federal Facility Agreement (FFA) tanks. The SL Processing Facility Build-outs (SL-PFB) Project is integral to the EM cleanup mission at ORNL and is being accelerated by DOE to meet updated regulatory commitments in the Site Treatment Plan. To meet these commitments a Baseline (BL) Change Proposal (BCP) is being submitted to provide continued spending authority as the project re-initiation extends across fiscal year 2012 (FY2012) into fiscal year 2013. Future waste from the ORNL Building 3019 U-233 Disposition project, in the form of U-233 dissolved in nitric acid and water, down-blended with depleted uranyl nitrate solution is also expected to be transferred to the 7856 MVST Annex Facility (formally the Capacity Increase Project (CIP) Tanks) for co-processing with the SL. The SL-PFB project will construct and install the necessary integrated systems to process the accumulated MVST Facilities SL inventory at the TWPC thus enabling safe and effective disposal of the waste. This BCP does not include work to support current MVST Facility Surveillance and Maintenance programs or the ORNL Building 3019 U-233 Disposition project, since they are not currently part of the TWPC prime contract. The purpose of the environmental compliance strategy is to identify the environmental permits and other required regulatory documents necessary for the construction and operation of the SL- PFB at the TWPC, Oak Ridge, TN. The permits and other regulatory documents identified are necessary to comply with the environmental laws and regulations of DOE Orders, and other requirements documented in the SL-PFB, Safety Design Strategy (SDS), SL-A-AD-002, R0 draft, and the Systems, Function and Requirements Document (SFRD), SL-X-AD-002, R1 draft. This compliance strategy is considered a 'living strategy' and it is anticipated that it will be revised as design progresses and more detail is known. The design basis on which this environmental permitting and compliance strategy is based is the Wastren Advantage, Inc., (WAI), TWPC, SL-PFB (WAI-BL-B.01.06) baseline. (authors)« less

Under construction: building a safer industry.

PubMed Central

Tibbetts, John

2002-01-01

A revolution in the building industry over the past decade has spawned a new generation of safer materials and practices, decreasing some health risks for construction workers. Concerned consumers, builders, materials manufacturers, and government regulatory agencies have all contributed to a turn toward "green" building materials and practices, meaning that homeowners and office workers now are better able to live and work in healthier environments, and many construction workers are handling and installing less-toxic materials. PMID:11882489

An Integrative Approach to Computational Modelling of the Gene Regulatory Network Controlling Clostridium botulinum Type A1 Toxin Production.

PubMed

Ihekwaba, Adaoha E C; Mura, Ivan; Walshaw, John; Peck, Michael W; Barker, Gary C

2016-11-01

Clostridium botulinum produces botulinum neurotoxins (BoNTs), highly potent substances responsible for botulism. Currently, mathematical models of C. botulinum growth and toxigenesis are largely aimed at risk assessment and do not include explicit genetic information beyond group level but integrate many component processes, such as signalling, membrane permeability and metabolic activity. In this paper we present a scheme for modelling neurotoxin production in C. botulinum Group I type A1, based on the integration of diverse information coming from experimental results available in the literature. Experiments show that production of BoNTs depends on the growth-phase and is under the control of positive and negative regulatory elements at the intracellular level. Toxins are released as large protein complexes and are associated with non-toxic components. Here, we systematically review and integrate those regulatory elements previously described in the literature for C. botulinum Group I type A1 into a population dynamics model, to build the very first computational model of toxin production at the molecular level. We conduct a validation of our model against several items of published experimental data for different wild type and mutant strains of C. botulinum Group I type A1. The result of this process underscores the potential of mathematical modelling at the cellular level, as a means of creating opportunities in developing new strategies that could be used to prevent botulism; and potentially contribute to improved methods for the production of toxin that is used for therapeutics.

Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries.

PubMed

Penazzato, Martina; Lewis, Linda; Watkins, Melynda; Prabhu, Vineet; Pascual, Fernando; Auton, Martin; Kreft, Wesley; Morin, Sébastien; Vicari, Marissa; Lee, Janice; Jamieson, David; Siberry, George K

2018-02-01

Despite the coordinated efforts by several stakeholders to speed up access to HIV treatment for children, development of optimal paediatric formulations still lags 8 to 10 years behind that of adults, due mainly to lack of market incentives and technical complexities in manufacturing. The small and fragmented paediatric market also hinders launch and uptake of new formulations. Moreover, the problems affecting HIV similarly affect other disease areas where development and introduction of optimal paediatric formulations is even slower. Therefore, accelerating processes for developing and commercializing optimal paediatric drug formulations for HIV and other disease areas is urgently needed. The Global Accelerator for Paediatric Formulations (GAP-f) is an innovative collaborative model that will accelerate availability of optimized treatment options for infectious diseases, such as HIV, tuberculosis and viral hepatitis, affecting children in low- and middle-income countries (LMICs). It builds on the HIV experience and existing efforts in paediatric drug development, formalizing collaboration between normative bodies, research networks, regulatory agencies, industry, supply and procurement organizations and funding bodies. Upstream, the GAP-f will coordinate technical support to companies to design and study optimal paediatric formulations, harmonize efforts with regulators and incentivize manufacturers to conduct formulation development. Downstream, the GAP-f will reinforce coordinated procurement and communication with suppliers. The GAP-f will be implemented in a three-stage process: (1) development of a strategic framework and promotion of key regulatory efficiencies; (2) testing of feasibility and results, building on the work of existing platforms such as the Paediatric HIV Treatment Initiative (PHTI) including innovative approaches to incentivize generic development and (3) launch as a fully functioning structure. GAP-f is a key partnership example enhancing North-South and international cooperation on and access to science and technology and capacity building, responding to Sustainable Development Goal (SDG) 17.6 (technology) and 17.9. (capacity-building). By promoting access to the most needed paediatric formulations for HIV and high-burden infectious diseases in low-and middle-income countries, GAP-f will support achievement of SDG 3.2 (infant mortality), 3.3 (end of AIDS and combat other communicable diseases) and 3.8 (access to essential medicines), and be an essential component of meeting the global Start Free, Stay Free, AIDS Free super-fast-track targets. © 2018 World Health Organization; licensee IAS.

A National Framework for Energy Audit Ordinances

DOE Office of Scientific and Technical Information (OSTI.GOV)

Taylor, Cody; Costa, Marc; Long, Nicholas

A handful of U.S. cities have begun to incorporate energy audits into their building energy performance policies. Cities are beginning to recognize an opportunity to use several information tools to bring to real estate markets both motivation to improve efficiency and actionable pointers on how to improve. Care is necessary to combine such tools as operational ratings, energy audits, asset ratings, and building retro-commissioning in an effective policy regime that maximizes market impact. In this paper, the authors focus on energy audits and consider both the needs of the policies' implementers in local governments and the emerging standards and federalmore » tools to improve data collection and practitioner engagement. Over the past two years, we have compared several related data formats such as New York City's existing audit reporting spreadsheet, ASHRAE guidance on building energy auditing, and the DOE Building Energy Asset Score, to identify a possible set of required and optional fields for energy audit reporting programs. Doing so revealed tensions between the ease of data collection and the value of more detailed information, which had implications for the effort and qualifications needed to complete the energy audit. The resulting list of data fields is now feeding back into the regulatory process in several cities currently working on implementing or developing audit policies. Using complementary policies and standardized tools for data transmission, the next generation of policies and programs will be tailored to local building stock and can more effectively target improvement opportunities through each building's life.« less

10 CFR 40.42 - Expiration and termination of licenses and decommissioning of sites and separate buildings or...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas. 40.42 Section 40.42 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL Licenses § 40.42 Expiration and termination of licenses and...

10 CFR 40.42 - Expiration and termination of licenses and decommissioning of sites and separate buildings or...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas. 40.42 Section 40.42 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL Licenses § 40.42 Expiration and termination of licenses and...

10 CFR 40.42 - Expiration and termination of licenses and decommissioning of sites and separate buildings or...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas. 40.42 Section 40.42 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL Licenses § 40.42 Expiration and termination of licenses and...

10 CFR 40.42 - Expiration and termination of licenses and decommissioning of sites and separate buildings or...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas. 40.42 Section 40.42 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL Licenses § 40.42 Expiration and termination of licenses and...

10 CFR 40.42 - Expiration and termination of licenses and decommissioning of sites and separate buildings or...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas. 40.42 Section 40.42 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL Licenses § 40.42 Expiration and termination of licenses and...

78 FR 49551 - Vogtle Electric Generating Station, Units 3 and 4; Southern Nuclear Operating Company; Change to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

... design and layout of the turbine building. As part of this request, the licensee needed to change the... information related to the design and layout of the Turbine Building detailed in the amendment request. These... Structures and Layout AGENCY: Nuclear Regulatory Commission. ACTION: Exemption and combined license amendment...

10 CFR 30.36 - Expiration and termination of licenses and decommissioning of sites and separate buildings or...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas. 30.36 Section 30.36 Energy NUCLEAR REGULATORY... section if the Commission determines that the alternative schedule is necessary to the effective conduct...

76 FR 44374 - Environmental Assessment and Finding of No Significant Impact for License Amendment to Source...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-25

... information to the NRC to demonstrate that the Building 1103A Area meets the criteria in Subpart E of 10 CFR... Licensee conducted site-specific dose modeling using input parameters specific to the Building 1103A area... AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability. FOR FURTHER INFORMATION CONTACT...

Identification of miRNA-mRNA regulatory modules by exploring collective group relationships.

PubMed

Masud Karim, S M; Liu, Lin; Le, Thuc Duy; Li, Jiuyong

2016-01-11

microRNAs (miRNAs) play an essential role in the post-transcriptional gene regulation in plants and animals. They regulate a wide range of biological processes by targeting messenger RNAs (mRNAs). Evidence suggests that miRNAs and mRNAs interact collectively in gene regulatory networks. The collective relationships between groups of miRNAs and groups of mRNAs may be more readily interpreted than those between individual miRNAs and mRNAs, and thus are useful for gaining insight into gene regulation and cell functions. Several computational approaches have been developed to discover miRNA-mRNA regulatory modules (MMRMs) with a common aim to elucidate miRNA-mRNA regulatory relationships. However, most existing methods do not consider the collective relationships between a group of miRNAs and the group of targeted mRNAs in the process of discovering MMRMs. Our aim is to develop a framework to discover MMRMs and reveal miRNA-mRNA regulatory relationships from the heterogeneous expression data based on the collective relationships. We propose DIscovering COllective group RElationships (DICORE), an effective computational framework for revealing miRNA-mRNA regulatory relationships. We utilize the notation of collective group relationships to build the computational framework. The method computes the collaboration scores of the miRNAs and mRNAs on the basis of their interactions with mRNAs and miRNAs, respectively. Then it determines the groups of miRNAs and groups of mRNAs separately based on their respective collaboration scores. Next, it calculates the strength of the collective relationship between each pair of miRNA group and mRNA group using canonical correlation analysis, and the group pairs with significant canonical correlations are considered as the MMRMs. We applied this method to three gene expression datasets, and validated the computational discoveries. Analysis of the results demonstrates that a large portion of the regulatory relationships discovered by DICORE is consistent with the experimentally confirmed databases. Furthermore, it is observed that the top mRNAs that are regulated by the miRNAs in the identified MMRMs are highly relevant to the biological conditions of the given datasets. It is also shown that the MMRMs identified by DICORE are more biologically significant and functionally enriched.

10 CFR 51.4 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... the land for public recreational purposes; (ii) Site exploration, including necessary borings to... building with space for installation of a training reactor). NRC means the Nuclear Regulatory Commission...

10 CFR 51.4 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the land for public recreational purposes; (ii) Site exploration, including necessary borings to... building with space for installation of a training reactor). NRC means the Nuclear Regulatory Commission...

76 FR 2753 - Agency Information Collection Activities: Proposed Agency Information Collection Activities...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-14

... title V of the Riegle Community Development and Regulatory Improvement Act,\\2\\ the National Flood... renewing a loan secured by a building or a mobile home located in a special flood hazard area to advise the... transferring a loan secured by a building or a mobile home located in a special flood hazard area to notify...

Biosafety capacity building: experiences and challenges from a distance learning approach.

PubMed

Pertry, Ine; Sabbadini, Silvia; Goormachtig, Sofie; Lokko, Yvonne; Gheysen, Godelieve; Burssens, Sylvia; Mezzetti, Bruno

2014-01-25

Biotechnology is revolutionizing industrial and agricultural practice as the number of commercial biotechnology products is increasing each year. Simultaneously, several regulatory approaches are put into place to allow technological advancement while preserving public health and the environment. Developing and/or emerging countries often face major barriers to access biotechnologies and biotechnology derived products as they frequently lack the institutional capacities and professional competence in exercising regulatory oversight. To address this need, intensive biosafety capacity building is required. Different training approaches can be used to train individuals in biosafety ranging from long-term leading to a postgraduate certificate or a Masters degree, to short term courses. In this paper, we discuss the applicability of a different approach to biosafety capacity building based on a distance e-learning system, the UNIDO e-Biosafety program that has been annually organized at the Marche Polytechnic University (MPU) in Italy and Ghent University (UGent) in Belgium since 2006. Even though there are some challenges, we can conclude based on our experience that distance learning in combination with on-campus tuition is amendable for biosafety capacity building. Copyright © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

Design of orthogonal genetic switches based on a crosstalk map of σs, anti-σs, and promoters

PubMed Central

Rhodius, Virgil A; Segall-Shapiro, Thomas H; Sharon, Brian D; Ghodasara, Amar; Orlova, Ekaterina; Tabakh, Hannah; Burkhardt, David H; Clancy, Kevin; Peterson, Todd C; Gross, Carol A; Voigt, Christopher A

2013-01-01

Cells react to their environment through gene regulatory networks. Network integrity requires minimization of undesired crosstalk between their biomolecules. Similar constraints also limit the use of regulators when building synthetic circuits for engineering applications. Here, we mapped the promoter specificities of extracytoplasmic function (ECF) σs as well as the specificity of their interaction with anti-σs. DNA synthesis was used to build 86 ECF σs (two from every subgroup), their promoters, and 62 anti-σs identified from the genomes of diverse bacteria. A subset of 20 σs and promoters were found to be highly orthogonal to each other. This set can be increased by combining the −35 and −10 binding domains from different subgroups to build chimeras that target sequences unrepresented in any subgroup. The orthogonal σs, anti-σs, and promoters were used to build synthetic genetic switches in Escherichia coli. This represents a genome-scale resource of the properties of ECF σs and a resource for synthetic biology, where this set of well-characterized regulatory parts will enable the construction of sophisticated gene expression programs. PMID:24169405

Construction Sector (NAICS 23)

EPA Pesticide Factsheets

Find environmental regulatory information for the construction sector, including the construction of buildings or engineering projects. This includes RCRA information for hazardous waste, refrigeration compliance, asbestos, effluent guidelines & lead laws

Pipe inspection using the pipe crawler. Innovative technology summary report

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1999-05-01

The US Department of Energy (DOE) continually seeks safer and more cost-effective remediation technologies for use in the decontamination and decommissioning (D and D) of nuclear facilities. In several of the buildings at the Fernald Site, there is piping that was used to transport process materials. As the demolition of these buildings occur, disposal of this piping has become a costly issue. Currently, all process piping is cut into ten-foot or less sections, the ends of the piping are wrapped and taped to prevent the release of any potential contaminants into the air, and the piping is placed in rollmore » off boxes for eventual repackaging and shipment to the Nevada Test Site (NTS) for disposal. Alternatives that allow for the onsite disposal of process piping are greatly desired due to the potential for dramatic savings in current offsite disposal costs. No means is currently employed to allow for the adequate inspection of the interior of piping, and consequently, process piping has been assumed to be internally contaminated and thus routinely disposed of at NTS. The BTX-II system incorporates a high-resolution micro color camera with lightheads, cabling, a monitor, and a video recorder. The complete probe is capable of inspecting pipes with an internal diameter (ID) as small as 1.4 inches. By using readily interchangeable lightheads, the same system is capable of inspecting piping up to 24 inches in ID. The original development of the BTX system was for inspection of boiler tubes and small diameter pipes for build-up, pitting, and corrosion. However, the system is well suited for inspecting the interior of most types of piping and other small, confined areas. The report describes the technology, its performance, uses, cost, regulatory and policy issues, and lessons learned.« less

Splitting nodes and linking channels: A method for assembling biocircuits from stochastic elementary units

NASA Astrophysics Data System (ADS)

Ferwerda, Cameron; Lipan, Ovidiu

2016-11-01

Akin to electric circuits, we construct biocircuits that are manipulated by cutting and assembling channels through which stochastic information flows. This diagrammatic manipulation allows us to create a method which constructs networks by joining building blocks selected so that (a) they cover only basic processes; (b) it is scalable to large networks; (c) the mean and variance-covariance from the Pauli master equation form a closed system; and (d) given the initial probability distribution, no special boundary conditions are necessary to solve the master equation. The method aims to help with both designing new synthetic signaling pathways and quantifying naturally existing regulatory networks.

Building muscle: molecular regulation of myogenesis.

PubMed

Bentzinger, C Florian; Wang, Yu Xin; Rudnicki, Michael A

2012-02-01

The genesis of skeletal muscle during embryonic development and postnatal life serves as a paradigm for stem and progenitor cell maintenance, lineage specification, and terminal differentiation. An elaborate interplay of extrinsic and intrinsic regulatory mechanisms controls myogenesis at all stages of development. Many aspects of adult myogenesis resemble or reiterate embryonic morphogenetic episodes, and related signaling mechanisms control the genetic networks that determine cell fate during these processes. An integrative view of all aspects of myogenesis is imperative for a comprehensive understanding of muscle formation. This article provides a holistic overview of the different stages and modes of myogenesis with an emphasis on the underlying signals, molecular switches, and genetic networks.

Building quality into medical product software design.

PubMed

Mallory, S R

1993-01-01

The software engineering and quality assurance disciplines are a requisite to the design of safe and effective software-based medical devices. It is in the areas of software methodology and process that the most beneficial application of these disciplines to software development can be made. Software is a product of complex operations and methodologies and is not amenable to the traditional electromechanical quality assurance processes. Software quality must be built in by the developers, with the software verification and validation engineers acting as the independent instruments for ensuring compliance with performance objectives and with development and maintenance standards. The implementation of a software quality assurance program is a complex process involving management support, organizational changes, and new skill sets, but the benefits are profound. Its rewards provide safe, reliable, cost-effective, maintainable, and manageable software, which may significantly speed the regulatory review process and therefore potentially shorten the overall time to market. The use of a trial project can greatly facilitate the learning process associated with the first-time application of a software quality assurance program.

Modular arrangement of regulatory RNA elements.

PubMed

Roßmanith, Johanna; Narberhaus, Franz

2017-03-04

Due to their simple architecture and control mechanism, regulatory RNA modules are attractive building blocks in synthetic biology. This is especially true for riboswitches, which are natural ligand-binding regulators of gene expression. The discovery of various tandem riboswitches inspired the design of combined RNA modules with activities not yet found in nature. Riboswitches were placed in tandem or in combination with a ribozyme or temperature-responsive RNA thermometer resulting in new functionalities. Here, we compare natural examples of tandem riboswitches with recently designed artificial RNA regulators suggesting substantial modularity of regulatory RNA elements. Challenges associated with modular RNA design are discussed.

Cracking the egg: virtual embryogenesis of real robots.

PubMed

Cussat-Blanc, Sylvain; Pollack, Jordan

2014-01-01

All multicellular living beings are created from a single cell. A developmental process, called embryogenesis, takes this first fertilized cell down a complex path of reproduction, migration, and specialization into a complex organism adapted to its environment. In most cases, the first steps of the embryogenesis take place in a protected environment such as in an egg or in utero. Starting from this observation, we propose a new approach to the generation of real robots, strongly inspired by living systems. Our robots are composed of tens of specialized cells, grown from a single cell using a bio-inspired virtual developmental process. Virtual cells, controlled by gene regulatory networks, divide, migrate, and specialize to produce the robot's body plan (morphology), and then the robot is manually built from this plan. Because the robot is as easy to assemble as Lego, the building process could be easily automated.

MINER: exploratory analysis of gene interaction networks by machine learning from expression data.

PubMed

Kadupitige, Sidath Randeni; Leung, Kin Chun; Sellmeier, Julia; Sivieng, Jane; Catchpoole, Daniel R; Bain, Michael E; Gaëta, Bruno A

2009-12-03

The reconstruction of gene regulatory networks from high-throughput "omics" data has become a major goal in the modelling of living systems. Numerous approaches have been proposed, most of which attempt only "one-shot" reconstruction of the whole network with no intervention from the user, or offer only simple correlation analysis to infer gene dependencies. We have developed MINER (Microarray Interactive Network Exploration and Representation), an application that combines multivariate non-linear tree learning of individual gene regulatory dependencies, visualisation of these dependencies as both trees and networks, and representation of known biological relationships based on common Gene Ontology annotations. MINER allows biologists to explore the dependencies influencing the expression of individual genes in a gene expression data set in the form of decision, model or regression trees, using their domain knowledge to guide the exploration and formulate hypotheses. Multiple trees can then be summarised in the form of a gene network diagram. MINER is being adopted by several of our collaborators and has already led to the discovery of a new significant regulatory relationship with subsequent experimental validation. Unlike most gene regulatory network inference methods, MINER allows the user to start from genes of interest and build the network gene-by-gene, incorporating domain expertise in the process. This approach has been used successfully with RNA microarray data but is applicable to other quantitative data produced by high-throughput technologies such as proteomics and "next generation" DNA sequencing.

Mind-sets matter: a meta-analytic review of implicit theories and self-regulation.

PubMed

Burnette, Jeni L; O'Boyle, Ernest H; VanEpps, Eric M; Pollack, Jeffrey M; Finkel, Eli J

2013-05-01

This review builds on self-control theory (Carver & Scheier, 1998) to develop a theoretical framework for investigating associations of implicit theories with self-regulation. This framework conceptualizes self-regulation in terms of 3 crucial processes: goal setting, goal operating, and goal monitoring. In this meta-analysis, we included articles that reported a quantifiable assessment of implicit theories and at least 1 self-regulatory process or outcome. With a random effects approach used, meta-analytic results (total unique N = 28,217; k = 113) across diverse achievement domains (68% academic) and populations (age range = 5-42; 10 different nationalities; 58% from United States; 44% female) demonstrated that implicit theories predict distinct self-regulatory processes, which, in turn, predict goal achievement. Incremental theories, which, in contrast to entity theories, are characterized by the belief that human attributes are malleable rather than fixed, significantly predicted goal setting (performance goals, r = -.151; learning goals, r = .187), goal operating (helpless-oriented strategies, r = -.238; mastery-oriented strategies, r = .227), and goal monitoring (negative emotions, r = -.233; expectations, r = .157). The effects for goal setting and goal operating were stronger in the presence (vs. absence) of ego threats such as failure feedback. Discussion emphasizes how the present theoretical analysis merges an implicit theory perspective with self-control theory to advance scholarship and unlock major new directions for basic and applied research.

Asbestos-Containing Materials (ACM) and Demolition

EPA Pesticide Factsheets

There are specific federal regulatory requirements that require the identification of asbestos-containing materials (ACM) in many of the residential buildings that are being demolished or renovated by a municipality.

Commercialization of New Beam Applications

NASA Astrophysics Data System (ADS)

McKeown, Joseph

1996-05-01

The commercialization of electron processing applications is driven by demonstrated technical advantages over current practice. Mature and reliable accelerator technology has permitted more consistent product quality and the development of new processes. However, the barriers to commercial adoption are often not amenable to solution within the laboratory alone. Aspects of the base accelerator technology, plant engineering, production, project management, financing, regulatory control, product throughput and plant operational efficiency all contribute to the business risk. Experiences in building three 10 MeV, 50 kW, IMPELA electron accelerators at approximately 8 M each and achieving cumulative operational availability greater than 98% in commercial environments have identified key parameters defining those aspects. The allowed ranges of these parameters to generate the 1.5 M annual revenue that is typically necessary to support outlays of this scale are presented. Such data have been used in proposals to displace expensive chemicals in the viscose industry, sterilize sewage sludge, detoxify chemically contaminated soils and build radiation service centers for a diversity of applications. The proposals face stiff competition from traditional chemical methods. Quantitative technical and business details of these activities are provided and an attempt is made to establish realistic expectations for the exploitation of electron beam technologies in emerging applications.

The Path to Advanced Practice Licensure for Clinical Nurse Specialists in Washington State.

PubMed

Schoonover, Heather

The aim of this study was to provide a review of the history and process to obtaining advanced practice licensure for clinical nurse specialists in Washington State. Before 2016, Washington State licensed certified nurse practitioners, certified nurse midwives, and certified nurse anesthetists under the designation of an advanced registered nurse practitioner; however, the state did not recognize clinical nurse specialists as advanced practice nurses. The work to drive the rule change began in 2007. The Washington Affiliate of the National Association of Clinical Nurse Specialists used the Power Elite Theory to guide advocacy activities, building coalitions and support for the desired rule changes. On January 8, 2016, the Washington State Nursing Care Quality Assurance Commission voted to amend the state's advanced practice rules, including clinical nurse specialists in the designation of an advanced practice nurse. Since the rule revision, clinical nurse specialists in Washington State have been granted advanced registered nurse practitioner licenses. Driving changes in state regulatory rules requires diligent advocacy, partnership, and a deep understanding of the state's rule-making processes. To be successful in changing rules, clinical nurse specialists must build strong partnerships with key influencers and understand the steps in practice required to make the desired changes.

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

Dynamics of embryonic stem cell differentiation inferred from single-cell transcriptomics show a series of transitions through discrete cell states

PubMed Central

Jang, Sumin; Choubey, Sandeep; Furchtgott, Leon; Zou, Ling-Nan; Doyle, Adele; Menon, Vilas; Loew, Ethan B; Krostag, Anne-Rachel; Martinez, Refugio A; Madisen, Linda; Levi, Boaz P; Ramanathan, Sharad

2017-01-01

The complexity of gene regulatory networks that lead multipotent cells to acquire different cell fates makes a quantitative understanding of differentiation challenging. Using a statistical framework to analyze single-cell transcriptomics data, we infer the gene expression dynamics of early mouse embryonic stem (mES) cell differentiation, uncovering discrete transitions across nine cell states. We validate the predicted transitions across discrete states using flow cytometry. Moreover, using live-cell microscopy, we show that individual cells undergo abrupt transitions from a naïve to primed pluripotent state. Using the inferred discrete cell states to build a probabilistic model for the underlying gene regulatory network, we further predict and experimentally verify that these states have unique response to perturbations, thus defining them functionally. Our study provides a framework to infer the dynamics of differentiation from single cell transcriptomics data and to build predictive models of the gene regulatory networks that drive the sequence of cell fate decisions during development. DOI: http://dx.doi.org/10.7554/eLife.20487.001 PMID:28296635

Advancing Drug Safety Through Prospective Pharmacovigilance.

PubMed

Pitts, Peter J; Le Louet, Hervé

2018-01-01

Much has changed in a relatively short period of time. There is a raging debate over the level of evidence expected to first introduce a treatment to patients based on smaller, more adaptive data sets. Some argue for less data followed by postapproval follow-up, others for more adaptive clinical trial designs and end-point modification driven by patient-focused drug development and use of real-world evidence. The transition in both the review and postmarketing regulatory framework is happening in front of our eyes in real time. To improve the ability of patients to receive high-quality, safe, effective, and timely care, better information via pharmacovigilance must be a priority as the world's many regulatory systems build the capacity to harness electronic health information to improve health, care quality, and safety. Globally, the widely variable ability of nations to build reliable regulatory systems (from precise review to robust pharmacovigilance) is a dangerous source of health care inequality. Developing validated tools and techniques for "predictive pharmacovigilance" will assist all health systems in better understanding the risks and benefits of the medicines they regulate by understanding what should be happening once a new medicine moves from risk-benefit regulatory efficacy to real-world risk-effectiveness. This will be of particular utility for smaller regulatory agencies with fewer resources. By comparing preapproval predictive pharmacovigilance data, developing regulatory authorities will be able to better understand the potential gap between what was predicted and what was actually measured (via more traditional pharmacovigilance methodologies). Predictive pharmacovigilance recognizes the value of understanding the imperfect reporting of real-world clinical use and that the absence of reporting is, in itself, an important postmarketing signal.

Enhancing the value delivered by the statistician throughout drug discovery and development: putting statistical science into regulated pharmaceutical innovation.

PubMed

Enas, G G; Andersen, J S

With the dawn of the 21st century, the pharmaceutical industry faces a dramatically different constellation of business and scientific predictors of success than those of just a few years ago. Significant advances in science at the genetic, molecular and cellular levels, combined with progress demonstrated around the globe with drug regulations, have increased business and competitive opportunities. This has occurred in search of better and cheaper medicines that reach patients with unmet medical needs as quickly as possible. Herein lie new opportunities for those who can help business and regulatory leaders make good decisions about drug development and market authorization as quickly and efficiently as possible in the presence of uncertainty. The statistician is uniquely trained and qualified to render such value. We show how the statistician can contribute to the process of drug innovation from the very early stages of drug discovery until patients, payers and regulators are satisfied. Indeed, the very nature of regulated innovation demands that efficient and effective processes are implemented which yield the right information for good decision making. The statistician can take the lead in setting a strategy that directs such processes in the direction of greatest value. This demands skills that enable one to identify important sources of variability and uncertainty and then leverage those skills to make decisions. If such decisions call for more information, then the statistician can render experimental designs which generate the right information needed to make the decision in an efficient, timely manner. To add value to the enterprise, statisticians will have to become more intimately associated with business and regulatory decisions by building on their traditional roles (for example, numerical analyst, tactician) and unique skill sets (for example, analysis, computation, logical thought and work process, precision, accuracy). Business and regulatory savvy, coupled with excellent communication and interpersonal skills, will allow statisticians to help create the knowledge needed to drive success in the future. Copyright 2001 John Wiley & Sons, Ltd.

An Integrative Approach to Computational Modelling of the Gene Regulatory Network Controlling Clostridium botulinum Type A1 Toxin Production

PubMed Central

Walshaw, John; Peck, Michael W.; Barker, Gary C.

2016-01-01

Clostridium botulinum produces botulinum neurotoxins (BoNTs), highly potent substances responsible for botulism. Currently, mathematical models of C. botulinum growth and toxigenesis are largely aimed at risk assessment and do not include explicit genetic information beyond group level but integrate many component processes, such as signalling, membrane permeability and metabolic activity. In this paper we present a scheme for modelling neurotoxin production in C. botulinum Group I type A1, based on the integration of diverse information coming from experimental results available in the literature. Experiments show that production of BoNTs depends on the growth-phase and is under the control of positive and negative regulatory elements at the intracellular level. Toxins are released as large protein complexes and are associated with non-toxic components. Here, we systematically review and integrate those regulatory elements previously described in the literature for C. botulinum Group I type A1 into a population dynamics model, to build the very first computational model of toxin production at the molecular level. We conduct a validation of our model against several items of published experimental data for different wild type and mutant strains of C. botulinum Group I type A1. The result of this process underscores the potential of mathematical modelling at the cellular level, as a means of creating opportunities in developing new strategies that could be used to prevent botulism; and potentially contribute to improved methods for the production of toxin that is used for therapeutics. PMID:27855161

49 CFR 211.5 - Regulatory docket.

Code of Federal Regulations, 2010 CFR

2010-10-01

.... Department of Transportation, Docket Operations (M-30), West Building Ground Floor, Room W12-140, 1200 New...://www.regulations.gov. All docketed materials are available for viewing and may be downloaded for...

Mindfulness Broadens Awareness and Builds Eudaimonic Meaning: A Process Model of Mindful Positive Emotion Regulation

PubMed Central

Garland, Eric L.; Farb, Norman A.; Goldin, Philippe; Fredrickson, Barbara L.

2015-01-01

Contemporary scholarship on mindfulness casts it as a form of purely non-evaluative engagement with experience. Yet, traditionally mindfulness was not intended to operate in a vacuum of dispassionate observation, but was seen as facilitative of eudaimonic mental states. In spite of this historical context, modern psychological research has neglected to ask the question of how the practice of mindfulness affects downstream emotion regulatory processes to impact the sense of meaning in life. To fill this lacuna, here we describe the Mindfulness-to-Meaning Theory, from which we derive a novel process model of mindful positive emotion regulation informed by affective science, in which mindfulness is proposed to introduce flexibility in the generation of cognitive appraisals by enhancing interoceptive attention, thereby expanding the scope of cognition to facilitate reappraisal of adversity and savoring of positive experience. This process is proposed to culminate in a deepened capacity for meaning-making and greater engagement with life. PMID:27087765

Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making:: A Policy Process Perspective.

PubMed

Kuehn, Carrie M

2018-01-01

The influence of patient advocates on FDA regulatory decision making has increased. Despite enhanced engagement with FDA, there remain challenges to achieving the regulatory goals of patients within FDA's regulatory framework. Gaps exist between patient advocates' knowledge of the agency's processes and FDA's need for rigorous, clinically meaningful patient experience data. This study examined the policy process in which patient experience data are collected by patient advocates and provided to FDA for regulatory decision making. Semistructured, narrative interviews were conducted with 14 professionals working in patient advocacy or at FDA. The purpose was to examine, in depth, participants' perceptions and experiences regarding this new regulatory process. Interviews were coded and examined for themes. The use of patient experience data by FDA is an evolving regulatory process. Participants identified a number of barriers and contributors to regulatory success. Well-organized and sophisticated patient advocacy groups with access to scientific and policy expertise are more likely to find success meeting FDA's patient experience data requirements. A conceptual model of this regulatory process was developed. Use of patient experience data by FDA has the potential to positively influence the regulation of medical products in the United States. Success within this new regulatory process will depend on clear guidance from FDA regarding the collection, analysis, and use of patient experience data. Patient advocacy groups must enhance internal capacity and expertise while engaging in substantive collaborations with FDA and other stakeholders in order to meaningfully contribute to the regulatory review of new therapeutics.

On the nature and consequences of early loss.

PubMed

Hofer, M A

1996-01-01

To describe how an animal model system can be used to explore basic questions about the nature of loss and the effects of early loss on later vulnerability to disease. The physiological and behavioral responses of infant rats to separation from their mothers are first described and then analyzed experimentally into component mechanisms. These studies have revealed an extensive layer of processes underlying the psychological constructs generally used to understand the response to loss. Hidden within the observable interactions of parent and offspring, we found a number of discrete sensorimotor, thermal, and nutrient-based events that have unexpected long-term regulatory effects on specific components of infant physiology and behavior. Release from all of these inhibitory and excitatory regulators together during maternal separation constitutes a novel mechanism by which the experience of loss can be translated into a complex patterned response. Evidence for early regulatory processes has also been found in monkey and human mother-infant interactions. Here they may well constitute the building blocks from which attachment and object representations develop. We and others have found long-term effects of loss, and of selective replacement of regulators, on behavioral development and on later vulnerability to disease. The results give us a new understanding of early attachment as a developmental force and of human grief as a risk to health.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Muldoon, Joe; Yankovich, Tamara; Schramm, Laurier L.

The Gunnar Mine and mill site was the largest of some 38 now-abandoned uranium mines that were developed and operated in Northern Saskatchewan, Canada, during the Cold War years. During their operating lifetimes these mines produced large quantities of ore and tailings. The Gunnar mine (open pit and underground) produced over 5 million tonnes of uranium ore and nearly 4.4 million tonnes of mine tailings during its operations from 1955 through 1963. An estimated 2.2 to 2.7 million m{sup 3} of waste rock that was generated during the processing of the ore abuts the shores of Lake Athabasca, the 22.more » largest lake in the world. After closure in the 1960's, the Gunnar site was abandoned with little to no decommissioning being done. The Saskatchewan Research Council has been contracted to manage the clean-up of these abandoned northern uranium mine and mill sites. The Gunnar Mine, because of the magnitude of tailings and waste rock, is subject to an environmental site assessment process regulated by both provincial and federal governments. This process requires a detailed study of the environmental impacts that have resulted from the mining activities and an analysis of projected impacts from remediation efforts. The environmental assessment process, specific site studies, and public involvement initiatives are all now well underway. Due to the many uncertainties associated with an abandoned site, an adaptive remediation approach, utilizing a decision tree, presented within the environmental assessment documents will be used as part of the site regulatory licensing. A critical early task was dealing with major public safety hazards on the site. The site originally included many buildings that were remnants of a community of approximately 800 people who once occupied the site. These buildings, many of which contained high levels of asbestos, had to be appropriately abated and demolished. Similarly, the original mine head frame and mill site buildings, many of which still contained the original machinery and equipment, also had to be dismantled. Remediation options for the accumulated demolition debris have been assessed, as have remediation options for the waste rock and tailings, all of which form part of the environmental assessment. The regulatory requirements include the environmental assessment processes, a complex public involvement strategy, and licensing from the Canadian Nuclear Safety Commission (CNSC) with the long-term goal of releasing the property in a remediated and stable state to the Province of Saskatchewan. Prescribed environmental and land use endpoints will be determined based on the environmental assessment studies and remediation options analyzed and implemented. Ultimately, the site will be released into an institutional controls program that will allow long-term government management and monitoring. (authors)« less

An Initial Evaluation of Siting Considerations on Current and Future Wind Deployment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tegen, Suzanne; Lantz, Eric; Mai, Trieu

This report provides a deeper understanding of the wind project development process, from desktop studies to a successful project in the ground. It examines three siting consideration categories that wind project sponsors must include in the development process: wildlife (species that live in, near, or migrate through the area where wind development is possible), radar (wind turbines can cause interference with radar signals), and public engagement (representing communities and stakeholders who live near wind power projects). The research shows that although this country's abundant wind resource provides numerous options for addressing siting considerations, actually siting individual projects is becoming moremore » difficult because of regulatory and other uncertainties. Model results are based on the premise that developers will be able to site, permit, and build successful projects, which is not always the case in reality.« less

[Regulatory science: modern trends in science and education for pharmaceutical products].

PubMed

Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

2012-01-01

This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

Final Memorandum on Remedial-Action Objectives for Operable Units 4-10. Tooele Army Depot-North Area

DTIC Science & Technology

1992-12-01

HAZARDOUS MATERIALS AGENCY (USATHAMA) ABERDEEN PROVING GROUND, MARYLAND Prepared by SEC Donohue, Inc. (Formerly Chem- Nuclear Environmental Services, Inc...Inc. (formerly Chem- Nuclear Environmental Services, Inc.), as deliverables under a Federal Facilities Agreement (FFA) between TEAD, the State of Utah...of Building 659. The building has a concrete floor and bermed containment and is a Nuclear Regulatory Commission (NRC)-licensed facility for the

The problem of epistemic jurisdiction in global governance: The case of sustainability standards for biofuels.

PubMed

Winickoff, David E; Mondou, Matthieu

2017-02-01

While there is ample scholarly work on regulatory science within the state, or single-sited global institutions, there is less on its operation within complex modes of global governance that are decentered, overlapping, multi-sectorial and multi-leveled. Using a co-productionist framework, this study identifies 'epistemic jurisdiction' - the power to produce or warrant technical knowledge for a given political community, topical arena or geographical territory - as a central problem for regulatory science in complex governance. We explore these dynamics in the arena of global sustainability standards for biofuels. We select three institutional fora as sites of inquiry: the European Union's Renewable Energy Directive, the Roundtable on Sustainable Biomaterials, and the International Organization for Standardization. These cases allow us to analyze how the co-production of sustainability science responds to problems of epistemic jurisdiction in the global regulatory order. First, different problems of epistemic jurisdiction beset different standard-setting bodies, and these problems shape both the content of regulatory science and the procedures designed to make it authoritative. Second, in order to produce global regulatory science, technical bodies must manage an array of conflicting imperatives - including scientific virtue, due process and the need to recruit adoptees to perpetuate the standard. At different levels of governance, standard drafters struggle to balance loyalties to country, to company or constituency and to the larger project of internationalization. Confronted with these sometimes conflicting pressures, actors across the standards system quite self-consciously maneuver to build or retain authority for their forum through a combination of scientific adjustment and political negotiation. Third, the evidentiary demands of regulatory science in global administrative spaces are deeply affected by 1) a market for standards, in which firms and states can choose the cheapest sustainability certification, and 2) the international trade regime, in which the long shadow of WTO law exerts a powerful disciplining function.

Modeling regulated water utility investment incentives

NASA Astrophysics Data System (ADS)

Padula, S.; Harou, J. J.

2014-12-01

This work attempts to model the infrastructure investment choices of privatized water utilities subject to rate of return and price cap regulation. The goal is to understand how regulation influences water companies' investment decisions such as their desire to engage in transfers with neighbouring companies. We formulate a profit maximization capacity expansion model that finds the schedule of new supply, demand management and transfer schemes that maintain the annual supply-demand balance and maximize a companies' profit under the 2010-15 price control process in England. Regulatory incentives for costs savings are also represented in the model. These include: the CIS scheme for the capital expenditure (capex) and incentive allowance schemes for the operating expenditure (opex) . The profit-maximizing investment program (what to build, when and what size) is compared with the least cost program (social optimum). We apply this formulation to several water companies in South East England to model performance and sensitivity to water network particulars. Results show that if companies' are able to outperform the regulatory assumption on the cost of capital, a capital bias can be generated, due to the fact that the capital expenditure, contrarily to opex, can be remunerated through the companies' regulatory capital value (RCV). The occurrence of the 'capital bias' or its entity depends on the extent to which a company can finance its investments at a rate below the allowed cost of capital. The bias can be reduced by the regulatory penalties for underperformances on the capital expenditure (CIS scheme); Sensitivity analysis can be applied by varying the CIS penalty to see how and to which extent this impacts the capital bias effect. We show how regulatory changes could potentially be devised to partially remove the 'capital bias' effect. Solutions potentially include allowing for incentives on total expenditure rather than separately for capex and opex and allowing both opex and capex to be remunerated through a return on the company's regulatory capital value.

Ship and Boat Building Sector (NAICS 3336)

EPA Pesticide Factsheets

Find environmental regulatory and compliance information for the shipbuilding sector (NAICS 3336), including NESHAPs and air toxics regulations, nonroad engines and vehicles, managing used oil, and polluted runoff from marinas and boating areas.

Environmental Management Waste Management Facility Proxy Waste Lot Profile 6.999 for Building K-25 West Wing, East Tennessee Technology Park, Oak Ridge, Tennessee

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rigsby V.P.

2009-02-12

In 1989, the Oak Ridge Reservation (ORR), which includes the East Tennessee Technology Park (ETTP), was placed on the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) National Priorities List. The Federal Facility Agreement (FFA) (DOE 1992), effective January 1, 1992, now governs environmental restoration activities conducted under CERCLA at the ORR. Following signing of the FFA, U.S. Department of Energy (DOE), U.S. Environmental Protection Agency (EPA), and the state of Tennessee signed the Oak Ridge Accelerated Cleanup Plan Agreement on June 18, 2002. The purpose of this agreement is to define a streamlined decision-making process to facilitatemore » the accelerated implementation of cleanup, resolve ORR milestone issues, and establish future actions necessary to complete the accelerated cleanup plan by the end of fiscal year 2008. While the FFA continues to serve as the overall regulatory framework for remediation, the Accelerated Cleanup Plan Agreement supplements existing requirements to streamline the decision-making process. Decontamination and decommissioning (D&D) activities of Bldg. K-25, the original gaseous diffusion facility, is being conducted by Bechtel Jacobs Company LLC (BJC) on behalf of the DOE. The planned CERCLA action covering disposal of building structure and remaining components from the K-25 building is scheduled as a non-time-critical CERCLA action as part of DOE's continuous risk reduction strategy for ETTP. The K-25 building is proposed for D&D because of its poor physical condition and the expense of surveillance and maintenance activities. The K-25/K-27 D&D Project proposes to dispose of the commingled waste listed below from the K-25 west side building structure and remaining components and process gas equipment and piping at the Environmental Management Waste Management Facility (EMWMF) under waste disposal proxy lot (WPXL) 6.999: (1) Building structure (e.g. concrete floors [excluding basement slab], roofing, structural steel supports, interior walls, and exterior walls) and support system components including the recirculation cooling water (RCW); electrical; communication; fire protection; ventilation; process coolant; process lube oil; utilities such as steam, water and drain lines; (2) Process Piping; (3) Seal Exhaust Headers; (4) Seal Exhaust Traps; (5) Process Valves; (6) Differential Blind Multipliers (DBM)/Partial Blind Multipliers (PBM); and (7) Aftercoolers (also known as Intercell coolers). Converters and compressors while components of the process gas system, are not included in this commingled waste lot. On January 6, 2009, a meeting was held with EPA, TDEC, DOE and the team for the sole purpose of finalizing the objectives, format, and content of WPXL 6.999. The objective of WPXL 6.999 was to provide a crosswalk to the building structure and the PGE components profiles. This was accomplished by providing tables with references to the specific section of the individual profiles for each of the WLs. There are two building profiles and eight PGE profiles. All of the waste identified in the individual profiles will be commingled, shipped, and disposed exclusively under WPXL 6.999. The individual profiles were provided to the EPA and Tennessee Department of Environment and Conservation (TDEC) for information purposes only. This summary WPXL 6.999 will be submitted to EPA, TDEC, and DOE for review and approval. The format agreed upon by the regulators and DOE form the basis for WPXL 6.999. The agreed format is found on pages v and vi of the CONTENTS section of this profile. The disposal of this waste will be executed in accordance with the Action Memorandum for the Decontamination and Decommissioning of the K-25 and K-27 Buildings, East Tennessee Technology Park, Oak Ridge, Tennessee (DOE 2002), Removal Action Work Plan for the K-25 and K-27 Buildings, Process Equipment Removal and Demolition, K-25/K-27 Project, East Tennessee Technology Park, Oak Ridge, Tennessee (DOE 2008a); Waste Handling Plan for Demolition of the K-25 and K-27 Building Structures and Remaining Components Located at the East Tennessee Technology Park, Oak Ridge, Tennessee (DOE 2005); and Waste Handling Plan for Building K-25 West Wing Process Equipment and Piping at the East Tennessee Technology Park, Oak Ridge, Tennessee (DOE 2008b).« less

FALCON: a toolbox for the fast contextualization of logical networks

PubMed Central

De Landtsheer, Sébastien; Trairatphisan, Panuwat; Lucarelli, Philippe; Sauter, Thomas

2017-01-01

Abstract Motivation Mathematical modelling of regulatory networks allows for the discovery of knowledge at the system level. However, existing modelling tools are often computation-heavy and do not offer intuitive ways to explore the model, to test hypotheses or to interpret the results biologically. Results We have developed a computational approach to contextualize logical models of regulatory networks with biological measurements based on a probabilistic description of rule-based interactions between the different molecules. Here, we propose a Matlab toolbox, FALCON, to automatically and efficiently build and contextualize networks, which includes a pipeline for conducting parameter analysis, knockouts and easy and fast model investigation. The contextualized models could then provide qualitative and quantitative information about the network and suggest hypotheses about biological processes. Availability and implementation FALCON is freely available for non-commercial users on GitHub under the GPLv3 licence. The toolbox, installation instructions, full documentation and test datasets are available at https://github.com/sysbiolux/FALCON. FALCON runs under Matlab (MathWorks) and requires the Optimization Toolbox. Contact thomas.sauter@uni.lu Supplementary information Supplementary data are available at Bioinformatics online. PMID:28673016

FALCON: a toolbox for the fast contextualization of logical networks.

PubMed

De Landtsheer, Sébastien; Trairatphisan, Panuwat; Lucarelli, Philippe; Sauter, Thomas

2017-11-01

Mathematical modelling of regulatory networks allows for the discovery of knowledge at the system level. However, existing modelling tools are often computation-heavy and do not offer intuitive ways to explore the model, to test hypotheses or to interpret the results biologically. We have developed a computational approach to contextualize logical models of regulatory networks with biological measurements based on a probabilistic description of rule-based interactions between the different molecules. Here, we propose a Matlab toolbox, FALCON, to automatically and efficiently build and contextualize networks, which includes a pipeline for conducting parameter analysis, knockouts and easy and fast model investigation. The contextualized models could then provide qualitative and quantitative information about the network and suggest hypotheses about biological processes. FALCON is freely available for non-commercial users on GitHub under the GPLv3 licence. The toolbox, installation instructions, full documentation and test datasets are available at https://github.com/sysbiolux/FALCON. FALCON runs under Matlab (MathWorks) and requires the Optimization Toolbox. thomas.sauter@uni.lu. Supplementary data are available at Bioinformatics online. © The Author(s) 2017. Published by Oxford University Press.

Regulatory gene networks and the properties of the developmental process

NASA Technical Reports Server (NTRS)

Davidson, Eric H.; McClay, David R.; Hood, Leroy

2003-01-01

Genomic instructions for development are encoded in arrays of regulatory DNA. These specify large networks of interactions among genes producing transcription factors and signaling components. The architecture of such networks both explains and predicts developmental phenomenology. Although network analysis is yet in its early stages, some fundamental commonalities are already emerging. Two such are the use of multigenic feedback loops to ensure the progressivity of developmental regulatory states and the prevalence of repressive regulatory interactions in spatial control processes. Gene regulatory networks make it possible to explain the process of development in causal terms and eventually will enable the redesign of developmental regulatory circuitry to achieve different outcomes.

Development of More Cost-Effective Methods for Long-Term Monitoring of Soil Vapor Intrusion to Indoor Air Using Quantitative Passive Diffusive-Adsorptive Sampling Techniques

DTIC Science & Technology

2015-05-01

challenging component of assessing human health risks associated with contaminated soil and groundwater since the late 1990s, during which time...and analysis. 1.3 REGULATORY DRIVERS Regulatory guidance for assessment and management of risks associated with VI has been issued by at least 27...requirements to assess potential human health risks , and this possibility exists where VOCs are present in the subsurface near occupied buildings

Generation of dTALEs and Libraries of Synthetic TALE-Activated Promoters for Engineering of Gene Regulatory Networks in Plants.

PubMed

Schreiber, Tom; Tissier, Alain

2017-01-01

Transcription factors with programmable DNA-binding specificity constitute valuable tools for the design of orthogonal gene regulatory networks for synthetic biology. Transcription activator-like effectors (TALEs), as natural transcription regulators, were used to design, build, and test libraries of synthetic TALE-activated promoters (STAPs) that show a broad range of expression levels in plants. In this chapter, we present protocols for the construction of artificial TALEs and corresponding STAPs.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kobos, Peter Holmes; Malczynski, Leonard A.; Walker, La Tonya Nicole

People save for retirement throughout their career because it is virtually impossible to save all you’ll need in retirement the year before you retire. Similarly, without installing incremental amounts of clean fossil, renewable or transformative energy technologies throughout the coming decades, a radical and immediate change will be near impossible the year before a policy goal is set to be in place. This notion of steady installation growth over acute installations of technology to meet policy goals is the core topic of discussion for this research. This research operationalizes this notion by developing the theoretical underpinnings of regulatory and marketmore » acceptance delays by building upon the common Technology Readiness Level (TRL) framework and offers two new additions to the research community. The new and novel Regulatory Readiness Level (RRL) and Market Readiness Level (MRL) frameworks were developed. These components, collectively called the Technology, Regulatory and Market (TRM) readiness level framework allow one to build new constraints into existing Integrated Assessment Models (IAMs) to address research questions such as, ‘To meet our desired technical and policy goals, what are the factors that affect the rate we must install technology to achieve these goals in the coming decades?’« less

Cannabis regulatory science: risk-benefit considerations for mental disorders.

PubMed

Borodovsky, Jacob T; Budney, Alan J

2018-05-29

The evolving legal cannabis landscape in the US continues to present novel regulatory challenges that necessitate the development of a Cannabis Regulatory Science. Two specific issues of concern within Cannabis Regulatory Science are (1) the impact that cannabis use has on the incidence, prevalence, and severity of mental disorders, and (2) how cannabis laws and regulations modify this impact. This paper first provides several conceptual points that are useful for evaluating the relationship between cannabis use and mental disorders. Second, it selectively reviews and comments on data relevant to the relationship between cannabis use and depression, several forms of anxiety, post-traumatic stress disorder, schizophrenia, and bipolar disorder. Next, regulatory and public health parallels between the nascent cannabis industry and the pharmaceutical, tobacco, and alcohol industries are discussed. The focus is on specific types of industry practices that may harm those with or at risk for mental disorders. Recommendations are then offered for legal cannabis regulations that could mitigate this harm. Last, future research goals are discussed for building the field of Cannabis Regulatory Science and addressing the potential negative impact of cannabis on those with mental disorders.

[The system theory of aging: methodological principles, basic tenets and applications].

PubMed

Krut'ko, V N; Dontsov, V I; Zakhar'iashcheva, O V

2009-01-01

The paper deals with the system theory of aging constructed on the basis of present-day scientific methodology--the system approach. The fundamental cause for aging is discrete existence of individual life forms, i.e. living organisms which, from the thermodynamic point of view, are not completely open systems. The primary aging process (build-up of chaos and system disintegration of aging organism) obeys the second law of thermodynamics or the law of entropy increase in individual partly open systems. In living organisms the law is exhibited as synergy of four main aging mechanisms: system "pollution" of organism, loss of non-regenerative elements, accumulation of damages and deformations, generation of variability on all levels, and negative changes in regulation processes and consequent degradation of the organism systematic character. These are the general aging mechanisms; however, the regulatory mechanisms may be important equally for organism aging and search for ways to prolong active life.

Emerging principles of regulatory evolution.

PubMed

Prud'homme, Benjamin; Gompel, Nicolas; Carroll, Sean B

2007-05-15

Understanding the genetic and molecular mechanisms governing the evolution of morphology is a major challenge in biology. Because most animals share a conserved repertoire of body-building and -patterning genes, morphological diversity appears to evolve primarily through changes in the deployment of these genes during development. The complex expression patterns of developmentally regulated genes are typically controlled by numerous independent cis-regulatory elements (CREs). It has been proposed that morphological evolution relies predominantly on changes in the architecture of gene regulatory networks and in particular on functional changes within CREs. Here, we discuss recent experimental studies that support this hypothesis and reveal some unanticipated features of how regulatory evolution occurs. From this growing body of evidence, we identify three key operating principles underlying regulatory evolution, that is, how regulatory evolution: (i) uses available genetic components in the form of preexisting and active transcription factors and CREs to generate novelty; (ii) minimizes the penalty to overall fitness by introducing discrete changes in gene expression; and (iii) allows interactions to arise among any transcription factor and downstream CRE. These principles endow regulatory evolution with a vast creative potential that accounts for both relatively modest morphological differences among closely related species and more profound anatomical divergences among groups at higher taxonomical levels.

Extension of quality-by-design concept to the early development phase of pharmaceutical R&D processes.

PubMed

Csóka, Ildikó; Pallagi, Edina; Paál, Tamás L

2018-03-27

Here, we propose the extension of the quality-by-design (QbD) concept to also fit the early development phases of pharmaceuticals by adding elements that are currently widely applied, but not yet included in the QbD model in a structured way. These are the introduction of a 'zero' preformulation phase (i.e., selection of drug substance, possible dosage forms and administration routes based on the evaluated therapeutic need); building in stakeholders' (industry, patient, and regulatory) requirements into the quality target product profile (QTTP); and the use of modern quality management tools during the composition and process design phase [collecting critical quality attributes (CQAs) and selection of CPPs) for (still laboratory-scale) design space (DS) development. Moreover, during industrial scale-up, CQAs (as well as critical process parameters; CPPs) can be changed; however, we recommend that the existing QbD elements are reconsidered and updated after this phase. Copyright © 2018 Elsevier Ltd. All rights reserved.

Participatory Modeling Processes to Build Community Knowledge Using Shared Model and Data Resources and in a Transboundary Pacific Northwest Watershed (Nooksack River Basin, Washington, USA)

NASA Astrophysics Data System (ADS)

Bandaragoda, C.; Dumas, M.

2014-12-01

As with many western US watersheds, the Nooksack River Basin faces strong pressures associated with climate variability and change, rapid population growth, and deep-rooted water law. This transboundary basin includes contributing areas in British Columbia, Canada, and has a long history of joint data collection, model development, and facilitated communication between governmental (federal, tribal, state, local), environmental, timber, agricultural, and recreational user groups. However, each entity in the watershed responds to unique data coordination, information sharing, and adaptive management regimes and thresholds, further increasing the complexity of watershed management. Over the past four years, participatory methods were used to compile and review scientific data and models, including fish habitat (endangered salmonid species), channel hydraulics, climate data, agricultural, municipal and industrial water use, and integrated watershed scale distributed hydrologic models from over 15 years of projects (from jointly funded to independent shared work by individual companies, agencies, and universities). A specific outcome of the work includes participatory design of a collective problem statement used for guidance on future investment of shared resources and development of a data-generation process where modeling results are communicated in a three-tiers for 1) public/decision-making, 2) technical, and 3) research audiences. We establish features for successful participation using tools that are iteratively developed, tested for usability through incremental knowledge building, and designed to provide rigor in modeling. A general outcome of the work is ongoing support by tribal, state, and local governments, as well as the agricultural community, to continue the generation of shared watershed data using models in a dynamic legal and regulatory setting, where two federally recognized tribes have requested federal court resolution of federal treaty rights. Our participatory modeling process aims to integrate disciplines and watershed processes over time and space, while building capacity for more holistic watershed-scale thinking, or community knowledge, by research, governmental and public interests.

WASTE HANDLING BUILDING VENTILATION SYSTEM DESCRIPTION DOCUMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

P.A. Kumar

2000-06-21

The Waste Handling Building Ventilation System provides heating, ventilation, and air conditioning (HVAC) for the contaminated, potentially contaminated, and uncontaminated areas of the Monitored Geologic Repository's (MGR) Waste Handling Building (WHB). In the uncontaminated areas, the non-confinement area ventilation system maintains the proper environmental conditions for equipment operation and personnel comfort. In the contaminated and potentially contaminated areas, in addition to maintaining the proper environmental conditions for equipment operation and personnel comfort, the contamination confinement area ventilation system directs potentially contaminated air away from personnel in the WHB and confines the contamination within high-efficiency particulate air (HEPA) filtration units. Themore » contamination confinement areas ventilation system creates airflow paths and pressure zones to minimize the potential for spreading contamination within the building. The contamination confinement ventilation system also protects the environment and the public by limiting airborne releases of radioactive or other hazardous contaminants from the WHB. The Waste Handling Building Ventilation System is designed to perform its safety functions under accident conditions and other Design Basis Events (DBEs) (such as earthquakes, tornadoes, fires, and loss of the primary electric power). Additional system design features (such as compartmentalization with independent subsystems) limit the potential for cross-contamination within the WHB. The system provides status of important system parameters and equipment operation, and provides audible and/or visual indication of off-normal conditions and equipment failures. The Waste Handling Building Ventilation System confines the radioactive and hazardous material within the building such that the release rates comply with regulatory limits. The system design, operations, and maintenance activities incorporate ALARA (as low as is reasonably achievable) principles to maintain personnel radiation doses to all occupational workers below regulatory limits and as low as is reasonably achievable. The Waste Handling Building Ventilation System interfaces with the Waste Handling Building System by being located within the WHB and by maintaining specific pressures, temperatures, and humidity within the building. The system also depends on the WHB for water supply. The system interfaces with the Site Radiological Monitoring System for continuous monitoring of the exhaust air; the Waste Handling Building Fire Protection System for detection of fire and smoke; the Waste Handling Building Electrical System for normal, emergency, and standby power; and the Monitored Geologic Repository Operations Monitoring and Control System for monitoring and control of the system.« less

Energy performance assessment with empirical methods: application of energy signature

NASA Astrophysics Data System (ADS)

Belussi, L.; Danza, L.; Meroni, I.; Salamone, F.

2015-03-01

Energy efficiency and reduction of building consumption are deeply felt issues both at Italian and international level. The recent regulatory framework sets stringent limits on energy performance of buildings. Awaiting the adoption of these principles, several methods have been developed to solve the problem of energy consumption of buildings, among which the simplified energy audit is intended to identify any anomalies in the building system, to provide helpful tips for energy refurbishments and to raise end users' awareness. The Energy Signature is an operational tool of these methodologies, an evaluation method in which energy consumption is correlated with climatic variables, representing the actual energy behaviour of the building. In addition to that purpose, the Energy Signature can be used as an empirical tool to determine the real performances of the technical elements. The latter aspect is illustrated in this article.

Environmental site assessments and audits: Building inspection requirements

NASA Astrophysics Data System (ADS)

Lange, John H.; Kaiser, Genevieve; Thomulka, Kenneth W.

1994-01-01

Environmental site assessment criteria were originally developed by organizations that focused, almost exclusively, on surface, subsurface, and pollution source contamination. Many of the hazards associated with indoor environments and building structures were traditionally not considered when evaluating sources and entities of environmental pollution. Since a large number of building materials are potentially hazardous, careful evaluation is necessary. Until recently, little information on building inspection requirements of environmental problems has been published. Traditionally, asbestos has been the main component of concern. The ever-changing environmental standards have dramatically expanded the scope of building surveys. Indoor environmental concerns, for example, currently include formaldehyde, lead-based paint, polychlorinated biphenyls, radon, and indoor air pollution. Environmental regulations are being expanded and developed that specifically include building structures. These regulatory standards are being triggered by an increased awareness of health effects from indoor exposure, fires, spills, and other accidents that have resulted in injury, death, and financial loss. This article discusses various aspects of assessments for building structures.

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Maximizing profit and endangering health: corporate strategies to avoid litigation and regulation.

PubMed

Bohme, Susanna Rankin; Zorabedian, John; Egilman, David S

2005-01-01

Corporations and industries use various tactics to obscure the fact that their products are dangerous or deadly. Their aim is to secure the least restrictive possible regulatory environment and avert legal liability for deaths or injuries in order to maximize profit. They work with attorneys and public relations professionals, using scientists, science advisory boards; front groups, industry organizations, think tanks, and the media to influence scientific and popular opinion of the risks of their products or processes. The strategy, which depends on corrupt science, profits corporations at the expense of public health. Public health professionals can learn from this strategy how to effectively build scientific and public opinion that prioritizes both good science and the public health.

Biomolecular computing systems: principles, progress and potential.

PubMed

Benenson, Yaakov

2012-06-12

The task of information processing, or computation, can be performed by natural and man-made 'devices'. Man-made computers are made from silicon chips, whereas natural 'computers', such as the brain, use cells and molecules. Computation also occurs on a much smaller scale in regulatory and signalling pathways in individual cells and even within single biomolecules. Indeed, much of what we recognize as life results from the remarkable capacity of biological building blocks to compute in highly sophisticated ways. Rational design and engineering of biological computing systems can greatly enhance our ability to study and to control biological systems. Potential applications include tissue engineering and regeneration and medical treatments. This Review introduces key concepts and discusses recent progress that has been made in biomolecular computing.

The migratory bird treaty and a century of waterfowl conservation

USGS Publications Warehouse

Anderson, Michael G.; Alisauskas, Ray T.; Batt, Bruce D. J.; Blohm, Robert J.; Higgins, Kenneth F.; Perry, Matthew; Ringelman, James K.; Sedinger, James S.; Serie, Jerome R.; Sharp, David E.; Trauger, David L.; Williams, Christopher K.

2018-01-01

In the final decades of the nineteenth century, concern was building about the status of migratory bird populations in North America. In this literature review, we describe how that concern led to a landmark conservation agreement in 1916, between the United States and Great Britain (on behalf of Canada) to conserve migratory birds shared by Canada and the United States. Drawing on published literature and our personal experience, we describe how subsequent enabling acts in both countries gave rise to efforts to better estimate population sizes and distributions, assess harvest rates and demographic impacts, design and fund landscape-level habitat conservation initiatives, and organize necessary political and regulatory processes. Executing these steps required large-scale thinking, unprecedented regional and international cooperation, ingenuity, and a commitment to scientific rigor and adaptive management. We applaud the conservation efforts begun 100 years ago with the Migratory Bird Treaty Convention. The agreement helped build the field of wildlife ecology and conservation in the twentieth century but only partially prepares us for the ecological and social challenges ahead. 

GIS-assisted spatial analysis for urban regulatory detailed planning: designer's dimension in the Chinese code system

NASA Astrophysics Data System (ADS)

Yu, Yang; Zeng, Zheng

2009-10-01

By discussing the causes behind the high amendments ratio in the implementation of urban regulatory detailed plans in China despite its law-ensured status, the study aims to reconcile conflict between the legal authority of regulatory detailed planning and the insufficient scientific support in its decision-making and compilation by introducing into the process spatial analysis based on GIS technology and 3D modeling thus present a more scientific and flexible approach to regulatory detailed planning in China. The study first points out that the current compilation process of urban regulatory detailed plan in China employs mainly an empirical approach which renders it constantly subjected to amendments; the study then discusses the need and current utilization of GIS in the Chinese system and proposes the framework of a GIS-assisted 3D spatial analysis process from the designer's perspective which can be regarded as an alternating processes between the descriptive codes and physical design in the compilation of regulatory detailed planning. With a case study of the processes and results from the application of the framework, the paper concludes that the proposed framework can be an effective instrument which provides more rationality, flexibility and thus more efficiency to the compilation and decision-making process of urban regulatory detailed plan in China.

Incidental experiences of regulatory fit and the processing of persuasive appeals.

PubMed

Koenig, Anne M; Cesario, Joseph; Molden, Daniel C; Kosloff, Spee; Higgins, E Tory

2009-10-01

This article examines how the subjective experiences of "feeling right" from regulatory fit and of "feeling wrong" from regulatory non-fit influence the way people process persuasive messages. Across three studies, incidental experiences of regulatory fit increased reliance on source expertise and decreased resistance to counterpersuasion, whereas incidental experiences of regulatory non-fit increased reliance on argument strength and increased resistance to counterpersuasion. These results suggest that incidental fit and non-fit experiences can produce, respectively, more superficial or more thorough processing of persuasive messages. The mechanisms underlying these effects, and the conditions under which they should and should not be expected, are discussed.

Alternative Asbestos Control Method (AACM), Washington

EPA Science Inventory

This presentation describes the status to date of the Alternative Asbestos Control Method research, which is intended as a possible alternative technology for use in the demolition of buildings that contain asbestos and are covered under the regulatory requirements of the Asbesto...

Alternative Asbestos Control Method (AACM) Research

EPA Science Inventory

This presentation describes the status to date of the Alternative Asbestos Control Method research, which is intended as a possible alternative technology for use in the demolition of buildings that contain asbestos and are covered under the regulatory requirements of the Asbesto...

30 CFR 913.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Illinois Department of Natural Resources, Office of Mines and Minerals, Land Reclamation Division, One Natural Resources Way, Springfield, Illinois 62701-1787. (b) Illinois Department of Natural Resources... Office, Minton-Capehart Federal Building, 575 North Pennsylvania Street, Room 301, Indianapolis, IN 46204...

77 FR 14837 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

... function of solar activity. The agenda is subject to change. The current agenda and any updates will be.... Address for Public Meeting: U.S. Nuclear Regulatory Commission, Two White Flint North Building, Room T2...

Mexico's Geothermal Market Assessment Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Flores-Espino, Francisco; Booth, Sarah; Graves, Andrew

This report is intended to help U.S. companies in the geothermal sector understand potential business opportunities created by recent changes in the Mexican energy market and regulatory environment. can also provide a variety of technology products and services for export into the Mexican market. This report will help U.S. companies identify the many public and private sector stakeholders in the United States and Mexico, which can help U.S. companies navigate the new regulatory and permitting environment, build new partnerships, and identify vehicles for financial assistance and risk mitigation.

Inferring gene dependency network specific to phenotypic alteration based on gene expression data and clinical information of breast cancer.

PubMed

Zhou, Xionghui; Liu, Juan

2014-01-01

Although many methods have been proposed to reconstruct gene regulatory network, most of them, when applied in the sample-based data, can not reveal the gene regulatory relations underlying the phenotypic change (e.g. normal versus cancer). In this paper, we adopt phenotype as a variable when constructing the gene regulatory network, while former researches either neglected it or only used it to select the differentially expressed genes as the inputs to construct the gene regulatory network. To be specific, we integrate phenotype information with gene expression data to identify the gene dependency pairs by using the method of conditional mutual information. A gene dependency pair (A,B) means that the influence of gene A on the phenotype depends on gene B. All identified gene dependency pairs constitute a directed network underlying the phenotype, namely gene dependency network. By this way, we have constructed gene dependency network of breast cancer from gene expression data along with two different phenotype states (metastasis and non-metastasis). Moreover, we have found the network scale free, indicating that its hub genes with high out-degrees may play critical roles in the network. After functional investigation, these hub genes are found to be biologically significant and specially related to breast cancer, which suggests that our gene dependency network is meaningful. The validity has also been justified by literature investigation. From the network, we have selected 43 discriminative hubs as signature to build the classification model for distinguishing the distant metastasis risks of breast cancer patients, and the result outperforms those classification models with published signatures. In conclusion, we have proposed a promising way to construct the gene regulatory network by using sample-based data, which has been shown to be effective and accurate in uncovering the hidden mechanism of the biological process and identifying the gene signature for phenotypic change.

Bench Scale Process for Low Cost CO2 Capture Using a Phase-Changing Absorbent: Topical Report EH&S Risk Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Westendorf, Tiffany; Farnum, Rachel; Perry, Robert

2016-05-11

GE Global Research was contracted by the Department of Energy to design and build a bench-scale process for a novel phase-changing aminosilicone-based CO2 capture solvent (award number DEFE0013687). As part of this program, a technology EH&S assessment (Subtask 5.1) has been completed for a CO2 capture system for a 550 MW coal-fired power plant. The assessment focuses on two chemicals used in the process, the aminosilicone solvent, GAP-0, and dodecylbenzenesulfonic acid (DDBSA), the GAP-0 carbamate formed upon reaction of the GAP-0 with CO2, and two potential byproducts formed in the process, GAP-0/SOx salts and amine-terminated, urea-containing silicone (also referred tomore » as “ureas” in this report). The EH&S assessment identifies and estimates the magnitude of the potential air and water emissions and solid waste generated by the process and reviews the toxicological profiles of the chemicals associated with the process. Details regarding regulatory requirements, engineering controls, and storage and handling procedures are also provided in the following sections.« less

Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Barriers to Building Energy Efficiency (BEE) promotion: A transaction costs perspective

NASA Astrophysics Data System (ADS)

Qian Kun, Queena

Worldwide, buildings account for a surprisingly high 40% of global energy consumption, and the resulting carbon footprint significantly exceeds that of all forms of transportation combined. Large and attractive opportunities exist to reduce buildings' energy use at lower costs and higher returns than in other sectors. This thesis analyzes the concerns of the market stakeholders, mainly real estate developers and end-users, in terms of transaction costs as they make decisions about investing in Building Energy Efficiency (BEE). It provides a detailed analysis of the current situation and future prospects for BEE adoption by the market's stakeholders. It delineates the market and lays out the economic and institutional barriers to the large-scale deployment of energy-efficient building techniques. The aim of this research is to investigate the barriers raised by transaction costs that hinder market stakeholders from investing in BEES. It explains interactions among stakeholders in general and in the specific case of Hong Kong as they consider transaction costs. It focuses on the influence of transaction costs on the decision-making of the stakeholders during the entire process of real estate development. The objectives are: 1) To establish an analytical framework for understanding the barriers to BEE investment with consideration of transaction costs; 2) To build a theoretical game model of decision making among the BEE market stakeholders; 3) To study the empirical data from questionnaire surveys of building designers and from focused interviews with real estate developers in Hong Kong; 4) To triangulate the study's empirical findings with those of the theoretical model and analytical framework. The study shows that a coherent institutional framework needs to be established to ensure that the design and implementation of BEE policies acknowledge the concerns of market stakeholders by taking transaction costs into consideration. Regulatory and incentive options should be integrated into BEE policies to minimize efficiency gaps and to realize a sizeable increase in the number of energy-efficient buildings in the next decades. Specifically, the analysis shows that a thorough understanding of the transaction costs borne by particular stakeholders could improve the energy efficiency of buildings, even without improvements in currently available technology.

Creating and validating cis-regulatory maps of tissue-specific gene expression regulation

PubMed Central

O'Connor, Timothy R.; Bailey, Timothy L.

2014-01-01

Predicting which genomic regions control the transcription of a given gene is a challenge. We present a novel computational approach for creating and validating maps that associate genomic regions (cis-regulatory modules–CRMs) with genes. The method infers regulatory relationships that explain gene expression observed in a test tissue using widely available genomic data for ‘other’ tissues. To predict the regulatory targets of a CRM, we use cross-tissue correlation between histone modifications present at the CRM and expression at genes within 1 Mbp of it. To validate cis-regulatory maps, we show that they yield more accurate models of gene expression than carefully constructed control maps. These gene expression models predict observed gene expression from transcription factor binding in the CRMs linked to that gene. We show that our maps are able to identify long-range regulatory interactions and improve substantially over maps linking genes and CRMs based on either the control maps or a ‘nearest neighbor’ heuristic. Our results also show that it is essential to include CRMs predicted in multiple tissues during map-building, that H3K27ac is the most informative histone modification, and that CAGE is the most informative measure of gene expression for creating cis-regulatory maps. PMID:25200088

[Convergence of healthcare regulation in the Americas: history, development, and new challenges].

PubMed

Silva, Ana Paula Jucá; Tagliari, Patrícia Oliveira Pereira

2016-05-01

The present article describes the changing relationship among healthcare regulatory authorities in various international settings, with special emphasis on the Americas. As other sectors, healthcare also faces the need to regulate international practices, while at the same time taking into consideration the specific realities of each country. Regulatory convergence - a movement towards technical alignment to enable the adoption of local regulatory mechanisms that take into account internationally recognized standards and principles to promote a single sanitary goal - has emerged as a means to address this challenge. Organizations that already use this tool, such as the International Conference of Drug Regulatory Authorities (ICDRA), Pan American Network for Drug Regulatory Harmonization (PANDRH), International Generic Drug Regulators Programme (IGDRP), and the International Medical Device Regulators Forum (IMDRF), among others, are currently working to gather knowledge, data, and specialists from different countries to build an international technical and scientific standard that can be used for decision-making by local regulators. This would ensure convergence of national regulations despite the need to adapt international standards to local needs, structure, and capacities. The most recent resolutions issued by the World Health Organization recognize the need to bring regulatory systems closer to the reality of national healthcare systems, and underscore the advantages of using existing local guidelines as input for cooperation with regulatory authorities.

Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop.

PubMed

Ramirez, Tzutzuy; Beken, Sonja; Chlebus, Magda; Ellis, Graham; Griesinger, Claudius; De Jonghe, Sandra; Manou, Irene; Mehling, Annette; Reisinger, Kerstin; Rossi, Laura H; van Benthem, Jan; van der Laan, Jan Willem; Weissenhorn, Renate; Sauer, Ursula G

2015-10-01

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them. Copyright © 2015 Elsevier Inc. All rights reserved.

ALTERNATIVE ASBESTOS CONTROL METHOD (AACM) AT GEBO

EPA Science Inventory

This presentation describes the status to date of the AACM research, which is intended as a possible alternative technology for use in the demolition of buildings that contain asbestos and are covered under the regulatory requirements of the Asbestos NESHAP. This abstract and pr...

Alternative Asbestos Control Method (AACM) Research, 5/06/2008

EPA Science Inventory

This presentation describes the status to date of the Alternative Asbestos Control Method research, which is intended as a possible alternative technology for use in the demolition of buildings that contain asbestos and are covered under the regulatory requirements of the Asbesto...

Alternative Asbestos Control Method (AACM) Research - Feb 2008

EPA Science Inventory

This presentation describes the status to date of the Alternative Asbestos Control Method research, which is intended as a possible alternative technology for use in the demolition of buildings that contain asbestos and are covered under the regulatory requirements of the Asbesto...

ALTERNATIVE ASBESTOS CONTROL METHOD (AACM) RESEARCH - BALTIMORE, MD

EPA Science Inventory

This presentation describes the status to date of the Alternative Asbestos Control Method research, which is intended as a possible alternative technology for use in the demolition of buildings that contain asbestos and are covered under the regulatory requirements of the Asbesto...

A FRAMEWORK FOR FINE-SCALE COMPUTATIONAL FLUID DYNAMICS AIR QUALITY MODELING AND ANALYSIS

EPA Science Inventory

Fine-scale Computational Fluid Dynamics (CFD) simulation of pollutant concentrations within roadway and building microenvironments is feasible using high performance computing. Unlike currently used regulatory air quality models, fine-scale CFD simulations are able to account rig...

The UAV and the Current and Future Regulatory Construction for Integration into the National Airspace System

DTIC Science & Technology

2005-07-01

vehicles to deliver mail or packages across town, in a large indoor complex or building, or even to deliver...drugs, marihuana , depressants or stimulants.330 Further, current licenses and certified personnel may have their

75 FR 6417 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below...

75 FR 8760 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below...

The regulatory sciences for stem cell-based medicinal products.

PubMed

Yuan, Bao-Zhu; Wang, Junzhi

2014-06-01

Over the past few years, several new achievements have been made from stem cell studies, many of which have moved up from preclinical stages to early, or from early to middle or late, stages thanks to relatively safe profile and preliminary evidence of effectiveness. Moreover, some stem cell-based products have been approved for marketing by different national regulatory authorities. However, many critical issues associated mainly with incomplete understanding of stem cell biology and the relevant risk factors, and lack of effective regulations still exist and need to be urgently addressed, especially in countries where establishment of appropriate regulatory system just commenced. More relevantly, the stem cell regulatory sciences need to be established or improved to more effectively evaluate quality, safety and efficacy of stem cell products, and for building up the appropriate regulatory framework. In this review, we summarize some new achievements in stem cell studies, especially the preclinical and clinical studies, the existing regulations, and the associated challenges, and we then propose some considerations for improving stem cell regulatory sciences with a goal of promoting the steadfast growth of the well-regulated stem cell therapies abreast of evolvement of stem cell sciences and technologies.

Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas.

PubMed

Allchurch, Martin Harvey; Barbano, Dirceu Brás Aparecido; Pinheiro, Marie-Hélène; Lazdin-Helds, Janis

2016-05-01

This report considers how the experience of the European regulatory system might be applied to help strengthen the regulatory systems for medicines in the Region of the Americas. The work of the European Medicines Agencies (EMA) is carried out through its scientific committees, composed of members from European Economic Area countries. A robust legal framework allows EMA to coordinate resources from Member States' competent authorities, including, for example, assisting candidate countries as they prepare to join the European Union (EU). Capacity-building programs help countries adjust their regulatory systems ahead of full participation in the European medicines regulatory network. These programs facilitate adoption of common technical requirements, identify areas where action might be needed to ensure the smooth transposition of EU pharmaceutical law into national legislation, and prepare candidate countries for participation in EMA committees and the European regulatory network. The methodology of these programs could be of potential interest to the Pan American Health Organization (PAHO), the Regional Office of the World Health Organization for the Americas. Given resolutions adopted by the World Health Assembly and the PAHO Directing Council, there is a strong indication that the countries of the Region of the Americas wish to assemble a system that uses the existing regulatory capacity of some countries to strengthen local regulatory capacities in others.

77 FR 53236 - Proposed International Isotopes Fluorine Extraction Process and Depleted Uranium Deconversion...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-31

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0143] Proposed International Isotopes Fluorine Extraction Process and Depleted Uranium Deconversion Plant in Lea County, New Mexico AGENCY: Nuclear Regulatory... U.S. Nuclear Regulatory Commission (NRC or the Commission) has published the Final Environmental...

30 CFR 761.16 - Submission and processing of requests for valid existing rights determinations.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) Requirements for property rights demonstration. You must provide a property rights demonstration under... matter Regulatory authority Regulatory program 2 (d) Public roads Does not matter Regulatory authority Regulatory program 2 (e) Occupied dwellings Does not matter Regulatory authority Regulatory program 2 (f...

A physiologist's view of homeostasis

PubMed Central

Cliff, William; Michael, Joel; McFarland, Jenny; Wenderoth, Mary Pat; Wright, Ann

2015-01-01

Homeostasis is a core concept necessary for understanding the many regulatory mechanisms in physiology. Claude Bernard originally proposed the concept of the constancy of the “milieu interieur,” but his discussion was rather abstract. Walter Cannon introduced the term “homeostasis” and expanded Bernard's notion of “constancy” of the internal environment in an explicit and concrete way. In the 1960s, homeostatic regulatory mechanisms in physiology began to be described as discrete processes following the application of engineering control system analysis to physiological systems. Unfortunately, many undergraduate texts continue to highlight abstract aspects of the concept rather than emphasizing a general model that can be specifically and comprehensively applied to all homeostatic mechanisms. As a result, students and instructors alike often fail to develop a clear, concise model with which to think about such systems. In this article, we present a standard model for homeostatic mechanisms to be used at the undergraduate level. We discuss common sources of confusion (“sticky points”) that arise from inconsistencies in vocabulary and illustrations found in popular undergraduate texts. Finally, we propose a simplified model and vocabulary set for helping undergraduate students build effective mental models of homeostatic regulation in physiological systems. PMID:26628646

Applying Evolutionary Prototyping In Developing LMIS: A Spatial Web-Based System For Land Management

NASA Astrophysics Data System (ADS)

Agustiono, W.

2018-01-01

Software development project is a difficult task. Especially for software designed to comply with regulations that are constantly being introduced or changed, it is almost impossible to make just one change during the development process. Even if it is possible, nonetheless, the developers may take bulk of works to fix the design to meet specified needs. This iterative work also means that it takes additional time and potentially leads to failing to meet the original schedule and budget. In such inevitable changes, it is essential for developers to carefully consider and use an appropriate method which will help them carry out software project development. This research aims to examine the implementation of a software development method called evolutionary prototyping for developing software for complying regulation. It investigates the development of Land Management Information System (pseudonym), initiated by the Australian government, for use by farmers to meet regulatory demand requested by Soil and Land Conservation Act. By doing so, it sought to provide understanding the efficacy of evolutionary prototyping in helping developers address frequent changing requirements and iterative works but still within schedule. The findings also offer useful practical insights for other developers who seek to build similar regulatory compliance software.

m6A-Driver: Identifying Context-Specific mRNA m6A Methylation-Driven Gene Interaction Networks

PubMed Central

Zhang, Song-Yao; Zhang, Shao-Wu; Liu, Lian; Huang, Yufei

2016-01-01

As the most prevalent mammalian mRNA epigenetic modification, N6-methyladenosine (m6A) has been shown to possess important post-transcriptional regulatory functions. However, the regulatory mechanisms and functional circuits of m6A are still largely elusive. To help unveil the regulatory circuitry mediated by mRNA m6A methylation, we develop here m6A-Driver, an algorithm for predicting m6A-driven genes and associated networks, whose functional interactions are likely to be actively modulated by m6A methylation under a specific condition. Specifically, m6A-Driver integrates the PPI network and the predicted differential m6A methylation sites from methylated RNA immunoprecipitation sequencing (MeRIP-Seq) data using a Random Walk with Restart (RWR) algorithm and then builds a consensus m6A-driven network of m6A-driven genes. To evaluate the performance, we applied m6A-Driver to build the context-specific m6A-driven networks for 4 known m6A (de)methylases, i.e., FTO, METTL3, METTL14 and WTAP. Our results suggest that m6A-Driver can robustly and efficiently identify m6A-driven genes that are functionally more enriched and associated with higher degree of differential expression than differential m6A methylated genes. Pathway analysis of the constructed context-specific m6A-driven gene networks further revealed the regulatory circuitry underlying the dynamic interplays between the methyltransferases and demethylase at the epitranscriptomic layer of gene regulation. PMID:28027310

VirtualLeaf: an open-source framework for cell-based modeling of plant tissue growth and development.

PubMed

Merks, Roeland M H; Guravage, Michael; Inzé, Dirk; Beemster, Gerrit T S

2011-02-01

Plant organs, including leaves and roots, develop by means of a multilevel cross talk between gene regulation, patterned cell division and cell expansion, and tissue mechanics. The multilevel regulatory mechanisms complicate classic molecular genetics or functional genomics approaches to biological development, because these methodologies implicitly assume a direct relation between genes and traits at the level of the whole plant or organ. Instead, understanding gene function requires insight into the roles of gene products in regulatory networks, the conditions of gene expression, etc. This interplay is impossible to understand intuitively. Mathematical and computer modeling allows researchers to design new hypotheses and produce experimentally testable insights. However, the required mathematics and programming experience makes modeling poorly accessible to experimental biologists. Problem-solving environments provide biologically intuitive in silico objects ("cells", "regulation networks") required for setting up a simulation and present those to the user in terms of familiar, biological terminology. Here, we introduce the cell-based computer modeling framework VirtualLeaf for plant tissue morphogenesis. The current version defines a set of biologically intuitive C++ objects, including cells, cell walls, and diffusing and reacting chemicals, that provide useful abstractions for building biological simulations of developmental processes. We present a step-by-step introduction to building models with VirtualLeaf, providing basic example models of leaf venation and meristem development. VirtualLeaf-based models provide a means for plant researchers to analyze the function of developmental genes in the context of the biophysics of growth and patterning. VirtualLeaf is an ongoing open-source software project (http://virtualleaf.googlecode.com) that runs on Windows, Mac, and Linux.

Towards a catchment-scale macro-ecological model to support integrated catchment management in Europe

NASA Astrophysics Data System (ADS)

Lerner, R. N.; Lerner, D. N.; Surridge, B.; Paetzold, A.; Harris, B.; Anderson, C. W.

2005-12-01

In Europe, the Water Framework Directive (WFD) is providing a powerful regulatory driver to adopt integrated catchment management, and so pressurizing researchers to build suitable supporting tools. The WFD requires agencies to drive towards `good ecological quality' by 2015. After the initial step of characterising water bodies and the pressures on them, the next substantive step is the preparation of river basin management plans and proposed programmes of measures by 2009. Ecological quality is a complex concept and poorly defined, unless it is taken as a simple measure such as the abundance of a particular species of organism. There is clearly substantial work to do to build a practical but sound definition of ecological quality; practical in the sense of being easy to measure and explain to stakeholders, and sound in the sense that it reflects ecological complexity within catchments, the variability between catchments, and the conflicts demands for goods and services that human society places upon the ecological system. However ecological quality is defined, it will be driven by four interacting groups of factors. These represent the physical, chemical, ecological and socio-economic environments within and encompassing the catchment. Some of these groupings are better understood than others, for example hydrological processes and the transport of solutes are reasonably understood, even though they remain research areas in their own right. There are much larger gaps in our understanding at the interfaces, i.e. predicting how, for example, hydrological processes such as flow and river morphology influence ecological quality. Overall, it is clear we are not yet in a position to build deterministic models of the overall ecological behaviour of catchment. But we need predictive tools to support catchment management agencies in preparing robust plans. This poster describes our current exploration of soft modelling options to build a comprehensive macro-ecological model of UK catchments. This is taking place within the Catchment Science Centre, a joint venture between the University of Sheffield and the Environment Agency.

Building pathway graphs from BioPAX data in R.

PubMed

Benis, Nirupama; Schokker, Dirkjan; Kramer, Frank; Smits, Mari A; Suarez-Diez, Maria

2016-01-01

Biological pathways are increasingly available in the BioPAX format which uses an RDF model for data storage. One can retrieve the information in this data model in the scripting language R using the package rBiopaxParser , which converts the BioPAX format to one readable in R. It also has a function to build a regulatory network from the pathway information. Here we describe an extension of this function. The new function allows the user to build graphs of entire pathways, including regulated as well as non-regulated elements, and therefore provides a maximum of information. This function is available as part of the rBiopaxParser distribution from Bioconductor.

75 FR 30113 - Rural Microentrepreneur Assistance Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-28

... government levels. Regulatory Flexibility Act This interim rule has been reviewed with regard to the... efforts to build the capacity of the microenterprise development industry to achieve new levels of... loan program level and legislative intent in the USDA FY 2010 appropriations bill. If this information...

7 CFR 4274.337 - Other regulatory requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

....337 Agriculture Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE... recipient on the basis of sex, marital status, race, color, religion, national origin, age, physical or... of one of the following model building codes or the latest edition of that code providing an...

TRENDS IN THE U.S. WATER MARKET SHAPING TECHNOLOGY INNOVATION

EPA Science Inventory

The US water market—and the new technologies that will increasingly define its growth—are entering a new era. Increased scarcity, new regulatory imperatives, public discontent over caustic treatments and practices, and the decline of the design-bid-build model (through which maj...

76 FR 57771 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget... display a valid Office of Management and Budget (OMB) control number. Background documentation for this... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington...

78 FR 9434 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building....), the Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below...

76 FR 75921 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-05

... Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget... of Management and Budget (OMB) control number. The public may view the background documentation for... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington...

Design Principles of Regulatory Networks: Searching for the Molecular Algorithms of the Cell

PubMed Central

Lim, Wendell A.; Lee, Connie M.; Tang, Chao

2013-01-01

A challenge in biology is to understand how complex molecular networks in the cell execute sophisticated regulatory functions. Here we explore the idea that there are common and general principles that link network structures to biological functions, principles that constrain the design solutions that evolution can converge upon for accomplishing a given cellular task. We describe approaches for classifying networks based on abstract architectures and functions, rather than on the specific molecular components of the networks. For any common regulatory task, can we define the space of all possible molecular solutions? Such inverse approaches might ultimately allow the assembly of a design table of core molecular algorithms that could serve as a guide for building synthetic networks and modulating disease networks. PMID:23352241

Making Child Care Centers SAFER: A Non-Regulatory Approach to Improving Child Care Center Siting

PubMed Central

Somers, Tarah S; Harvey, Margaret L.; Rusnak, Sharee Major

2011-01-01

Licensed child care centers are generally considered to be safe because they are required to meet state licensing regulations. As part of their licensing requirements, many states inspect child care centers and include an assessment of the health and safety of the facility to look for hazardous conditions or practices that may harm children. However, most states do not require an environmental assessment of the child care center building or land to prevent a center from being placed on, next to, or inside contaminated buildings. Having worked on several sites where child care centers were affected by environmental contaminants, the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry (ATSDR) endeavor to raise awareness of this issue. One of ATSDR's partner states, Connecticut, took a proactive, non-regulatory approach to the issue with the development its Child Day Care Screening Assessment for Environmental Risk Program. PMID:21563710

Finding the genes to build C4 rice.

PubMed

Wang, Peng; Vlad, Daniela; Langdale, Jane A

2016-06-01

Rice, a C3 crop, is a staple food for more than half of the world's population, with most consumers living in developing countries. Engineering C4 photosynthetic traits into rice is increasingly suggested as a way to meet the 50% yield increase that is predicted to be needed by 2050. Advances in genome-wide deep-sequencing, gene discovery and genome editing platforms have brought the possibility of engineering a C3 to C4 conversion closer than ever before. Because C4 plants have evolved independently multiple times from C3 origins, it is probably that key genes and gene regulatory networks that regulate C4 were recruited from C3 ancestors. In the past five years there have been over 20 comparative transcriptomic studies published that aimed to identify these recruited C4 genes and regulatory mechanisms. Here we present an overview of what we have learned so far and preview the efforts still needed to provide a practical blueprint for building C4 rice. Copyright © 2016 Elsevier Ltd. All rights reserved.

A comprehensive study on regulatory requirements for development and filing of generic drugs globally

PubMed Central

Handoo, Shweta; Arora, Vandana; Khera, Deepak; Nandi, Prafulla Kumar; Sahu, Susanta Kumar

2012-01-01

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. PMID:23373001

75 FR 60157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

76 FR 20759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

The role of women in nuclear - attracting public participation in regulatory decision-making process

NASA Astrophysics Data System (ADS)

Mohamad Jais, Azlina; Hassan, Najwa

2018-01-01

Public participation is vital in demonstrating transparency and enhancing effectiveness of a nuclear regulatory process. As such, it is necessary for nuclear practitioners to involve the public in key nuclear delivery milestones. This paper specifically discusses challenges faced in attracting public participation throughout the nuclear regulatory decision-making process, and highlights the roles of women in nuclear (WiN) in initiating the said public discourse.

Regulating health care markets in China and India.

PubMed

Bloom, Gerald; Kanjilal, Barun; Peters, David H

2008-01-01

Health care markets in China and India have expanded rapidly. The regulatory response has lagged behind in both countries and has followed a different pathway in each. Using the examples of front-line health providers and health insurance, this paper discusses how their different approaches have emerged from their own historical and political contexts and have led to different ways to address the main regulatory questions concerning quality of care, value for money, social agreement, and accountability. In both countries, the challenge is to build trust-based institutions that rely less on state-dominated approaches to regulation and involve other key actors.

Achieving Effective Risk Management Reduction Throughout Decommissioning at the Columbus Closure Project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anderson, K.D.

2006-07-01

Nuclear facility decontamination, dismantlement, and demolition activities provide a myriad of challenges along the path to reaching a safe, effective, and compliant decommissioning. Among the challenges faced during decommissioning, is the constant management and technical effort to eliminate, mitigate, or minimize the potential of risks of radiation exposures and other hazards to the worker, the surrounding community, and the environment. Management strategies to eliminate, mitigate, or minimize risks include incorporating strong safety and As Low As Reasonably Achievable (ALARA) principles into an integrated work planning process. Technical and operational strategies may include utilizing predictive risk analysis tools to establish contaminationmore » limits for demolition and using remote handling equipment to reduce occupational and radiation exposures to workers. ECC and E2 Closure Services, LLC (Closure Services) have effectively utilized these management and technical tools to eliminate, mitigate, and reduce radiation exposures under contract to the U.S. Department of Energy (DOE) for the decontamination and decommissioning Columbus Closure Project (CCP). In particular, Closure Services achieved significant dose reduction during the dismantling, decontamination, and demolition activities for Building JN-1. Management strategies during the interior dismantlement, decontamination, and demolition of the facility demanded an integrated work planning processes that involved project disciplines. Integrated planning processes identified multiple opportunities to incorporate the use of remote handling equipment during the interior dismantling and demolition activities within areas of high radiation. Technical strategies employed predictive risk analysis tools to set upper bounding contamination limits, allowed for the radiological demolition of the building without exceeding administrative dose limits to the worker, general public, and the environment. Adhering to management and technical strategies during the dismantlement, decontamination, and demolition of Building JN-1 enabled Closure Services to achieve strong ALARA performance, maintain absolute compliance under the regulatory requirements and meeting licensing conditions for decommissioning. (authors)« less

5 strategies for combating market uncertainty to deliver value.

PubMed

Hegwer, Laura Ramos

2014-10-01

To strengthen their market share and balance sheets in preparation for greater financial and regulatory pressures, middle-market hospitals are: Merging when it makes sense. Building strategic partnerships. Developing clinically integrated networks. Making their health plans exchange-ready. Focusing on patient satisfaction and employee engagement.

Drinking Water Corrosion Control and POU/POE: Where Are the Boundaries?

EPA Science Inventory

Protection of public health often has to go beyond regulatory limits, because the health threats do not necessarily arise under the "legal control" of the public water system. Residential and building plumbing can be a very significant contamination source under typical usage co...

78 FR 65605 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-01

... local Area Office Manager with a general view of the public's perception of customer service and... to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters...

76 FR 39009 - Changes in Flood Elevation Determinations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

... buildings. The changes in BFEs are in accordance with 44 CFR 65.4. National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. Regulatory Flexibility Act. As flood...

77 FR 423 - Changes in Flood Elevation Determinations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-05

... contents in those buildings. The changes in BFEs are in accordance with 44 CFR 65.4. National Environmental..., Environmental Consideration. An environmental impact assessment has not been prepared. Regulatory Flexibility...). Bluff Daily News. Board of Supervisors, 1450 Court Street, Suite 308B, Redding, CA 96001. Tehama (FEMA...

75 FR 18575 - Mandatory Reporting of Greenhouse Gases: Injection and Geologic Sequestration of Carbon Dioxide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-12

... perfluorocarbon QA/QC quality assurance/quality control R&D research and development RFA Regulatory Flexibility... Climate Change.'' Joint Global Change Research Institute, Battelle Pacific Northwest Division. PNWD-3602... research, demonstration, and deployment programs throughout the world, are building confidence that...

78 FR 16853 - Agency Information Collection Activities: Proposed Collection Renewal; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... with the ``Principles for Sound Liquidity Risk Management and Supervision'' issued by the Basel... of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building...: Interagency Policy Statement on Funding and Liquidity Risk Management. OMB Number: 3064-0174. Form Number...

76 FR 60106 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... 14, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

Validation of an entirely in vitro approach for rapid prototyping of DNA regulatory elements for synthetic biology

PubMed Central

Chappell, James; Jensen, Kirsten; Freemont, Paul S.

2013-01-01

A bottleneck in our capacity to rationally and predictably engineer biological systems is the limited number of well-characterized genetic elements from which to build. Current characterization methods are tied to measurements in living systems, the transformation and culturing of which are inherently time-consuming. To address this, we have validated a completely in vitro approach for the characterization of DNA regulatory elements using Escherichia coli extract cell-free systems. Importantly, we demonstrate that characterization in cell-free systems correlates and is reflective of performance in vivo for the most frequently used DNA regulatory elements. Moreover, we devise a rapid and completely in vitro method to generate DNA templates for cell-free systems, bypassing the need for DNA template generation and amplification from living cells. This in vitro approach is significantly quicker than current characterization methods and is amenable to high-throughput techniques, providing a valuable tool for rapidly prototyping libraries of DNA regulatory elements for synthetic biology. PMID:23371936

77 FR 33253 - Regulatory Guide 8.24, Revision 2, Health Physics Surveys During Enriched Uranium-235 Processing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-05

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0115] Regulatory Guide 8.24, Revision 2, Health Physics..., ``Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication'' was issued with a... specifically with the following aspects of an acceptable occupational health physics program that are closely...

Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture.

PubMed

Ratcliffe, Elizabeth; Hourd, Paul; Guijarro-Leach, Juan; Rayment, Erin; Williams, David J; Thomas, Robert J

2013-01-01

Commercial regenerative medicine will require large quantities of clinical-specification human cells. The cost and quality of manufacture is notoriously difficult to control due to highly complex processes with poorly defined tolerances. As a step to overcome this, we aimed to demonstrate the use of 'quality-by-design' tools to define the operating space for economic passage of a scalable human embryonic stem cell production method with minimal cell loss. Design of experiments response surface methodology was applied to generate empirical models to predict optimal operating conditions for a unit of manufacture of a previously developed automatable and scalable human embryonic stem cell production method. Two models were defined to predict cell yield and cell recovery rate postpassage, in terms of the predictor variables of media volume, cell seeding density, media exchange and length of passage. Predicted operating conditions for maximized productivity were successfully validated. Such 'quality-by-design' type approaches to process design and optimization will be essential to reduce the risk of product failure and patient harm, and to build regulatory confidence in cell therapy manufacturing processes.

Drawing lines and borders: how the dehiscent fruit of Arabidopsis is patterned.

PubMed

Dinneny, José R; Yanofsky, Martin F

2005-01-01

The advent of fruits marked a key innovation in the evolution of flowering plants and helped generate a diverse array of mechanisms for seed dispersal. In the model plant, Arabidopsis thaliana, seed dispersal occurs through a process known as "pod-shatter" in which the fruit structure falls to pieces upon light mechanical pressures. This dispersal mechanism is dependent on the careful patterning of tissues in the fruit, which perform diverse functions that enable the fruit to open at maturation. Using the genetic power of Arabidopsis, many of the molecular components that help specify these tissues have been identified. Studies of the interactions among these genes have revealed a regulatory network that limits processes such as cell-cell separation and lignification to discreet regions of the fruit. Knowledge of these processes in a model fruit creates a foundation on which to build an understanding of the evolution of fruit form in other species and provides tools to engineer shatter-resistant seed pods to prevent crop loss in plants of agronomic importance such as canola. Copyright 2004 Wiley Periodicals, Inc.

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

77 FR 7218 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states.

PubMed

Preston, Charles; Chahal, Harinder S; Porrás, Analia; Cargill, Lucette; Hinds, Maryam; Olowokure, Babatunde; Cummings, Rudolph; Hospedales, James

2016-05-01

Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. "Regionalization"-an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems-may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative's concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

Roles of the oviduct in mammalian fertilization

PubMed Central

Coy, P; García-Vázquez, FA; Visconti, PE; Avilés, M

2014-01-01

The oviduct or Fallopian tube is the anatomical region where every new life begins in mammalian species. After a long journey, the spermatozoa meet the oocyte in the specific site of the oviduct named ampulla, and fertilization takes place. The successful fertilization depends on several biological processes which occur in the oviduct some hours before this rendezvous and affect both gametes. Estrogen and progesterone, released from the ovary, orchestrate a series of changes by genomic- and non-genomic pathways in the oviductal epithelium affecting gene expression, proteome and secretion of its cells into the fluid bathing the oviductal lumen. In addition, new regulatory molecules are being discovered playing important roles in oviductal physiology and fertilization. The present review tries to describe these processes, building a comprehensive map of the physiology of the oviduct, to better understand the importance of this organ in reproduction. With this purpose, gamete transport, sperm and oocyte changes in the oviductal environment and other interactions between gametes and oviduct are discussed in light of recent publications in the field. PMID:23028122

75 FR 51813 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

... information collection unless it displays a currently valid Office of Management and Budget (OMB) control... Complex Structured Finance Transactions (OMB No. 3064-0148). No comments were received. Therefore, the... Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503. FOR...

Risk, Reward, and Regulations: Reshaping the Financial Services Industry.

ERIC Educational Resources Information Center

Saul, Ralph S.

1984-01-01

Deregulation has had much to do with the competitive drive and vitality of financial services within the United States. The risks and rewards of deregulation for financial institutions are discussed, and principles which should serve as a guide in building any new regulatory structure are examined. (RM)

Psychology in the Prescription Era: Building a Firewall between Marketing and Science

ERIC Educational Resources Information Center

Antonuccio, David O.; Danton, William G.; McClanahan, Terry Michael

2003-01-01

The pharmaceutical industry has contributed to many life-saving innovations in medicine and has become one of the most successful industries in the world. As a result, pharmaceutical industry financial and marketing influences extend to federal regulatory agencies, professional organizations, medical journals, continuing medical education,…

18 CFR 367.56 - Structures and improvements.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Water meters and supply system for a building or for general company purposes. (61) Water supply piping... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Structures and improvements. 367.56 Section 367.56 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY...

75 FR 6416 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... Securities and Exchange Commission (``Commission'') has submitted to the Office of Management and Budget this... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington... to register securities that are offered for cash upon the exercise of rights that are granted to a...

77 FR 31899 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... and Exchange Commission (the ``Commission'') has submitted to the Office of Management and Budget a... Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington... closed-end fund to repurchase its securities for cash if in addition to the other requirements set forth...

12 CFR 704.3 - Corporate credit union capital.

Code of Federal Regulations, 2010 CFR

2010-01-01

... strategies which provide for the building of capital consistent with regulatory requirements, the maintenance... remains in effect. (8) Adjusted balance accounts: (i) May be adjusted no more frequently than once every... governed by the regulation in effect at the time the paid-in capital was issued. When a grandfathered paid...

77 FR 37906 - Agency Information Collection Activities: Proposed Collection Renewal; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-25

... announcement information. Data is used by the Office of Minority and Women Inclusion and the Human Resources... of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building...: On occasion. Affected Public: FDIC job applicants who are not current FDIC employees. Estimated...

23 CFR 650.115 - Design standards.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., STRUCTURES, AND HYDRAULICS Location and Hydraulic Design of Encroachments on Flood Plains § 650.115 Design... a regulatory floodway. (b) Rest area buildings and related water supply and waste treatment... highway fills are to be used as dams to permanently impound water more than 50 acre-feet (6.17×104 cubic...

23 CFR 650.115 - Design standards.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., STRUCTURES, AND HYDRAULICS Location and Hydraulic Design of Encroachments on Flood Plains § 650.115 Design... a regulatory floodway. (b) Rest area buildings and related water supply and waste treatment... highway fills are to be used as dams to permanently impound water more than 50 acre-feet (6.17×104 cubic...

23 CFR 650.115 - Design standards.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., STRUCTURES, AND HYDRAULICS Location and Hydraulic Design of Encroachments on Flood Plains § 650.115 Design... a regulatory floodway. (b) Rest area buildings and related water supply and waste treatment... highway fills are to be used as dams to permanently impound water more than 50 acre-feet (6.17×104 cubic...

23 CFR 650.115 - Design standards.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., STRUCTURES, AND HYDRAULICS Location and Hydraulic Design of Encroachments on Flood Plains § 650.115 Design... a regulatory floodway. (b) Rest area buildings and related water supply and waste treatment... highway fills are to be used as dams to permanently impound water more than 50 acre-feet (6.17×104 cubic...

23 CFR 650.115 - Design standards.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., STRUCTURES, AND HYDRAULICS Location and Hydraulic Design of Encroachments on Flood Plains § 650.115 Design... a regulatory floodway. (b) Rest area buildings and related water supply and waste treatment... highway fills are to be used as dams to permanently impound water more than 50 acre-feet (6.17×104 cubic...

Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

PubMed

Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

2017-11-01

Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

The Tasman Spirit oil spill: implications for regulatory change in Pakistan.

PubMed

Mian, Saima; Bennett, Suzan

2009-07-01

An oil spill in July 2003 from the tanker Tasman Spirit attracted considerable public and media attention in Pakistan. This paper focuses on the experience of a developing country such as Pakistan in dealing with a major oil spill and its impact on bringing about change in the national regulatory framework. A major outcome has been the ratification of the International Convention on Civil Liability for Oil Pollution Damage 1992, which came into force in March 2006 in Pakistan. The convention provides a compensation mechanism for victims incurring oil pollution damages from maritime casualties involving oil laden ships. Several additional changes are still required to improve the country's ability to cope with marine oil spills. These include the development of a comprehensive domestic regulatory framework, implementation of an effective contingency plan, and capacity building of all relevant agencies.

AP1 Keeps Chromatin Poised for Action | Center for Cancer Research

Cancer.gov

The human genome harbors gene-encoding DNA, the blueprint for building proteins that regulate cellular function. Embedded across the genome, in non-coding regions, are DNA elements to which regulatory factors bind. The interaction of regulatory factors with DNA at these sites modifies gene expression to modulate cell activity. In cells, DNA exists in a complex with proteins called chromatin that compacts the DNA in the nucleus, strongly restricting access to DNA sequences. As a result, regulatory factors only interact with a small subset of their potential binding elements in a given cell to regulate genes. How factors recognize and select sites in chromatin across the genome is not well understood -- but several discoveries in CCR’s Laboratory of Receptor Biology and Gene Expression (LRBGE) have shed light on the mechanisms that direct factors to DNA.

Modularity and design principles in the sea urchin embryo gene regulatory network

PubMed Central

Peter, Isabelle S.; Davidson, Eric H.

2010-01-01

The gene regulatory network (GRN) established experimentally for the pre-gastrular sea urchin embryo provides causal explanations of the biological functions required for spatial specification of embryonic regulatory states. Here we focus on the structure of the GRN which controls the progressive increase in complexity of territorial regulatory states during embryogenesis; and on the types of modular subcircuits of which the GRN is composed. Each of these subcircuit topologies executes a particular operation of spatial information processing. The GRN architecture reflects the particular mode of embryogenesis represented by sea urchin development. Network structure not only specifies the linkages constituting the genomic regulatory code for development, but also indicates the various regulatory requirements of regional developmental processes. PMID:19932099

Self-regulatory processes mediate the intention-behavior relation for adherence and exercise behaviors.

PubMed

de Bruin, Marijn; Sheeran, Paschal; Kok, Gerjo; Hiemstra, Anneke; Prins, Jan M; Hospers, Harm J; van Breukelen, Gerard J P

2012-11-01

Understanding the gap between people's intentions and actual health behavior is an important issue in health psychology. Our aim in this study was to investigate whether self-regulatory processes (monitoring goal progress and responding to discrepancies) mediate the intention-behavior relation in relation to HIV medication adherence (Study 1) and intensive exercise behavior (Study 2). In Study 1, questionnaire and electronically monitored adherence data were collected at baseline and 3 months later from patients in the control arm of an HIV-adherence intervention study. In Study 2, questionnaire data was collected at 3 time points 6-weeks apart in a cohort study of physical activity. Complete data at all time points were obtained from 51 HIV-infected patients and 499 intensive exercise participants. Intentions were good predictors of behavior and explained 25 to 30% of the variance. Self-regulatory processes explained an additional 11% (Study 1) and 6% (Study 2) of variance in behavior on top of intentions. Regression and bootstrap analyses revealed at least partial, and possibly full, mediation of the intention-behavior relation by self-regulatory processes. The present studies indicate that self-regulatory processes may explain how intentions drive behavior. Future tests, using different health behaviors and experimental designs, could firmly establish whether self-regulatory processes complement current health behavior theories and should become routine targets for intervention. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

75 FR 6422 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Incorporated NYSE Rule 411(a)(ii)(5) as Part of the Process of Developing the Consolidated FINRA Rulebook February 2, 2010. On December 4, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

Biomedical device innovation methodology: applications in biophotonics

NASA Astrophysics Data System (ADS)

Beswick, Daniel M.; Kaushik, Arjun; Beinart, Dylan; McGarry, Sarah; Yew, Ming Khoon; Kennedy, Brendan F.; Maria, Peter Luke Santa

2018-02-01

The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a "to market" strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.

IT Requirements Integration in High-Rise Construction Design Projects

NASA Astrophysics Data System (ADS)

Levina, Anastasia; Ilin, Igor; Esedulaev, Rustam

2018-03-01

The paper discusses the growing role of IT support for the operation of modern high-rise buildings, due to the complexity of managing engineering systems of buildings and the requirements of consumers for the IT infrastructure. The existing regulatory framework for the development of design documentation for construction, including high-rise buildings, is analyzed, and the lack of coherence in the development of this documentation with the requirements for the creation of an automated management system and the corresponding IT infrastructure is stated. The lack of integration between these areas is the cause of delays and inefficiencies both at the design stage and at the stage of putting the building into operation. The paper proposes an approach to coordinate the requirements of the IT infrastructure of high-rise buildings and design documentation for construction. The solution to this problem is possible within the framework of the enterprise architecture concept by coordinating the requirements of the IT and technological layers at the design stage of the construction.

Digital management and regulatory submission of medical images from clinical trials: role and benefits of the core laboratory

NASA Astrophysics Data System (ADS)

Robbins, William L.; Conklin, James J.

1995-10-01

Medical images (angiography, CT, MRI, nuclear medicine, ultrasound, x ray) play an increasingly important role in the clinical development and regulatory review process for pharmaceuticals and medical devices. Since medical images are increasingly acquired and archived digitally, or are readily digitized from film, they can be visualized, processed and analyzed in a variety of ways using digital image processing and display technology. Moreover, with image-based data management and data visualization tools, medical images can be electronically organized and submitted to the U.S. Food and Drug Administration (FDA) for review. The collection, processing, analysis, archival, and submission of medical images in a digital format versus an analog (film-based) format presents both challenges and opportunities for the clinical and regulatory information management specialist. The medical imaging 'core laboratory' is an important resource for clinical trials and regulatory submissions involving medical imaging data. Use of digital imaging technology within a core laboratory can increase efficiency and decrease overall costs in the image data management and regulatory review process.

Soil Management Plan for the Oak Ridge Y-12 National Security Complex Oak Ridge, Tennessee

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2005-03-02

This Soil Management Plan applies to all activities conducted under the auspices of the National Nuclear Security Administration (NNSA) Oak Ridge Y-12 National Security Complex (Y-12) that involve soil disturbance and potential management of waste soil. The plan was prepared under the direction of the Y-12 Environmental Compliance Department of the Environment, Safety, and Health Division. Soil disturbances related to maintenance activities, utility and building construction projects, or demolition projects fall within the purview of the plan. This Soil Management Plan represents an integrated, visually oriented, planning and information resource tool for decision making involving excavation or disturbance of soilmore » at Y-12. This Soil Management Plan addresses three primary elements. (1) Regulatory and programmatic requirements for management of soil based on the location of a soil disturbance project and/or the regulatory classification of any contaminants that may be present (Chap. 2). Five general regulatory or programmatic classifications of soil are recognized to be potentially present at Y-12; soil may fall under one or more these classifications: (a) Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) pursuant to the Oak Ridge Reservation (ORR) Federal Facilities Agreement; (b) Resource Conservation and Recovery Act (RCRA); (c) RCRA 3004(u) solid waste managements units pursuant to the RCRA Hazardous and Solid Waste Amendments Act of 1984 permit for the ORR; (d) Toxic Substances and Control Act-regulated soil containing polychlorinated biphenyls; and (e) Radiologically contaminated soil regulated under the Atomic Energy Act review process. (2) Information for project planners on current and future planned remedial actions (RAs), as prescribed by CERCLA decision documents (including the scope of the actions and remedial goals), land use controls implemented to support or maintain RAs, RCRA post-closure regulatory requirements for former waste management units, legacy contamination source areas and distribution of contamination in soils, and environmental infrastructure (e.g., caps, monitoring systems, etc.) that is in place or planned in association with RAs. (3) Regulatory considerations and processes for management and disposition of waste soil upon generation, including regulatory drivers, best management practices (BMPs), waste determination protocols, waste acceptance criteria, and existing waste management procedures and BMPs for Y-12. This Soil Management Plan provides information to project planners to better coordinate their activities with other organizations and programs with a vested interest in soil disturbance activities at Y-12. The information allows project managers and maintenance personnel to evaluate and anticipate potential contaminant levels that may be present at a proposed soil disturbance site prior to commencement of activities and allows a more accurate assessment of potential waste management requirements.« less

Improving investigational drug service operations through development of an innovative computer system.

PubMed

Sweet, Burgunda V; Tamer, Helen R; Siden, Rivka; McCreadie, Scott R; McGregory, Michael E; Benner, Todd; Tankanow, Roberta M

2008-05-15

The development of a computerized system for protocol management, dispensing, inventory accountability, and billing by the investigational drug service (IDS) of a university health system is described. After an unsuccessful search for a commercial system that would accommodate the variation among investigational protocols and meet regulatory requirements, the IDS worked with the health-system pharmacy's information technology staff and informatics pharmacists to develop its own system. The informatics pharmacists observed work-flow and information capture in the IDS and identified opportunities for improved efficiency with an automated system. An iterative build-test-design process was used to provide the flexibility needed for individual protocols. The intent was to design a system that would support most IDS processes, using components that would allow automated backup and redundancies. A browser-based system was chosen to allow remote access. Servers, bar-code scanners, and printers were integrated into the final system design. Initial implementation involved 10 investigational protocols chosen on the basis of dispensing volume and complexity of study design. Other protocols were added over a two-year period; all studies whose drugs were dispensed from the IDS were added, followed by those for which the drugs were dispensed from decentralized pharmacy areas. The IDS briefly used temporary staff to free pharmacist and technician time for system implementation. Decentralized pharmacy areas that rarely dispense investigational drugs continue to use manual processes, with subsequent data transcription into the system. Through the university's technology transfer division, the system was licensed by an external company for sale to other IDSs. The WebIDS system has improved daily operations, enhanced safety and efficiency, and helped meet regulatory requirements for investigational drugs.

Purity and the dangers of regenerative medicine: regulatory innovation of human tissue-engineered technology.

PubMed

Faulkner, Alex; Kent, Julie; Geesink, Ingrid; FitzPatrick, David

2006-11-01

This paper examines the development of innovation in human tissue technologies as a form of regenerative medicine, firstly by applying 'pollution ideas' to contemporary trends in its risk regulation and to the processes of regulatory policy formation, and secondly by analysing the classificatory processes deployed in regulatory policy. The analysis draws upon data from fieldwork and documentary materials with a focus on the UK and EU (2002-05) and explores four arenas: governance and regulatory policy; commercialisation and the market; 'evidentiality' manifest in evidence-based policy; and publics' and technology users' values and ethics. The analysis suggests that there is a trend toward 'purification' across these arenas, both material and socio-political. A common process of partitioning is found in stakeholders' attempts to define a clear terrain, which the field of tissue-engineered technology might occupy. We conclude that pollution ideas and partitioning processes are useful in understanding regulatory ordering and innovation in the emerging technological zone of human tissue engineering.

Regulatory Promotion of Emergent CCS Technology

DOE Office of Scientific and Technical Information (OSTI.GOV)

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 comprehensivemore » 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.« less

Analysis of the systems of ventilation of residential houses of Ukraine and Estonia

NASA Astrophysics Data System (ADS)

Savchenko, Olena; Zhelykh, Vasyl; Voll, Hendrik

2017-12-01

The most common ventilation system in residential buildings in Ukraine is natural ventilation. In recent years, due to increased tightness of structures, an increase in the content of synthetic finishing materials in them, the quality of microclimate parameters deteriorated. One of the measures to improve the parameters of indoor air in residential buildings is the use of mechanical inflow and exhaust ventilation system. In this article the regulatory documents concerning the design of ventilation systems in Ukraine and Estonia and the requirements for air exchange in residential buildings are considered. It is established that the existing normative documents in Ukraine are analogous to European norms, which allow design the system of ventilation of residential buildings according to European standards. However, the basis for the design of ventilation systems in Ukraine is the national standards, in which mechanical ventilation, unfortunately, is provided only for the design of high-rise buildings. To maintain acceptable microclimate parameters in residential buildings, it is advisable for designers to apply the requirements for designing ventilation systems in accordance with European standards.

Treatment of Chlorinated Solvents in Groundwater Beneath an Occupied Building at the Young-Rainey STAR Center, Pinellas, FL

DOE Office of Scientific and Technical Information (OSTI.GOV)

Daniel, Joe; Surovchak, Scott; Tabor, Charles

Groundwater contamination, consisting of two dissolved-phase plumes originating from chlorinated solvent source areas, in the southeastern portion of the Young- Rainey Star Center (also known as the Pinellas County, Florida, Site) in Largo, Florida, has migrated beyond the property boundary, beneath the roadways, and beneath adjacent properties to the south and east. Groundwater contamination will persist as long as the onsite contaminant source remains. The origin of the contamination appears to be multiple long-term point sources beneath Building 100, a 4.5 ha (11 acre) building that housed manufacturing facilities during US DOE operations at the site. The site is nowmore » owned by Pinellas County, and most of the space inside the building is leased to private companies, so DOE chose not to conduct characterization or remediation through the floor of the building, instead choosing to conduct all work from outside the building. Injection of emulsified soybean oil and a microbial culture has been used at other areas of the site to accelerate naturally occurring bacterial processes that degrade groundwater contaminants to harmless compounds, and that same approach was chosen for this task. The technical approach consisted of installing horizontal wells from outside the building footprint, extending through and around the identified subsurface treatment areas, and terminating beneath the building. Two 107 m (350 ft) long wells, two 122 m (400 ft) long wells, and four 137 m (450 ft) long wells have been installed to intersect the inferred source areas and confirmed contaminant plumes beneath the building. DOE then injected emulsified vegetable oil and a microbial culture into the horizontal wells at each of several target areas beneath the building where the highest groundwater contaminant concentrations have been detected. The target areas are the northwest corner of the building between the old drum storage pad locations and monitoring well PIN12-S35B, the vicinity of former monitoring well PIN12-S57B, and hydraulically upgradient from the south plume and the east plume at the points where they exit from beneath the building. We describe the details of designing and constructing horizontal injection wells for bioremediation beneath a large, occupied industrial production facility, including lessons learned; technical, logistical, and environmental challenges; community relations; and regulatory relations. Because of the expected lag in biological acclimation and response, distance between the treatment areas and associated monitoring points, and low groundwater velocity, it will likely be years before the full impact of the project will be realized.« less

Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit

DOE Office of Scientific and Technical Information (OSTI.GOV)

Levine, Aaron L

Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit presentation from the WPTO FY14-FY16 Peer Review. The toolkit is aimed at regulatory agencies, consultants, project developers, the public, and any other party interested in learning more about the hydropower regulatory process.

Reverse engineering highlights potential principles of large gene regulatory network design and learning.

PubMed

Carré, Clément; Mas, André; Krouk, Gabriel

2017-01-01

Inferring transcriptional gene regulatory networks from transcriptomic datasets is a key challenge of systems biology, with potential impacts ranging from medicine to agronomy. There are several techniques used presently to experimentally assay transcription factors to target relationships, defining important information about real gene regulatory networks connections. These techniques include classical ChIP-seq, yeast one-hybrid, or more recently, DAP-seq or target technologies. These techniques are usually used to validate algorithm predictions. Here, we developed a reverse engineering approach based on mathematical and computer simulation to evaluate the impact that this prior knowledge on gene regulatory networks may have on training machine learning algorithms. First, we developed a gene regulatory networks-simulating engine called FRANK (Fast Randomizing Algorithm for Network Knowledge) that is able to simulate large gene regulatory networks (containing 10 4 genes) with characteristics of gene regulatory networks observed in vivo. FRANK also generates stable or oscillatory gene expression directly produced by the simulated gene regulatory networks. The development of FRANK leads to important general conclusions concerning the design of large and stable gene regulatory networks harboring scale free properties (built ex nihilo). In combination with supervised (accepting prior knowledge) support vector machine algorithm we (i) address biologically oriented questions concerning our capacity to accurately reconstruct gene regulatory networks and in particular we demonstrate that prior-knowledge structure is crucial for accurate learning, and (ii) draw conclusions to inform experimental design to performed learning able to solve gene regulatory networks in the future. By demonstrating that our predictions concerning the influence of the prior-knowledge structure on support vector machine learning capacity holds true on real data ( Escherichia coli K14 network reconstruction using network and transcriptomic data), we show that the formalism used to build FRANK can to some extent be a reasonable model for gene regulatory networks in real cells.

Toward a General Research Process for Using Dubin's Theory Building Model

ERIC Educational Resources Information Center

Holton, Elwood F.; Lowe, Janis S.

2007-01-01

Dubin developed a widely used methodology for theory building, which describes the components of the theory building process. Unfortunately, he does not define a research process for implementing his theory building model. This article proposes a seven-step general research process for implementing Dubin's theory building model. An example of a…

Summary of Building Protection Factor Studies for External Exposure to Ionizing Radiation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dillon, Michael B.; Kane, Jave; Nasstrom, John

Radiation dose assessments are used to help inform decisions to minimize health risks in the event of an atmospheric release of radioactivity including, for example, from a Radiological Dispersal Device, an Improvised Nuclear Device detonation, or a Nuclear Power Plant accident. During these incidents, radiation dose assessments for both indoor and outdoor populations are needed to make informed decisions. These dose assessments inform emergency plans and decisions including, for example, identifying areas in which people should be sheltered and determining when controlled population evacuations should be made. US dose assessment methodologies allow consideration of the protection, and therefore dose reduction,more » that buildings provide their occupants. However, these methodologies require an understanding of the protection provided by various building types that is currently lacking. To help address this need, Lawrence Livermore National Laboratory, in cooperation with Sandia National Laboratories and the Nuclear Regulatory Commission, was tasked with (a) identifying prior building protection studies, (b) extracting results relevant to US building construction, and (c) summarizing building protection by building type. This report focuses primarily on the protection against radiation from outdoor fallout particles (external gamma radiation).« less

78 FR 47012 - Developing Software Life Cycle Processes Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Developing Software Life Cycle Processes Used in... revised regulatory guide (RG), revision 1 of RG 1.173, ``Developing Software Life Cycle Processes for... Developing a Software Project Life Cycle Process,'' issued 2006, with the clarifications and exceptions as...

78 FR 18947 - Fisheries of the Northeastern United States; Tilefish Fishery Management Plan; Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-28

... IFQ cost recovery process. This action proposes regulatory changes to Sec. 648.294(h) to reconcile the... different aspects of the cost recovery fee collection process, including Payment Responsibility, IFQ Fee... process for appealing the cost recovery fee. Under the appeals process, an IFQ allocation permit holder...

Legal and regulatory capacity to support the global health security agenda.

PubMed

Morhard, Ryan; Katz, Rebecca

2014-01-01

On February 13, 2014, 27 nations, along with 3 international organizations, launched the Global Health Security Agenda (GHSA). The intent of GHSA is to accelerate progress in enabling countries around the world to prevent, detect, and respond to public health emergencies-capacities to be achieved through 9 core objectives. Building national, regional, and international capacity includes creating strong legal and regulatory regimes to support national and international capacities to prevent, detect, and respond to public health emergencies. Accordingly, establishing and reinforcing international and national-level legal preparedness is central to advancing elements of each of the 9 objectives of the GHSA.

78 FR 35056 - Effectiveness of the Reactor Oversight Process Baseline Inspection Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0125] Effectiveness of the Reactor Oversight Process... the effectiveness of the reactor oversight process (ROP) baseline inspection program with members of... Nuclear Reactor Regulations, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301...

Gibberllin driven growth in elf3 mutants requires PIF4 and PIF5

USDA-ARS?s Scientific Manuscript database

The regulatory connections between the circadian clock and hormone signaling are essential to understand, as these two regulatory processes work together to time growth processes relative to predictable environmental events. Gibberellins (GAs) are phytohormones that control many growth processes thr...

77 FR 39447 - Revisions to Electric Quarterly Report Filing Process

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... Quarterly Report Filing Process AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Notice of... Rule which governs the filing of Electric Quarterly Reports (EQRs), to change the process for filing... Regulatory Commission (Commission) proposes changes to the method for filing Electric Quarterly Reports (EQRs...

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2014-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

76 FR 14953 - Notice of Availability of Draft Environmental Impact Statement for the Proposed Honolulu Seawater...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Notice of Availability of Draft Environmental Impact Statement for the Proposed Honolulu Seawater Air Conditioning Project, Honolulu, HI AGENCY... District; Regulatory Branch (CEPOH-EC-R); Building 230; Fort Shafter, HI 96858-5440. Comments may also be...

78 FR 49726 - International Framework for Nuclear Energy Cooperation Finance/Regulatory/Energy Planning...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-15

..., (2) government commitment and support, and (3) a sound business plan. This workshop will be designed... power purchase agreements, are playing today in the financing of nuclear power projects in emerging... opportunity to network, build relationships in the global civil nuclear sector and learn more about current...

77 FR 17471 - PetroLogistics Natural Gas Storage Company, LLC; Notice of Availability of the Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP11-50-000] PetroLogistics... by PetroLogistics Natural Gas Storage, LLC (PetroLogistics) in the above-referenced docket. PetroLogistics requests authorization to build and operate high-deliverability, multi-cycle natural gas storage...

76 FR 52326 - Agency Information Collection Activities: Proposed Collection Renewals; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington... section 7 of the Bank Service Corporation Act (12 U.S.C. 1867), of the relationship with a bank service... their availability policies to customers, and begin accruing interest on such deposits promptly. The...

75 FR 52046 - Development of U.S. Nuclear Regulatory Commission Safety Culture Policy Statement: Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-24

... focuses on the unique aspects of nuclear safety and security and highlights the Commission's expectations... safety culture and (2) high level descriptions or traits of areas important to safety culture. The... NRC headquarters. Please allow time at both locations to register with building security upon entering...

77 FR 77073 - York Haven Power Company, LLC; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-31

... Company, LLC; Notice of Meeting On Wednesday, January 9, 2013, Commission staff will meet with York Haven Power Company, LLC (applicant) in Washington, DC. The purpose of the meeting is to discuss the required... begin at 10 a.m. at the Federal Energy Regulatory Commission headquarters building located at 888 First...

77 FR 58541 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Applicant...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... valid Office of Management and Budget (OMB) control number. The FDIC, as part of its continuing effort... Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington.... Frequency of Response: On occasion. Affected Public: FDIC job applicants who are not current FDIC employees...

Between a Rock and a Hard Place: Organizational Change and Performance under Conditions of Fundamental Environmental Transformation.

ERIC Educational Resources Information Center

Haveman, Heather A.

1992-01-01

Organizational change may benefit performance and survival chances if it occurs in response to dramatic restructuring of environmental conditions and builds on established routines and competencies. These propositions are tested on the savings and loan industry in California, which has experienced technological, economic, and regulatory shifts…

The CLIA-Model: A Framework for Designing Powerful Learning Environments for Thinking and Problem Solving

ERIC Educational Resources Information Center

De Corte, Erik; Verschaffel, Lieven; Masui, Chris

2004-01-01

A major challenge for education and educational research is to build on our present understanding of learning for designing environments for education that are conducive to fostering in students self-regulatory and cooperative learning skills, transferable knowledge, and a disposition toward competent thinking and problem solving. Taking into…

78 FR 23507 - Notice of Regulatory Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

.... 2013-N-06] Notice of Regulatory Review AGENCY: Federal Housing Finance Agency. ACTION: Request for comment. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of a regulatory review that will be conducted in accordance with the process set forth in the regulatory review plan published...

U.S. Nuclear Regulatory Commission natural analogue research program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kovach, L.A.; Ott, W.R.

1995-09-01

This article describes the natural analogue research program of the U.S. Nuclear Regulatory Commission (US NRC). It contains information on the regulatory context and organizational structure of the high-level radioactive waste research program plan. It also includes information on the conditions and processes constraining selection of natural analogues, describes initiatives of the US NRC, and describes the role of analogues in the licensing process.

Emotion and Cognition: An Intricately Bound Developmental Process

ERIC Educational Resources Information Center

Bell, Martha Ann; Wolfe, Christy D.

2004-01-01

Regulatory aspects of development can best be understood by research that conceptualizes relations between cognition and emotion. The neural mechanisms associated with regulatory processes may be the same as those associated with higher order cognitive processes. Thus, from a developmental cognitive neuroscience perspective, emotion and cognition…

77 FR 823 - Guidance for Fuel Cycle Facility Change Processes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-06

... NUCLEAR REGULATORY COMMISSION [NRC-2009-0262] Guidance for Fuel Cycle Facility Change Processes... Fuel Cycle Facility Change Processes.'' This regulatory guide describes the types of changes for which fuel cycle facility licensees should seek prior approval from the NRC and discusses how licensees can...

Principles of dynamical modularity in biological regulatory networks

PubMed Central

Deritei, Dávid; Aird, William C.; Ercsey-Ravasz, Mária; Regan, Erzsébet Ravasz

2016-01-01

Intractable diseases such as cancer are associated with breakdown in multiple individual functions, which conspire to create unhealthy phenotype-combinations. An important challenge is to decipher how these functions are coordinated in health and disease. We approach this by drawing on dynamical systems theory. We posit that distinct phenotype-combinations are generated by interactions among robust regulatory switches, each in control of a discrete set of phenotypic outcomes. First, we demonstrate the advantage of characterizing multi-switch regulatory systems in terms of their constituent switches by building a multiswitch cell cycle model which points to novel, testable interactions critical for early G2/M commitment to division. Second, we define quantitative measures of dynamical modularity, namely that global cell states are discrete combinations of switch-level phenotypes. Finally, we formulate three general principles that govern the way coupled switches coordinate their function. PMID:26979940

Investigation of occupational radiation exposures to NORM at an Irish peat-fired power station and potential use of peat fly ash by the construction industry.

PubMed

Organo, C; Lee, E M; Menezes, G; Finch, E C

2005-12-01

Annually, approximately 15% of Ireland's electricity requirement is provided through the combustion of 3 x 10(6) tonnes of peat. While the literature on coal-fired power generation is quite abundant, studies on the peat-fired power generation industry from a radiological point of view are scarce. A study of the largest Irish peat-fired power plant was initiated to review the potential occupational radiation exposures arising from the occurrence of naturally occurring radioactive material (NORM) at different stages of the industrial process and to investigate any radiological health consequences that may arise should peat fly ash be used as a component of building materials. Ambient gamma dose rate measurements, radon measurements, quantification of the occupational exposure from inhalation of airborne particles (personal air sampling) and gamma spectrometry analysis of peat, peat ash and effluent samples from the ash ponds were undertaken. The results indicate that the radiation dose received by any worker involved in the processing of the peat and the handling of the ash resulting from peat combustion does not exceed 150 microSv per annum. Regulatory control of the peat-fired power generation is therefore unnecessary according to the Irish legislation with regards to NORM. The potential use of peat fly ash as a by-product in the building industry was also found to have a negligible radiological impact for construction workers and for members of the public.

75 FR 29793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on May 4, 2010, Financial.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

Hours of work and rest in the rail industry.

PubMed

Anderson, C; Grunstein, R R; Rajaratnam, S M W

2013-06-01

Currently, the National Transport Commission is considering four options to form the regulatory framework for rail safety within Australia with respect to fatigue. While the National Transport Commission currently recommends no limitations around hours of work or rest, we provide evidence which suggests regulatory frameworks should incorporate a traditional hours of service regulation over more flexible policies. Our review highlights: Shift durations >12 h are associated with a doubling of risk for accident and injury. Fatigue builds cumulatively with each successive shift where rest in between is inadequate (<12 h). A regulatory framework for fatigue management within the rail industry should prescribe limits on hours of work and rest, including maximum shift duration and successive number of shifts. Appropriately, validated biomathematical models and technologies may be used as a part of a fatigue management system, to augment the protection afforded by limits on hours of work and rest. A comprehensive sleep disorder screening and management programme should form an essential component of any regulatory framework. © 2013 The Authors; Internal Medicine Journal © 2013 Royal Australasian College of Physicians.

Genomics in the land of regulatory science.

PubMed

Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

2015-06-01

Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making. Published by Elsevier Inc.

76 FR 44049 - Guidance for Fuel Cycle Facility Change Processes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... NUCLEAR REGULATORY COMMISSION [NRC-2009-0262] Guidance for Fuel Cycle Facility Change Processes...-issued Draft Regulatory Guide, DG- 3037, ``Guidance for Fuel Cycle Facility Change Processes'' in the...-3037 from August 12, 2011 to September 16, 2011. DG-3037 describes the types of changes for fuel cycle...

The control of branching morphogenesis

PubMed Central

Iber, Dagmar; Menshykau, Denis

2013-01-01

Many organs of higher organisms are heavily branched structures and arise by an apparently similar process of branching morphogenesis. Yet the regulatory components and local interactions that have been identified differ greatly in these organs. It is an open question whether the regulatory processes work according to a common principle and how far physical and geometrical constraints determine the branching process. Here, we review the known regulatory factors and physical constraints in lung, kidney, pancreas, prostate, mammary gland and salivary gland branching morphogenesis, and describe the models that have been formulated to analyse their impacts. PMID:24004663

Development of Regulatory Documents for Creation (Upgrade) of Physical Protection Systems under the Russian/American MPC&A Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Izmaylov, Alexandr V.; Babkin, Vladimir; Kurov, Valeriy

2009-10-07

The development of new or the upgrade of existing physical protection systems (PPS) for nuclear facilities involves a multi-step and multidimensional process. The process consists of conceptual design, design, and commissioning stages. The activities associated with each of these stages are governed by Russian government and agency regulations. To ensure a uniform approach to development or upgrading of PPS at Russian nuclear facilities, the development of a range of regulatory and methodological documents is necessary. Some issues of PPS development are covered by the regulatory documents developed by Rosatom, as well as other Russian agencies with nuclear facilities under theirmore » control. This regulatory development has been accomplished as part of the U.S.-Russian MPC&A cooperation or independently by the Russian Federation. While regulatory coverage is extensive, there are a number of issues such as vulnerability analysis, effectiveness assessment, upgrading PPS, and protection of information systems for PPS that require additional regulations be developed. This paper reports on the status of regulatory coverage for PPS development or upgrade, and outlines a new approach to regulatory document development. It describes the evolutionary process of regulatory development through experience gained in the design, development and implementation of PPS as well as experience gained through the cooperative efforts of Russian and U.S. experts involved the development of MPC&A regulations.« less

Predictive computation of genomic logic processing functions in embryonic development

PubMed Central

Peter, Isabelle S.; Faure, Emmanuel; Davidson, Eric H.

2012-01-01

Gene regulatory networks (GRNs) control the dynamic spatial patterns of regulatory gene expression in development. Thus, in principle, GRN models may provide system-level, causal explanations of developmental process. To test this assertion, we have transformed a relatively well-established GRN model into a predictive, dynamic Boolean computational model. This Boolean model computes spatial and temporal gene expression according to the regulatory logic and gene interactions specified in a GRN model for embryonic development in the sea urchin. Additional information input into the model included the progressive embryonic geometry and gene expression kinetics. The resulting model predicted gene expression patterns for a large number of individual regulatory genes each hour up to gastrulation (30 h) in four different spatial domains of the embryo. Direct comparison with experimental observations showed that the model predictively computed these patterns with remarkable spatial and temporal accuracy. In addition, we used this model to carry out in silico perturbations of regulatory functions and of embryonic spatial organization. The model computationally reproduced the altered developmental functions observed experimentally. Two major conclusions are that the starting GRN model contains sufficiently complete regulatory information to permit explanation of a complex developmental process of gene expression solely in terms of genomic regulatory code, and that the Boolean model provides a tool with which to test in silico regulatory circuitry and developmental perturbations. PMID:22927416

Computational Process Modeling for Additive Manufacturing

NASA Technical Reports Server (NTRS)

Bagg, Stacey; Zhang, Wei

2014-01-01

Computational Process and Material Modeling of Powder Bed additive manufacturing of IN 718. Optimize material build parameters with reduced time and cost through modeling. Increase understanding of build properties. Increase reliability of builds. Decrease time to adoption of process for critical hardware. Potential to decrease post-build heat treatments. Conduct single-track and coupon builds at various build parameters. Record build parameter information and QM Meltpool data. Refine Applied Optimization powder bed AM process model using data. Report thermal modeling results. Conduct metallography of build samples. Calibrate STK models using metallography findings. Run STK models using AO thermal profiles and report STK modeling results. Validate modeling with additional build. Photodiode Intensity measurements highly linear with power input. Melt Pool Intensity highly correlated to Melt Pool Size. Melt Pool size and intensity increase with power. Applied Optimization will use data to develop powder bed additive manufacturing process model.

Science in the regulatory setting: a challenging but incompatible mix?

PubMed

Yetley, Elizabeth A

2007-01-01

Regulatory decisions informed by sound science have an important role in many regulatory applications involving drugs and foods, including applications related to dietary supplements. However, science is only one of many factors that must be taken into account in the regulatory decision-making process. In many cases, the scientific input to a regulatory decision must compete with other factors (e.g. economics, legal requirements, stakeholder interests) for impact on the resultant policy decision. Therefore, timely and effective articulation of the available science to support a regulatory decision can significantly affect the relative weight given to science. However, the incorporation of science into the regulatory process for dietary supplements is often fraught with challenges. The available scientific evidence has rarely been designed for the purpose of addressing regulatory questions and is often preliminary and of widely varying scientific quality. To add to the confusion, the same scientific evidence may result in what appears to be different regulatory decisions because the context in which the science is used differs. The underlying assumption is that scientists who have a basic understanding of the interface between science and policy decisions can more effectively provide scientific input into these decisions.

Analysis of Criteria Influencing Contractor Selection Using TOPSIS Method

NASA Astrophysics Data System (ADS)

Alptekin, Orkun; Alptekin, Nesrin

2017-10-01

Selection of the most suitable contractor is an important process in public construction projects. This process is a major decision which may influence the progress and success of a construction project. Improper selection of contractors may lead to problems such as bad quality of work and delay in project duration. Especially in the construction projects of public buildings, the proper choice of contractor is beneficial to the public institution. Public procurement processes have different characteristics in respect to dissimilarities in political, social and economic features of every country. In Turkey, Turkish Public Procurement Law PPL 4734 is the main regulatory law for the procurement of the public buildings. According to the PPL 4734, public construction administrators have to contract with the lowest bidder who has the minimum requirements according to the criteria in prequalification process. Public administrators are not sufficient for selection of the proper contractor because of the restrictive provisions of the PPL 4734. The lowest bid method does not enable public construction administrators to select the most qualified contractor and they have realised the fact that the selection of a contractor based on lowest bid alone is inadequate and may lead to the failure of the project in terms of time delay Eand poor quality standards. In order to evaluate the overall efficiency of a project, it is necessary to identify selection criteria. This study aims to focus on identify importance of other criteria besides lowest bid criterion in contractor selection process of PPL 4734. In this study, a survey was conducted to staff of Department of Construction Works of Eskisehir Osmangazi University. According to TOPSIS (Technique for Order Preference by Similarity to the Ideal Solution) for analysis results, termination of construction work in previous tenders is the most important criterion of 12 determined criteria. The lowest bid criterion is ranked in rank 5.

A practical approach for exploration and modeling of the design space of a bacterial vaccine cultivation process.

PubMed

Streefland, M; Van Herpen, P F G; Van de Waterbeemd, B; Van der Pol, L A; Beuvery, E C; Tramper, J; Martens, D E; Toft, M

2009-10-15

A licensed pharmaceutical process is required to be executed within the validated ranges throughout the lifetime of product manufacturing. Changes to the process, especially for processes involving biological products, usually require the manufacturer to demonstrate that the safety and efficacy of the product remains unchanged by new or additional clinical testing. Recent changes in the regulations for pharmaceutical processing allow broader ranges of process settings to be submitted for regulatory approval, the so-called process design space, which means that a manufacturer can optimize his process within the submitted ranges after the product has entered the market, which allows flexible processes. In this article, the applicability of this concept of the process design space is investigated for the cultivation process step for a vaccine against whooping cough disease. An experimental design (DoE) is applied to investigate the ranges of critical process parameters that still result in a product that meets specifications. The on-line process data, including near infrared spectroscopy, are used to build a descriptive model of the processes used in the experimental design. Finally, the data of all processes are integrated in a multivariate batch monitoring model that represents the investigated process design space. This article demonstrates how the general principles of PAT and process design space can be applied for an undefined biological product such as a whole cell vaccine. The approach chosen for model development described here, allows on line monitoring and control of cultivation batches in order to assure in real time that a process is running within the process design space.

Integration of multi-omics data for integrative gene regulatory network inference.

PubMed

Zarayeneh, Neda; Ko, Euiseong; Oh, Jung Hun; Suh, Sang; Liu, Chunyu; Gao, Jean; Kim, Donghyun; Kang, Mingon

2017-01-01

Gene regulatory networks provide comprehensive insights and indepth understanding of complex biological processes. The molecular interactions of gene regulatory networks are inferred from a single type of genomic data, e.g., gene expression data in most research. However, gene expression is a product of sequential interactions of multiple biological processes, such as DNA sequence variations, copy number variations, histone modifications, transcription factors, and DNA methylations. The recent rapid advances of high-throughput omics technologies enable one to measure multiple types of omics data, called 'multi-omics data', that represent the various biological processes. In this paper, we propose an Integrative Gene Regulatory Network inference method (iGRN) that incorporates multi-omics data and their interactions in gene regulatory networks. In addition to gene expressions, copy number variations and DNA methylations were considered for multi-omics data in this paper. The intensive experiments were carried out with simulation data, where iGRN's capability that infers the integrative gene regulatory network is assessed. Through the experiments, iGRN shows its better performance on model representation and interpretation than other integrative methods in gene regulatory network inference. iGRN was also applied to a human brain dataset of psychiatric disorders, and the biological network of psychiatric disorders was analysed.

Integration of multi-omics data for integrative gene regulatory network inference

PubMed Central

Zarayeneh, Neda; Ko, Euiseong; Oh, Jung Hun; Suh, Sang; Liu, Chunyu; Gao, Jean; Kim, Donghyun

2017-01-01

Gene regulatory networks provide comprehensive insights and indepth understanding of complex biological processes. The molecular interactions of gene regulatory networks are inferred from a single type of genomic data, e.g., gene expression data in most research. However, gene expression is a product of sequential interactions of multiple biological processes, such as DNA sequence variations, copy number variations, histone modifications, transcription factors, and DNA methylations. The recent rapid advances of high-throughput omics technologies enable one to measure multiple types of omics data, called ‘multi-omics data’, that represent the various biological processes. In this paper, we propose an Integrative Gene Regulatory Network inference method (iGRN) that incorporates multi-omics data and their interactions in gene regulatory networks. In addition to gene expressions, copy number variations and DNA methylations were considered for multi-omics data in this paper. The intensive experiments were carried out with simulation data, where iGRN’s capability that infers the integrative gene regulatory network is assessed. Through the experiments, iGRN shows its better performance on model representation and interpretation than other integrative methods in gene regulatory network inference. iGRN was also applied to a human brain dataset of psychiatric disorders, and the biological network of psychiatric disorders was analysed. PMID:29354189

[Strengthening health regulation in the Americas: regulatory authorities of regional reference].

PubMed

Ojeda, Lisette Pérez; Cristiá, Rafael Pérez

2016-05-01

Health technology regulation and quality assurance are critical to the development of national pharmaceutical policies, and implementing these actions is the responsibility of national regulatory authorities, whose level of development and maturity affect the quality, safety, and effectiveness of the products made available to the public. On the initiative of the regulatory authorities themselves, together with the Pan American Health Organization, the Region of the Americas promotes the strengthening of health regulation through an evaluation and certification process that allows for the designation of regulatory authorities of regional reference for drugs and biological products. Over the period from its implementation to the present, six authorities have been certified and one is in the process of obtaining certification. These authorities work jointly and promote dialogue and regulatory convergence, information-sharing to facilitate regulatory decision making, and regional cooperation to support the establishment of other authorities in the Region--actions having direct impact on access to effective and quality-assured health technologies. Their combined efforts have led to the recognition of this process of evaluation and certification by the World Health Organization (WHO). Among the actions resulting from the International Consultation on Regulatory Systems Strengthening, WHO recommended taking a close look at this model to assess its potential scale-up at the global level.

23 CFR 636.109 - How does the NEPA process relate to the design-build procurement process?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 23 Highways 1 2014-04-01 2014-04-01 false How does the NEPA process relate to the design-build... TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS DESIGN-BUILD CONTRACTING General § 636.109 How does the NEPA process relate to the design-build procurement process? The purpose of this section is to ensure that...

23 CFR 636.109 - How does the NEPA process relate to the design-build procurement process?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 23 Highways 1 2011-04-01 2011-04-01 false How does the NEPA process relate to the design-build... TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS DESIGN-BUILD CONTRACTING General § 636.109 How does the NEPA process relate to the design-build procurement process? The purpose of this section is to ensure that...

23 CFR 636.109 - How does the NEPA process relate to the design-build procurement process?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false How does the NEPA process relate to the design-build... TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS DESIGN-BUILD CONTRACTING General § 636.109 How does the NEPA process relate to the design-build procurement process? The purpose of this section is to ensure that...

23 CFR 636.109 - How does the NEPA process relate to the design-build procurement process?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 23 Highways 1 2012-04-01 2012-04-01 false How does the NEPA process relate to the design-build... TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS DESIGN-BUILD CONTRACTING General § 636.109 How does the NEPA process relate to the design-build procurement process? The purpose of this section is to ensure that...

23 CFR 636.109 - How does the NEPA process relate to the design-build procurement process?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 23 Highways 1 2013-04-01 2013-04-01 false How does the NEPA process relate to the design-build... TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS DESIGN-BUILD CONTRACTING General § 636.109 How does the NEPA process relate to the design-build procurement process? The purpose of this section is to ensure that...

Rapid evolution of regulatory element libraries for tunable transcriptional and translational control of gene expression.

PubMed

Jin, Erqing; Wong, Lynn; Jiao, Yun; Engel, Jake; Holdridge, Benjamin; Xu, Peng

2017-12-01

Engineering cell factories for producing biofuels and pharmaceuticals has spurred great interests to develop rapid and efficient synthetic biology tools customized for modular pathway engineering. Along the way, combinatorial gene expression control through modification of regulatory element offered tremendous opportunity for fine-tuning gene expression and generating digital-like genetic circuits. In this report, we present an efficient evolutionary approach to build a range of regulatory control elements. The reported method allows for rapid construction of promoter, 5'UTR, terminator and trans -activating RNA libraries. Synthetic overlapping oligos with high portion of degenerate nucleotides flanking the regulatory element could be efficiently assembled to a vector expressing fluorescence reporter. This approach combines high mutation rate of the synthetic DNA with the high assembly efficiency of Gibson Mix. Our constructed library demonstrates broad range of transcriptional or translational gene expression dynamics. Specifically, both the promoter library and 5'UTR library exhibits gene expression dynamics spanning across three order of magnitude. The terminator library and trans -activating RNA library displays relatively narrowed gene expression pattern. The reported study provides a versatile toolbox for rapidly constructing a large family of prokaryotic regulatory elements. These libraries also facilitate the implementation of combinatorial pathway engineering principles and the engineering of more efficient microbial cell factory for various biomanufacturing applications.

Environmental Public Health Policy for Asbestos in Schools: Unintended Consequences.

ERIC Educational Resources Information Center

Corn, Jacqueline Karnell

This book explores the history of asbestos in schools and buildings and how this issue shaped the development of public health policy. It provides insight into past policy including how and why action was taken and who caused it to be taken; it also offers guidance for the scientific and regulatory communities in the future. While explaining…

77 FR 19277 - Orders Granting Authority To Import and Export Natural Gas and Liquefied Natural Gas During...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-30

... of Fossil Energy, Department of Energy. ACTION: Notice of orders. SUMMARY: The Office of Fossil... attached appendix and may be found on the FE Web site at http://www.fossil.energy.gov/programs... of Fossil Energy, Office of Natural Gas Regulatory Activities, Docket Room 3E-033, Forrestal Building...

78 FR 32432 - Notice of Regulatory Waiver Requests Granted for the First Quarter of Calendar Year 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

..., IL. The project includes the construction of eight mixed income rental buildings and an additional... statistical data evidencing high vacancy and abandonment rates due to significant population and job loss. The... data evidencing high vacancy and abandonment rates due to significant population and job loss. The city...

Mitochondrial Replacement Techniques: Divergence in Global Policy.

PubMed

Schandera, Johanna; Mackey, Tim K

2016-07-01

In 2015, the UK became the first country permitting the clinical application of mitochondrial replacement techniques (MRT). Here, we explore how MRT have led to diverging international policy. In response, we recommend focused regulatory efforts coupled with United Nations (UN) leadership to build international consensus on the future of MRT. Copyright © 2016 Elsevier Ltd. All rights reserved.

75 FR 32460 - Natural Gas Pipeline Company of America LLC; Notice of Request Under Blanket Authorization

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-08

..., an instrument building, cathodic protection for all piping and equipment. Natural also states that it... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP10-431-000] Natural Gas... that on May 14, 2010, Natural Gas Pipeline Company of America LLC (Natural), 3250 Lacey Road, Suite 700...

76 FR 77981 - Build-A-Bear Workshop, Inc., Provisional Acceptance of a Settlement Agreement and Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-15

...), and (11). 6. The Chairs are defective because the sharp edges of the Chair's folding wooden frame can... Product Safety Act (``CPSA''). The Agreement and the incorporated attached Order resolve staff's... regulatory agency established pursuant to, and responsible for, the enforcement of the CPSA, 15 U.S.C. 2051...

The Land of Make-Believe: Using Sociodramatic Play to Increase Kindergartners' Self-Regulatory Abilities

ERIC Educational Resources Information Center

Sinha, Joanna M.

2012-01-01

Prominent theorists assert that engaging in sociodramatic play is an essential activity for the development of self-regulation. This study proposed the use of sociodramatic play as an intervention tool for building self-regulation in kindergartners. In this study, two sociodramatic play intervention paradigms were compared to a control group. In…

Building Scientific Confidence in the Development and Evaluation of Read-Across - GenRA: Evaluating local validity for read-across prediction using chemical and biological information (SOT/QSAR conference)

EPA Science Inventory

Read-across remains a popular data gap filling technique within category and analogue approaches for regulatory purposes. Acceptance of read-across is an ongoing challenge with several efforts underway for identifying and addressing uncertainties. Here we demonstrate an algorithm...

Depressive Symptoms and Parenting Competence: An Analysis of 13 Regulatory Processes

ERIC Educational Resources Information Center

Dix, Theodore; Meunier, Leah N.

2009-01-01

Mechanisms that lead depressive symptoms to undermine parenting are poorly understood. This review examines cognitive, affective, and motivational processes thought to be responsible for the impact of depressive symptoms on parenting. We present a five-step, action-control model and review 152 studies relevant to 13 regulatory processes. Evidence…

Evolving Regulatory Processes Used by Students and Experts in the Acquiring of Improvisational Skills: A Qualitative Study

ERIC Educational Resources Information Center

de Bruin, Leon R.

2018-01-01

The way an improviser practices is a vital and significant aspect to a musician's means and capacities of expression. Expert music performers utilize extensive self-regulatory processes involving planning, strategic development, and systemized approaches to learning and reflective practice. Scholars posit that these processes are constructivist…

76 FR 27114 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-10

... CRD Processing Fee, the NASD Annual System Processing Fee, and the NYSE Arca Transfer/Re-license... Fees, the NASD Annual System Processing Fee, and the NYSE Arca Transfer/Re-license Individual Fee. Fees... Options Regulatory Surveillance Authority (``ORSA'') national market system plan and in doing so shares...

Present-day monitoring underestimates the risk of exposure to pathogenic bacteria from cold water storage tanks

PubMed Central

2018-01-01

Water-borne bacteria, found in cold water storage tanks, are causative agents for various human infections and diseases including Legionnaires’ disease. Consequently, regular microbiological monitoring of tank water is undertaken as part of the regulatory framework used to control pathogenic bacteria. A key assumption is that a small volume of water taken from under the ball valve (where there is easy access to the stored water) will be representative of the entire tank. To test the reliability of this measure, domestic water samples taken from different locations of selected tanks in London properties between November 2015 and July 2016 were analysed for TVCs, Pseudomonas and Legionella at an accredited laboratory, according to regulatory requirements. Out of ~6000 tanks surveyed, only 15 were selected based on the ability to take a water sample from the normal sampling hatch (located above the ball valve) and from the far end of the tank (usually requiring disassembly of the tank lid with risk of structural damage), and permission being granted by the site manager to undertake the additional investigation and sampling. Despite seasonal differences in water temperature, we found 100% compliance at the ball valve end. In contrast, 40% of the tanks exceeded the regulatory threshold for temperature at the far end of the tank in the summer months. Consequently, 20% of the tanks surveyed failed to trigger appropriate regulatory action based on microbiological analyses of the water sample taken under the ball valve compared to the far end sample using present-day standards. These data show that typical water samples collected for routine monitoring may often underestimate the microbiological status of the water entering the building, thereby increasing the risk of exposure to water bourne pathogens with potential public health implications. We propose that water storage tanks should be redesigned to allow access to the far end of tanks for routine monitoring purposes, and that water samples used to ascertain the regulatory compliance of stored water in tanks should be taken at the point at which water is abstracted for use in the building. PMID:29649274

Comparative analysis of gene regulatory networks: from network reconstruction to evolution.

PubMed

Thompson, Dawn; Regev, Aviv; Roy, Sushmita

2015-01-01

Regulation of gene expression is central to many biological processes. Although reconstruction of regulatory circuits from genomic data alone is therefore desirable, this remains a major computational challenge. Comparative approaches that examine the conservation and divergence of circuits and their components across strains and species can help reconstruct circuits as well as provide insights into the evolution of gene regulatory processes and their adaptive contribution. In recent years, advances in genomic and computational tools have led to a wealth of methods for such analysis at the sequence, expression, pathway, module, and entire network level. Here, we review computational methods developed to study transcriptional regulatory networks using comparative genomics, from sequence to functional data. We highlight how these methods use evolutionary conservation and divergence to reliably detect regulatory components as well as estimate the extent and rate of divergence. Finally, we discuss the promise and open challenges in linking regulatory divergence to phenotypic divergence and adaptation.

Innovation under Regulatory Uncertainty: Evidence from Medical Technology

PubMed Central

Stern, Ariel Dora

2016-01-01

This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34 percent (7.2 months) longer than follow-on entrants in regulatory approval. Back-of-the- envelope calculations suggest that the cost of a delay of this length is upwards of 7 percent of the total cost of bringing a new high-risk device to market. Considering potential explanations, I find that approval times are largely unrelated to technological novelty, but are meaningfully reduced by the publication of objective regulatory guidelines. Finally, I consider how the regulatory process affects small firms’ market entry patterns and find that small firms are less likely to be pioneers in new device markets, a fact consistent with relatively higher costs of doing so for more financially constrained firms. PMID:28652646

Pharmacogenomics: a new clinical or regulatory paradigm? European experiences of pharmacogenomics in drug regulation and regulatory initiatives.

PubMed

Prasad, Krishna; Breckenridge, Alasdair

2011-10-01

Are regulatory agencies and processes up to speed? This is an often asked question. Recent advances in science and the improved knowledge of the human genome have a considerable influence on drug development and their impact on the regulatory aspect is also significant for several reasons, including changing stakeholder expectations and treatment paradigms. One of the challenges faced by the regulators is the need to adapt regulatory processes to accommodate the newer methodologies and techniques while ensuring that the biomarkers, tests and/or diagnostics, and the clinical trials are appropriate and fit for purpose. The change in emphasis in pharmacological treatment from a phenotype-based approach to newer methods is attractive but is it ready for universal adoption? This paper details some of the regulatory responses to the developments in this area. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

Rooftop Solar Technical Potential for Low-to-Moderate Income Households in the United States

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sigrin, Benjamin O; Mooney, Meghan E

This report presents a first-of-kind assessment of the technical potential of rooftop solar for low and moderate-income households, as well as providing insight on the distribution of solar potential by tenure, income, and other building characteristics. We find that a substantial fraction of the national rooftop solar potential is located on LMI buildings and, for all incomes, a substantial fraction on multi-family and renter-occupied buildings. We also find that rooftop solar can significantly contribute to long-term penetration targets established by the U.S. DOE, though to do so requires deployment on multi-family and renter-occupied buildings. Traditional deployment models have insufficiently enabledmore » access to solar for these income groups and building types. Without innovation either in regulatory, market, or policy factors, a large fraction of the U.S. potential is unlikely to be addressed, as well as leading to inequalities in solar access. Ironically, potential electric bill savings from rooftop solar would have the greatest material impact on the lives of low-income households as compared to their high-income counterparts.« less

Rooftop Solar Technical Potential for Low-to-Moderate Income (LMI) Households

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sigrin, Benjamin O

This report presents a first-of-kind assessment of the technical potential of rooftop solar for low and moderate-income households, as well as providing insight on the distribution of solar potential by tenure, income, and other building characteristics. We find that a substantial fraction of the national rooftop solar potential is located on LMI buildings and, for all incomes, a substantial fraction on multi-family and renter-occupied buildings. We also find that rooftop solar can significantly contribute to long-term penetration targets established by the U.S. DOE, though to do so requires deployment on multi-family and renter-occupied buildings. Traditional deployment models have insufficiently enabledmore » access to solar for these income groups and building types. Without innovation either in regulatory, market, or policy factors, a large fraction of the U.S. potential is unlikely to be addressed, as well as leading to inequalities in solar access. Ironically, potential electric bill savings from rooftop solar would have the greatest material impact on the lives of low-income households as compared to their high-income counterparts.« less

Evaluation of exposure to lead from drinking water in large buildings.

PubMed

Deshommes, Elise; Andrews, Robert C; Gagnon, Graham; McCluskey, Tim; McIlwain, Brad; Doré, Evelyne; Nour, Shokoufeh; Prévost, Michèle

2016-08-01

Lead results from 78,971 water samples collected in four Canadian provinces from elementary schools, daycares, and other large buildings using regulatory and investigative sampling protocols were analyzed to provide lead concentration distributions. Maximum concentrations reached 13,200 and 3890 μg/L following long and short stagnation periods respectively. High lead levels were persistent in some large buildings, reflected by high median values considering all taps, or specific to a few taps in the building. Simulations using the Integrated Uptake Biokinetic (IEUBK) model and lead concentrations after 30 min of stagnation in the dataset showed that, for most buildings, exposure to lead at the tap does not increase children's blood lead levels (BLLs). However, buildings or taps with extreme concentrations represent a significant health risk to young children attending school or daycare, as the estimated BLL far exceeded the 5 μg/dL threshold. Ingestion of water from specific taps could lead to acute exposure. Finally, for a few taps, the total daily lead intake reached the former World Health Organization (WHO) tolerable level for adults, suggesting potential health risks. Copyright © 2016 Elsevier Ltd. All rights reserved.

Mindful Emotion Regulation: Exploring the Neurocognitive Mechanisms behind Mindfulness

PubMed Central

Grecucci, Alessandro; Job, Remo

2015-01-01

The purpose of this paper is to review some of the psychological and neural mechanisms behind mindfulness practice in order to explore the unique factors that account for its positive impact on emotional regulation and health. After reviewing the mechanisms of mindfulness and its effects on clinical populations we will consider how the practice of mindfulness contributes to the regulation of emotions. We argue that mindfulness has achieved effective outcomes in the treatment of anxiety, depression, and other psychopathologies through the contribution of mindfulness to emotional regulation. We consider the unique factors that mindfulness meditation brings to the process of emotion regulation that may account for its effectiveness. We review experimental evidence that points towards the unique effects of mindfulness specifically operating over and above the regulatory effects of cognitive reappraisal mechanisms. A neuroanatomical circuit that leads to mindful emotion regulation is also suggested. This paper thereby aims to contribute to proposed models of mindfulness for research and theory building by proposing a specific model for the unique psychological and neural processes involved in mindful detachment that account for the effects of mindfulness over and above the effects accounted for by other well-established emotional regulation processes such as cognitive reappraisal. PMID:26137490

Regulatory guidelines for biosimilars in Malaysia.

PubMed

Abas, Arpah

2011-09-01

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.

Applying gene regulatory network logic to the evolution of social behavior.

PubMed

Baran, Nicole M; McGrath, Patrick T; Streelman, J Todd

2017-06-06

Animal behavior is ultimately the product of gene regulatory networks (GRNs) for brain development and neural networks for brain function. The GRN approach has advanced the fields of genomics and development, and we identify organizational similarities between networks of genes that build the brain and networks of neurons that encode brain function. In this perspective, we engage the analogy between developmental networks and neural networks, exploring the advantages of using GRN logic to study behavior. Applying the GRN approach to the brain and behavior provides a quantitative and manipulative framework for discovery. We illustrate features of this framework using the example of social behavior and the neural circuitry of aggression.

[Inconsistencies between building regulations in force in Italy for indoor environment and wellness factors].

PubMed

Faggioli, A; Capasso, L

2015-01-01

Indoor environment is one of major health determinants, and the regulations that set the sanitary requirements are of primary importance for the protection of public health. The authors analyse the critical aspects of the complex Italian regulatory system, starting from the EU regulations, through national and regional laws, and finally the municipal regulations. They underline the need for more uniformity and clarity in the determination of health standards, as well as for a simplification of the existing legislation. Moreover, they highlight the importance of controlling and monitoring indoor environment, currently almost completely absent in Italy due to the effects of the regulatory changes of the latest years.

Innovative farmers and regulatory gatekeepers: Genetically modified crops regulation and adoption in developing countries

PubMed Central

Sinebo, Woldeyesus; Maredia, Karim

2016-01-01

ABSTRACT The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human health is recommended. PMID:26954893

Corrective Action Decision Document/Corrective Action Plan for Corrective Action Unit 98: Frenchman Flat, Nevada National Security Site, Nevada, Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Irene Farnham and Sam Marutzky

2011-07-01

This CADD/CAP follows the Corrective Action Investigation (CAI) stage, which results in development of a set of contaminant boundary forecasts produced from groundwater flow and contaminant transport modeling of the Frenchman Flat CAU. The Frenchman Flat CAU is located in the southeastern portion of the NNSS and comprises 10 underground nuclear tests. The tests were conducted between 1965 and 1971 and resulted in the release of radionuclides in the subsurface in the vicinity of the test cavities. Two important aspects of the corrective action process are presented within this CADD/CAP. The CADD portion describes the results of the Frenchman Flatmore » CAU data-collection and modeling activities completed during the CAI stage. The corrective action objectives and the actions recommended to meet the objectives are also described. The CAP portion describes the corrective action implementation plan. The CAP begins with the presentation of CAU regulatory boundary objectives and initial use restriction boundaries that are identified and negotiated by NNSA/NSO and the Nevada Division of Environmental Protection (NDEP). The CAP also presents the model evaluation process designed to build confidence that the flow and contaminant transport modeling results can be used for the regulatory decisions required for CAU closure. The first two stages of the strategy have been completed for the Frenchman Flat CAU. A value of information analysis and a CAIP were developed during the CAIP stage. During the CAI stage, a CAIP addendum was developed, and the activities proposed in the CAIP and addendum were completed. These activities included hydrogeologic investigation of the underground testing areas, aquifer testing, isotopic and geochemistry-based investigations, and integrated geophysical investigations. After these investigations, a groundwater flow and contaminant transport model was developed to forecast contaminant boundaries that enclose areas potentially exceeding the Safe Drinking Water Act radiological standards at any time within 1,000 years. An external peer review of the groundwater flow and contaminant transport model was completed, and the model was accepted by NDEP to allow advancement to the CADD/CAP stage. The CADD/CAP stage focuses on model evaluation to ensure that existing models provide adequate guidance for the regulatory decisions regarding monitoring and institutional controls. Data-collection activities are identified and implemented to address key uncertainties in the flow and contaminant transport models. During the CR stage, final use restriction boundaries and CAU regulatory boundaries are negotiated and established; a long-term closure monitoring program is developed and implemented; and the approaches and policies for institutional controls are initiated. The model evaluation process described in this plan consists of an iterative series of five steps designed to build confidence in the site conceptual model and model forecasts. These steps are designed to identify data-collection activities (Step 1), document the data-collection activities in the 0CADD/CAP (Step 2), and perform the activities (Step 3). The new data are then assessed; the model is refined, if necessary; the modeling results are evaluated; and a model evaluation report is prepared (Step 4). The assessments are made by the modeling team and presented to the pre-emptive review committee. The decision is made by the modeling team with the assistance of the pre-emptive review committee and concurrence of NNSA/NSO to continue data and model assessment/refinement, recommend additional data collection, or recommend advancing to the CR stage. A recommendation to advance to the CR stage is based on whether the model is considered to be sufficiently reliable for designing a monitoring system and developing effective institutional controls. The decision to advance to the CR stage or to return to step 1 of the process is then made by NDEP (Step 5).« less

Gene regulatory networks and the underlying biology of developmental toxicity

EPA Science Inventory

Embryonic cells are specified by large-scale networks of functionally linked regulatory genes. Knowledge of the relevant gene regulatory networks is essential for understanding phenotypic heterogeneity that emerges from disruption of molecular functions, cellular processes or sig...

BUILDING DETAILS AND SECTIONS OF MAIN PROCESSING BUILDING (CPP601). INL ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

BUILDING DETAILS AND SECTIONS OF MAIN PROCESSING BUILDING (CPP-601). INL DRAWING NUMBER 200-0601-00-291-103080. ALTERNATE ID NUMBER 542-11-B-74. - Idaho National Engineering Laboratory, Idaho Chemical Processing Plant, Fuel Reprocessing Complex, Scoville, Butte County, ID

Design Automation in Synthetic Biology.

PubMed

Appleton, Evan; Madsen, Curtis; Roehner, Nicholas; Densmore, Douglas

2017-04-03

Design automation refers to a category of software tools for designing systems that work together in a workflow for designing, building, testing, and analyzing systems with a target behavior. In synthetic biology, these tools are called bio-design automation (BDA) tools. In this review, we discuss the BDA tools areas-specify, design, build, test, and learn-and introduce the existing software tools designed to solve problems in these areas. We then detail the functionality of some of these tools and show how they can be used together to create the desired behavior of two types of modern synthetic genetic regulatory networks. Copyright © 2017 Cold Spring Harbor Laboratory Press; all rights reserved.

Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development.

PubMed

Bertram, Timothy A; Johnson, Peter C; Tawil, Bill J; Van Dyke, Mark; Hellman, Kiki B

2015-10-01

TERMIS-AM Industry Committee (TERMIS-AM/IC), in collaboration with the TERMIS-Europe (EU)/IC, conducted a symposium involving the European Medicines Agency and the U.S. Food and Drug Administration (FDA) toward building an understanding of the rational basis for regulatory decision-making and providing a framework for decisions made during the evaluation of safety and efficacy of TE/RM technologies. This symposium was held in August 2012 during the TERMIS-WC in Vienna, Austria. Emerging from this international initiative by the European Union and the United States, representatives from the respective agencies demonstrated that there are ongoing interagency efforts for developing common national practices toward harmonization of regulatory requirements for the TE/RM products. To extend a broad-based understanding of the role of science in regulatory decision-making, TERMIS-AM/IC, in cooperation with the FDA, organized a symposium at the 2014 TERMIS-AM Annual Meeting, which was held in Washington, DC. This event provided insights from leaders in the FDA and TERMIS on the current status of regulatory approaches for the approved TE/RM products, the use of science in making regulatory decisions, and TE/RM technologies that are in the development pipeline to address unmet medical needs. A far-ranging discussion with FDA representatives, industrialists, physicians, regenerative medicine biologists, and tissue engineers considered the gaps in today's scientific and regulatory understanding of TE/RM technologies. The identified gaps represent significant opportunities to advance TE/RM technologies toward commercialization.

Modeling gene regulatory network motifs using statecharts

PubMed Central

2012-01-01

Background Gene regulatory networks are widely used by biologists to describe the interactions among genes, proteins and other components at the intra-cellular level. Recently, a great effort has been devoted to give gene regulatory networks a formal semantics based on existing computational frameworks. For this purpose, we consider Statecharts, which are a modular, hierarchical and executable formal model widely used to represent software systems. We use Statecharts for modeling small and recurring patterns of interactions in gene regulatory networks, called motifs. Results We present an improved method for modeling gene regulatory network motifs using Statecharts and we describe the successful modeling of several motifs, including those which could not be modeled or whose models could not be distinguished using the method of a previous proposal. We model motifs in an easy and intuitive way by taking advantage of the visual features of Statecharts. Our modeling approach is able to simulate some interesting temporal properties of gene regulatory network motifs: the delay in the activation and the deactivation of the "output" gene in the coherent type-1 feedforward loop, the pulse in the incoherent type-1 feedforward loop, the bistability nature of double positive and double negative feedback loops, the oscillatory behavior of the negative feedback loop, and the "lock-in" effect of positive autoregulation. Conclusions We present a Statecharts-based approach for the modeling of gene regulatory network motifs in biological systems. The basic motifs used to build more complex networks (that is, simple regulation, reciprocal regulation, feedback loop, feedforward loop, and autoregulation) can be faithfully described and their temporal dynamics can be analyzed. PMID:22536967

Regulating outdoor advertisement boards; employing spatial decision support system to control urban visual pollution

NASA Astrophysics Data System (ADS)

Wakil, K.; Hussnain, MQ; Tahir, A.; Naeem, M. A.

2016-06-01

Unmanaged placement, size, location, structure and contents of outdoor advertisement boards have resulted in severe urban visual pollution and deterioration of the socio-physical living environment in urban centres of Pakistan. As per the regulatory instruments, the approval decision for a new advertisement installation is supposed to be based on the locational density of existing boards and their proximity or remoteness to certain land- uses. In cities, where regulatory tools for the control of advertisement boards exist, responsible authorities are handicapped in effective implementation due to the absence of geospatial analysis capacity. This study presents the development of a spatial decision support system (SDSS) for regularization of advertisement boards in terms of their location and placement. The knowledge module of the proposed SDSS is based on provisions and restrictions prescribed in regulatory documents. While the user interface allows visualization and scenario evaluation to understand if the new board will affect existing linear density on a particular road and if it violates any buffer restrictions around a particular land use. Technically the structure of the proposed SDSS is a web-based solution which includes open geospatial tools such as OpenGeo Suite, GeoExt, PostgreSQL, and PHP. It uses three key data sets including road network, locations of existing billboards and building parcels with land use information to perform the analysis. Locational suitability has been calculated using pairwise comparison through analytical hierarchy process (AHP) and weighted linear combination (WLC). Our results indicate that open geospatial tools can be helpful in developing an SDSS which can assist solving space related iterative decision challenges on outdoor advertisements. Employing such a system will result in effective implementation of regulations resulting in visual harmony and aesthetic improvement in urban communities.

AZOrange - High performance open source machine learning for QSAR modeling in a graphical programming environment

PubMed Central

2011-01-01

Background Machine learning has a vast range of applications. In particular, advanced machine learning methods are routinely and increasingly used in quantitative structure activity relationship (QSAR) modeling. QSAR data sets often encompass tens of thousands of compounds and the size of proprietary, as well as public data sets, is rapidly growing. Hence, there is a demand for computationally efficient machine learning algorithms, easily available to researchers without extensive machine learning knowledge. In granting the scientific principles of transparency and reproducibility, Open Source solutions are increasingly acknowledged by regulatory authorities. Thus, an Open Source state-of-the-art high performance machine learning platform, interfacing multiple, customized machine learning algorithms for both graphical programming and scripting, to be used for large scale development of QSAR models of regulatory quality, is of great value to the QSAR community. Results This paper describes the implementation of the Open Source machine learning package AZOrange. AZOrange is specially developed to support batch generation of QSAR models in providing the full work flow of QSAR modeling, from descriptor calculation to automated model building, validation and selection. The automated work flow relies upon the customization of the machine learning algorithms and a generalized, automated model hyper-parameter selection process. Several high performance machine learning algorithms are interfaced for efficient data set specific selection of the statistical method, promoting model accuracy. Using the high performance machine learning algorithms of AZOrange does not require programming knowledge as flexible applications can be created, not only at a scripting level, but also in a graphical programming environment. Conclusions AZOrange is a step towards meeting the needs for an Open Source high performance machine learning platform, supporting the efficient development of highly accurate QSAR models fulfilling regulatory requirements. PMID:21798025

AZOrange - High performance open source machine learning for QSAR modeling in a graphical programming environment.

PubMed

Stålring, Jonna C; Carlsson, Lars A; Almeida, Pedro; Boyer, Scott

2011-07-28

Machine learning has a vast range of applications. In particular, advanced machine learning methods are routinely and increasingly used in quantitative structure activity relationship (QSAR) modeling. QSAR data sets often encompass tens of thousands of compounds and the size of proprietary, as well as public data sets, is rapidly growing. Hence, there is a demand for computationally efficient machine learning algorithms, easily available to researchers without extensive machine learning knowledge. In granting the scientific principles of transparency and reproducibility, Open Source solutions are increasingly acknowledged by regulatory authorities. Thus, an Open Source state-of-the-art high performance machine learning platform, interfacing multiple, customized machine learning algorithms for both graphical programming and scripting, to be used for large scale development of QSAR models of regulatory quality, is of great value to the QSAR community. This paper describes the implementation of the Open Source machine learning package AZOrange. AZOrange is specially developed to support batch generation of QSAR models in providing the full work flow of QSAR modeling, from descriptor calculation to automated model building, validation and selection. The automated work flow relies upon the customization of the machine learning algorithms and a generalized, automated model hyper-parameter selection process. Several high performance machine learning algorithms are interfaced for efficient data set specific selection of the statistical method, promoting model accuracy. Using the high performance machine learning algorithms of AZOrange does not require programming knowledge as flexible applications can be created, not only at a scripting level, but also in a graphical programming environment. AZOrange is a step towards meeting the needs for an Open Source high performance machine learning platform, supporting the efficient development of highly accurate QSAR models fulfilling regulatory requirements.

Adult Neurogenesis in the Mammalian Brain: Significant Answers and Significant Questions

PubMed Central

Ming, Guo-li; Song, Hongjun

2011-01-01

Summary Adult neurogenesis, a process of generating functional neurons from adult neural precursors, occurs throughout life in restricted brain regions in mammals. The past decade has witnessed tremendous progress in addressing questions related to almost every aspect of adult neurogenesis in the mammalian brain. Here we review major advances in our understanding of adult mammalian neurogenesis in the dentate gyrus of the hippocampus and from the subventricular zone of the lateral ventricle, the rostral migratory stream to the olfactory bulb. We highlight emerging principles that have significant implications for stem cell biology, developmental neurobiology, neural plasticity, and disease mechanisms. We also discuss remaining questions related to adult neural stem cells and their niches, underlying regulatory mechanisms and potential functions of newborn neurons in the adult brain. Building upon the recent progress and aided by new technologies, the adult neurogenesis field is poised to leap forward in the next decade. PMID:21609825

Pancreatic Cancer Metabolism: Breaking It Down to Build It Back Up.

PubMed

Perera, Rushika M; Bardeesy, Nabeel

2015-12-01

How do cancer cells escape tightly controlled regulatory circuits that link their proliferation to extracellular nutrient cues? An emerging theme in cancer biology is the hijacking of normal stress response mechanisms to enable growth even when nutrients are limiting. Pancreatic ductal adenocarcinoma (PDA) is the quintessential aggressive malignancy that thrives in nutrient-poor, hypoxic environments. PDAs overcome these limitations through appropriation of unorthodox strategies for fuel source acquisition and utilization. In addition, the interplay between evolving PDA and whole-body metabolism contributes to disease pathogenesis. Deciphering how these pathways function and integrate with one another can reveal novel angles of therapeutic attack. Alterations in tumor cell and systemic metabolism are central to the biology of pancreatic cancer. Further investigation of these processes will provide important insights into how these tumors develop and grow, and suggest new approaches for its detection, prevention, and treatment. ©2015 American Association for Cancer Research.

Understanding Biological Regulation Through Synthetic Biology.

PubMed

Bashor, Caleb J; Collins, James J

2018-05-20

Engineering synthetic gene regulatory circuits proceeds through iterative cycles of design, building, and testing. Initial circuit designs must rely on often-incomplete models of regulation established by fields of reductive inquiry-biochemistry and molecular and systems biology. As differences in designed and experimentally observed circuit behavior are inevitably encountered, investigated, and resolved, each turn of the engineering cycle can force a resynthesis in understanding of natural network function. Here, we outline research that uses the process of gene circuit engineering to advance biological discovery. Synthetic gene circuit engineering research has not only refined our understanding of cellular regulation but furnished biologists with a toolkit that can be directed at natural systems to exact precision manipulation of network structure. As we discuss, using circuit engineering to predictively reorganize, rewire, and reconstruct cellular regulation serves as the ultimate means of testing and understanding how cellular phenotype emerges from systems-level network function.

ASME Code Efforts Supporting HTGRs

DOE Office of Scientific and Technical Information (OSTI.GOV)

D.K. Morton

2010-09-01

In 1999, an international collaborative initiative for the development of advanced (Generation IV) reactors was started. The idea behind this effort was to bring nuclear energy closer to the needs of sustainability, to increase proliferation resistance, and to support concepts able to produce energy (both electricity and process heat) at competitive costs. The U.S. Department of Energy has supported this effort by pursuing the development of the Next Generation Nuclear Plant, a high temperature gas-cooled reactor. This support has included research and development of pertinent data, initial regulatory discussions, and engineering support of various codes and standards development. This reportmore » discusses the various applicable American Society of Mechanical Engineers (ASME) codes and standards that are being developed to support these high temperature gascooled reactors during construction and operation. ASME is aggressively pursuing these codes and standards to support an international effort to build the next generation of advanced reactors so that all can benefit.« less

ASME Code Efforts Supporting HTGRs

DOE Office of Scientific and Technical Information (OSTI.GOV)

D.K. Morton

2011-09-01

In 1999, an international collaborative initiative for the development of advanced (Generation IV) reactors was started. The idea behind this effort was to bring nuclear energy closer to the needs of sustainability, to increase proliferation resistance, and to support concepts able to produce energy (both electricity and process heat) at competitive costs. The U.S. Department of Energy has supported this effort by pursuing the development of the Next Generation Nuclear Plant, a high temperature gas-cooled reactor. This support has included research and development of pertinent data, initial regulatory discussions, and engineering support of various codes and standards development. This reportmore » discusses the various applicable American Society of Mechanical Engineers (ASME) codes and standards that are being developed to support these high temperature gascooled reactors during construction and operation. ASME is aggressively pursuing these codes and standards to support an international effort to build the next generation of advanced reactors so that all can benefit.« less

Guidelines for clinical supervision in health service psychology.

PubMed

2015-01-01

This document outlines guidelines for supervision of students in health service psychology education and training programs. The goal was to capture optimal performance expectations for psychologists who supervise. It is based on the premises that supervisors (a) strive to achieve competence in the provision of supervision and (b) employ a competency-based, meta-theoretical approach to the supervision process. The Guidelines on Supervision were developed as a resource to inform education and training regarding the implementation of competency-based supervision. The Guidelines on Supervision build on the robust literatures on competency-based education and clinical supervision. They are organized around seven domains: supervisor competence; diversity; relationships; professionalism; assessment/evaluation/feedback; problems of professional competence, and ethical, legal, and regulatory considerations. The Guidelines on Supervision represent the collective effort of a task force convened by the American Psychological Association (APA) Board of Educational Affairs (BEA). PsycINFO Database Record (c) 2015 APA, all rights reserved.

ASME Code Efforts Supporting HTGRs

DOE Office of Scientific and Technical Information (OSTI.GOV)

D.K. Morton

2012-09-01

In 1999, an international collaborative initiative for the development of advanced (Generation IV) reactors was started. The idea behind this effort was to bring nuclear energy closer to the needs of sustainability, to increase proliferation resistance, and to support concepts able to produce energy (both electricity and process heat) at competitive costs. The U.S. Department of Energy has supported this effort by pursuing the development of the Next Generation Nuclear Plant, a high temperature gas-cooled reactor. This support has included research and development of pertinent data, initial regulatory discussions, and engineering support of various codes and standards development. This reportmore » discusses the various applicable American Society of Mechanical Engineers (ASME) codes and standards that are being developed to support these high temperature gascooled reactors during construction and operation. ASME is aggressively pursuing these codes and standards to support an international effort to build the next generation of advanced reactors so that all can benefit.« less

Building a roadmap to biomarker qualification: challenges and opportunities.

PubMed

Amur, Shashi G; Sanyal, Sarmistha; Chakravarty, Aloka G; Noone, Marianne H; Kaiser, James; McCune, Susan; Buckman-Garner, ShaAvhree Y

2015-01-01

The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.

Regulatory network rewiring for secondary metabolism in Arabidopsis thaliana under various conditions

PubMed Central

2014-01-01

Background Plant secondary metabolites are critical to various biological processes. However, the regulations of these metabolites are complex because of regulatory rewiring or crosstalk. To unveil how regulatory behaviors on secondary metabolism reshape biological processes, we constructed and analyzed a dynamic regulatory network of secondary metabolic pathways in Arabidopsis. Results The dynamic regulatory network was constructed through integrating co-expressed gene pairs and regulatory interactions. Regulatory interactions were either predicted by conserved transcription factor binding sites (TFBSs) or proved by experiments. We found that integrating two data (co-expression and predicted regulatory interactions) enhanced the number of highly confident regulatory interactions by over 10% compared with using single data. The dynamic changes of regulatory network systematically manifested regulatory rewiring to explain the mechanism of regulation, such as in terpenoids metabolism, the regulatory crosstalk of RAV1 (AT1G13260) and ATHB1 (AT3G01470) on HMG1 (hydroxymethylglutaryl-CoA reductase, AT1G76490); and regulation of RAV1 on epoxysqualene biosynthesis and sterol biosynthesis. Besides, we investigated regulatory rewiring with expression, network topology and upstream signaling pathways. Regulatory rewiring was revealed by the variability of genes’ expression: pathway genes and transcription factors (TFs) were significantly differentially expressed under different conditions (such as terpenoids biosynthetic genes in tissue experiments and E2F/DP family members in genotype experiments). Both network topology and signaling pathways supported regulatory rewiring. For example, we discovered correlation among the numbers of pathway genes, TFs and network topology: one-gene pathways (such as δ-carotene biosynthesis) were regulated by a fewer TFs, and were not critical to metabolic network because of their low degrees in topology. Upstream signaling pathways of 50 TFs were identified to comprehend the underlying mechanism of TFs’ regulatory rewiring. Conclusion Overall, this dynamic regulatory network largely improves the understanding of perplexed regulatory rewiring in secondary metabolism in Arabidopsis. PMID:24993737

A Framework for Integrating Environmental Justice in Regulatory Analysis

PubMed Central

Nweke, Onyemaechi C.

2011-01-01

With increased interest in integrating environmental justice into the process for developing environmental regulations in the United States, analysts and decision makers are confronted with the question of what methods and data can be used to assess disproportionate environmental health impacts. However, as a first step to identifying data and methods, it is important that analysts understand what information on equity impacts is needed for decision making. Such knowledge originates from clearly stated equity objectives and the reflection of those objectives throughout the analytical activities that characterize Regulatory Impact Analysis (RIA), a process that is traditionally used to inform decision making. The framework proposed in this paper advocates structuring analyses to explicitly provide pre-defined output on equity impacts. Specifically, the proposed framework emphasizes: (a) defining equity objectives for the proposed regulatory action at the onset of the regulatory process, (b) identifying specific and related sub-objectives for key analytical steps in the RIA process, and (c) developing explicit analytical/research questions to assure that stated sub-objectives and objectives are met. In proposing this framework, it is envisioned that information on equity impacts informs decision-making in regulatory development, and that this is achieved through a systematic and consistent approach that assures linkages between stated equity objectives, regulatory analyses, selection of policy options, and the design of compliance and enforcement activities. PMID:21776235

77 FR 38866 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

... supra note 6. System Processing Fee Under Section 4(b)(6) of Schedule A, FINRA currently charges an annual $30 system processing fee for each member's registered individuals. FINRA is proposing to increase the system processing fee to $45. This fee has not been increased since January 2000.\\11\\ Since 2000...

75 FR 60158 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... Process in Providing Trustee Access to the Security Position Report Service September 24, 2010. Pursuant...'') service with an automated approval process. II. Self-Regulatory Organization's Statement of the Purpose of... approve a Trustee's access to the SPR service for a security is done manually, and the process is...

Psychological and neural mechanisms associated with effort-related cardiovascular reactivity and cognitive control: An integrative approach.

PubMed

Silvestrini, Nicolas

2017-09-01

Numerous studies have assessed cardiovascular (CV) reactivity as a measure of effort mobilization during cognitive tasks. However, psychological and neural processes underlying effort-related CV reactivity are still relatively unclear. Previous research reliably found that CV reactivity during cognitive tasks is mainly determined by one region of the brain, the dorsal anterior cingulate cortex (dACC), and that this region is systematically engaged during cognitively demanding tasks. The present integrative approach builds on the research on cognitive control and its brain correlates that shows that dACC function can be related to conflict monitoring and integration of information related to task difficulty and success importance-two key variables in determining effort mobilization. In contrast, evidence also indicates that executive cognitive functioning is processed in more lateral regions of the prefrontal cortex. The resulting model suggests that, when automatic cognitive processes are insufficient to sustain behavior, the dACC determines the amount of required and justified effort according to task difficulty and success importance, which leads to proportional adjustments in CV reactivity and executive cognitive functioning. These propositions are discussed in relation to previous findings on effort-related CV reactivity and cognitive performance, new predictions for future studies, and relevance for other self-regulatory processes. Copyright © 2016 Elsevier B.V. All rights reserved.

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

PubMed

2015-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

Mechanisms of nuclear pore complex assembly - two different ways of building one molecular machine.

PubMed

Otsuka, Shotaro; Ellenberg, Jan

2018-02-01

The nuclear pore complex (NPC) mediates all macromolecular transport across the nuclear envelope. In higher eukaryotes that have an open mitosis, NPCs assemble at two points in the cell cycle: during nuclear assembly in late mitosis and during nuclear growth in interphase. How the NPC, the largest nonpolymeric protein complex in eukaryotic cells, self-assembles inside cells remained unclear. Recent studies have started to uncover the assembly process, and evidence has been accumulating that postmitotic and interphase NPC assembly use fundamentally different mechanisms; the duration, structural intermediates, and regulation by molecular players are different and different types of membrane deformation are involved. In this Review, we summarize the current understanding of these two modes of NPC assembly and discuss the structural and regulatory steps that might drive the assembly processes. We furthermore integrate understanding of NPC assembly with the mechanisms for rapid nuclear growth in embryos and, finally, speculate on the evolutionary origin of the NPC implied by the presence of two distinct assembly mechanisms. © 2017 The Authors. FEBS Letters published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.

Cadmium Recycling in the United States in 2000

USGS Publications Warehouse

Plachy, Jozef

2003-01-01

Recycling of cadmium is a young and growing industry that has been influenced by environmental concerns and regulatory constraints. Domestic recycling of cadmium began in 1989 as a byproduct of processing of spent nickel-cadmium batteries. In 1995, International Metals Reclamation Co. Inc. expanded its operations by building a dedicated cadmium recycling plant. In 2000, an estimated 13 percent of cadmium consumption in the United States was sourced from recycled cadmium, which is derived mainly from old scrap or, to lesser degree, new scrap. The easiest forms of old scrap to recycle are small spent nickel-cadmium batteries followed by flue dust generated during recycling of galvanized steel and small amounts of alloys that contain cadmium. Most of new scrap is generated during manufacturing processes, such as nickel-cadmium battery production. All other uses of cadmium are in low concentrations and, therefore, difficult to recycle. Consequently, much of this cadmium is dissipated and lost. The amount of cadmium in scrap that was unrecovered in 2000 was estimated to be 2,030 t, and an estimated 285 t was recovered. Recycling efficiency was estimated to be about 15 percent.

Cadmium recycling in the United States in 2000

USGS Publications Warehouse

Plachy, Jozef

2003-01-01

Recycling of cadmium is a young and growing industry that has been influenced by environmental concerns and regulatory constraints. Domestic recycling of cadmium began in 1989 as a byproduct of processing of spent nickel-cadmium batteries. In 1995, International Metals Reclamation Co. Inc. expanded its operations by building a dedicated cadmium recycling plant. In 2000, an estimated 13 percent of cadmium consumption in the United States was sourced from recycled cadmium, which is derived mainly from old scrap or, to lesser degree, new scrap. The easiest forms of old scrap to recycle are small spent nickel-cadmium batteries followed by flue dust generated during recycling of galvanized steel and small amounts of alloys that contain cadmium. Most of new scrap is generated during manufacturing processes, such as nickel-cadmium battery production. All other uses of cadmium are in low concentrations and, therefore, difficult to recycle. Consequently, much of this cadmium is dissipated and lost. The amount of cadmium in scrap that was unrecovered in 2000 was estimated to be 2,030 metric tons, and an estimated 285 tons was recovered. Recycling efficiency was estimated to be about 15 percent.

Synthetic in vitro transcriptional oscillators

PubMed Central

Kim, Jongmin; Winfree, Erik

2011-01-01

The construction of synthetic biochemical circuits from simple components illuminates how complex behaviors can arise in chemistry and builds a foundation for future biological technologies. A simplified analog of genetic regulatory networks, in vitro transcriptional circuits, provides a modular platform for the systematic construction of arbitrary circuits and requires only two essential enzymes, bacteriophage T7 RNA polymerase and Escherichia coli ribonuclease H, to produce and degrade RNA signals. In this study, we design and experimentally demonstrate three transcriptional oscillators in vitro. First, a negative feedback oscillator comprising two switches, regulated by excitatory and inhibitory RNA signals, showed up to five complete cycles. To demonstrate modularity and to explore the design space further, a positive-feedback loop was added that modulates and extends the oscillatory regime. Finally, a three-switch ring oscillator was constructed and analyzed. Mathematical modeling guided the design process, identified experimental conditions likely to yield oscillations, and explained the system's robust response to interference by short degradation products. Synthetic transcriptional oscillators could prove valuable for systematic exploration of biochemical circuit design principles and for controlling nanoscale devices and orchestrating processes within artificial cells. PMID:21283141

Detection of concealed mercury with thermal neutrons

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bell, Z.W.

1994-08-18

In the United States today, governments at all levels and the citizenry are paying increasing attention to the effects, both real and hypothetical, of industrial activity on the environment. Responsible modem industries, reflecting this heightened public and regulatory awareness, are either substituting benign materials for hazardous ones, or using hazardous materials only under carefully controlled conditions. In addition, present-day environmental consciousness dictates that we deal responsibly with legacy wastes. The decontamination and decommissioning (D&D) of facilities at which mercury was used or processed presents a variety of challenges. Elemental mercury is a liquid at room temperature and readily evaporates inmore » air. In large mercury-laden buildings, droplets may evaporate from one area only to recondense in other cooler areas. The rate of evaporation is a function of humidity and temperature; consequently, different parts of a building may be sources or sinks of mercury at different times of the day or even the year. Additionally, although mercury oxidizes in air, the oxides decompose upon heating. Hence, oxides contained within pipes or equipment, may be decomposed when those pipes and equipment are cut with saws or torches. Furthermore, mercury seeps through the pores and cracks in concrete blocks and pads, and collects as puddles and blobs in void spaces within and under them.« less

Cytoskeleton in Mast Cell Signaling

PubMed Central

Dráber, Pavel; Sulimenko, Vadym; Dráberová, Eduarda

2012-01-01

Mast cell activation mediated by the high affinity receptor for IgE (FcεRI) is a key event in allergic response and inflammation. Other receptors on mast cells, as c-Kit for stem cell factor and G protein-coupled receptors (GPCRs) synergistically enhance the FcεRI-mediated release of inflammatory mediators. Activation of various signaling pathways in mast cells results in changes in cell morphology, adhesion to substrate, exocytosis, and migration. Reorganization of cytoskeleton is pivotal in all these processes. Cytoskeletal proteins also play an important role in initial stages of FcεRI and other surface receptors induced triggering. Highly dynamic microtubules formed by αβ-tubulin dimers as well as microfilaments build up from polymerized actin are affected in activated cells by kinases/phosphatases, Rho GTPases and changes in concentration of cytosolic Ca2+. Also important are nucleation proteins; the γ-tubulin complexes in case of microtubules or Arp 2/3 complex with its nucleation promoting factors and formins in case of microfilaments. The dynamic nature of microtubules and microfilaments in activated cells depends on many associated/regulatory proteins. Changes in rigidity of activated mast cells reflect changes in intermediate filaments build up from vimentin. This review offers a critical appraisal of current knowledge on the role of cytoskeleton in mast cells signaling. PMID:22654883

Bringing the frame into focus: the influence of regulatory fit on processing fluency and persuasion.

PubMed

Lee, Angela Y; Aaker, Jennifer L

2004-02-01

This research demonstrates that people's goals associated with regulatory focus moderate the effect of message framing on persuasion. The results of 6 experiments show that appeals presented in gain frames are more persuasive when the message is promotion focused, whereas loss-framed appeals are more persuasive when the message is prevention focused. These regulatory focus effects suggesting heightened vigilance against negative outcomes and heightened eagerness toward positive outcomes are replicated when perceived risk is manipulated. Enhanced processing fluency leading to more favorable evaluations in conditions of compatibility appears to underlie these effects. The findings underscore the regulatory fit principle that accounts for the persuasiveness of message framing effects and highlight how processing fluency may contribute to the "feeling right" experience when the strategy of goal pursuit matches one's goal.

Assessing the role of regulatory bodies in managing health professional issues and errors in Europe.

PubMed

Risso-Gill, Isabelle; Legido-Quigley, H; Panteli, D; Mckee, M

2014-08-01

This paper explores how medical regulatory bodies in nine European countries manage professional issues involving quality and patient safety, to build on limited existing information on procedures for regulating medical professionals in Europe. Twelve vignettes describing scenarios of concerns about standards of physicians were developed, covering clinical, criminal and administrative matters. Medical regulatory bodies in nine European countries were asked what action they would normally take in each situation. Their responses were related to their regulatory mandate. Responses varied greatly across participating countries. Regulators are always involved where patients are at risk or where a criminal offence is committed within the clinical setting. Non-criminal medical issues were generally handled by the employer, if any, at their discretion. Countries varied in the use of punitive measures, the extent to which they took an interest in issues arising outside professional activities, and whether they dealt with issues themselves or referred cases to another regulatory authority or took no action at all. There is little consistency across Europe on the regulation of medical professionals. There is considerable diversity in the range of topics that regulatory bodies oversee, with almost all covering health care quality and safety and others encompassing issues related to reputation, respect and trust. These inconsistencies have significant implications for professional mobility, patient safety and quality of care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

On the Concept of Cis-regulatory Information: From Sequence Motifs to Logic Functions

NASA Astrophysics Data System (ADS)

Tarpine, Ryan; Istrail, Sorin

The regulatory genome is about the “system level organization of the core genomic regulatory apparatus, and how this is the locus of causality underlying the twin phenomena of animal development and animal evolution” (E.H. Davidson. The Regulatory Genome: Gene Regulatory Networks in Development and Evolution, Academic Press, 2006). Information processing in the regulatory genome is done through regulatory states, defined as sets of transcription factors (sequence-specific DNA binding proteins which determine gene expression) that are expressed and active at the same time. The core information processing machinery consists of modular DNA sequence elements, called cis-modules, that interact with transcription factors. The cis-modules “read” the information contained in the regulatory state of the cell through transcription factor binding, “process” it, and directly or indirectly communicate with the basal transcription apparatus to determine gene expression. This endowment of each gene with the information-receiving capacity through their cis-regulatory modules is essential for the response to every possible regulatory state to which it might be exposed during all phases of the life cycle and in all cell types. We present here a set of challenges addressed by our CYRENE research project aimed at studying the cis-regulatory code of the regulatory genome. The CYRENE Project is devoted to (1) the construction of a database, the cis-Lexicon, containing comprehensive information across species about experimentally validated cis-regulatory modules; and (2) the software development of a next-generation genome browser, the cis-Browser, specialized for the regulatory genome. The presentation is anchored on three main computational challenges: the Gene Naming Problem, the Consensus Sequence Bottleneck Problem, and the Logic Function Inference Problem.

Environmental Regulatory Update Table, January/February 1995

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1995-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Final Regulatory Determination for Special Wastes From Mineral Processing (Mining Waste Exclusion) - Federal Register Notice, June 13, 1991

EPA Pesticide Factsheets

This action presents the Agency's final regulatory determination required by section 3001(b)(3)(C) of the Resource Conservation and Recovery Act (RCRA) for 20 special wastes from the processing of ores and minerals.

Webinar Presentation: Exposures to Polycyclic Aromatic Hydrocarbons and Childhood Growth Trajectories and Body Composition: Linkages to Disrupted Self-Regulatory Processes

EPA Pesticide Factsheets

This presentation, Exposures to Polycyclic Aromatic Hydrocarbons and Childhood Growth Trajectories and Body Composition: Linkages to Disrupted Self-Regulatory Processes, was given at the NIEHS/EPA Children's Centers 2016 Webinar Series: Childhood Obesity

76 FR 33181 - Regulatory Review Schedule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review... conducting a comprehensive review of all its regulations and requesting public comment on the process for conducting the regulatory review. On April 4, 2011, after holding eight consultation meetings and reviewing...

76 FR 26967 - Regulatory Review Schedule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-10

... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review... review of its regulations and requesting public comment on the process for conducting the regulatory review. On April 4, 2011, after holding eight consultation meetings and reviewing all comments, NIGC...

Bridging Research and Environmental Regulatory Processes: The Role of Knowledge Brokers

PubMed Central

Pennell, Kelly G.; Thompson, Marcella; Rice, James W.; Senier, Laura; Brown, Phil; Suuberg, Eric

2013-01-01

Federal funding agencies increasingly require research investigators to ensure that federally-sponsored research demonstrates broader societal impact. Specifically, the National Institutes of Environmental Health Sciences (NIEHS) Superfund Research Program (SRP) requires research centers to include research translation and community engagement cores to achieve broader impacts, with special emphasis on improving environmental health policies through better scientific understanding. This paper draws on theoretical insights from the social sciences to show how incorporating knowledge brokers in research centers can facilitate translation of scientific expertise to influence regulatory processes and thus promote public health. Knowledge brokers connect academic researchers with decision-makers, to facilitate the translation of research findings into policies and programs. In this article, we describe the stages of the regulatory process and highlight the role of the knowledge broker and scientific expert at each stage. We illustrate the cooperation of knowledge brokers, scientific experts and policymakers using a case from the Brown University (Brown) SRP. We show how the Brown SRP incorporated knowledge brokers to engage scientific experts with regulatory officials around the emerging public health problem of vapor intrusion. In the Brown SRP, the knowledge broker brought regulatory officials into the research process, to help scientific experts understand the critical nature of this emerging public health threat, and helped scientific experts develop a research agenda that would inform the development of timely measures to protect public health. Our experience shows that knowledge brokers can enhance the impact of environmental research on public health by connecting policy decision-makers with scientific experts at critical points throughout the regulatory process. PMID:24083557

75 FR 55840 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of a Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-14

... Listing and Trading of Shares of the PIMCO Build America Bond Strategy Fund September 7, 2010. I..., which governs the listing and trading of Managed Fund Shares. The Shares will be offered by the Trust.\\4...% in the case of Recovery Zone Economic Development Bonds) of the interest paid. The federal interest...

78 FR 35014 - Orders Granting Authority to Import and Export Natural Gas, and to Import Liquefied Natural Gas...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... Fossil Energy, Department of Energy (DOE). ACTION: Notice of orders. SUMMARY: The Office of Fossil Energy... in the attached appendix and may be found on the FE Web site at http://www.fossil.energy.gov/programs... of Fossil Energy, Office of Natural Gas Regulatory Activities, Docket Room 3E-033, Forrestal Building...

Hard and Soft Policies in Music Education: Building the Capacity of Teachers to Understand, Study, and Influence Them

ERIC Educational Resources Information Center

Jones, Patrick M.

2009-01-01

Music education exists within a web of policies. Those most often identified by music teachers and professional associations are the policies imposed on the profession by governmental and regulatory bodies. Advocacy efforts to change policy are mostly directed toward these bodies. However, the practice of music education is perhaps more influenced…

Breaking the Cycle: Using a Relational Approach to Address the Impact of Maternal Substance Use on Regulation and Attachment in Children

ERIC Educational Resources Information Center

Motz, Mary; Leslie, Margaret; DeMarchi, Gina

2007-01-01

Breaking the Cycle (BTC), founded in 1995, is an early identification, prevention, and treatment program for pregnant and parenting women who abuse substances. The authors explore the impact of substance abuse on early attachment relationships and on infant regulatory functioning. BTC focuses on building and enhancing the mother's relationships,…

Fundamentals of Day Camping. An Ideal Reference for Administrators of Day Camps and School-Age Day Care Programs. Revised.

ERIC Educational Resources Information Center

Mitchell, Grace; And Others

This revised edition of a 1961 publication outlines the steps involved in establishing a new day camp, and presents guidelines for day camp operation. Four chapters cover: (1) preliminary decisions and planning for a new camp; (2) site selection, legal and regulatory considerations, and property management; (3) deciding on buildings and equipment…

75 FR 20398 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on AP1000...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-19

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on AP1000; Notice of Meeting The ACRS Subcommittee on the AP1000 will hold a meeting on April 22... Loss of Large Areas due to Fire/Explosions, and by Westinghouse on the subject of Shield Building...

36 CFR 1234.20 - What rules apply if there is a conflict between NARA standards and other regulatory standards...

Code of Federal Regulations, 2014 CFR

2014-07-01

... regional building codes, the following rules of precedence apply: (1) Between differing levels of fire... cannot be reconciled with a requirement of this part, the local or regional code applies. (b) If any of... require documentation of the mandatory nature of the conflicting code and the inability to reconcile that...

36 CFR 1234.20 - What rules apply if there is a conflict between NARA standards and other regulatory standards...

Code of Federal Regulations, 2012 CFR

2012-07-01

... regional building codes, the following rules of precedence apply: (1) Between differing levels of fire... cannot be reconciled with a requirement of this part, the local or regional code applies. (b) If any of... require documentation of the mandatory nature of the conflicting code and the inability to reconcile that...

36 CFR 1234.20 - What rules apply if there is a conflict between NARA standards and other regulatory standards...

Code of Federal Regulations, 2011 CFR

2011-07-01

... regional building codes, the following rules of precedence apply: (1) Between differing levels of fire... cannot be reconciled with a requirement of this part, the local or regional code applies. (b) If any of... require documentation of the mandatory nature of the conflicting code and the inability to reconcile that...

36 CFR § 1234.20 - What rules apply if there is a conflict between NARA standards and other regulatory standards...

Code of Federal Regulations, 2013 CFR

2013-07-01

... regional building codes, the following rules of precedence apply: (1) Between differing levels of fire... cannot be reconciled with a requirement of this part, the local or regional code applies. (b) If any of... require documentation of the mandatory nature of the conflicting code and the inability to reconcile that...

Early Childhood Curriculum Development: The Role of Play in Building Self-Regulatory Capacity in Young Children

ERIC Educational Resources Information Center

Kroll, Linda R.

2017-01-01

This case study examines the development of self-regulation, socially, cognitively and emotionally, through the use of play in the curriculum in five preschool classrooms for children ages 2-5 years old at a university laboratory school. Five teachers were interviewed about their deliberate use of play to support the development of self-regulation…

Optimal management of nutrient reserves in microorganisms under time-varying environmental conditions.

PubMed

Nev, Olga A; Nev, Oleg A; van den Berg, Hugo A

2017-09-21

Intracellular reserves are a conspicuous feature of many bacteria; such internal stores are often present in the form of inclusions in which polymeric storage compounds are accumulated. Such reserves tend to increase in times of plenty and be used up in times of scarcity. Mathematical models that describe the dynamical nature of reserve build-up and use are known as "cell quota," "dynamic energy/nutrient budget," or "variable-internal-stores" models. Here we present a stoichiometrically consistent macro-chemical model that accounts for variable stores as well as adaptive allocation of building blocks to various types of catalytic machinery. The model posits feedback loops linking expression of assimilatory machinery to reserve density. The precise form of the "regulatory law" at the heart of such a loop expresses how the cell manages internal stores. We demonstrate how this "regulatory law" can be recovered from experimental data using several empirical data sets. We find that stores should be expected to be negligibly small in stable growth-sustaining environments, but prominent in environments characterised by marked fluctuations on time scales commensurate with the inherent dynamic time scale of the organismal system. Copyright © 2017 Elsevier Ltd. All rights reserved.

EXTERIOR VIEW, THE SA WETSIDE BUILDING (ALSO KNOWN AS DISTILLATION ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

EXTERIOR VIEW, THE SA WETSIDE BUILDING (ALSO KNOWN AS DISTILLATION BUILDING OR SOLVAY TOWERS BUILDING) THE HEART OF THE SOLVAY PROCESS. VIEW LOOKING EAST. THIS BUILDING WAS BUILT IN 1954 TO REPLACE A SIMILAR STRUCTURE BUILT CIRCA 1907. - Solvay Process Company, SA Wetside Building, Between Willis & Milton Avenue, Solvay, Onondaga County, NY

A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

PubMed

Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

2015-01-01

Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

A novel method for in silico identification of regulatory SNPs in human genome.

PubMed

Li, Rong; Zhong, Dexing; Liu, Ruiling; Lv, Hongqiang; Zhang, Xinman; Liu, Jun; Han, Jiuqiang

2017-02-21

Regulatory single nucleotide polymorphisms (rSNPs), kind of functional noncoding genetic variants, can affect gene expression in a regulatory way, and they are thought to be associated with increased susceptibilities to complex diseases. Here a novel computational approach to identify potential rSNPs is presented. Different from most other rSNPs finding methods which based on hypothesis that SNPs causing large allele-specific changes in transcription factor binding affinities are more likely to play regulatory functions, we use a set of documented experimentally verified rSNPs and nonfunctional background SNPs to train classifiers, so the discriminating features are found. To characterize variants, an extensive range of characteristics, such as sequence context, DNA structure and evolutionary conservation etc. are analyzed. Support vector machine is adopted to build the classifier model together with an ensemble method to deal with unbalanced data. 10-fold cross-validation result shows that our method can achieve accuracy with sensitivity of ~78% and specificity of ~82%. Furthermore, our method performances better than some other algorithms based on aforementioned hypothesis in handling false positives. The original data and the source matlab codes involved are available at https://sourceforge.net/projects/rsnppredict/. Copyright © 2016 Elsevier Ltd. All rights reserved.

NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Scroggins, Sharon; Duda, Kristen

2008-01-01

This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

Building a self-regulatory model of sleep deprivation and deception: the role of caffeine and social influence.

PubMed

Welsh, David T; Ellis, Aleksander P J; Christian, Michael S; Mai, Ke Michael

2014-11-01

Employees are getting less sleep, which has been shown to deplete self-regulatory resources and increase unethical behavior (Barnes, Schaubroeck, Huth, & Ghumman, 2011; Christian & Ellis, 2011). In this study, we extend the original mediated model by examining the role of 2 moderators in the relationship between sleep deprivation, depletion, and deceptive behavior. First, we derive psychological arguments from the psychopharmacology literature to hypothesize that caffeine moderates the relationship between sleep deprivation and depletion by replenishing self-regulatory resources. Second, we draw from recent research in social psychology to hypothesize that social influence moderates the relationship between depletion and deceptive behavior, such that depleted individuals are less able to resist the negative influence of others. Results of a laboratory study provide support for our expanded model combining mediation and moderation, adding to our understanding of the role of sleep deprivation in the incidence of workplace deception. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

China’s Rapidly Aging Population Creates Policy Challenges In Shaping A Viable Long-Term Care System

PubMed Central

Feng, Zhanlian; Liu, Chang; Guan, Xinping; Mor, Vincent

2013-01-01

In China, formal long-term care services for the large aging population have increased to meet escalating demands as demographic shifts and socioeconomic changes have eroded traditional elder care. We analyze China’s evolving long-term care landscape and trace major government policies and private-sector initiatives shaping it. Although home and community-based services remain spotty, institutional care is booming with little regulatory oversight. Chinese policy makers face mounting challenges overseeing the rapidly growing residential care sector, given the tension arising from policy inducements to further institutional growth, a weak regulatory framework, and the lack of enforcement capacity. We recommend addressing the following pressing policy issues: building a balanced system of services and avoiding an “institutional bias” that promotes rapid growth of elder care institutions over home or community-based care; strengthening regulatory oversight and quality assurance with information systems; and prioritizing education and training initiatives to grow a professionalized long-term care workforce. PMID:23213161

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

PubMed

Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

2015-10-01

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.

Environmental Regulatory Update Table, October 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, December 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January--February 1993

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, March--April 1994

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, September--October 1992

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September/October 1993

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operation and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January--February 1994

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations ad contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table November--December 1994

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1995-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1992

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1993-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly wit information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, July--August 1992

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-10-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table July/August 1993

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, August 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M., Hawkins, G.T.; Salk, M.S.

1991-09-01

This Environmental Regulatory Update Table (August 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-12-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, March/April 1993

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July/August 1994

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1994-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1993

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1994-01-01

The Environmental Regulatory Update Table provides information on regulatory of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, March/April 1993. Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, May/June 1993

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1993-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, May--June 1994

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1994-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Recommendations for Cycle II of National Water-Quality Assessment (NAWQA) Program

USGS Publications Warehouse

,; Mallard, Gail E.; Armbruster, Jeffrey T.; Broshears, Robert E.; Evenson, Eric J.; Luoma, Samuel N.; Phillips, Patrick J.; Prince, Keith R.

1999-01-01

The Planning Team for the U.S. Geological Survey (USGS) National Water-Quality Assessment (NAWQA) Program defines a successful NAWQA Program as one that makes a balanced contribution to study-unit issues, national issues, and to the pursuit of scientific knowledge. Using this criterion, NAWQA has been a success. The program has provided important new knowledge and understanding of scientific processes, and insights into the occurrence and distribution of contaminants that have been key to local and national policy decisions. Most of the basic design characteristics of NAWQA's first decade (1991-2000), hereafter called cycle I) remain appropriate as the program enters its second decade (cycle II) in 2001. In cycle II, the program has the opportunity to build on its successful base and to evolve to take advantage of the knowledge generated in cycle I. In addition to this expected evolution, NAWQA must also make some changes to compensate for the fact that program funding has not kept pace with inflation. An important theme for the second cycle of NAWQA will be the integration of knowledge across scales and across disciplines. The question that drove the NAWQA design in the first cycle was "How is water quality related to land use?" Cycle II will build upon what was learned in cycle I and use land-use and water-quality gradients to identify and understand potential sources of various constituents and the processes affecting transport and fate of those constituents and their effects on receptors. The understanding we gain from applying this approach will be relevant to the interests of policymakers, regulatory agencies, and resource managers.

PROCESS WATER BUILDING, TRA605. CONTEXTUAL VIEW, CAMERA FACING SOUTHEAST. PROCESS ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

PROCESS WATER BUILDING, TRA-605. CONTEXTUAL VIEW, CAMERA FACING SOUTHEAST. PROCESS WATER BUILDING AND ETR STACK ARE IN LEFT HALF OF VIEW. TRA-666 IS NEAR CENTER, ABUTTED BY SECURITY BUILDING; TRA-626, AT RIGHT EDGE OF VIEW BEHIND BUS. INL NEGATIVE NO. HD46-34-1. Mike Crane, Photographer, 4/2005 - Idaho National Engineering Laboratory, Test Reactor Area, Materials & Engineering Test Reactors, Scoville, Butte County, ID

The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

PubMed

Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

2018-01-01

The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

PubMed

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Arousal regulation and affective adaptation to human responsiveness by a robot that explores and learns a novel environment.

PubMed

Hiolle, Antoine; Lewis, Matthew; Cañamero, Lola

2014-01-01

In the context of our work in developmental robotics regarding robot-human caregiver interactions, in this paper we investigate how a "baby" robot that explores and learns novel environments can adapt its affective regulatory behavior of soliciting help from a "caregiver" to the preferences shown by the caregiver in terms of varying responsiveness. We build on two strands of previous work that assessed independently (a) the differences between two "idealized" robot profiles-a "needy" and an "independent" robot-in terms of their use of a caregiver as a means to regulate the "stress" (arousal) produced by the exploration and learning of a novel environment, and (b) the effects on the robot behaviors of two caregiving profiles varying in their responsiveness-"responsive" and "non-responsive"-to the regulatory requests of the robot. Going beyond previous work, in this paper we (a) assess the effects that the varying regulatory behavior of the two robot profiles has on the exploratory and learning patterns of the robots; (b) bring together the two strands previously investigated in isolation and take a step further by endowing the robot with the capability to adapt its regulatory behavior along the "needy" and "independent" axis as a function of the varying responsiveness of the caregiver; and (c) analyze the effects that the varying regulatory behavior has on the exploratory and learning patterns of the adaptive robot.

76 FR 11830 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-03

... Effectiveness of Proposed Rule Change to Eliminate Duplicative Filings Under FINRA Rule 9610(a) February 25... the proposed change will make the process of seeking exemptive relief more efficient by eliminating... the efficiency of the exemptive relief process by eliminating duplicative filings and providing...

10 CFR 51.26 - Requirement to publish notice of intent and conduct scoping process.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Requirement to publish notice of intent and conduct scoping process. 51.26 Section 51.26 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy...

75 FR 9626 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-03

... maintain variables and systems that can affect the fission process, the integrity of the reactor core, the... on some other defined basis. GDC 24 requires that interconnection of the protection and control..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc...

FLOOR PLAN OF MAIN PROCESSING BUILDING (CPP601) BASEMENT SHOWING PROCESS ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

FLOOR PLAN OF MAIN PROCESSING BUILDING (CPP-601) BASEMENT SHOWING PROCESS CORRIDOR AND EIGHTEEN CELLS. TO LEFT IS LABORATORY BUILDING (CPP-602). INL DRAWING NUMBER 200-0601-00-706-051981. ALTERNATE ID NUMBER CPP-E-1981. - Idaho National Engineering Laboratory, Idaho Chemical Processing Plant, Fuel Reprocessing Complex, Scoville, Butte County, ID

Key Elements for Judging the Quality of a Risk Assessment

PubMed Central

Fenner-Crisp, Penelope A.; Dellarco, Vicki L.

2016-01-01

Background: Many reports have been published that contain recommendations for improving the quality, transparency, and usefulness of decision making for risk assessments prepared by agencies of the U.S. federal government. A substantial measure of consensus has emerged regarding the characteristics that high-quality assessments should possess. Objective: The goal was to summarize the key characteristics of a high-quality assessment as identified in the consensus-building process and to integrate them into a guide for use by decision makers, risk assessors, peer reviewers and other interested stakeholders to determine if an assessment meets the criteria for high quality. Discussion: Most of the features cited in the guide are applicable to any type of assessment, whether it encompasses one, two, or all four phases of the risk-assessment paradigm; whether it is qualitative or quantitative; and whether it is screening level or highly sophisticated and complex. Other features are tailored to specific elements of an assessment. Just as agencies at all levels of government are responsible for determining the effectiveness of their programs, so too should they determine the effectiveness of their assessments used in support of their regulatory decisions. Furthermore, if a nongovernmental entity wishes to have its assessments considered in the governmental regulatory decision-making process, then these assessments should be judged in the same rigorous manner and be held to similar standards. Conclusions: The key characteristics of a high-quality assessment can be summarized and integrated into a guide for judging whether an assessment possesses the desired features of high quality, transparency, and usefulness. Citation: Fenner-Crisp PA, Dellarco VL. 2016. Key elements for judging the quality of a risk assessment. Environ Health Perspect 124:1127–1135; http://dx.doi.org/10.1289/ehp.1510483 PMID:26862984

Iterative performance assessments as a regulatory tool for evaluating repository safety: How experiences from SKI Project-90 were used in formulating the new performance assessment project SITE-94

DOE Office of Scientific and Technical Information (OSTI.GOV)

Andersson, J.

1993-12-31

The Swedish Nuclear Power Inspectorate, SKI, regulatory research program has to prepare for the process of licensing a repository for spent nuclear fuel, by building up the necessary knowledge and review capacity. SKIs main strategy for meeting this demand is to develop an independent performance assessment capability. SKIs first own performance assessment project, Project-90, was completed in 1991 and is now followed by a new project, SITE-94. SITE-94 is based on conclusions reached within Project-90. An independent review of Project-90, carried out by a NEA team of experts, has also contributed to the formation of the project. Another important reasonmore » for the project is that the implementing organization in Sweden, SKB, has proposed to submit an application to start detailed investigation of a repository candidate site around 1997. SITE-94 is a performance assessment of a hypothetical repository at a real site. The main objective of the project is to determine how site specific data should be assimilated into the performance assessment process, and to evaluate how uncertainties inherent in site characterization will influence performance assessment results. This will be addressed by exploring multiple interpretations, conceptual models, and parameters consistent with the site data. The site evaluation will strive for consistency between geological, hydrological, rock mechanical, and geochemical descriptions. Other important elements of SITE-94 are the development of a practical and defensible methodology for defining, constructing and analyzing scenarios, the development of approaches for treatment of uncertainties, evaluation of canister integrity, and the development and application of an appropriate quality assurance plan for performance assessments.« less

The progress and challenges in metabolic research in China.

PubMed

Xu, Li; Ren, Hao; Gao, Guangang; Zhou, Linkang; Malik, Muhammad Arshad; Li, Peng

2016-11-01

Metabolism refers to a chain of chemical reactions converting food/fuel into energy to conduct cellular processes, including the synthesis of the building blocks of the body, such as proteins, lipids, nucleic acids, and carbohydrates, and the elimination of nitrogenous wastes. Metabolic chain reactions are catalyzed by various enzymes that are orchestrated in specific pathways. Metabolic pathways are important for organisms to grow and reproduce, maintain their structures, and respond to their environments. The coordinated regulation of metabolic pathways is important for maintaining metabolic homeostasis. The key steps and crucial enzymes in these pathways have been well investigated. However, the crucial regulatory factors and feedback (or feedforward) mechanisms of nutrients and intermediate metabolites of these biochemical processes remain to be fully elucidated. In addition, the roles of these enzymes and regulatory factors in controlling metabolism under physiological and pathological conditions are largely unknown. In particular, metabolic dysregulation is closely linked to the development of many diseases, including obesity, fatty liver, diabetes, cancer, cardiovascular, cerebrovascular, and neurodegenerative diseases. Therefore, metabolism, an old area of biochemistry, has attracted much attention in the last decade. With substantially increased government funding, the involvement of talented researchers, an improved infrastructure and scientific environment over the last ten years, the basic research in the field of metabolism in China has dramatically advanced. Here, we have summarized the major discoveries of scientists in China in the last decade in the area of metabolism. Due to the vast amount of information, we focused this review on specific aspects of metabolism, particularly metabolic regulation and lipid metabolism in vertebrates. © 2016 IUBMB Life, 68(11):847-853, 2016. © 2016 International Union of Biochemistry and Molecular Biology.

Toxicological aspects of fire.

PubMed

Stefanidou, M; Athanaselis, S

2004-08-01

Most fatalities from fires are not due to burns, but are a result of inhalation of toxic gases produced during combustion. Fire produces a complex toxic environment, involving flame, heat, oxygen depletion, smoke and toxic gases. As a wide variety of synthetic materials is used in buildings (insulation, furniture, carpeting, electric wiring covering, decorative items), the potential for poisoning from inhalation of products of combustion is continuously increasing. In the present review, the problems that are present in a fire event, the toxicology of the toxic substances and the specific chemical hazards to firefighters are described. Regulatory toxicology aspects are presented concerning the use of non-flammable building and furnishing materials to prevent fires and decrease of poisonings and deaths resulting from fires.

Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

PubMed

Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

2016-05-01

Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

76 FR 72220 - Incorporation of Risk Management Concepts in Regulatory Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-22

... and support the adoption of improved designs or processes. \\1\\ A deterministic approach to regulation... longstanding goal to move toward more risk-informed, performance- based approaches in its regulatory programs... regulatory approach that would continue to ensure the safe and secure use of nuclear material. As part of...

21 CFR 601.14 - Regulatory submissions in electronic format.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Regulatory submissions in electronic format. 601... SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.14 Regulatory submissions in electronic format. (a) General. Electronic format submissions must be in a form that FDA can process, review, and...

21 CFR 601.14 - Regulatory submissions in electronic format.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Regulatory submissions in electronic format. 601... SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.14 Regulatory submissions in electronic format. (a) General. Electronic format submissions must be in a form that FDA can process, review, and...

21 CFR 601.14 - Regulatory submissions in electronic format.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Regulatory submissions in electronic format. 601... SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.14 Regulatory submissions in electronic format. (a) General. Electronic format submissions must be in a form that FDA can process, review, and...

78 FR 32686 - Final Supplemental Environmental Impact Statement on the Issuance of Annual Regulations...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-31

... process. (2) Frequency of review and adoption of duck regulatory packages. Duck regulatory packages are the set of framework regulations that apply to the general duck hunting seasons. Packages include..., we present two alternatives regarding how frequently duck regulatory packages should be reviewed and...

Regulatory Fit Improves Fitness for People With Low Exercise Experience.

PubMed

Kay, Sophie A; Grimm, Lisa R

2017-04-01

Considering only 20.8% of American adults meet current physical activity recommendations, it is important to examine the psychological processes that affect exercise motivation and behavior. Drawing from regulatory fit theory, this study examined how manipulating regulatory focus and reward structures would affect exercise performance, with a specific interest in investigating whether exercise experience would moderate regulatory fit effects. We predicted that regulatory fit effects would appear only for participants with low exercise experience. One hundred and sixty-five young adults completed strength training exercise tasks (i.e., sit-ups, squats, plank, and wall-sit) in regulatory match or mismatch conditions. Consistent with predictions, only participants low in experience in regulatory match conditions exercised more compared with those in regulatory mismatch conditions. Although this is the first study manipulating regulatory fit in a controlled setting to examine exercise behavior, findings suggest that generating regulatory fit could positively influence those low in exercise experience.

Dynamic integration of splicing within gene regulatory pathways

PubMed Central

Braunschweig, Ulrich; Gueroussov, Serge; Plocik, Alex; Graveley, Brenton R.; Blencowe, Benjamin J.

2013-01-01

Precursor mRNA splicing is one of the most highly regulated processes in metazoan species. In addition to generating vast repertoires of RNAs and proteins, splicing has a profound impact on other gene regulatory layers, including mRNA transcription, turnover, transport and translation. Conversely, factors regulating chromatin and transcription complexes impact the splicing process. This extensive cross-talk between gene regulatory layers takes advantage of dynamic spatial, physical and temporal organizational properties of the cell nucleus, and further emphasizes the importance of developing a multidimensional understanding of splicing control. PMID:23498935

Reconstructing the Prostate Cancer Transcriptional Regulatory Network

DTIC Science & Technology

2010-07-01

the Medical Scientist Training Program. The funders had no role in study design , data collection and analysis , decision to publish, or preparation of...reverse analysis , building a cell line subtype classifier to classify 86 breast tumors (from the original Stanford/Norway study defining the five tumor...Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public

Building a Better Canine Warrior

DTIC Science & Technology

2017-10-12

without adversely affecting pe r formance and to develop technical methodology that would dissipate metabolic heat without the expense o f body water...technical methodology that would dissipate metabolic heat without the expense of body water. Neither an increase in dietary salt nor decrease in...from a methodological aspect as well as emerging regulatory issues related to research in working dogs. Data suggested that the effect of high

A site-specific approach for assessing the fire risk to structures at the wildland/urban interface

Treesearch

Jack Cohen

1991-01-01

The essence of the wildland/urban interface fire problem is the loss of homes. The problem is not new, but is becoming increasingly important as more homes with inadequate adherence to safety codes are built at the wildland/urban interface. Current regulatory codes are inflexible. Specifications for building and site characteristics cannot be adjusted to accommodate...

Electricity pricing policy: A neo-institutional, developmental and cross-national policy design map

NASA Astrophysics Data System (ADS)

Koundinya, Sridarshan Umesh

This dissertation explores the role of ideas and ideology in the mental policy design maps of regulators in the US and in India. The research approach is to describe the regulatory design process in the history of the US electric industry from a neo-institutional and developmental perspective. And then to use the insights of such a study to suggest policy options to a sample of Indian experts. A regulatory process model explores the interactions among normative values, regulatory instruments and historical phases in policy design. A spectrum of seven regulatory instruments--subsidized rates, average cost pricing, marginal cost pricing, time-of-use pricing, ramsey pricing, incentive regulation and spot pricing is examined. A neo-institutional perspective characterizes the process of institutionalizing these regulatory instruments as a design process that infuses them with values beyond mere technical requirements. The process model includes normative values such as efficiency, fairness, free choice and political feasibility. These values arise from an analytical classification of various market metaphors debated in the history of economic thought. The theory of development and co-evolution applied to the history of electricity regulation yields a typology of evolutionary phases in the US. The typology describes hierarchically emergent relationships between supply and demand and among the normative values. The theory hypothesizes technologically contingent relationships between pricing policies and normative values in the historical phases of dependence (or rural), independence (or urban) and interdependence (or informational). The contents of this model are represented as related elements in a policy design map that simplifies the process of designing regulatory instruments in the US. This neo-institutional, developmental policy design map was used to design a survey instrument. The survey was conducted among electricity experts in India to test the hypothesized inter-relationships among various elements at different levels of the policy design map in a cross-national context. The study adds value with a comprehensive design map that helps to organize and give coherence to the policy prescriptions made by Indian experts as they converge on one institutional model. Thus the dissertation contributes to the transfer of knowledge about regulatory practice from the US to India.

Integrating Green Building Criteria Into Housing Design Processes Case Study: Tropical Apartment At Kebon Melati, Jakarta

NASA Astrophysics Data System (ADS)

Farid, V. L.; Wonorahardjo, S.

2018-05-01

The implementation of Green Building criteria is relatively new in architectural practice, especially in Indonesia. Consequently, the integration of these criteria into design process has the potential to change the design process itself. The implementation of the green building criteria into the conventional design process will be discussed in this paper. The concept of this project is to design a residential unit with a natural air-conditioning system. To achieve this purpose, the Green Building criteria has been implemented since the beginning of the design process until the detailing process on the end of the project. Several studies was performed throughout the design process, such as: (1) Conceptual review, where several professionally proved theories related to Tropical Architecture and passive design are used for a reference, and (2) Computer simulations, such as Computational Fluid Dynamics (CFD) and wind tunnel simulation, used to represent the dynamic response of the surrounding environment towards the building. Hopefully this paper may become a reference for designing a green residential building.

Structures of the Porphyromonas gingivalis OxyR regulatory domain explain differences in expression of the OxyR regulon in Escherichia coli and P. gingivalis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Svintradze, David V.; Virginia Commonwealth University, Richmond, VA 23219-1540; Peterson, Darrell L.

Differences in OxyR regulated expression of oxidative stress genes between Escherichia coli and Porphyromonas gingivalis are explained by very minor differences in structure and amino-acid sequence of the respective oxidized and reduced OxyR regulatory domains. These differences affect OxyR quaternary structures and are predicted from model building of full length OxyR–DNA complexes to confer distinct modes of DNA binding on this transcriptional regulator. OxyR transcriptionally regulates Escherichia coli oxidative stress response genes through a reversibly reducible cysteine disulfide biosensor of cellular redox status. Structural changes induced by redox changes in these cysteines are conformationally transmitted to the dimer subunit interfaces,more » which alters dimer and tetramer interactions with DNA. In contrast to E. coli OxyR regulatory-domain structures, crystal structures of Porphyromonas gingivalis OxyR regulatory domains show minimal differences in dimer configuration on changes in cysteine disulfide redox status. This locked configuration of the P. gingivalis OxyR regulatory-domain dimer closely resembles the oxidized (activating) form of the E. coli OxyR regulatory-domain dimer. It correlates with the observed constitutive activation of some oxidative stress genes in P. gingivalis and is attributable to a single amino-acid insertion in P. gingivalis OxyR relative to E. coli OxyR. Modelling of full-length P. gingivalis, E. coli and Neisseria meningitidis OxyR–DNA complexes predicts different modes of DNA binding for the reduced and oxidized forms of each.« less

FLOOR PLAN OF MAIN PROCESSING BUILDING (CPP601), SECOND FLOOR SHOWING ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

FLOOR PLAN OF MAIN PROCESSING BUILDING (CPP-601), SECOND FLOOR SHOWING PROCESS MAKEUP AREA AND EIGHTEEN CELLS AND ADJOINING REMOTE ANALYTICAL FACILITY (CPP-627) SHOWING COLD LAB, DECONTAMINATION ROOM, MULTICURIE CELL ROOM, AND OFFICES. TO LEFT ARE LABORATORY BUILDING (CPP-602) AND MAINTENANCE BUILDING (CPP-630). INL DRAWING NUMBER 200-0601-00-706-051980. ALTERNATE ID NUMBER CPP-E-1980. - Idaho National Engineering Laboratory, Idaho Chemical Processing Plant, Fuel Reprocessing Complex, Scoville, Butte County, ID

Examining Shifts in Medical Students' Microanalytic Motivation Beliefs and Regulatory Processes during a Diagnostic Reasoning Task

ERIC Educational Resources Information Center

Cleary, Timothy J.; Dong, Ting; Artino, Anthony R., Jr.

2015-01-01

This study examined within-group shifts in the motivation beliefs and regulatory processes of second-year medical students as they engaged in a diagnostic reasoning activity. Using a contextualized assessment methodology called self-regulated learning microanalysis, the authors found that the 71 medical student participants showed statistically…

Laboratory Exercise: Study of Digestive and Regulatory Processes through the Exploration of Fasted and Postprandial Blood Glucose

ERIC Educational Resources Information Center

Hopper, Mari K.; Maurer, Luke W.

2013-01-01

Digestive physiology laboratory exercises often explore the regulation of enzyme action rather than systems physiology. This laboratory exercise provides a systems approach to digestive and regulatory processes through the exploration of postprandial blood glucose levels. In the present exercise, students enrolled in an undergraduate animal…

77 FR 18282 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-27

... the fingerprint processing fees that are collected and retained by the Financial Industry Regulatory... change is reasonable because the fees for fingerprint processing will now be lower than it previously was. The proposed change is equitable and not unfairly discriminatory because the new, lower fingerprint...

Source sampling of particulate matter emissions from cotton harvesting - System field testing and emission factor development

USDA-ARS?s Scientific Manuscript database

Emission factors are used in the air pollution regulatory process to quantify the mass of pollutants emitted from a source. Accurate emission factors must be used in the air pollution regulatory process to ensure fair and appropriate regulation for all sources. Agricultural sources, including cotton...

75 FR 63725 - Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... NUCLEAR REGULATORY COMMISSION 10 CFR Part 70 [Docket No. PRM-70-8; NRC-2009-0184] Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process AGENCY: Nuclear Regulatory Commission. ACTION... Commission (NRC) will consider five of the issues raised in a petition submitted by the Nuclear Energy...

75 FR 61502 - Cooperative Agreement With the Pan American Health Organization for the Development of an...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... Medical Products and Related Regulatory Processes and Systems in the Americas Region AGENCY: Food and Drug... Health Organization (PAHO) for the development of an information hub in the areas of medical products and related regulatory processes and systems (e.g., including drugs, biologics, vaccines, medical devices, and...

[ASSESSMENT OF EXTREME FACTORS OF SHIFT WORK IN ARCTIC CONDITIONS BY WORKERS WITH DIFFERENT REGULATORY PROCESSES].

PubMed

Korneeva, Ya A; Simonova, N N

2016-01-01

A man working on a shift basis in the Arctic, every day is under the influence of various extreme factors which are inevitable for oil and gas indudtry. To adapt to shift work employees use various resources of the individual. The purpose of research is the determination of personal resources of shift workers to overcome the adverse factors of the environment in the Arctic. The study involved 191 builder of main gas pipelines, working in shifts in the Tyumen region (the length of the shift 52 days of arrival) at the age of 23 to 59 (mean age 34.9 ± 8.1) years. Methods: psychological testing, questioning, observation, descriptive statistics, discriminant step by step analysis. There was revealed the correlation between the subjective assessment of the majority of adverse climatic factors in the regulatory process "assessment of results"; production factors--regulatory processes such as flexibility, autonomy, simulation, and the general level of self-regulation; social factors are more associated with the severity of such regulatory processes, flexibility and evaluation of results.

Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.

PubMed

Smith, Jeffrey K

2013-04-01

Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database.

Licensing of future mobile satellite systems

NASA Technical Reports Server (NTRS)

Lepkowski, Ronald J.

1990-01-01

The regulatory process for licensing mobile satellite systems is complex and can require many years to complete. This process involves frequency allocations, national licensing, and frequency coordination. The regulatory process that resulted in the establishment of the radiodetermination satellite service (RDSS) between 1983 and 1987 is described. In contrast, each of these steps in the licensing of the mobile satellite service (MSS) is taking a significantly longer period of time to complete.

Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences.

PubMed

Tsoi, Bernice; Masucci, Lisa; Campbell, Kaitryn; Drummond, Michael; O'Reilly, Daria; Goeree, Ron

2013-08-01

A considerable degree of overlap exists between reimbursement and regulatory approval of health technologies, and harmonization of certain aspects is both possible and feasible. Various models to harmonization have been suggested in which a number of practical attempts have been drawn from. Based on a review of the literature, approaches can be categorized into those focused on reducing uncertainty and developing economies of scale in the evidentiary requirements; and/or aligning timeframes and logistical aspects of the review process. These strategies can further be classified based on the expected level of structural and organizational change required to implement them into the existing processes. Passive processes require less modification, whereas active processes are associated with greater restructuring. Attempts so far at harmonization have raised numerous legal and practical issues and these must be considered when introducing a more harmonized framework into the existing regulatory and reimbursement arrangements.

Discrepancy between mRNA and protein abundance: Insight from information retrieval process in computers

PubMed Central

Wang, Degeng

2008-01-01

Discrepancy between the abundance of cognate protein and RNA molecules is frequently observed. A theoretical understanding of this discrepancy remains elusive, and it is frequently described as surprises and/or technical difficulties in the literature. Protein and RNA represent different steps of the multi-stepped cellular genetic information flow process, in which they are dynamically produced and degraded. This paper explores a comparison with a similar process in computers - multi-step information flow from storage level to the execution level. Functional similarities can be found in almost every facet of the retrieval process. Firstly, common architecture is shared, as the ribonome (RNA space) and the proteome (protein space) are functionally similar to the computer primary memory and the computer cache memory respectively. Secondly, the retrieval process functions, in both systems, to support the operation of dynamic networks – biochemical regulatory networks in cells and, in computers, the virtual networks (of CPU instructions) that the CPU travels through while executing computer programs. Moreover, many regulatory techniques are implemented in computers at each step of the information retrieval process, with a goal of optimizing system performance. Cellular counterparts can be easily identified for these regulatory techniques. In other words, this comparative study attempted to utilize theoretical insight from computer system design principles as catalysis to sketch an integrative view of the gene expression process, that is, how it functions to ensure efficient operation of the overall cellular regulatory network. In context of this bird’s-eye view, discrepancy between protein and RNA abundance became a logical observation one would expect. It was suggested that this discrepancy, when interpreted in the context of system operation, serves as a potential source of information to decipher regulatory logics underneath biochemical network operation. PMID:18757239

Discrepancy between mRNA and protein abundance: insight from information retrieval process in computers.

PubMed

Wang, Degeng

2008-12-01

Discrepancy between the abundance of cognate protein and RNA molecules is frequently observed. A theoretical understanding of this discrepancy remains elusive, and it is frequently described as surprises and/or technical difficulties in the literature. Protein and RNA represent different steps of the multi-stepped cellular genetic information flow process, in which they are dynamically produced and degraded. This paper explores a comparison with a similar process in computers-multi-step information flow from storage level to the execution level. Functional similarities can be found in almost every facet of the retrieval process. Firstly, common architecture is shared, as the ribonome (RNA space) and the proteome (protein space) are functionally similar to the computer primary memory and the computer cache memory, respectively. Secondly, the retrieval process functions, in both systems, to support the operation of dynamic networks-biochemical regulatory networks in cells and, in computers, the virtual networks (of CPU instructions) that the CPU travels through while executing computer programs. Moreover, many regulatory techniques are implemented in computers at each step of the information retrieval process, with a goal of optimizing system performance. Cellular counterparts can be easily identified for these regulatory techniques. In other words, this comparative study attempted to utilize theoretical insight from computer system design principles as catalysis to sketch an integrative view of the gene expression process, that is, how it functions to ensure efficient operation of the overall cellular regulatory network. In context of this bird's-eye view, discrepancy between protein and RNA abundance became a logical observation one would expect. It was suggested that this discrepancy, when interpreted in the context of system operation, serves as a potential source of information to decipher regulatory logics underneath biochemical network operation.

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

PubMed

McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

2012-07-01

There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

REGULATORY STRATEGIES TO MINIMIZE GENERATION OF REGULATED WASTES FROM CLEANUP, CONTINUED USE OR DECOMMISSIONING OF NUCLEAR FACILITIES CONTAMINATED WITH POLYCHLORINATED BIPHENYLS (PCBS) - 11198

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lowry, N.

Disposal costs for liquid PCB radioactive waste are among the highest of any category of regulated waste. The high cost is driven by the fact that disposal options are extremely limited. Toxic Substances Control Act (TSCA) regulations require most liquids with PCBs at concentration of {ge} 50 parts-per-million to be disposed by incineration or equivalent destructive treatment. Disposal fees can be as high as $200 per gallon. This figure does not include packaging and the cost to transport the waste to the disposal facility, or the waste generator's labor costs for managing the waste prior to shipment. Minimizing the generationmore » of liquid radioactive PCB waste is therefore a significant waste management challenge. PCB spill cleanups often generate large volumes of waste. That is because the removal of PCBs typically requires the liberal use of industrial solvents followed by a thorough rinsing process. In a nuclear facility, the cleanup process may be complicated by the presence of radiation and other occupational hazards. Building design and construction features, e.g., the presence of open grating or trenches, may also complicate cleanup. In addition to the technical challenges associated with spill cleanup, selection of the appropriate regulatory requirements and approach may be challenging. The TSCA regulations include three different sections relating to the cleanup of PCB contamination or spills. EPA has also promulgated a separate guidance policy for fresh PCB spills that is published as Subpart G of 40 CFR 761 although it is not an actual regulation. Applicability is based on the circumstances of each contamination event or situation. Other laws or regulations may also apply. Identification of the allowable regulatory options is important. Effective communication with stakeholders, particularly regulators, is just as important. Depending on the regulatory path that is taken, cleanup may necessitate the generation of large quantities of regulated waste. Allowable options must be evaluated carefully in order to reduce compliance risks, protect personnel, limit potential negative impacts on facility operations, and minimize the generation of wastes subject to TSCA. This paper will identify critical factors in selecting the appropriate TSCA regulatory path in order to minimize the generation of radioactive PCB waste and reduce negative impacts to facilities. The importance of communicating pertinent technical issues with facility staff, regulatory personnel, and subsequently, the public, will be discussed. Key points will be illustrated by examples from five former production reactors at the DOE Savannah River Site. In these reactors a polyurethane sealant was used to seal piping penetrations in the biological shield walls. During the intense neutron bombardment that occurred during reactor operation, the sealant broke down into a thick, viscous material that seeped out of the piping penetrations over adjacent equipment and walls. Some of the walls were painted with a PCB product. PCBs from the paint migrated into the degraded sealant, creating PCB 'spill areas' in some of these facilities. The regulatory cleanup approach selected for each facility was based on its operational status, e.g., active, inactive or undergoing decommissioning. The selected strategies served to greatly minimize the generation of radioactive liquid PCB waste. It is expected that this information would be useful to other DOE sites, DOD facilities, and commercial nuclear facilities constructed prior to the 1979 TSCA ban on most manufacturing and uses of PCBs.« less

Decreasing institutionally imposed regulatory burden for animal research.

PubMed

Pritt, Stacy; McNulty, Justin A; Greene, Molly; Light, Sally; Brown, Marcy

2016-07-20

With the ever-increasing call to reduce self-imposed regulatory and administrative burden in the animal research oversight process, knowledge of the regulations and a desire to streamline policies and procedures are needed to affect a change in culture. In this opinion piece, we provide details on why institutionally imposed regulatory burden can arise.

75 FR 39577 - Draft Supplemental Environmental Impact Statement on the Issuance of Annual Regulations...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

... timing of the general regulatory process. (2) Frequency of review and adoption of duck regulatory packages. Duck regulatory packages are the set of framework regulations that apply to the general duck... limits), and closed. In the draft SEIS, we present two alternatives regarding how frequently duck...

Enhancing Self-Regulatory Skills through an Intervention Embedded in a Middle School Mathematics Curriculum

ERIC Educational Resources Information Center

Digiacomo, Gregory; Chen, Peggy P.

2016-01-01

We investigated the effects of a self-regulatory intervention strategy designed to improve middle-school students' calibration accuracy, self-regulatory skills, and math achievement. Focusing on self-monitoring and self-reflection as the two key processes of this intervention in relation to improving students' math achievement and overall…

Building Information Modeling (BIM) Primer. Report 1: Facility Life-Cycle Process and Technology Innovation

DTIC Science & Technology

2012-08-01

Building Information Modeling ( BIM ) Primer Report 1: Facility Life-cycle Process and Technology Innovation In fo...is unlimited. ERDC/ITL TR-12-2 August 2012 Building Information Modeling ( BIM ) Primer Report 1: Facility Life-cycle Process and Technology...and to enhance the quality of projects through the design, construction, and handover phases. Building Information Modeling ( BIM ) is a

COLLABORATIVE NEGOTIATIONS A SUCCESSFUL APPROACH FOR NEGOTIATING COMPLIANCE MILESTONES FOR THE TRANSITION OF THE PLUTONIUM FINISHING PLANT (PFP), HANFORD NUCLEAR RESERVATION, AND HANFORD, WASHINGTON

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hebdon, J.; Yerxa, J.; Romine, L.

The Hanford Nuclear Reservation is a former U. S. Department of Energy Defense Production Site. The site is currently listed on the National Priorities List of the Comprehensive Environmental Response Compensation and Liability Act of 1980 (CERCLA) and is undergoing cleanup and environmental restoration. The PFP is a former Plutonium metal production facility. The operating mission of the PFP ended with a DOE Headquarters shutdown letter in October of 1996. Generally, the receipt of a shutdown letter initiates the start of Transition (as the first step of Decommissioning) of a facility. The Hanford site is subject to the Hanford Federalmore » Facilities Compliance Act and Consent Order (HFFCCO), an order on consent signed by the DOE, the U. S. Environmental Protection Agency, (EPA) and the Washington Department of Ecology (WDOE). Under the HFFCCO, negotiations for transition milestones begin within six months after the issuance of a shutdown order. In the case of the PFP, the Nuclear Materials disposition and stabilization activities, a DOE responsibility, were necessary as precursor activities to Transition. This situation precipitated a crisis in the negotiations between the agencies, and formal negotiations initiated in 1997 ended in failure. The negotiations reached impasse on several key regulatory and operational issues. The 1997 negotiation was characterized by a strongly positional style. DOE and the regulatory personnel took hard lines early in the negotiations and were unable to move to resolution of key issues after a year and a half. This resulted in unhappy stakeholders, poor publicity and work delays as well as wounded relationships between DOE and the regulatory community. In the 2000-2001 PFP negotiations, a completely different approach was suggested and eventually initiated: Collaborative Negotiations. The collaborative negotiation style resulted in agreement between the agencies on all key issues within 6 months of initiation. All parties were very pleased with the results and all parties were relieved that protracted negotiations sessions were not needed with the new style of working together collaboratively to serve each other's interests. The characteristics of collaborative negotiations included building trust, emphasizing equality of team members, problem solving by the entire team, relying on individual communications and self-management skills. The team found that trust building sessions were key to successfully working through issues. Relationship differences were too often ignored in the past negotiations and were recognized and worked through in the collaborative process.« less

Regulatory factors governing adenosine-to-inosine (A-to-I) RNA editing.

PubMed

Hong, HuiQi; Lin, Jaymie Siqi; Chen, Leilei

2015-03-31

Adenosine-to-inosine (A-to-I) RNA editing, the most prevalent mode of transcript modification in higher eukaryotes, is catalysed by the adenosine deaminases acting on RNA (ADARs). A-to-I editing imposes an additional layer of gene regulation as it dictates various aspects of RNA metabolism, including RNA folding, processing, localization and degradation. Furthermore, editing events in exonic regions contribute to proteome diversity as translational machinery decodes inosine as guanosine. Although it has been demonstrated that dysregulated A-to-I editing contributes to various diseases, the precise regulatory mechanisms governing this critical cellular process have yet to be fully elucidated. However, integration of previous studies revealed that regulation of A-to-I editing is multifaceted, weaving an intricate network of auto- and transregulations, including the involvement of virus-originated factors like adenovirus-associated RNA. Taken together, it is apparent that tipping of any regulatory components will have profound effects on A-to-I editing, which in turn contributes to both normal and aberrant physiological conditions. A complete understanding of this intricate regulatory network may ultimately be translated into new therapeutic strategies against diseases driven by perturbed RNA editing events. Herein, we review the current state of knowledge on the regulatory mechanisms governing A-to-I editing and propose the role of other co-factors that may be involved in this complex regulatory process.

Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: expert opinions on the state of affairs and the way forward.

PubMed

Schiffelers, Marie-Jeanne W A; Blaauboer, Bas J; Bakker, Wieger E; Beken, Sonja; Hendriksen, Coenraad F M; Koëter, Herman B W M; Krul, Cyrille

2014-06-01

Pharmaceuticals and chemicals are subjected to regulatory safety testing accounting for approximately 25% of laboratory animal use in Europe. This testing meets various objections and has led to the development of a range of 3R models to Replace, Reduce or Refine the animal models. However, these models must overcome many barriers before being accepted for regulatory risk management purposes. This paper describes the barriers and drivers and options to optimize this acceptance process as identified by two expert panels, one on pharmaceuticals and one on chemicals. To untangle the complex acceptance process, the multilevel perspective on technology transitions is applied. This perspective defines influences at the micro-, meso- and macro level which need alignment to induce regulatory acceptance of a 3R model. This paper displays that there are many similar mechanisms within both sectors that prevent 3R models from becoming accepted for regulatory risk assessment and management. Shared barriers include the uncertainty about the value of the new 3R models (micro level), the lack of harmonization of regulatory requirements and acceptance criteria (meso level) and the high levels of risk aversion (macro level). In optimizing the process commitment, communication, cooperation and coordination are identified as critical drivers. Copyright © 2014 Elsevier Inc. All rights reserved.

Regulatory constraints as seen from the pharmaceutical industry.

PubMed

Galligani, G; David-Andersen, I; Fossum, B

2005-01-01

In Chile, Canada, Europe, Japan, and the USA, which are the main geographical areas for fish farming of high value fish such as salmonids, sea bass, sea bream, yellowtail and catfish, vaccination has been established as an important method for the prevention of infectious diseases. To make new vaccines available to the fish farming industry, pharmaceutical companies must comply with the regulatory framework for licensing of fish vaccines, which in recent years has become more regulated. Considerable scientific and regulatory skills are thus required to develop, document and license vaccines in accordance with the requirements in the different geographical areas. International co-operation to harmonise requirements for the licensing documentation is ongoing. Even though there are obvious benefits to the pharmaceutical industry from the harmonisation process, it may sometimes impose unreasonable requirements. The regulatory framework for fish vaccines clearly has an impact on the time for bringing a new fish vaccine to the market. Several hurdles need to be passed to complete the regulatory process, i.e. obtain a licence. Fulfilment of the rather detailed and extensive requirements for documentation of the production and controls, as well as safety and efficacy of the vaccine, represent a challenge to the pharmaceutical industry, as do the different national and regional licensing procedures. This paper describes regulatory constraints related to the documentation, the licensing process, the site of production and the continuing international harmonisation work, with emphasis on inactivated conventional fish vaccines.

Passive fire building protection system evaluation (case study: millennium ict centre)

NASA Astrophysics Data System (ADS)

Rahman, Vinky; Stephanie

2018-03-01

Passive fire protection system is a system that refers to the building design, both regarding of architecture and structure. This system usually consists of structural protection that protects the structure of the building and prevents the spread of fire and facilitate the evacuation process in case of fire. Millennium ICT Center is the largest electronic shopping center in Medan, Indonesia. As a public building that accommodates the crowd, this building needs a fire protection system by the standards. Therefore, the purpose of this study is to evaluate passive fire protection system of Millennium ICT Center building. The study was conducted to describe the facts of the building as well as direct observation to the research location. The collected data is then processed using the AHP (Analytical Hierarchy Process) method in its weighting process to obtain the reliability value of passive fire protection fire system. The results showed that there are some components of passive fire protection system in the building, but some are still unqualified. The first section in your paper

A multiscale modelling methodology applicable for regulatory purposes taking into account effects of complex terrain and buildings on pollutant dispersion: a case study for an inner Alpine basin.

PubMed

Oettl, D

2015-11-01

Dispersion modelling in complex terrain always has been challenging for modellers. Although a large number of publications are dedicated to that field, candidate methods and models for usage in regulatory applications are scarce. This is all the more true when the combined effect of topography and obstacles on pollutant dispersion has to be taken into account. In Austria, largely situated in Alpine regions, such complex situations are quite frequent. This work deals with an approach, which is in principle capable of considering both buildings and topography in simulations by combining state-of-the-art wind field models at the micro- (<1 km) and mesoscale γ (2-20 km) with a Lagrangian particle model. In order to make such complex numerical models applicable for regulatory purposes, meteorological input data for the models need to be readily derived from routine observations. Here, use was made of the traditional way to bin meteorological data based on wind direction, speed, and stability class, formerly mainly used in conjunction with Gaussian-type models. It is demonstrated that this approach leads to reasonable agreements (fractional bias < 0.1) between observed and modelled annual average concentrations in an Alpine basin with frequent low-wind-speed conditions, temperature inversions, and quite complex flow patterns, while keeping the simulation times within the frame of possibility with regard to applications in licencing procedures. However, due to the simplifications in the derivation of meteorological input data as well as several ad hoc assumptions regarding the boundary conditions of the mesoscale wind field model, the methodology is not suited for computing detailed time and space variations of pollutant concentrations.

Medical revalidation as professional regulatory reform: Challenging the power of enforceable trust in the United Kingdom.

PubMed

Spendlove, Zoey

2018-05-01

For more than two decades, international healthcare crises and ensuing political debates have led to increasing professional governance and regulatory policy reform. Governance and policy reforms, commonly representing a shift from embodied trust in professionals to state enforceable trust, have challenged professional power and self-regulatory privileges. However, controversy remains as to whether such policies do actually shift the balance of power and what the resulting effects of policy introduction would be. This paper explores the roll-out and operationalisation of revalidation as medical regulatory reform within a United Kingdom National Health Service hospital from 2012 to 2013, and its impact upon professional power. Revalidation policy was subject to the existing governance and management structures of the organisation, resulting in the formal policy process being shaped at the local level. This paper explores how the disorganised nature of the organisation hindered rather than facilitated robust processes of professional governance and regulation, fostering formalistic rather than genuine professional engagement with the policy process. Formalistic engagement seemingly assisted the medical profession in retaining self-regulatory privileges whilst maintaining professional power over the policy process. The paper concludes by challenging the concept of state enforceable trust and the theorisation that professional groups are effectively regulated and controlled by means of national and organisational objectives, such as revalidation. Copyright © 2018 Elsevier Ltd. All rights reserved.

Adolescent transformations of behavioral and neural processes as potential targets for prevention.

PubMed

Eldreth, Dana; Hardin, Michael G; Pavletic, Nevia; Ernst, Monique

2013-06-01

Adolescence is a transitional period in development that is marked by a distinct, typical behavioral profile of high rates of exploration, novelty-seeking, and emotional lability. While these behaviors generally assist the adolescent transition to independence, they can also confer vulnerability for excessive risk-taking and psychopathology, particularly in the context of specific environmental or genetic influences. As prevention research depends on the identification of targets of vulnerability, the following review will discuss the interplay among motivational systems including reward-related, avoidance-related, and regulatory processes in typical and atypical adolescent development. Each set of processes will be discussed in relation to their underlying neural correlates and distinct developmental trajectories. Evidence suggests that typical adolescent behavior and the risk for atypical development are mediated by heightened adolescent responsiveness of reward-related and avoidance-related systems under specific conditions, concurrent with poor modulation by immature regulatory processes. Finally, we will propose strategies to exploit heightened reward processing to reinforce inhibitory control, which is an essential component of regulatory processes in prevention interventions.

The Temporal and Dynamic Nature of Self-Regulatory Processes during Independent and Externally Assisted Hypermedia Learning

ERIC Educational Resources Information Center

Johnson, Amy M.; Azevedo, Roger; D'Mello, Sidney K.

2011-01-01

This study examined the temporal and dynamic nature of students' self-regulatory processes while learning about the circulatory system with hypermedia. A total of 74 undergraduate students were randomly assigned to 1 of 2 conditions: independent learning or externally assisted learning. Participants in the independent learning condition used a…

Learning by Preparing to Teach: Fostering Self-Regulatory Processes and Achievement during Complex Mathematics Problem Solving

ERIC Educational Resources Information Center

Muis, Krista R.; Psaradellis, Cynthia; Chevrier, Marianne; Di Leo, Ivana; Lajoie, Susanne P.

2016-01-01

We developed an intervention based on the learning by teaching paradigm to foster self-regulatory processes and better learning outcomes during complex mathematics problem solving in a technology-rich learning environment. Seventy-eight elementary students were randomly assigned to 1 of 2 conditions: learning by preparing to teach, or learning for…

Process innovation in high-performance systems: From polymeric composites R&D to design and build of airplane showers

NASA Astrophysics Data System (ADS)

Wu, Yi-Jui

In the aerospace industry reducing aircraft weight is key because it increases flight performance and drives down operating costs. With fierce competition in the commercial aircraft industry, companies that focused primarily on exterior aircraft performance design issues are turning more attention to the design of aircraft interior. Simultaneously, there has been an increase in the number of new amenities offered to passengers especially in first class travel and executive jets. These new amenities present novel and challenging design parameters that include integration into existing aircraft systems without sacrificing flight performance. The objective of this study was to design a re-circulating shower system for an aircraft that weighs significantly less than pre-existing shower designs. This was accomplished by integrating processes from polymeric composite materials, water filtration, and project management. Carbon/epoxy laminates exposed to hygrothermal cycling conditions were evaluated and compared to model calculations. Novel materials and a variety of fabrication processes were developed to create new types of paper for honeycomb applications. Experiments were then performed on the properties and honeycomb processability of these new papers. Standard water quality tests were performed on samples taken from the re-circulating system to see if current regulatory standards were being met. These studies were executed and integrated with tools from project management to design a better shower system for commercial aircraft applications.

Soil Methane Sink Capacity Response to a Long-Term Wildfire Chronosequence in Northern Sweden.

PubMed

McNamara, Niall P; Gregg, Ruth; Oakley, Simon; Stott, Andy; Rahman, Md Tanvir; Murrell, J Colin; Wardle, David A; Bardgett, Richard D; Ostle, Nick J

2015-01-01

Boreal forests occupy nearly one fifth of the terrestrial land surface and are recognised as globally important regulators of carbon (C) cycling and greenhouse gas emissions. Carbon sequestration processes in these forests include assimilation of CO2 into biomass and subsequently into soil organic matter, and soil microbial oxidation of methane (CH4). In this study we explored how ecosystem retrogression, which drives vegetation change, regulates the important process of soil CH4 oxidation in boreal forests. We measured soil CH4 oxidation processes on a group of 30 forested islands in northern Sweden differing greatly in fire history, and collectively representing a retrogressive chronosequence, spanning 5000 years. Across these islands the build-up of soil organic matter was observed to increase with time since fire disturbance, with a significant correlation between greater humus depth and increased net soil CH4 oxidation rates. We suggest that this increase in net CH4 oxidation rates, in the absence of disturbance, results as deeper humus stores accumulate and provide niches for methanotrophs to thrive. By using this gradient we have discovered important regulatory controls on the stability of soil CH4 oxidation processes that could not have not been explored through shorter-term experiments. Our findings indicate that in the absence of human interventions such as fire suppression, and with increased wildfire frequency, the globally important boreal CH4 sink could be diminished.

Soil Methane Sink Capacity Response to a Long-Term Wildfire Chronosequence in Northern Sweden

PubMed Central

McNamara, Niall P.; Gregg, Ruth; Oakley, Simon; Stott, Andy; Rahman, Md. Tanvir; Murrell, J. Colin; Wardle, David A.; Bardgett, Richard D.; Ostle, Nick J.

2015-01-01

Boreal forests occupy nearly one fifth of the terrestrial land surface and are recognised as globally important regulators of carbon (C) cycling and greenhouse gas emissions. Carbon sequestration processes in these forests include assimilation of CO2 into biomass and subsequently into soil organic matter, and soil microbial oxidation of methane (CH4). In this study we explored how ecosystem retrogression, which drives vegetation change, regulates the important process of soil CH4 oxidation in boreal forests. We measured soil CH4 oxidation processes on a group of 30 forested islands in northern Sweden differing greatly in fire history, and collectively representing a retrogressive chronosequence, spanning 5000 years. Across these islands the build-up of soil organic matter was observed to increase with time since fire disturbance, with a significant correlation between greater humus depth and increased net soil CH4 oxidation rates. We suggest that this increase in net CH4 oxidation rates, in the absence of disturbance, results as deeper humus stores accumulate and provide niches for methanotrophs to thrive. By using this gradient we have discovered important regulatory controls on the stability of soil CH4 oxidation processes that could not have not been explored through shorter-term experiments. Our findings indicate that in the absence of human interventions such as fire suppression, and with increased wildfire frequency, the globally important boreal CH4 sink could be diminished. PMID:26372346

Analysis of Design-Build Processes, Best Practices, and Applications to the Department of Defense

DTIC Science & Technology

2006-06-01

NAVFAC design-build processes published in trade journals, books , magazines, internet articles, and DoD policy. In their book , Contract Management...literature review concentrates on recent articles published in books , trade magazines, and on the internet to determine design-build processes and...Keith Molenaar ) Design-build projects under the State of California’s Public Contract Code (Legaltips.org, 2006) requires the owner, for example the

A study of structural properties of gene network graphs for mathematical modeling of integrated mosaic gene networks.

PubMed

Petrovskaya, Olga V; Petrovskiy, Evgeny D; Lavrik, Inna N; Ivanisenko, Vladimir A

2017-04-01

Gene network modeling is one of the widely used approaches in systems biology. It allows for the study of complex genetic systems function, including so-called mosaic gene networks, which consist of functionally interacting subnetworks. We conducted a study of a mosaic gene networks modeling method based on integration of models of gene subnetworks by linear control functionals. An automatic modeling of 10,000 synthetic mosaic gene regulatory networks was carried out using computer experiments on gene knockdowns/knockouts. Structural analysis of graphs of generated mosaic gene regulatory networks has revealed that the most important factor for building accurate integrated mathematical models, among those analyzed in the study, is data on expression of genes corresponding to the vertices with high properties of centrality.

Refining metabolic models and accounting for regulatory effects.

PubMed

Kim, Joonhoon; Reed, Jennifer L

2014-10-01

Advances in genome-scale metabolic modeling allow us to investigate and engineer metabolism at a systems level. Metabolic network reconstructions have been made for many organisms and computational approaches have been developed to convert these reconstructions into predictive models. However, due to incomplete knowledge these reconstructions often have missing or extraneous components and interactions, which can be identified by reconciling model predictions with experimental data. Recent studies have provided methods to further improve metabolic model predictions by incorporating transcriptional regulatory interactions and high-throughput omics data to yield context-specific metabolic models. Here we discuss recent approaches for resolving model-data discrepancies and building context-specific metabolic models. Once developed highly accurate metabolic models can be used in a variety of biotechnology applications. Copyright © 2014 Elsevier Ltd. All rights reserved.

Petitioning process for irradiated foods and animal feeds in North America

NASA Astrophysics Data System (ADS)

Marcotte, Michelle; Kunstadt, Peter

1993-07-01

The lack of sufficient regulatory approvals continues to delay the commercial application of food irradiation in several countries. Often, the regulatory approval process itself appears too challenging and approvals are not even requested. We believe that petitions can be successful and want to encourage interested parties to submit good quality approval petitions to the regulatory authorities. The objective of this paper is to review petition requirements so that researchers and companies in other countries will be able to prepare petitions requesting approval for the import and sale of irradiated foods into North America.

Reconstructing the Prostate Cancer Transcriptional Regulatory Network

DTIC Science & Technology

2010-09-01

funders had no role in study design , data collection and analysis , decision to publish, or preparation of the manuscript. Competing Interests: The authors...basal-like or ERBB2 tumors (despite that none were ERBB2-positive). We also carried out the reverse analysis , building a cell line subtype classifier to...Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No

The role of consent in medical research: breaking or building walls? A call for legislative reform.

PubMed

Dangata, Yohanna Yanshiyi

2011-12-01

Research has been integral to the practice of medicine for almost as long as the discipline has existed. Until fairly recently research used to be conducted on human subjects without mandatory requirement for their consent. However, over time medical research became associated with significant cruelty resulting in an outcry for regulation of research actives. This resulted in significant legislation in place for monitoring. Today it is mandatory to obtain consent from subjects before embarking on medical research, and indeed treatment. Its significant regulatory role notwithstanding, the issue of consent at times becomes a hindrance to research. This paper examines the issue of consent in relation to medical research in the context of present legislation. It lays out the background to medical research with respect to purpose, scope, standard protocol and related issues; it then addresses the issue of consent in various scenarios, highlighting problems and the need for legislative reform. It is maintained that while regulatory measures have brought a lot of sanity to medical research and the medical profession, some measures are building walls inhibitory to research activities. Research being integral to the development and growth of healthcare delivery, there is need for reformation of current medical law for balance between patient protectionism and progress in medical research for effective patient care.

29. Perimeter acquisition radar building room #318, data processing system ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

29. Perimeter acquisition radar building room #318, data processing system area; data processor maintenance and operations center, showing data processing consoles - Stanley R. Mickelsen Safeguard Complex, Perimeter Acquisition Radar Building, Limited Access Area, between Limited Access Patrol Road & Service Road A, Nekoma, Cavalier County, ND

Risk-informed regulation and safety management of nuclear power plants--on the prevention of severe accidents.

PubMed

Himanen, Risto; Julin, Ari; Jänkälä, Kalle; Holmberg, Jan-Erik; Virolainen, Reino

2012-11-01

There are four operating nuclear power plant (NPP) units in Finland. The Teollisuuden Voima (TVO) power company has two 840 MWe BWR units supplied by Asea-Atom at the Olkiluoto site. The Fortum corporation (formerly IVO) has two 500 MWe VVER 440/213 units at the Loviisa site. In addition, a 1600 MWe European Pressurized Water Reactor supplied by AREVA NP (formerly the Framatome ANP--Siemens AG Consortium) is under construction at the Olkiluoto site. Recently, the Finnish Parliament ratified the government Decision in Principle that the utilities' applications to build two new NPP units are in line with the total good of the society. The Finnish utilities, Fenno power company, and TVO company are in progress of qualifying the type of the new nuclear builds. In Finland, risk-informed applications are formally integrated in the regulatory process of NPPs that are already in the early design phase and these are to run through the construction and operation phases all through the entire plant service time. A plant-specific full-scope probabilistic risk assessment (PRA) is required for each NPP. PRAs shall cover internal events, area events (fires, floods), and external events such as harsh weather conditions and seismic events in all operating modes. Special attention is devoted to the use of various risk-informed PRA applications in the licensing of Olkiluoto 3 NPP. © 2012 Society for Risk Analysis.

78 FR 44193 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-23

... regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a... officials early in the process of developing the regulation. In addition, the agency must provide to the... result, in an annual effect on the economy of $100 million or more or meets other criteria specified in...

T regulatory cells in contact hypersensitivity.

PubMed

Cavani, Andrea

2008-08-01

The review summarizes the recent investigations focused on T regulatory cells in hapten diseases. Multiple mechanisms ensure tolerance to small chemicals penetrating the skin. Among these, specific T regulatory cells play a major role in controlling harmful immune responses to environmental antigens. Most of the T regulatory cells involved in this process belongs to the CD4 subset and suppress hapten-specific immune response through the release of IL-10 and through direct interaction with effector T cells, blocking their function. Methods for in-vitro and in-vivo expansion of specific T regulatory cells may represent an innovative approach for the cure of contact hypersensitivity.

Arousal regulation and affective adaptation to human responsiveness by a robot that explores and learns a novel environment

PubMed Central

Hiolle, Antoine; Lewis, Matthew; Cañamero, Lola

2014-01-01

In the context of our work in developmental robotics regarding robot–human caregiver interactions, in this paper we investigate how a “baby” robot that explores and learns novel environments can adapt its affective regulatory behavior of soliciting help from a “caregiver” to the preferences shown by the caregiver in terms of varying responsiveness. We build on two strands of previous work that assessed independently (a) the differences between two “idealized” robot profiles—a “needy” and an “independent” robot—in terms of their use of a caregiver as a means to regulate the “stress” (arousal) produced by the exploration and learning of a novel environment, and (b) the effects on the robot behaviors of two caregiving profiles varying in their responsiveness—“responsive” and “non-responsive”—to the regulatory requests of the robot. Going beyond previous work, in this paper we (a) assess the effects that the varying regulatory behavior of the two robot profiles has on the exploratory and learning patterns of the robots; (b) bring together the two strands previously investigated in isolation and take a step further by endowing the robot with the capability to adapt its regulatory behavior along the “needy” and “independent” axis as a function of the varying responsiveness of the caregiver; and (c) analyze the effects that the varying regulatory behavior has on the exploratory and learning patterns of the adaptive robot. PMID:24860492

Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

PubMed

Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

2015-04-01

The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. Published by Elsevier Inc.

Components of laboratory accreditation.

PubMed

Royal, P D

1995-12-01

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

WASTE TREATMENT BUILDING SYSTEM DESCRIPTION DOCUMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

F. Habashi

2000-06-22

The Waste Treatment Building System provides the space, layout, structures, and embedded subsystems that support the processing of low-level liquid and solid radioactive waste generated within the Monitored Geologic Repository (MGR). The activities conducted in the Waste Treatment Building include sorting, volume reduction, and packaging of dry waste, and collecting, processing, solidification, and packaging of liquid waste. The Waste Treatment Building System is located on the surface within the protected area of the MGR. The Waste Treatment Building System helps maintain a suitable environment for the waste processing and protects the systems within the Waste Treatment Building (WTB) from mostmore » of the natural and induced environments. The WTB also confines contaminants and provides radiological protection to personnel. In addition to the waste processing operations, the Waste Treatment Building System provides space and layout for staging of packaged waste for shipment, industrial and radiological safety systems, control and monitoring of operations, safeguards and security systems, and fire protection, ventilation and utilities systems. The Waste Treatment Building System also provides the required space and layout for maintenance activities, tool storage, and administrative facilities. The Waste Treatment Building System integrates waste processing systems within its protective structure to support the throughput rates established for the MGR. The Waste Treatment Building System also provides shielding, layout, and other design features to help limit personnel radiation exposures to levels which are as low as is reasonably achievable (ALARA). The Waste Treatment Building System interfaces with the Site Generated Radiological Waste Handling System, and with other MGR systems that support the waste processing operations. The Waste Treatment Building System interfaces with the General Site Transportation System, Site Communications System, Site Water System, MGR Site Layout, Safeguards and Security System, Site Radiological Monitoring System, Site Electrical Power System, Site Compressed Air System, and Waste Treatment Building Ventilation System.« less

Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients.

PubMed

Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B

2017-01-01

Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

CAPACITY BUILDING PROCESS IN ENVIRONMENTAL AND HEALTH IMPACT ASSESSMENT FOR A THAI COMMUNITY.

PubMed

Chaithui, Suthat; Sithisarankul, Pornchai; Hengpraprom, Sarunya

2017-03-01

This research aimed at exploring the development of the capacitybuilding process in environmental and health impact assessment, including the consideration of subsequent, capacity-building achievements. Data were gathered through questionnaires, participatory observations, in-depth interviews, focus group discussions, and capacity building checklist forms. These data were analyzed using content analysis, descriptive statistics, and inferential statistics. Our study used the components of the final draft for capacity-building processes consisting of ten steps that were formulated by synthesis from each respective process. Additionally, the evaluation of capacity building levels was performed using 10-item evaluation criteria for nine communities. The results indicated that the communities performed well under these criteria. Finally, exploration of the factors influencing capacity building in environmental and health impact assessment indicated that the learning of community members by knowledge exchange via activities and study visits were the most influential factors of the capacity building processes in environmental and health impact assessment. The final revised version of capacitybuilding process in environmental and health impact assessment could serve as a basis for the consideration of interventions in similar areas, so that they increased capacity in environmental and health impact assessments.

The politics of smoking in federal buildings: an executive order case study.

PubMed

Cook, Daniel M; Bero, Lisa A

2009-09-01

Executive orders are important presidential tools for health policymaking that are subject to less public scrutiny than are legislation and regulatory rulemaking. President Bill Clinton banned smoking in federal government buildings by executive order in 1997, after the administration of George H. W. Bush had twice considered and abandoned a similar policy. The 1991 and 1993 Bush proposals drew objections from agency heads and labor unions, many coordinated by the tobacco industry. We analyzed internal tobacco industry documents and found that the industry engaged in extensive executive branch lobbying and other political activity surrounding the Clinton smoking ban. Whereas some level of stakeholder politics might have been expected, this policy also featured jockeying among various agencies and the participation of organized labor.

Evolution of the concept of Capacity-building, results achieved during the past years and the future

NASA Astrophysics Data System (ADS)

Laffaiteur, M.; Camacho, S.

Capacity-building is one of the key elements for the implementation of space applications programmes, particularly in developing countries. As early as 1982, the work programme of the United Nations Programme on Space Applications was expanded in order to promote education and training by organizing seminars, training courses and workshops in various areas, such as astronomy, telecommunications and Earth observation. In the framework of this Programme, the Office for Outer Space Affairs undertook the initiative, at the beginning of the 1990's, aimed at establishing regional centres for space science and technology education, affiliated to the United Nations and located in developing countries. These centres have started their activities between 1995 and 2000 in Africa, Asia and the Pacific, and Latin America and the Caribbean. The centres are based on the concept that by pooling material and human resources, developing countries can have education and training centres, of an international-level quality. A considerable impetus has been given to capacity-building after the UNISPACE III Conference, in particular in the "Vienna Declaration on Space and Human Development". The necessity to enhance capacity-building through the development of human and budgetary resources, the training of teachers, the exchange of teaching methods, materials and experience and the development of infrastructure and policy regulatories. In the process of the implementation of the recommendations of UNISPACE III, Action Teams led by Governments were established. One of them was exclusively dealing with capacity-building. Its proposals have been reviewed last June by the Committee on the Peaceful Uses of Outer Space (COPUOS) and will be examined, among other reports of Action Teams, by the General Assembly in next October. A lot of work has been done during the past years and have produced very important results. But there is still an important gap in capacity-building between space-faring countries and developing countries. A strategy has been presented by the Action Team in order to implement a strategy aimed at increasing again the impact of the various initiatives already going on. The promotion of the sharing of educational materials and information could be facilitated by a network of bodies in UN Member States, dedicated organizations and UN regional centres. This presentation will aim to show the current status of this issue and to present results already achieved and the way forward.

Using Wikis for Learning and Knowledge Building: Results of an Experimental Study

ERIC Educational Resources Information Center

Kimmerle, Joachim; Moskaliuk, Johannes; Cress, Ulrike

2011-01-01

Computer-supported learning and knowledge building play an increasing role in online collaboration. This paper outlines some theories concerning the interplay between individual processes of learning and collaborative processes of knowledge building. In particular, it describes the co-evolution model that attempts to examine processes of learning…

EAST ELEVATION OF MAIN PROCESSING BUILDING (CPP601) LOOKING NORTHWEST. MAINTENANCE ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

EAST ELEVATION OF MAIN PROCESSING BUILDING (CPP-601) LOOKING NORTHWEST. MAINTENANCE SHOP AND OFFICE BUILDING (CPP-630) ON RIGHT IN PHOTO. INL PHOTO NUMBER HD-22-3-2. Mike Crane, Photographer, 11/1998 - Idaho National Engineering Laboratory, Idaho Chemical Processing Plant, Fuel Reprocessing Complex, Scoville, Butte County, ID

How to build a course in mathematical-biological modeling: content and processes for knowledge and skill.

PubMed

Hoskinson, Anne-Marie

2010-01-01

Biological problems in the twenty-first century are complex and require mathematical insight, often resulting in mathematical models of biological systems. Building mathematical-biological models requires cooperation among biologists and mathematicians, and mastery of building models. A new course in mathematical modeling presented the opportunity to build both content and process learning of mathematical models, the modeling process, and the cooperative process. There was little guidance from the literature on how to build such a course. Here, I describe the iterative process of developing such a course, beginning with objectives and choosing content and process competencies to fulfill the objectives. I include some inductive heuristics for instructors seeking guidance in planning and developing their own courses, and I illustrate with a description of one instructional model cycle. Students completing this class reported gains in learning of modeling content, the modeling process, and cooperative skills. Student content and process mastery increased, as assessed on several objective-driven metrics in many types of assessments.

How to Build a Course in Mathematical–Biological Modeling: Content and Processes for Knowledge and Skill

PubMed Central

2010-01-01

Biological problems in the twenty-first century are complex and require mathematical insight, often resulting in mathematical models of biological systems. Building mathematical–biological models requires cooperation among biologists and mathematicians, and mastery of building models. A new course in mathematical modeling presented the opportunity to build both content and process learning of mathematical models, the modeling process, and the cooperative process. There was little guidance from the literature on how to build such a course. Here, I describe the iterative process of developing such a course, beginning with objectives and choosing content and process competencies to fulfill the objectives. I include some inductive heuristics for instructors seeking guidance in planning and developing their own courses, and I illustrate with a description of one instructional model cycle. Students completing this class reported gains in learning of modeling content, the modeling process, and cooperative skills. Student content and process mastery increased, as assessed on several objective-driven metrics in many types of assessments. PMID:20810966

Select Biosolids Regulatory Processes

EPA Pesticide Factsheets

Historical Regulatory Development and activities EPA has undertaken to respond to statutory obligations, respond to the National Academy of Sciences, understand pollutants that may occur in sewage sludge, and address dioxins in sewage sludge.

Improving Energy Efficiency of Buildings in the Urals

NASA Astrophysics Data System (ADS)

Kiyanets, A. V.

2017-11-01

The article is devoted to the results of studies of energy efficiency improvements of the buildings which are constructed under the climatic conditions of the Ural Federal District of the Russian Federation. The relevance of the stated problem is corroborated. The requirements of the existing regulatory legal acts of the Russian Federation on energy conservation and energy efficiency in construction are given. The article specifies that energy efficiency in construction refers to a set of measures aimed at the reduction of energy resources which are consumed by buildings and are necessary to maintain the required microclimate parameters indoors. The main modern measures for improving the energy efficiency of buildings are presented, and their application under the climatic conditions of the Urals are analyzed and calculated. Each of the proposed methods is evaluated. Basing on the research results, it is concluded that most of the currently known measures for improving the energy efficiency of buildings are significantly limited in the Ural Federal District due to the small economic effect connected with the complexity and high cost of their implementation and operation, the peculiarities of climatic conditions and the conditions of the population density of the territories or significant ineffectiveness of the measures themselves; the most promising measures for improving the energy efficiency of buildings under the climatic and economic conditions of the Urals are the measures for reducing heat loss through the building envelopes (for improving the heat-insulation characteristics of the applied materials and structures).

The Effectiveness of Full Day School System for Students’ Character Building

NASA Astrophysics Data System (ADS)

Benawa, A.; Peter, R.; Makmun, S.

2018-01-01

The study aims to put forward that full day school which was delivered in Marsudirini Elementary School in Bogor is effective for students’ character building. The study focused on the implementation of full day school system. The qualitative-based research method applied in the study is characteristic evaluation involving non-participant observation, interview, and documentation analysis. The result of this study concludes that the full day school system is significantly effective in education system for elementary students’ character building. The full day school system embraced the entire relevant processes based on the character building standard. The synergy of comprehensive components in instructional process at full day school has influenced the building of the students’ character effectively and efficiently. The relationship emerged between instructional development process in full day school system and the character building of the students. By developing instructional process through systemic and systematic process in full day school system, the support of stakeholders (leaders, human resources, students, parents’ role) and other components (learning resources, facilities, budget) provides a potent and expeditious contribution for character building among the students eventually.

Collaborative Learning in Higher Education: Evoking Positive Interdependence

PubMed Central

Scager, Karin; Boonstra, Johannes; Peeters, Ton; Vulperhorst, Jonne; Wiegant, Fred

2016-01-01

Collaborative learning is a widely used instructional method, but the learning potential of this instructional method is often underused in practice. Therefore, the importance of various factors underlying effective collaborative learning should be determined. In the current study, five different life sciences undergraduate courses with successful collaborative-learning results were selected. This study focuses on factors that increased the effectiveness of collaboration in these courses, according to the students. Nine focus group interviews were conducted and analyzed. Results show that factors evoking effective collaboration were student autonomy and self-regulatory behavior, combined with a challenging, open, and complex group task that required the students to create something new and original. The design factors of these courses fostered a sense of responsibility and of shared ownership of both the collaborative process and the end product of the group assignment. In addition, students reported the absence of any free riders in these group assignments. Interestingly, it was observed that students seemed to value their sense of achievement, their learning processes, and the products they were working on more than their grades. It is concluded that collaborative learning in higher education should be designed using challenging and relevant tasks that build shared ownership with students. PMID:27909019

The mechanisms of renal tubule electrolyte and water absorption, 100 years after Carl Ludwig.

PubMed

Greger, R

1996-01-01

Some 154 years after Carl Ludwig's Habilitationsschrift "Contributions to the theory of the mechanism of urine secretion" renal physiology has come a long way. The mechanisms of urine formation are now understood as the result of glomerular filtration and tubule absorption of most of the filtrate. The detailed understanding of tubule transport processes has become possible with the invention of several refined techniques such as the micropuncture techniques; the microchemical analysis of nanolitre tubule fluid samples; the in vitro perfusion of isolated tubule segments of defined origin; electrophysiological analysis of electrolyte transport including micropuncture and patch-clamp techniques; transport studies in membrane vesicle preparations; recordings of intracellular electrolyte concentrations and cloning techniques of the individual membrane transport proteins. With this wealth of information we are now starting to build an integrative understanding of the function of the individual nephron segments, the regulatory processes, the integrated function of the nephron and hence the formation of the final urine. Like anatomists of previous centuries we still state that the kidney is an "organum mirable" and we recognize that basic research in this area has fertilized the analysis of the function of a large number of other organs and cells.

Packaged water: optimizing local processes for sustainable water delivery in developing nations

PubMed Central

2011-01-01

With so much global attention and commitment towards making the Water and Sanitation targets of the Millennium Development Goals (MDGs) a reality, available figures seem to speak on the contrary as they reveal a large disparity between the expected and what currently obtains especially in developing countries. As studies have shown that the standard industrialized world model for delivery of safe drinking water technology may not be affordable in much of the developing world, packaged water is suggested as a low cost, readily available alternative water provision that could help bridge the gap. Despite the established roles that this drinking water source plays in developing nations, its importance is however significantly underestimated, and the source considered unimproved going by 'international standards'. Rather than simply disqualifying water from this source, focus should be on identifying means of improvement. The need for intervening global communities and developmental organizations to learn from and build on the local processes that already operate in the developing world is also emphasized. Identifying packaged water case studies of some developing nations, the implication of a tenacious focus on imported policies, standards and regulatory approaches on drinking water access for residents of the developing world is also discussed. PMID:21801391

Impact of regulatory assessment on clinical studies in Brazil.

PubMed

Russo, Luis Augusto Tavares; Eliaschewitz, Freddy Goldberg; Harada, Vitor; Trefiglio, Roberta Pereira; Picciotti, Raffaella; Machado, Paula Goulart Pinheiro; Kesselring, Gustavo Luiz Ferreira

2016-01-01

Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country's scientific development.

[Building Process and Architectural Planning Characteristics of Daehan Hospital Main Building].

PubMed

Lee, Geauchul

2016-04-01

This paper explores the introduction process of Daehan Hospital from Japan as the modern medical facility in Korea, and the architectural planning characteristics as a medical facility through the detailed building process of Daehan Hospital main building. The most noticeable characteristic of Daehan Hospital is that it was designed and constructed not by Korean engineers but by Japanese engineers. Therefore, Daehan Hospital was influenced by Japanese early modern medical facility, and Japanese engineers modeled Daehan Hospital main building on Tokyo Medical School main building which was constructed in 1876 as the first national medical school and hospital. The architectural type of Tokyo Medical School main building was a typical school architecture in early Japanese modern period which had a middle corridor and a pseudo Western-style tower, but Tokyo Medical School main building became the model of a medical facility as the symbol of the medical department in Tokyo Imperial University. This was the introduction and transplantation process of Japanese modern 'model' like as other modern systems and technologies during the Korean modern transition period. However, unlike Tokyo Medical School main building, Daehan Hospital main building was constructed not as a wooden building but as a masonry building. Comparing with the function of Daehan Hospital main building, its architectural form and construction costs was excessive scale, which was because Japanese Resident-General of Korea had the intention of ostentation that Japanese modernity was superior to Korean Empire.

Integrated Approach to Reconstruction of Microbial Regulatory Networks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rodionov, Dmitry A; Novichkov, Pavel S

2013-11-04

This project had the goal(s) of development of integrated bioinformatics platform for genome-scale inference and visualization of transcriptional regulatory networks (TRNs) in bacterial genomes. The work was done in Sanford-Burnham Medical Research Institute (SBMRI, P.I. D.A. Rodionov) and Lawrence Berkeley National Laboratory (LBNL, co-P.I. P.S. Novichkov). The developed computational resources include: (1) RegPredict web-platform for TRN inference and regulon reconstruction in microbial genomes, and (2) RegPrecise database for collection, visualization and comparative analysis of transcriptional regulons reconstructed by comparative genomics. These analytical resources were selected as key components in the DOE Systems Biology KnowledgeBase (SBKB). The high-quality data accumulated inmore » RegPrecise will provide essential datasets of reference regulons in diverse microbes to enable automatic reconstruction of draft TRNs in newly sequenced genomes. We outline our progress toward the three aims of this grant proposal, which were: Develop integrated platform for genome-scale regulon reconstruction; Infer regulatory annotations in several groups of bacteria and building of reference collections of microbial regulons; and Develop KnowledgeBase on microbial transcriptional regulation.« less

Evolution in performance assessment modeling as a result of regulatory review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rowat, J.H.; Dolinar, G.M.; Stephens, M.E.

1995-12-31

AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteformmore » as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.« less