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Sample records for acceptable regulatory limits

  1. Legitimization of regulatory norms: Waterfowl hunter acceptance of changing duck bag limits

    USGS Publications Warehouse

    Schroeder, Susan A.; Fulton, David C.; Lawrence, Jeffrey S.; Cordts, Steven D.

    2014-01-01

    Few studies have examined response to regulatory change over time, or addressed hunter attitudes about changes in hunting bag limits. This article explores Minnesota waterfowl hunters’ attitudes about duck bag limits, examining attitudes about two state duck bag limits that were initially more restrictive than the maximum set by the U.S. Fish and Wildlife Service (USFWS), but then increased to match federal limits. Results are from four mail surveys that examined attitudes about bag limits over time. Following two bag limit increases, a greater proportion of hunters rated the new bag limit “too high” and a smaller proportion rated it “too low.” Several years following the first bag limit increase, the proportion of hunters who indicated that the limit was “too high” had declined, suggesting hunter acceptance of the new regulation. Results suggest that waterfowl bag limits may represent legal norms that influence hunter attitudes and gain legitimacy over time.

  2. The limits of regulatory toxicology

    SciTech Connect

    Carrington, Clark D.; Bolger, P. Michael

    2010-03-01

    The Acceptable Daily Intake (ADI) has been used by regulatory and public health organizations (e.g., the U.S. Food and Drug and Administration, and the World Health Organization) for chemicals for more than 50 years. The ADI concept was also initially employed at the U.S. Environmental Protection Agency at its inception in 1971, although with the adoption of newer terminology, it later became known as the Reference Dose (RfD). It is clear from the literature that both were first devised as instruments of regulatory policy. In the intervening years, it has become common to use language that implies that these standards are statements of scientific fact. Similarly, some of the discretionary or default values that are used to derive regulatory standards are represented as scientific assumptions when in fact they also represent regulatory policy. This confusion impedes both the best use of the available science and informed public participation in policy making. In addition, the misconception of the ADI or the RfD as statements of scientific fact may impede the consideration of alternative means to reduce exposure to chemicals that may be harmful, including regulatory measures that do not involve prescribing a regulatory concentration limit.

  3. What Are Acceptable Limits of Radiation?

    NASA Video Gallery

    Brad Gersey, lead research scientist at the Center for Radiation Engineering and Science for Space Exploration, or CRESSE, at Prairie View A&M University, describes the legal and acceptable limits ...

  4. In vivo erythrocyte micronucleus assay III. Validation and regulatory acceptance of automated scoring and the use of rat peripheral blood reticulocytes, with discussion of non-hematopoietic target cells and a single dose-level limit test.

    PubMed

    Hayashi, Makoto; MacGregor, James T; Gatehouse, David G; Blakey, David H; Dertinger, Stephen D; Abramsson-Zetterberg, Lilianne; Krishna, Gopala; Morita, Takeshi; Russo, Antonella; Asano, Norihide; Suzuki, Hiroshi; Ohyama, Wakako; Gibson, Dave

    2007-02-03

    , but a consensus regarding acceptability for regulatory purposes could not be reached at that time. Subsequent validation efforts, combined with accumulated published data, demonstrate that blood-derived reticulocytes from rats as well as mice are acceptable when young reticulocytes are analyzed under proper assay protocol and sample size. The working group reviewed the results of micronucleus assays using target cells/tissues other than hematopoietic cells. We also discussed the relevance of the liver micronucleus assay using young rats, and the importance of understanding the maturation of enzyme systems involved in the processes of metabolic activation in the liver of young rats. Although the consensus of the group was that the more information with regard to the metabolic capabilities of young rats would be useful, the published literature shows that young rats have sufficient metabolic capacity for the purposes of this assay. The use of young rats as a model for detecting MN induction in the liver offers a good alternative methodology to the use of partial hepatectomy or mitogenic stimulation. Additional data obtained from colon and skin MN models have been integrated into the data bases, enhancing confidence in the utility of these models. A fourth topic discussed by the working group was the regulatory acceptance of the single-dose-level assay. There was no consensus regarding the acceptability of a single dose level protocol when dose-limiting toxicity occurs. The use of a single dose level can lead to problems in data interpretation or to the loss of animals due to unexpected toxicity, making it necessary to repeat the study with additional doses. A limit test at a single dose level is currently accepted when toxicity is not dose-limiting.

  5. [Validation and regulatory acceptance of alternative methods for toxicity evaluation].

    PubMed

    Ohno, Yasuo

    2004-01-01

    For regulatory acceptance of alternative methods (AMs) to animal toxicity tests, their reproducibility and relevance should be determined by intra- and inter-laboratory validation. Appropriate procedures of the validation and regulatory acceptance of AMs were recommended by OECD in 1996. According to those principles, several in vitro methods like skin corrosivity tests and phototoxicity tests were evaluated and accepted by ECVAM (European Center for the Validation of Alternative Methods), ICCVAM (The Interagency Coordinating Committee on the Validation of Alternative Methods), and OECD. Because of the difficulties in conducting inter-laboratory validation and relatively short period remained until EU's ban of animal experiments for safety evaluation of cosmetics, ECVAM and ICCVAM have recently started cooperation in validation and evaluation of AMs. It is also necessary to establish JaCVAM (Japanese Center for the Validation of AM) to contribute the issue and for the evaluation of new toxicity tests originated in Japan.

  6. 10 CFR 2.643 - Acceptance and docketing of application for limited work authorization.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... acceptable for processing, the Director of New Reactors or the Director of Nuclear Reactor Regulation will... 10 Energy 1 2013-01-01 2013-01-01 false Acceptance and docketing of application for limited work authorization. 2.643 Section 2.643 Energy NUCLEAR REGULATORY COMMISSION AGENCY RULES OF PRACTICE AND...

  7. Regulatory perspectives on acceptability testing of dosage forms in children.

    PubMed

    Kozarewicz, Piotr

    2014-08-05

    Current knowledge about the age-appropriateness of different dosage forms is still fragmented or limited. Applicants are asked to demonstrate that the target age group(s) can manage the dosage form or propose an alternative strategy. However, questions remain about how far the applicant must go and what percentage of patients must find the strategy 'acceptable'. The aim of this overview is to provide an update on current thinking and understanding of the problem, and discuss issues relating to the acceptability testing. This overview should be considered as means to start a wider discussion which hopefully will result in a harmonised, globally acceptable approach for confirmation of the acceptability in the future.

  8. 75 FR 6371 - Jordan Hydroelectric Limited Partnership; Notice of Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ... Application: Major Original License b. Project No.: P-12740-003 c. Date filed: July 13, 2009 d. Applicant: Jordan Hydroelectric Limited Partnership e. Name of Project: Flannagan Hydroelectric Project f. Location... Energy Regulatory Commission Jordan Hydroelectric Limited Partnership; Notice of Application Accepted...

  9. Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

    PubMed

    Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

    Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory

  10. The Acceptability Limit in Food Shelf Life Studies.

    PubMed

    Manzocco, Lara

    2016-07-26

    Despite its apparently intuitive nature, the acceptability limit is probably the most difficult parameter to be defined when developing a shelf life test. Although it dramatically affects the final shelf life value, it is surprising that discussion on its nature has been largely neglected in the literature and only rare indications about the possible methodologies for its determination are available in the literature. This is due to the fact that the definition of this parameter is a consumer- and market-oriented issue, requiring a rational evaluation of the potential negative consequences of food unacceptability in the actual market scenario. This paper critically analyzes the features of the acceptability limit and the role of the decision maker. The methodologies supporting the choice of the acceptability limit as well as acceptability limit values proposed in the literature to calculate shelf life of different foods are reviewed.

  11. Regulatory environment and claims - limits and opportunities.

    PubMed

    Martin, Ambroise

    2010-01-01

    During the past decade, the use of claims became more and more important in many countries in relation to the increased awareness of consumer about the link between foods and health, offering to industry a valuable opportunity to differentiate and valorize their products and to promote innovation. However, more and more stringent regulations are developed, all based on the general principles adopted by the Codex Alimentarius Commission. In addition to the different regulatory processes and administrative requirements according to the country, the high level (and cost) of scientific substantiation of claims, the constraints introduced by nutrient profiles and the poor knowledge of the impact on consumer depending on the cultural contexts may limit these opportunities or, at least complicate their use. All these issues are briefly analyzed, highlighting some striking convergences and differences between countries.

  12. Sociocognitive self-regulatory mechanisms governing judgments of the acceptability and likelihood of sport cheating.

    PubMed

    d'Arripe-Longueville, Fabienne; Corrion, Karine; Scoffier, Stéphanie; Roussel, Peggy; Chalabaev, Aïna

    2010-10-01

    This study extends previous psychosocial literature (Bandura et al., 2001, 2003) by examining a structural model of the self-regulatory mechanisms governing the acceptability and likelihood of cheating in a sport context. Male and female adolescents (N = 804), aged 15-20 years, took part in this study. Negative affective self-regulatory efficacy influenced the acceptability and likelihood of cheating through the mediating role of moral disengagement, in females and males. Affective efficacy positively influenced prosocial behavior through moral disengagement or through resistive self-regulatory efficacy and social efficacy, in both groups. The direct effects of affective efficacy on beliefs about cheating were only evident in females. These results extend the findings of Bandura et al. (2001, 2003) to the sport context and suggest that affective and resistive self-regulatory efficacy operate in concert in governing adolescents' moral disengagement and transgressive behaviors in sport.

  13. Fetal tolerance in human pregnancy--a crucial balance between acceptance and limitation of trophoblast invasion.

    PubMed

    von Rango, Ulrike

    2008-01-15

    During human pregnancy the semi-allogeneic/allogeneic fetal graft is normally accepted by the mother's immune system. Initially the contact between maternal and fetal cells is restricted to the decidua but during the 2nd trimester it is extended to the entire body. Two contrary requirements influence the extent of invasion of extravillous fetal trophoblast cells (EVT) in the maternal decidua: anchorage of the placenta to ensure fetal nutrition and protection of the uterine wall against over-invasion. To establish the crucial balance between tolerance of the EVT and its limitation, recognition of the semi-allogeneic/allogeneic fetal cell by maternal leukocytes is prerequisite. A key mechanism to limit EVT invasion is induction of EVT apoptosis. Apoptotic bodies are phagocytosed by antigen-presenting cells (APC). Peptides from apoptotic cells are presented by APC cells and induce an antigen-specific tolerance against the foreign antigens on EVT cells. These pathways, including up-regulation of the expression of IDO, IFNgamma and CTLA-4 as well as the induction of T(regulatory) cells, are general immunological mechanisms which have developed to maintain peripheral tolerance to self-antigens. Together these data suggest that the mother extends her "definition of self" for 9 months on the foreign antigens of the fetus.

  14. WTO accepts rules limiting medicine exports to poor countries.

    PubMed

    James, John S

    2003-09-12

    In a controversial decision on August 30, 2003, the World Trade Organization agreed to complex rules limiting the export of medications to developing countries. Reaction to the decision so far has shown a complete disconnect between trade delegates and the WTO, both of which praise the new rules as a humanitarian advance, and those working in treatment access in poor countries, who believe that they will effectively block treatment from reaching many who need it. We have prepared a background paper that analyzes this decision and its implications and offers the opinions of key figures on both sides of the debate. It is clear that the rules were largely written for and probably by the proprietary pharmaceutical industry, and imposed on the countries in the WTO mainly by the United States. The basic conflict is that this industry does not want the development of international trade in low-cost generic copies of its patented medicines--not even for poor countries, where little or no market exists. Yet millions of people die each year without medication for treatable conditions such as AIDS, and drug pricing remains one of several major obstacles to controlling global epidemics.

  15. DWPF COAL CARBON WASTE ACCEPTANCE CRITERIA LIMIT EVALUATION

    SciTech Connect

    Lambert, D.; Choi, A.

    2010-06-21

    A paper study was completed to assess the impact on the Defense Waste Processing Facility (DWPF)'s Chemical Processing Cell (CPC) acid addition and melter off-gas flammability control strategy in processing Sludge Batch 10 (SB10) to SB13 with an added Fluidized Bed Steam Reformer (FBSR) stream and two Salt Waste Processing Facility (SWPF) products (Strip Effluent and Actinide Removal Stream). In all of the cases that were modeled, an acid mix using formic acid and nitric acid could be achieved that would produce a predicted Reducing/Oxidizing (REDOX) Ratio of 0.20 Fe{sup +2}/{Sigma}Fe. There was sufficient formic acid in these combinations to reduce both the manganese and mercury present. Reduction of manganese and mercury are both necessary during Sludge Receipt and Adjustment Tank (SRAT) processing, however, other reducing agents such as coal and oxalate are not effective in this reduction. The next phase in this study will be experimental testing with SB10, FBSR, and both SWPF simulants to validate the assumptions in this paper study and determine whether there are any issues in processing these streams simultaneously. The paper study also evaluated a series of abnormal processing conditions to determine whether potential abnormal conditions in FBSR, SWPF or DWPF would produce melter feed that was too oxidizing or too reducing. In most of the cases that were modeled with one parameter at its extreme, an acid mix using formic acid and nitric acid could be achieved that would produce a predicted REDOX of 0.09-0.30 (target 0.20). However, when a run was completed with both high coal and oxalate, with minimum formic acid to reduce mercury and manganese, the final REDOX was predicted to be 0.49 with sludge and FBSR product and 0.47 with sludge, FBSR product and both SWPF products which exceeds the upper REDOX limit.

  16. Potential toxic effects of glyphosate and its commercial formulations below regulatory limits.

    PubMed

    Mesnage, R; Defarge, N; Spiroux de Vendômois, J; Séralini, G E

    2015-10-01

    Glyphosate-based herbicides (GlyBH), including Roundup, are the most widely used pesticides worldwide. Their uses have increased exponentially since their introduction on the market. Residue levels in food or water, as well as human exposures, are escalating. We have reviewed the toxic effects of GlyBH measured below regulatory limits by evaluating the published literature and regulatory reports. We reveal a coherent body of evidence indicating that GlyBH could be toxic below the regulatory lowest observed adverse effect level for chronic toxic effects. It includes teratogenic, tumorigenic and hepatorenal effects. They could be explained by endocrine disruption and oxidative stress, causing metabolic alterations, depending on dose and exposure time. Some effects were detected in the range of the recommended acceptable daily intake. Toxic effects of commercial formulations can also be explained by GlyBH adjuvants, which have their own toxicity, but also enhance glyphosate toxicity. These challenge the assumption of safety of GlyBH at the levels at which they contaminate food and the environment, albeit these levels may fall below regulatory thresholds. Neurodevelopmental, reproductive, and transgenerational effects of GlyBH must be revisited, since a growing body of knowledge suggests the predominance of endocrine disrupting mechanisms caused by environmentally relevant levels of exposure.

  17. Pain related catastrophizing on physical limitation in rheumatoid arthritis patients. Is acceptance important?

    PubMed

    Costa, Joana; Pinto-Gouveia, José; Marôco, João

    2014-01-01

    The experience of Rheumatoid Arthritis (RA) includes significant suffering and life disruption. This cross-sectional study examined the associations between pain, catastrophizing, acceptance and physical limitation in 55 individuals (11 males and 44 female; Mean age = 54.37; SD = 18.346), from the Portuguese population with (RA) 2 years after the diagnosis; also explored the role of acceptance as a mediator process between pain, catastrophizing and physical limitation. Results showed positive correlation between pain and catastrophizing (r = .544; p ≤ .001), and also between pain and 2-years' physical limitation (r = .531; p ≤ .001) Results also showed that acceptance was negatively correlated with physical limitation 2 years after the diagnosis (r = -.476; p ≤ .001). Path-analysis was performed to explore the direct effect of pain (ß = -.393; SD = .044; Z = 3.180; p ≤ .001) and catastrophizing (n.sig.) on physical limitation and also to explore the buffer effect of acceptance in this relationship (indirect effect ß = -.080). Results showed that physical limitation is not necessarily a direct product of pain and catastrophizing but acceptance was also involved. Pain and catastrophizing are associated but the influence of catastrophizing on physical limitation is promoted by low levels of acceptance. Results emphasize the relevance of acceptance as the emotional regulation process by which pain and catastrophizing influence physical functioning and establish the basic mechanism by which pain and catastrophizing operate in a contextual-based perspective. Also the study results offer a novel approach that may help behavioral health and medical providers prevent and treat these conditions.

  18. Summary of a workshop on regulatory acceptance of (Q)SARs for human health and environmental endpoints.

    PubMed Central

    Jaworska, Joanna S; Comber, M; Auer, C; Van Leeuwen, C J

    2003-01-01

    The "Workshop on Regulatory Use of (Q)SARs for Human Health and Environmental Endpoints," organized by the European Chemical Industry Council and the International Council of Chemical Associations, gathered more than 60 human health and environmental experts from industry, academia, and regulatory agencies from around the world. They agreed, especially industry and regulatory authorities, that the workshop initiated great potential for the further development and use of predictive models, that is, quantitative structure-activity relationships [(Q)SARs], for chemicals management in a much broader scope than is currently the case. To increase confidence in (Q)SAR predictions and minimization of their misuse, the workshop aimed to develop proposals for guidance and acceptability criteria. The workshop also described the broad outline of a system that would apply that guidance and acceptability criteria to a (Q)SAR when used for chemical management purposes, including priority setting, risk assessment, and classification and labeling. PMID:12896859

  19. Marine Biotoxins: Occurrence, Toxicity, Regulatory Limits and Reference Methods

    PubMed Central

    Visciano, Pierina; Schirone, Maria; Berti, Miriam; Milandri, Anna; Tofalo, Rosanna; Suzzi, Giovanna

    2016-01-01

    Harmful algal blooms are natural phenomena caused by the massive growth of phytoplankton that may contain highly toxic chemicals, the so-called marine biotoxins causing illness and even death to both aquatic organisms and humans. Their occurrence has been increased in frequency and severity, suggesting a worldwide public health risk. Marine biotoxins can accumulate in bivalve molluscs and regulatory limits have been set for some classes according to European Union legislation. These compounds can be distinguished in water- and fat-soluble molecules. The first group involves those of Paralytic Shellfish Poisoning and Amnesic Shellfish Poisoning, whereas the toxins soluble in fat can cause Diarrheic Shellfish Poisoning and Neurotoxic Shellfish Poisoning. Due to the lack of long-term toxicity studies, establishing tolerable daily intakes for any of these marine biotoxins was not possible, but an acute reference dose can be considered more appropriate, because these molecules show an acute toxicity. Dietary exposure assessment is linked both to the levels of marine biotoxins present in bivalve molluscs and the portion that could be eaten by consumers. Symptoms may vary from a severe gastrointestinal intoxication with diarrhea, nausea, vomiting, and abdominal cramps to neurological disorders such as ataxia, dizziness, partial paralysis, and respiratory distress. The official method for the detection of marine biotoxins is the mouse bioassay (MBA) showing some limits due to ethical restrictions and insufficient specificity. For this reason, the liquid chromatography–mass spectrometry method has replaced MBA as the reference technique. However, the monitoring of algal blooms producing marine biotoxins should be regularly assessed in order to obtain more reliable, accurate estimates of bloom toxicity and their potential impacts. PMID:27458445

  20. Marine Biotoxins: Occurrence, Toxicity, Regulatory Limits and Reference Methods.

    PubMed

    Visciano, Pierina; Schirone, Maria; Berti, Miriam; Milandri, Anna; Tofalo, Rosanna; Suzzi, Giovanna

    2016-01-01

    Harmful algal blooms are natural phenomena caused by the massive growth of phytoplankton that may contain highly toxic chemicals, the so-called marine biotoxins causing illness and even death to both aquatic organisms and humans. Their occurrence has been increased in frequency and severity, suggesting a worldwide public health risk. Marine biotoxins can accumulate in bivalve molluscs and regulatory limits have been set for some classes according to European Union legislation. These compounds can be distinguished in water- and fat-soluble molecules. The first group involves those of Paralytic Shellfish Poisoning and Amnesic Shellfish Poisoning, whereas the toxins soluble in fat can cause Diarrheic Shellfish Poisoning and Neurotoxic Shellfish Poisoning. Due to the lack of long-term toxicity studies, establishing tolerable daily intakes for any of these marine biotoxins was not possible, but an acute reference dose can be considered more appropriate, because these molecules show an acute toxicity. Dietary exposure assessment is linked both to the levels of marine biotoxins present in bivalve molluscs and the portion that could be eaten by consumers. Symptoms may vary from a severe gastrointestinal intoxication with diarrhea, nausea, vomiting, and abdominal cramps to neurological disorders such as ataxia, dizziness, partial paralysis, and respiratory distress. The official method for the detection of marine biotoxins is the mouse bioassay (MBA) showing some limits due to ethical restrictions and insufficient specificity. For this reason, the liquid chromatography-mass spectrometry method has replaced MBA as the reference technique. However, the monitoring of algal blooms producing marine biotoxins should be regularly assessed in order to obtain more reliable, accurate estimates of bloom toxicity and their potential impacts.

  1. Wireless smart meters and public acceptance: the environment, limited choices, and precautionary politics.

    PubMed

    Hess, David J; Coley, Jonathan S

    2014-08-01

    Wireless smart meters (WSMs) promise numerous environmental benefits, but they have been installed without full consideration of public acceptance issues. Although societal-implications research and regulatory policy have focused on privacy, security, and accuracy issues, our research indicates that health concerns have played an important role in the public policy debates that have emerged in California. Regulatory bodies do not recognize non-thermal health effects for non-ionizing electromagnetic radiation, but both homeowners and counter-experts have contested the official assurances that WSMs pose no health risks. Similarities and differences with the existing social science literature on mobile phone masts are discussed, as are the broader political implications of framing an alternative policy based on an opt-out choice. The research suggests conditions under which health-oriented precautionary politics can be particularly effective, namely, if there is a mandatory technology, a network of counter-experts, and a broader context of democratic contestation.

  2. Computational inference of gene regulatory networks: Approaches, limitations and opportunities.

    PubMed

    Banf, Michael; Rhee, Seung Y

    2017-01-01

    Gene regulatory networks lie at the core of cell function control. In E. coli and S. cerevisiae, the study of gene regulatory networks has led to the discovery of regulatory mechanisms responsible for the control of cell growth, differentiation and responses to environmental stimuli. In plants, computational rendering of gene regulatory networks is gaining momentum, thanks to the recent availability of high-quality genomes and transcriptomes and development of computational network inference approaches. Here, we review current techniques, challenges and trends in gene regulatory network inference and highlight challenges and opportunities for plant science. We provide plant-specific application examples to guide researchers in selecting methodologies that suit their particular research questions. Given the interdisciplinary nature of gene regulatory network inference, we tried to cater to both biologists and computer scientists to help them engage in a dialogue about concepts and caveats in network inference. Specifically, we discuss problems and opportunities in heterogeneous data integration for eukaryotic organisms and common caveats to be considered during network model evaluation. This article is part of a Special Issue entitled: Plant Gene Regulatory Mechanisms and Networks, edited by Dr. Erich Grotewold and Dr. Nathan Springer.

  3. Sampling hazelnuts for aflatoxin: effect of sample size and accept/reject limit on reducing the risk of misclassifying lots.

    PubMed

    Ozay, Guner; Seyhan, Ferda; Yilmaz, Aysun; Whitaker, Thomas B; Slate, Andrew B; Giesbrecht, Francis G

    2007-01-01

    About 100 countries have established regulatory limits for aflatoxin in food and feeds. Because these limits vary widely among regulating countries, the Codex Committee on Food Additives and Contaminants began work in 2004 to harmonize aflatoxin limits and sampling plans for aflatoxin in almonds, pistachios, hazelnuts, and Brazil nuts. Studies were developed to measure the uncertainty and distribution among replicated sample aflatoxin test results taken from aflatoxin-contaminated treenut lots. The uncertainty and distribution information is used to develop a model that can evaluate the performance (risk of misclassifying lots) of aflatoxin sampling plan designs for treenuts. Once the performance of aflatoxin sampling plans can be predicted, they can be designed to reduce the risks of misclassifying lots traded in either the domestic or export markets. A method was developed to evaluate the performance of sampling plans designed to detect aflatoxin in hazelnuts lots. Twenty hazelnut lots with varying levels of contamination were sampled according to an experimental protocol where 16 test samples were taken from each lot. The observed aflatoxin distribution among the 16 aflatoxin sample test results was compared to lognormal, compound gamma, and negative binomial distributions. The negative binomial distribution was selected to model aflatoxin distribution among sample test results because it gave acceptable fits to observed distributions among sample test results taken from a wide range of lot concentrations. Using the negative binomial distribution, computer models were developed to calculate operating characteristic curves for specific aflatoxin sampling plan designs. The effect of sample size and accept/reject limits on the chances of rejecting good lots (sellers' risk) and accepting bad lots (buyers' risk) was demonstrated for various sampling plan designs.

  4. Bridging the gap between regulatory acceptance and industry use of non-animal methods.

    PubMed

    Clippinger, Amy J; Hill, Erin; Curren, Rodger; Bishop, Patricia

    2016-01-01

    Collaboration between industry and regulators resulted in the development of a decision tree approach using in vitro or ex vivo assays to replace animal tests when determining the eye irritation potential of antimicrobial cleaning products (AMCPs) under the United States Environmental Protection Agency (EPA) Office of Pesticide Programs' hazard classification and labeling system. A policy document issued by the EPA in 2013 and updated in 2015 describes the alternate testing framework that industry could apply to new registrations of AMCPs and, on a case-by-case basis, to conventional pesticide products. Despite the collaborative effort, the availability of relevant non-animal methods, and the EPA's change in policy, only a limited number of AMCPs have been registered using the framework. Companies continue to conduct animal tests when registering AMCPs due to various challenges surrounding adoption of the new testing framework; however, recent discussions between industry, regulators, and other interested parties have identified ways these challenges may be overcome. In this article we explore how use of the alternate framework could be expanded through efforts such as increasing international harmonization, more proactively publicizing the framework, and enhancing the training of regulatory reviewers. Not only can these strategies help to increase use of the EPA alternate eye irritation framework, they can also be applied to facilitate the uptake of other alternative approaches to animal testing in the future.

  5. The U.S. Nuclear Regulatory Commission's Strategy for Revising the RIA Acceptance Criteria

    SciTech Connect

    Clifford, Paul M.

    2007-07-01

    The U.S. Nuclear Regulatory Commission (NRC) has issued interim criteria and guidance for the reactivity-initiated accident (RIA) within the latest revision to NUREG-0800, 'Standard Review Plan' (SRP), Section 4.2, 'Fuel System Design', Appendix B (Revision 03, March 2007). The purpose of this paper is as follows: 1. present a change in regulatory staff position regarding the requirements of 10 CFR 50, Appendix A, General Design Criteria 28 (GDC28) and changes in regulatory guidance provided in Regulatory Guide (RG) 1.77, RG 1.195, RG 1.183, and previous versions of NUREG-0800 SRP; 2. describe the implementation strategy and schedule for both new reactors and the existing fleet; and 3. encourage licensees and nuclear fuel vendors to (1) develop improved core physics analytical methods to allow a more deliberate transition to the new fuel cladding failure criteria and (2) develop the technical basis to address the new core coolability criteria. (authors)

  6. Application of Zoning and ``Limits of Acceptable Change'' to Manage Snorkelling Tourism

    NASA Astrophysics Data System (ADS)

    Roman, George S. J.; Dearden, Philip; Rollins, Rick

    2007-06-01

    Zoning and applying Limits of Acceptable Change (LAC) are two promising strategies for managing tourism in Marine Protected Areas (MPAs). Typically, these management strategies require the collection and integration of ecological and socioeconomic data. This problem is illustrated by a case study of Koh Chang National Marine Park, Thailand. Biophysical surveys assessed coral communities in the MPA to derive indices of reef diversity and vulnerability. Social surveys assessed visitor perceptions and satisfaction with conditions encountered on snorkelling tours. Notably, increased coral mortality caused a significant decrease in visitor satisfaction. The two studies were integrated to prescribe zoning and “Limits of Acceptable Change” (LAC). As a biophysical indicator, the data suggest a LAC value of 0.35 for the coral mortality index. As a social indicator, the data suggest that a significant fraction of visitors would find a LAC value of under 30 snorkellers per site as acceptable. The draft zoning plan prescribed four different types of zones: (I) a Conservation Zone with no access apart from monitoring or research; (II) Tourism Zones with high tourism intensities at less vulnerable reefs; (III) Ecotourism zones with a social LAC standard of <30 snorkellers per site, and (IV) General Use Zones to meet local artisanal fishery needs. This study illustrates how ecological and socioeconomic field studies in MPAs can be integrated to craft zoning plans addressing multiple objectives.

  7. Application of zoning and "limits of acceptable change" to manage snorkelling tourism.

    PubMed

    Roman, George S J; Dearden, Philip; Rollins, Rick

    2007-06-01

    Zoning and applying Limits of Acceptable Change (LAC) are two promising strategies for managing tourism in Marine Protected Areas (MPAs). Typically, these management strategies require the collection and integration of ecological and socioeconomic data. This problem is illustrated by a case study of Koh Chang National Marine Park, Thailand. Biophysical surveys assessed coral communities in the MPA to derive indices of reef diversity and vulnerability. Social surveys assessed visitor perceptions and satisfaction with conditions encountered on snorkelling tours. Notably, increased coral mortality caused a significant decrease in visitor satisfaction. The two studies were integrated to prescribe zoning and "Limits of Acceptable Change" (LAC). As a biophysical indicator, the data suggest a LAC value of 0.35 for the coral mortality index. As a social indicator, the data suggest that a significant fraction of visitors would find a LAC value of under 30 snorkellers per site as acceptable. The draft zoning plan prescribed four different types of zones: (I) a Conservation Zone with no access apart from monitoring or research; (II) Tourism Zones with high tourism intensities at less vulnerable reefs; (III) Ecotourism zones with a social LAC standard of <30 snorkellers per site, and (IV) General Use Zones to meet local artisanal fishery needs. This study illustrates how ecological and socioeconomic field studies in MPAs can be integrated to craft zoning plans addressing multiple objectives.

  8. Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.

    PubMed

    Amur, S; LaVange, L; Zineh, I; Buckman-Garner, S; Woodcock, J

    2015-07-01

    The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become accepted for use through submission of biomarker data during the drug approval process. Another emerging pathway for acceptance of biomarkers is via the biomarker qualification program developed by the Center for Drug Evaluation and Research (CDER, US Food and Drug Administration). Evidentiary standards are needed to develop and evaluate various types of biomarkers for their intended use and multiple stakeholders, including academia, industry, government, and consortia must work together to help develop this evidence. The article describes various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification. A path forward for coordinating efforts to identify and explore needed biomarkers is proposed for consideration.

  9. 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.

  10. PUBLIC AND REGULATORY ACCEPTANCE OF BLENDING OF RADIOACTIVE WASTE VS DILUTION

    SciTech Connect

    Goldston, W.

    2010-11-30

    On April 21, 2009, the Energy Facilities Contractors Group (EFCOG) Waste Management Working Group (WMWG) provided a recommendation to the Department of Energy's Environmental Management program (DOE-EM) concerning supplemental guidance on blending methodologies to use to classify waste forms to determine if the waste form meets the definition of Transuranic (TRU) Waste or can be classified as Low-Level Waste (LLW). The guidance provides specific examples and methods to allow DOE and its Contractors to properly classify waste forms while reducing the generation of TRU wastes. TRU wastes are much more expensive to characterize at the generator's facilities, ship, and then dispose at the Waste Isolation Pilot Plant (WIPP) than Low-Level Radioactive Waste's disposal. Also the reduction of handling and packaging of LLW is inherently less hazardous to the nuclear workforce. Therefore, it is important to perform the characterization properly, but in a manner that minimizes the generation of TRU wastes if at all possible. In fact, the generation of additional volumes of radioactive wastes under the ARRA programs, this recommendation should improve the cost effective implementation of DOE requirements while properly protecting human health and the environment. This paper will describe how the message of appropriate, less expensive, less hazardous blending of radioactive waste is the 'right' thing to do in many cases, but can be confused with inappropriate 'dilution' that is frowned upon by regulators and stakeholders in the public. A proposal will be made in this paper on how to communicate this very complex and confusing technical issue to regulatory bodies and interested stakeholders to gain understanding and approval of the concept. The results of application of the proposed communication method and attempt to change the regulatory requirements in this area will be discussed including efforts by DOE and the NRC on this very complex subject.

  11. 77 FR 77159 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-31

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate... Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission... primarily by ICE Clear Europe. ICE Clear Europe filed the proposal pursuant to Section 19(b)(3)(A)(iii)...

  12. 77 FR 76332 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-27

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...''),\\1\\ and Rule 19b-4 \\2\\ thereunder notice is hereby given that on December 19, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission'')...

  13. 78 FR 54718 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate... is hereby given that on August 20, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with... and II below, which Items have been prepared primarily by ICE Clear Europe. ICE Clear Europe filed...

  14. 78 FR 333 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-03

    ...-19] Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate... Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission... prepared primarily by ICE Clear Europe. ICE Clear Europe filed the proposal pursuant to Section...

  15. 77 FR 76318 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-27

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate... December 19, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange... have been prepared primarily by ICE Clear Europe. ICE Clear Europe filed the proposal pursuant...

  16. 77 FR 76315 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-27

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate... Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission... primarily by ICE Clear Europe. ICE Clear Europe filed the proposal pursuant to Section 19(b)(3)(A)(iii)...

  17. 78 FR 59401 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-26

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change..., 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission...) (SR-ICEEU-2013-11). II. Description of the Proposed Rule Change ICE Clear Europe proposes to...

  18. 78 FR 54713 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate..., 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission... primarily by ICE Clear Europe. ICE Clear Europe filed the proposal pursuant to Section 19(b)(3)(A)(ii)...

  19. Natural Conception May Be an Acceptable Option in HIV-Serodiscordant Couples in Resource Limited Settings.

    PubMed

    Sun, Lijun; Wang, Fang; Liu, An; Xin, Ruolei; Zhu, Yunxia; Li, Jianwei; Shao, Ying; Ye, Jiangzhu; Chen, Danqing; Li, Zaicun

    2015-01-01

    Many HIV serodiscordant couples have a strong desire to have their own biological children. Natural conception may be the only choice in some resource limited settings but data about natural conception is limited. Here, we reported our findings of natural conception in HIV serodiscordant couples. Between January 2008 and June 2014, we retrospectively collected data on 91 HIV serodiscordant couples presenting to Beijing Youan Hospital with childbearing desires. HIV counseling, effective ART on HIV infected partners, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) in negative female partners and timed intercourse were used to maximally reduce the risk of HIV transmission. Of the 91 HIV serodiscordant couples, 43 were positive in male partners and 48 were positive in female partners. There were 196 unprotected vaginal intercourses, 100 natural conception and 97 newborns. There were no cases of HIV seroconversion in uninfected sexual partners. Natural conception may be an acceptable option in HIV-serodiscordant couples in resource limited settings if HIV-positive individuals have undetectable viremia on HAART, combined with HIV counseling, PrEP, PEP and timed intercourse.

  20. QA/QC issues to aid regulatory acceptance of microarray gene expression data.

    PubMed

    Fuscoe, James C; Tong, Weida; Shi, Leming

    2007-06-01

    The U.S. Food and Drug Administration is responsible for (1) promoting and protecting public health by assuring the safety and effectiveness of medicines and medical devices and (2) advancing public health by helping to speed innovations that make medicines and foods safer, more effective, and more affordable. The genomics revolution has dramatically increased our knowledge of basic biology but this has not resulted in the expected acceleration of new medical product development. The Agency's Critical Path to New Medical Products stresses that new tools are needed to address this pipeline problem. Microarray technology is one of these promising tools although questions have risen about the reproducibility of measurements. The Microarray Quality Control (MAQC) Project was initiated by FDA scientists to address this issue. This large project, which evaluated reference RNA samples on seven microarray platforms, found good intralaboratory repeatability and interlaboratory reproducibility. In addition, there was high cross-platform consistency. All data are available free of cost and the reference RNA samples are available for proficiency testing. Thus, current microarray technology appears to provide both reliability and consistency for regulatory submissions.

  1. RFI to CMS: An Approach to Regulatory Acceptance of Site Remediation Technologies

    NASA Technical Reports Server (NTRS)

    Rowland, Martin A.

    2001-01-01

    Lockheed Martin made a smooth transition from RCRA Facility Investigation (RFI) at the National Aeronautics and Space Administrations'(NASA) Michoud Assembly Facility (MA-F) to its Corrective Measures Study (CMS) phase within the RCRA Corrective Action Process. We located trichloroethylene (TCE) contamination that resulted from the manufacture of the Apollo Program Saturn V rocket and the Space Shuttle External Tank, began the cleanup, and identified appropriate technologies for final remedies. This was accomplished by establishing a close working relationship with the state environmental regulatory agency through each step of the process, and resulted in receiving approvals for each of those steps. The agency has designated Lockheed Martin's management of the TCE-contamination at the MAF site as a model for other manufacturing sites in a similar situation. In February 1984, the Louisiana Department of Environmental Quality (LDEQ) issued a compliance order to begin the clean up of groundwater contaminated with TCE. In April 1984 Lockheed Martin began operating a groundwater recovery well to capture the TCE plume. The well not only removes contaminants, but also sustains an inward groundwater hydraulic gradient so that the potential offsite migration of the TCE plume is greatly diminished. This effort was successful, and for the agency to give orders and for a regulated industry to follow them is standard procedure, but this is a passive approach to solving environmental problems. The goal of the company thereafter was to take a leadership, proactive role and guide the MAF contamination clean up to its best conclusion at minimum time and lowest cost to NASA. To accomplish this goal, we have established a positive working relationship with LDEQ, involving them interactively in the implementation of advanced remedial activities at MAF as outlined in the following paragraphs.

  2. The Effect of Soil Properties on Metal Bioavailability: Field Scale Validation to Support Regulatory Acceptance

    DTIC Science & Technology

    2014-06-01

    The accuracy of these extraction methods to predict plant tissue contamination was limited to ± 35%. Similarly to metal bioaccessibility results...a soil extraction method will replicate the amount of metal absorbed by plants . The plant uptake system is too complex and dynamic to simulate by...available for making bioavailability adjustments 4 for metals exposure to soil invertebrates and plants . Weak salt extractions (e.g., calcium nitrate

  3. 78 FR 28680 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-15

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate... Futures Europe May 9, 2013. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act''),\\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 24, 2013, ICE Clear...

  4. Acceptable symbiont cell size differs among cnidarian species and may limit symbiont diversity.

    PubMed

    Biquand, Elise; Okubo, Nami; Aihara, Yusuke; Rolland, Vivien; Hayward, David C; Hatta, Masayuki; Minagawa, Jun; Maruyama, Tadashi; Takahashi, Shunichi

    2017-03-21

    Reef-building corals form symbiotic relationships with dinoflagellates of the genus Symbiodinium. Symbiodinium are genetically and physiologically diverse, and corals may be able to adapt to different environments by altering their dominant Symbiodinium phylotype. Notably, each coral species associates only with specific Symbiodinium phylotypes, and consequently the diversity of symbionts available to the host is limited by the species specificity. Currently, it is widely presumed that species specificity is determined by the combination of cell-surface molecules on the host and symbiont. Here we show experimental evidence supporting a new model to explain at least part of the specificity in coral-Symbiodinium symbiosis. Using the laboratory model Aiptasia-Symbiodinium system, we found that symbiont infectivity is related to cell size; larger Symbiodinium phylotypes are less likely to establish a symbiotic relationship with the host Aiptasia. This size dependency is further supported by experiments where symbionts were replaced by artificial fluorescent microspheres. Finally, experiments using two different coral species demonstrate that our size-dependent-infection model can be expanded to coral-Symbiodinium symbiosis, with the acceptability of large-sized Symbiodinium phylotypes differing between two coral species. Thus the selectivity of the host for symbiont cell size can affect the diversity of symbionts in corals.The ISME Journal advance online publication, 21 March 2017; doi:10.1038/ismej.2017.17.

  5. Validation of analytical methods involved in dissolution assays: acceptance limits and decision methodologies.

    PubMed

    Rozet, E; Ziemons, E; Marini, R D; Boulanger, B; Hubert, Ph

    2012-11-02

    Dissolution tests are key elements to ensure continuing product quality and performance. The ultimate goal of these tests is to assure consistent product quality within a defined set of specification criteria. Validation of an analytical method aimed at assessing the dissolution profile of products or at verifying pharmacopoeias compliance should demonstrate that this analytical method is able to correctly declare two dissolution profiles as similar or drug products as compliant with respect to their specifications. It is essential to ensure that these analytical methods are fit for their purpose. Method validation is aimed at providing this guarantee. However, even in the ICHQ2 guideline there is no information explaining how to decide whether the method under validation is valid for its final purpose or not. Are the entire validation criterion needed to ensure that a Quality Control (QC) analytical method for dissolution test is valid? What acceptance limits should be set on these criteria? How to decide about method's validity? These are the questions that this work aims at answering. Focus is made to comply with the current implementation of the Quality by Design (QbD) principles in the pharmaceutical industry in order to allow to correctly defining the Analytical Target Profile (ATP) of analytical methods involved in dissolution tests. Analytical method validation is then the natural demonstration that the developed methods are fit for their intended purpose and is not any more the inconsiderate checklist validation approach still generally performed to complete the filing required to obtain product marketing authorization.

  6. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of... section 13 (of the Federal Reserve Act), inasmuch as the laws of many States confer broader acceptance... section 13 of the Federal Reserve Act. Yet, this appears to be a development that Congress did...

  7. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of... section 13 (of the Federal Reserve Act), inasmuch as the laws of many States confer broader acceptance... section 13 of the Federal Reserve Act. Yet, this appears to be a development that Congress did...

  8. Guidance on the establishment of acceptable daily exposure limits (ADE) to support Risk-Based Manufacture of Pharmaceutical Products.

    PubMed

    Sargent, Edward V; Faria, Ellen; Pfister, Thomas; Sussman, Robert G

    2013-03-01

    Health-based limits for active pharmaceutical ingredients (API) referred to as acceptable daily exposures (ADEs) are necessary to the pharmaceutical industry and used to derive acceptance limits for cleaning validation purposes and evaluating cross-carryover. ADEs represent a dose of an API unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime. Derivations of ADEs need to be consistent with ICH Q9 as well as other scientific approaches for the derivation of health-based limits that help to manage risks to both product quality and operator safety during the manufacture of pharmaceutical products. Previous methods for the establishment of acceptance limits in cleaning validation programs are considered arbitrary and have largely ignored the available clinical and toxicological data available for a drug substance. Since the ADE utilizes all available pharmaceutical data and applies scientifically acceptable risk assessment methodology it is more holistic and consistent with other quantitative risk assessments purposes such derivation of occupational exposure limits. Processes for hazard identification, dose response assessment, uncertainty factor analysis and documentation are reviewed.

  9. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance... the provisions of section 13 (of the Federal Reserve Act), inasmuch as the laws of many States confer... the type described in section 13 of the Federal Reserve Act. Yet, this appears to be a...

  10. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance... the provisions of section 13 (of the Federal Reserve Act), inasmuch as the laws of many States confer... the type described in section 13 of the Federal Reserve Act. Yet, this appears to be a...

  11. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance... the provisions of section 13 (of the Federal Reserve Act), inasmuch as the laws of many States confer... the type described in section 13 of the Federal Reserve Act. Yet, this appears to be a...

  12. La composition academique: les limites de l'acceptabilite (Composition for Academic Purposes: Criteria for Acceptability).

    ERIC Educational Resources Information Center

    Grenall, G. M.

    1981-01-01

    Examines the pedagogical approaches and problems attendant to the development of English writing programs for foreign students. Discusses the skills necessary to handle course work, such as essay tests, term papers and reports, theses and dissertations, and focuses particularly on diagnostic problems and acceptability criteria. Societe Nouvelle…

  13. 77 FR 27254 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-09

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To Amend the ICE Clear Europe Limited CDS Procedures, Finance Procedures, and Rules With Respect to the... On March 12, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities...

  14. 77 FR 26066 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ...-04] Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change to... Europe Limited April 26, 2012. I. Introduction On March 6, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission'') the proposed rule change...

  15. 241-SY-101 DACS High hydrogen abort limit reduction (SCR 473) acceptance test report

    SciTech Connect

    ERMI, A.M.

    1999-09-09

    The capability of the 241-SY-101 Data Acquisition and Control System (DACS) computer system to provide proper control and monitoring of the 241-SY-101 underground storage tank hydrogen monitoring system utilizing the reduced hydrogen abort limit of 0.69% was systematically evaluated by the performance of ATP HNF-4927. This document reports the results of the ATP.

  16. Effect and acceptance of bluegill length limits in Nebraska natural lakes

    USGS Publications Warehouse

    Paukert, C.P.; Willis, D.W.; Gabelhouse, D.W.

    2002-01-01

    Bluegill Lepomis macrochirus populations in 18 Nebraska Sandhill lakes were evaluated to determine if a 200-mm minimum length limit would increase population size structure. Bluegills were trap-netted in May and June 1998 and 1999, and a creel survey was conducted during winter 1998-2001 on one or two lakes where bluegills had been tagged to determine angler exploitation. Thirty-three percent of anglers on one creeled lake were trophy anglers (i.e., fishing for large [???250 mm] bluegills), whereas 67% were there to harvest fish to eat. Exploitation was always less than 10% and the total annual mortality averaged 40% across all 18 lakes. The time to reach 200 mm ranged from 4.3 to 8.3 years. The relative stock density of preferred-length fish increased an average of 2.2 units in all 18 lakes with a 10% exploitation rate. However, yield declined 39% and the number harvested declined 62%. Bluegills would need to reach 200 mm in 4.2 years to ensure no reduction in yield at 10% exploitation. Both yield and size structure were higher with a 200-mm minimum length limit (relative to having no length limit) only in populations with the lowest natural mortality and at exploitation of 30% or more. Although 100% (N = 39) of anglers surveyed said they would favor a 200-mm minimum length limit to improve bluegill size structure, anglers would have to sacrifice harvest to achieve this goal. While a 200-mm minimum length limit did minimally increase size structure at current levels of exploitation across all 18 bluegill populations, the populations with the lowest natural mortality and fastest growth provided the highest increase in size structure with the lowest reduction in yield and number harvested.

  17. Predicting tool operator capacity to react against torque within acceptable handle deflection limits in automotive assembly.

    PubMed

    Radwin, Robert G; Chourasia, Amrish; Fronczak, Frank J; Subedi, Yashpal; Howery, Robert; Yen, Thomas Y; Sesto, Mary E; Irwin, Curtis B

    2016-05-01

    The proportion of tool operators capable of maintaining published psychophysically derived threaded fastener tool handle deflection limits were predicted using a biodynamic tool operator model, interacting with the tool, task and workstation. Tool parameters, including geometry, speed and torque were obtained from the specifications for 35 tools used in an auto assembly plant. Tool mass moments of inertia were measured for these tools using a novel device that engages the tool in a rotating system of known inertia. Task parameters, including fastener target torque and joint properties (soft, medium or hard), were ascertained from the vehicle design specifications. Workstation parameters, including vertical and horizontal distances from the operator were measured using a laser rangefinder for 69 tool installations in the plant. These parameters were entered into the model and tool handle deflection was predicted for each job. While handle deflection for most jobs did not exceed the capacity of 75% females and 99% males, six jobs exceeded the deflection criterion. Those tool installations were examined and modifications in tool speed and operator position improved those jobs within the deflection limits, as predicted by the model. We conclude that biodynamic tool operator models may be useful for identifying stressful tool installations and interventions that bring them within the capacity of most operators.

  18. 78 FR 10220 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...\\ and Rule 19b-4 thereunder \\2\\ notice is hereby given that on February 6, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission'')...

  19. 78 FR 9088 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-07

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To... Rules and Procedures February 1, 2013. I. Introduction On October 22, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``SEC'' or ``Commission'')...

  20. 77 FR 17537 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change To Amend the ICE Clear Europe CDS Procedures, Finance Procedures, and Rules With Respect to the... is hereby given that on March 12, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed...

  1. 78 FR 51248 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change... that on August 14, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and... Items have been prepared primarily by ICE Clear Europe. The Commission is publishing this notice...

  2. 78 FR 25129 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Withdrawal of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-29

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Withdrawal of Proposed Rule..., ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission... (Mar. 28, 2013). On April 19, 2013, ICE Clear Europe withdrew the proposed rule change...

  3. 78 FR 6371 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-30

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...''),\\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 10, 2013, ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing House'') filed with the Securities and Exchange...

  4. 77 FR 15174 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-14

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...\\ and Rule 19b-4 thereunder \\2\\ notice is hereby given that on March 6, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission'') the...

  5. 77 FR 11607 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting... thereunder \\2\\ notice is hereby given that on February 7, 2012, ICE Clear Europe Limited (``ICE Clear Europe... in Items I, II and III below, which Items have been prepared primarily by ICE Clear Europe....

  6. 77 FR 62289 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ...-2012-07] Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on September 25, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission'')...

  7. 78 FR 1281 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change..., 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission... prepared primarily by ICE Clear Europe. The Commission is publishing this notice to solicit comments on...

  8. 78 FR 15775 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting... thereunder,\\2\\ notice is hereby given that on February 28, 2013, ICE Clear Europe Limited (``ICE Clear Europe... in Items I and II below, which Items have been prepared primarily by ICE Clear Europe. The...

  9. 77 FR 66209 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-02

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change... that on October 15, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and..., which Items have been prepared primarily by ICE Clear Europe. The Commission is publishing this...

  10. 77 FR 17533 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To... Default Swap Contracts March 20, 2012. I. Introduction On January 24, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission'') the...

  11. 77 FR 7652 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Proposed Rule Change To Revise...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Proposed Rule Change To Revise... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 24, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission...

  12. 78 FR 19057 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing Proposed Rule Changes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... such a Clearing Member and capping its continuing liability to ICE Clear Europe, (iii) provide for... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing Proposed Rule Changes... hereby given that on March 7, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with...

  13. Statistical analysis of the limitation of half integer resonances on the available momentum acceptance of the High Energy Photon Source

    NASA Astrophysics Data System (ADS)

    Jiao, Yi; Duan, Zhe

    2017-01-01

    In a diffraction-limited storage ring, half integer resonances can have strong effects on the beam dynamics, associated with the large detuning terms from the strong focusing and strong sextupoles as required for an ultralow emittance. In this study, the limitation of half integer resonances on the available momentum acceptance (MA) was statistically analyzed based on one design of the High Energy Photon Source (HEPS). It was found that the probability of MA reduction due to crossing of half integer resonances is closely correlated with the level of beta beats at the nominal tunes, but independent of the error sources. The analysis indicated that for the presented HEPS lattice design, the rms amplitude of beta beats should be kept below 1.5% horizontally and 2.5% vertically to reach a small MA reduction probability of about 1%.

  14. Gene regulatory changes in yeast during life extension by nutrient limitation.

    PubMed

    Wang, Jinqing; Jiang, James C; Jazwinski, S Michal

    2010-08-01

    Genetic analyses aimed at identification of the pathways and downstream effectors of calorie restriction (CR) in the yeast Saccharomyces cerevisiae suggest the importance of central metabolism for the extension of replicative life span by CR. However, the limited gene expression studies to date are not informative, because they have been conducted using cells grown in batch culture which markedly departs from the conditions under which yeasts are grown during life span determinations. In this study, we have examined the gene expression changes that occur during either glucose limitation or elimination of nonessential-amino acids, both of which enhance yeast longevity, culturing cells in a chemostat at equilibrium, which closely mimics conditions they encounter during life span determinations. Expression of 59 genes was examined quantitatively by real-time, reverse transcriptase polymerase chain reaction (qRT-PCR), and the physiological state of the cultures was monitored. Extensive gene expression changes were detected, some of which were common to both CR regimes. The most striking of these was the induction of tricarboxylic acid (TCA) cycle and retrograde response target genes, which appears to be at least partially due to the up-regulation of the HAP4 gene. These gene regulatory events portend an increase in the generation of biosynthetic intermediates necessary for the production of daughter cells, which is the measure of yeast replicative life span.

  15. Regulatory cascade and biological activity of Beauveria bassiana oosporein that limits bacterial growth after host death.

    PubMed

    Fan, Yanhua; Liu, Xi; Keyhani, Nemat O; Tang, Guirong; Pei, Yan; Zhang, Wenwen; Tong, Sheng

    2017-02-28

    The regulatory network and biological functions of the fungal secondary metabolite oosporein have remained obscure. Beauveria bassiana has evolved the ability to parasitize insects and outcompete microbial challengers for assimilation of host nutrients. A novel zinc finger transcription factor, BbSmr1 (B. bassiana secondary metabolite regulator 1), was identified in a screen for oosporein overproduction. Deletion of Bbsmr1 resulted in up-regulation of the oosporein biosynthetic gene cluster (OpS genes) and constitutive oosporein production. Oosporein production was abolished in double mutants of Bbsmr1 and a second transcription factor, OpS3, within the oosporein gene cluster (ΔBbsmr1ΔOpS3), indicating that BbSmr1 acts as a negative regulator of OpS3 expression. Real-time quantitative PCR and a GFP promoter fusion construct of OpS1, the oosporein polyketide synthase, indicated that OpS1 is expressed mainly in insect cadavers at 24-48 h after death. Bacterial colony analysis in B. bassiana-infected insect hosts revealed increasing counts until host death, with a dramatic decrease (∼90%) after death that correlated with oosporein production. In vitro studies verified the inhibitory activity of oosporein against bacteria derived from insect cadavers. These results suggest that oosporein acts as an antimicrobial compound to limit microbial competition on B. bassiana-killed hosts, allowing the fungus to maximally use host nutrients to grow and sporulate on infected cadavers.

  16. 77 FR 27825 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on May 5, 2012, ICE Clear...

  17. 78 FR 32287 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-29

    ... COMMISSION Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change, and Amendment No. 1 Thereto, to Clear Contracts Traded on the LIFFE Administration and Management... rule change, as modified by Amendment No. 1, and as described in Items I, II, and III ] below,...

  18. Evaluation and Acceptability of a Simplified Test of Visual Function at Birth in a Limited-Resource Setting

    PubMed Central

    Carrara, Verena I.; Darakomon, Mue Chae; Thin, Nant War War; Paw, Naw Ta Kaw; Wah, Naw; Wah, Hser Gay; Helen, Naw; Keereecharoen, Suporn; Paw, Naw Ta Mlar; Jittamala, Podjanee; Nosten, François H.; Ricci, Daniela; McGready, Rose

    2016-01-01

    Neurological examination, including visual fixation and tracking of a target, is routinely performed in the Shoklo Malaria Research Unit postnatal care units on the Thailand-Myanmar border. We aimed to evaluate a simple visual newborn test developed in Italy and performed by non-specialized personnel working in neonatal care units. An intensive training of local health staff in Thailand was conducted prior to performing assessments at 24, 48 and 72 hours of life in healthy, low-risk term singletons. The 48 and 72 hours results were then compared to values obtained to those from Italy. Parents and staff administering the test reported on acceptability. One hundred and seventy nine newborns, between June 2011 and October 2012, participated in the study. The test was rapidly completed if the infant remained in an optimal behavioral stage (7 ± 2 minutes) but the test duration increased significantly (12 ± 4 minutes, p < 0.001) if its behavior changed. Infants were able to fix a target and to discriminate a colored face at 24 hours of life. Horizontal tracking of a target was achieved by 96% (152/159) of the infants at 48 hours. Circular tracking, stripe discrimination and attention to distance significantly improved between each 24-hour test period. The test was easily performed by non-specialized local staff and well accepted by the parents. Healthy term singletons in this limited-resource setting have a visual response similar to that obtained to gestational age matched newborns in Italy. It is possible to use these results as a reference set of values for the visual assessment in Karen and Burmese infants in the first 72 hours of life. The utility of the 24 hours test should be pursued. PMID:27300137

  19. Application of thresholds of potential concern and limits of acceptable change in the condition assessment of a significant wetland.

    PubMed

    Rogers, Kerrylee; Saintilan, Neil; Colloff, Matthew J; Wen, Li

    2013-10-01

    We propose a framework in which thresholds of potential concern (TPCs) and limits of acceptable change (LACs) are used in concert in the assessment of wetland condition and vulnerability and apply the framework in a case study. The lower Murrumbidgee River floodplain (the 'Lowbidgee') is one of the most ecologically important wetlands in Australia and the focus of intense management intervention by State and Federal government agencies. We used a targeted management stakeholder workshop to identify key values that contribute to the ecological significance of the Lowbidgee floodplain, and identified LACs that, if crossed, would signify the loss of significance. We then used conceptual models linking the condition of these values (wetland vegetation communities, waterbirds, fish species and the endangered southern bell frog) to measurable threat indicators, for which we defined a management goal and a TPC. We applied this framework to data collected across 70 wetland storages', or eco-hydrological units, at the peak of a prolonged drought (2008) and following extensive re-flooding (2010). At the suggestion of water and wetland mangers, we neither aggregated nor integrated indices but reported separately in a series of chloropleth maps. The resulting assessment clearly identified the effect of rewetting in restoring indicators within TPC in most cases, for most storages. The scale of assessment was useful in informing the targeted and timely management intervention and provided a context for retaining and utilising monitoring information in an adaptive management context.

  20. 21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Establishment of tolerances, regulatory...

  1. The effectiveness and limitations of regulatory warnings for the safe prescribing of citalopram

    PubMed Central

    Friesen, Kevin J; Bugden, Shawn C

    2015-01-01

    Background Citalopram is the most commonly prescribed antidepressant in Canada. Concerns have been raised about its cardiac safety, and a dose-dependent prolongation of the QT interval has been documented. Drug interactions involving concomitant use of other medications that prolong the QT interval or increase citalopram levels by interfering with its metabolism increase the cardiac risk. Regulatory bodies (Health Canada and the US Food and Drug Administration) issued warnings and required labeling changes in 2011/2012, suggesting maximum citalopram doses (<40 mg for those <65 years; <20 mg for those ≥65 years) and avoiding drug interactions that increase cardiac risk. The purpose of this study is to assess the impact of these warnings on citalopram prescribing practices. Methods A quasi-experimental interrupted time series analysis was conducted using all citalopram prescribing data from the population of Manitoba, Canada from 1999 to 2014. This allowed for the examination of high-dose prescribing (above regulatory warning levels) and the number of interacting medications per citalopram prescription. Results There was a dramatic decline in the prescribing of high doses in both age groups, with a 64.8% decline in those <65 years and 33.6% in those ≥65 years. Segmented regression models indicated significant breakpoints in the third quarter of 2011 for both age groups (P<0.0001), corresponding to the time the regulatory warnings were issued. There appeared to be no impact of the warnings on the prescribing of interacting medications. The number of interacting medications actually increased in the postwarning period (<65, 0.78–0.81 interactions per citalopram prescription; ≥65, 0.93–0.94, P<0.001). Conclusion Regulatory changes appear to have produced an important reduction in the high-dose prescribing of citalopram. In contrast to this relatively simple dosage change, there was no indication that the more complex issue of resolving drug–drug interactions

  2. 77 FR 76325 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-27

    ... Effectiveness of Proposed Rule Change Relating to the Acceptance of Letters of Credit or Pass-Through Letters of... requests to use Letters of Credit or Pass through Letters of Credit to meet Initial/Original Margin... Energy Clearing Members to deposit Letters of Credit or Pass-Through Letters of Credit to cover...

  3. Water-balance uncertainty in Honduras: a limits-of-acceptability approach to model evaluation using a time-variant rating curve

    NASA Astrophysics Data System (ADS)

    Westerberg, I.; Guerrero, J.-L.; Beven, K.; Seibert, J.; Halldin, S.; Lundin, L.-C.; Xu, C.-Y.

    2009-04-01

    The climate of Central America is highly variable both spatially and temporally; extreme events like floods and droughts are recurrent phenomena posing great challenges to regional water-resources management. Scarce and low-quality hydro-meteorological data complicate hydrological modelling and few previous studies have addressed the water-balance in Honduras. In the alluvial Choluteca River, the river bed changes over time as fill and scour occur in the channel, leading to a fast-changing relation between stage and discharge and difficulties in deriving consistent rating curves. In this application of a four-parameter water-balance model, a limits-of-acceptability approach to model evaluation was used within the General Likelihood Uncertainty Estimation (GLUE) framework. The limits of acceptability were determined for discharge alone for each time step, and ideally a simulated result should always be contained within the limits. A moving-window weighted fuzzy regression of the ratings, based on estimated uncertainties in the rating-curve data, was used to derive the limits. This provided an objective way to determine the limits of acceptability and handle the non-stationarity of the rating curves. The model was then applied within GLUE and evaluated using the derived limits. Preliminary results show that the best simulations are within the limits 75-80% of the time, indicating that precipitation data and other uncertainties like model structure also have a significant effect on predictability.

  4. Replacement of in vivo acute oral toxicity studies by in vitro cytotoxicity methods: opportunities, limits and regulatory status.

    PubMed

    Ukelis, Ute; Kramer, Peter-Jürgen; Olejniczak, Klaus; Mueller, Stefan O

    2008-06-01

    The development of a new medicinal product is a long and costly process in particular due to the regulatory requirements for quality, safety and efficacy. There is a common interest to increase the efficiency of drug development and to provide new, better quality medicinal products much faster to the public. One possible way to economize time and costs, as well as to consider animal protection issues, is to introduce new alternative methods into non-clinical toxicity testing. Currently, animal tests are mandatory for the evaluation of acute toxicity of chemicals and new drugs. The replacement of the in vivo tests by alternative in vitro assays would offer the opportunity to screen and assess numerous compounds at the same time, to predict acute oral toxicity and thus accelerate drug development. Moreover, the substitution of in vivo tests by in vitro methods shows a proactive pursuit of ethical and animal welfare issues. Importantly, the implementation of in vitro assays for acute oral toxicity would require the establishment of common test guidelines across the EU, USA and Japan, i.e., the regions of ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). Presently, alternative in vitro tests are being investigated internationally. Yet, in order to achieve regulatory acceptance and implementation of in vitro assays, convincing results from validation studies are required. In this review, we discuss the current regulatory status of acute oral toxicity testing and point out achievements of alternative methods. We describe the application of in vitro tests, correlating in vitro with in vivo data. The use of in vitro data to predict in vivo acute oral toxicity is analyzed using the Registry of Cytotoxicity, an official independent database. We have then analyzed opportunities and drawbacks for future implementation of in vitro test methods, with particular focus on industrial use.

  5. 50 CFR 648.53 - Acceptable biological catch (ABC), annual catch limits (ACL), annual catch targets (ACT), DAS...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... divided as sub-ACLs between limited access vessels, limited access vessels that are fishing under a LAGC... adjustment. (i) The limited access fishery sub-ACLs for fishing years 2014 and 2015 are: (A) 2014: 18,885 mt...). (i) The ACLs for fishing years 2014 and 2015 for LAGC IFQ vessels without a limited access...

  6. 50 CFR 648.53 - Acceptable biological catch (ABC), annual catch limits (ACL), annual catch targets (ACT), DAS...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... divided as sub-ACLs between limited access vessels, limited access vessels that are fishing under a LAGC... adjustment. (i) The limited access fishery sub-ACLs for fishing years 2013 and 2014 are: (A) 2013: 19,093 mt... paragraph (a). (i) The ACLs for fishing years 2013 and 2014 for LAGC IFQ vessels without a limited...

  7. Natural variations in expression of regulatory and detoxification related genes under limiting phosphate and arsenate stress in Arabidopsis thaliana

    PubMed Central

    Shukla, Tapsi; Kumar, Smita; Khare, Ria; Tripathi, Rudra D.; Trivedi, Prabodh K.

    2015-01-01

    Abiotic stress including nutrient deficiency and heavy metal toxicity severely affects plant growth, development, and productivity. Genetic variations within and in between species are one of the important factors in establishing interactions and responses of plants with the environment. In the recent past, natural variations in Arabidopsis thaliana have been used to understand plant development and response toward different stresses at genetic level. Phosphorus deficiency negatively affects plant growth and metabolism and modulates expression of the genes involved in Pi homeostasis. Arsenate, As(V), a chemical analog of Pi, is taken up by the plants via phosphate transport system. Studies suggest that during Pi deficiency, enhanced As(V) uptake leads to increased toxicity in plants. Here, the natural variations in Arabidopsis have been utilized to study the As(V) stress response under limiting Pi condition. The primary root length was compared to identify differential response of three Arabidopsis accessions (Col-0, Sij-1, and Slavi-1) under limiting Pi and As(V) stress. To study the molecular mechanisms responsible for the differential response, comprehensive expression profiling of the genes involved in uptake, detoxification, and regulatory mechanisms was carried out. Analysis suggests genetic variation-dependent regulatory mechanisms may affect differential response of Arabidopsis natural variants toward As(V) stress under limiting Pi condition. Therefore, it is hypothesized that detailed analysis of the natural variations under multiple stress conditions might help in the better understanding of the biological processes involved in stress tolerance and adaptation. PMID:26557133

  8. 50 CFR 648.53 - Acceptable biological catch (ABC), annual catch limits (ACL), annual catch targets (ACT), DAS...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... catch limits (ACL), annual catch targets (ACT), DAS allocations, and individual fishing quotas (IFQ... limits (ACL), annual catch targets (ACT), DAS allocations, and individual fishing quotas (IFQ). (a... limited access scallop fishery shall be allocated 94.5 percent of the ACL specified in paragraph (a)(1)...

  9. 50 CFR 648.53 - Acceptable biological catch (ABC), annual catch limits (ACL), annual catch targets (ACT), DAS...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... divided as sub-ACLs between limited access vessels, limited access vessels that are fishing under a... limited access fishery sub-ACLs for fishing years 2011 through 2013 are: (A) 2011: 24,954 mt. (B) 2012: 26... catch, observer set-aside, and research set-aside, as specified in this paragraph (a). The LAGC ACLs...

  10. LIMS user acceptance testing.

    PubMed

    Klein, Corbett S

    2003-01-01

    Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).

  11. Transcriptional and translational regulatory responses to iron limitation in the globally distributed marine bacterium Candidatus Pelagibacter ubique

    SciTech Connect

    Smith, Daniel P.; Kitner, J. B.; Norbeck, Angela D.; Clauss, Therese RW; Lipton, Mary S.; Schwalbach, M. S.; Steindler, L.; Nicora, Carrie D.; Smith, Richard D.; Giovannoni, Stephen J.

    2010-05-05

    Abstract Background: Iron is recognized as an important micronutrient that limits microbial plankton productivity over vast regions of the oceans. We investigated the gene expression responses of Candidatus Pelagibacter ubique cultures to iron limitation in natural seawater media supplemented with a siderophore to chelate iron. Methodology/Principal Findings: Microarray data indicated transcription of the periplasmic iron binding protein sfuC increased by 16-fold, and iron transporter subunits, iron-sulfur center assembly genes, and the putative ferroxidase rubrerythrin transcripts increased to a lesser extent. Quantitative peptide mass spectrometry revealed that sfuC protein abundance increased 27-fold, despite an average decrease of 59% across the global proteome. Two RNA-binding proteins, CspE and CspL, correlated well with iron availability, suggesting that they may contribute to the observed differences between the transcriptome and proteome. Conclusions/Significance: We propose sfuC as a marker gene for indicating iron limitation in marine metatranscriptomic and metaproteomic ecological surveys. The marked proteome reduction was not directly correlated to changes in the transcriptome, implicating post-transcriptional regulatory mechanisms as modulators of protein expression. We propose a model in which the RNA-binding activity of cspE and cspL selectively enables protein synthesis of the iron acquisition protein sfuC during transient growth-limiting episodes of iron scarcity.

  12. A novel chemometric classification for FTIR spectra of mycotoxin-contaminated maize and peanuts at regulatory limits.

    PubMed

    Kos, Gregor; Sieger, Markus; McMullin, David; Zahradnik, Celine; Sulyok, Michael; Öner, Tuba; Mizaikoff, Boris; Krska, Rudolf

    2016-10-01

    The rapid identification of mycotoxins such as deoxynivalenol and aflatoxin B1 in agricultural commodities is an ongoing concern for food importers and processors. While sophisticated chromatography-based methods are well established for regulatory testing by food safety authorities, few techniques exist to provide a rapid assessment for traders. This study advances the development of a mid-infrared spectroscopic method, recording spectra with little sample preparation. Spectral data were classified using a bootstrap-aggregated (bagged) decision tree method, evaluating the protein and carbohydrate absorption regions of the spectrum. The method was able to classify 79% of 110 maize samples at the European Union regulatory limit for deoxynivalenol of 1750 µg kg(-1) and, for the first time, 77% of 92 peanut samples at 8 µg kg(-1) of aflatoxin B1. A subset model revealed a dependency on variety and type of fungal infection. The employed CRC and SBL maize varieties could be pooled in the model with a reduction of classification accuracy from 90% to 79%. Samples infected with Fusarium verticillioides were removed, leaving samples infected with F. graminearum and F. culmorum in the dataset improving classification accuracy from 73% to 79%. A 500 µg kg(-1) classification threshold for deoxynivalenol in maize performed even better with 85% accuracy. This is assumed to be due to a larger number of samples around the threshold increasing representativity. Comparison with established principal component analysis classification, which consistently showed overlapping clusters, confirmed the superior performance of bagged decision tree classification.

  13. DWPF COAL-CARBON WASTE ACCEPTANCE CRITERIA LIMIT EVALUATION BASED ON EXPERIMENTAL WORK (TANK 48 IMPACT STUDY)

    SciTech Connect

    Lambert, D.; Choi, A.

    2010-10-15

    This report summarizes the results of both experimental and modeling studies performed using Sludge Batch 10 (SB10) simulants and FBSR product from Tank 48 simulant testing in order to develop higher levels of coal-carbon that can be managed by DWPF. Once the Fluidized Bed Steam Reforming (FBSR) process starts up for treatment of Tank 48 legacy waste, the FBSR product stream will contribute higher levels of coal-carbon in the sludge batch for processing at DWPF. Coal-carbon is added into the FBSR process as a reductant and some of it will be present in the FBSR product as unreacted coal. The FBSR product will be slurried in water, transferred to Tank Farm and will be combined with sludge and washed to produce the sludge batch that DWPF will process. The FBSR product is high in both water soluble sodium carbonate and unreacted coal-carbon. Most of the sodium carbonate is removed during washing but all of the coal-carbon will remain and become part of the DWPF sludge batch. A paper study was performed earlier to assess the impact of FBSR coal-carbon on the DWPF Chemical Processing Cell (CPC) operation and melter off-gas flammability by combining it with SB10-SB13. The results of the paper study are documented in Ref. 7 and the key findings included that SB10 would be the most difficult batch to process with the FBSR coal present and up to 5,000 mg/kg of coal-carbon could be fed to the melter without exceeding the off-gas flammability safety basis limits. In the present study, a bench-scale demonstration of the DWPF CPC processing was performed using SB10 simulants spiked with varying amounts of coal, and the resulting seven CPC products were fed to the DWPF melter cold cap and off-gas dynamics models to determine the maximum coal that can be processed through the melter without exceeding the off-gas flammability safety basis limits. Based on the results of these experimental and modeling studies, the presence of coal-carbon in the sludge feed to DWPF is found to have

  14. Deriving persistence indicators from regulatory water-sediment studies – opportunities and limitations in OECD 308 data.

    PubMed

    Honti, Mark; Fenner, Kathrin

    2015-05-19

    The OECD guideline 308 describes a laboratory test method to assess aerobic and anaerobic transformation of organic chemicals in aquatic sediment systems and is an integral part of tiered testing strategies in different legislative frameworks for the environmental risk assessment of chemicals. The results from experiments carried out according to OECD 308 are generally used to derive persistence indicators for hazard assessment or half-lives for exposure assessment. We used Bayesian parameter estimation and system representations of various complexities to systematically assess opportunities and limitations for estimating these indicators from existing data generated according to OECD 308 for 23 pesticides and pharmaceuticals. We found that there is a disparity between the uncertainty and the conceptual robustness of persistence indicators. Disappearance half-lives are directly extractable with limited uncertainty, but they lump degradation and phase transfer information and are not robust against changes in system geometry. Transformation half-lives are less system-specific but require inverse modeling to extract, resulting in considerable uncertainty. Available data were thus insufficient to derive indicators that had both acceptable robustness and uncertainty, which further supports previously voiced concerns about the usability and efficiency of these costly experiments. Despite the limitations of existing data, we suggest the time until 50% of the parent compound has been transformed in the entire system (DegT(50,system)) could still be a useful indicator of persistence in the upper, partially aerobic sediment layer in the context of PBT assessment. This should, however, be accompanied by a mandatory reporting or full standardization of the geometry of the experimental system. We recommend transformation half-lives determined by inverse modeling to be used as input parameters into fate models for exposure assessment, if due consideration is given to their

  15. Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.

    PubMed

    Grabowski, Henry G; Guha, Rahul; Salgado, Maria

    2014-06-01

    In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability-which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws-most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents. In other words, biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer's reputation with physicians, insurers, and patient groups. Biosimilars also will face dynamic competition from new biologics in the same therapeutic class-including "biobetters," which offer incremental improvements on reference products, such as extended duration of action. The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors.

  16. 13 CFR 124.504 - What circumstances limit SBA's ability to accept a procurement for award as an 8(a) contract?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... offer and acceptance. The procuring activity competed a requirement among Participants prior to offering... is offered to the 8(a) BD program. (2) In determining whether the acceptance of a requirement would... requests in writing that SBA decline to accept the offer prior to SBA's acceptance of the requirement...

  17. Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin

    PubMed Central

    Wildi, Karin; Gimenez, Maria Rubini; Twerenbold, Raphael; Reichlin, Tobias; Jaeger, Cedric; Heinzelmann, Amely; Arnold, Christiane; Nelles, Berit; Druey, Sophie; Haaf, Philip; Hillinger, Petra; Schaerli, Nicolas; Kreutzinger, Philipp; Tanglay, Yunus; Herrmann, Thomas; Moreno Weidmann, Zoraida; Krivoshei, Lian; Freese, Michael; Stelzig, Claudia; Puelacher, Christian; Rentsch, Katharina; Osswald, Stefan

    2015-01-01

    Background— Misdiagnosis of acute myocardial infarction (AMI) may significantly harm patients and may result from inappropriate clinical decision values (CDVs) for cardiac troponin (cTn) owing to limitations in the current regulatory process. Methods and Results— In an international, prospective, multicenter study, we quantified the incidence of inconsistencies in the diagnosis of AMI using fully characterized and clinically available high-sensitivity (hs) cTn assays (hs-cTnI, Abbott; hs-cTnT, Roche) among 2300 consecutive patients with suspected AMI. We hypothesized that the approved CDVs for the 2 assays are not biologically equivalent and might therefore contribute to inconsistencies in the diagnosis of AMI. Findings were validated by use of sex-specific CDVs and parallel measurements of other hs-cTnI assays. AMI was the adjudicated diagnosis in 473 patients (21%). Among these, 86 patients (18.2%) had inconsistent diagnoses when the approved uniform CDV was used. When sex-specific CDVs were used, 14.1% of female and 22.7% of male AMI patients had inconsistent diagnoses. Using biologically equivalent CDV reduced inconsistencies to 10% (P<0.001). These findings were confirmed with parallel measurements of other hs-cTn assays. The incidence of inconsistencies was only 7.0% for assays with CDVs that were nearly biologically equivalent. Patients with inconsistent AMI had long-term mortality comparable to that of patients with consistent diagnoses (P=NS) and a trend toward higher long-term mortality than patients diagnosed with unstable angina (P=0.05). Conclusions— Currently approved CDVs are not biologically equivalent and contribute to major inconsistencies in the diagnosis of AMI. One of 5 AMI patients will receive a diagnosis other than AMI if managed with the alternative hs-cTn assay. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587. PMID:25948541

  18. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Idaho. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Idaho state legislature has created the Idaho Public Utilities Commission and has given the Commission the power and jurisdiction to supervise and regulate every public utility in the state. The Commission is comprised of three members appointed by the governor with the approval of the senate. Commissioners serve full time and are appointed for six year terms. No more than two of the members may be from the same political party. Title 61 of the Idaho Code, which establishes the Commission and delineates its powers, vests all regulatory responsibility in the Commission to the exclusion of local government. However, as an incident to their franchising power, municipalities may impose reasonable regulations on the use of their streets. The Idaho Supreme Court holds that the transfer of regulatory power over public utilities to the Commission did not diminish the powers and duties of municipalities to control and maintain their streets and alleys. Limited statutory authority also exists giving municipalities the power to regulate the fares, rates, rentals, or charges made for the service rendered under any franchise granted in such city, except such as are subject to regulation by the Public Utilities Commission. With the exception of this limited power, the Commission is the sole agency having regulatory power over Idaho public utilities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  19. Limiter

    DOEpatents

    Cohen, S.A.; Hosea, J.C.; Timberlake, J.R.

    1984-10-19

    A limiter with a specially contoured front face is provided. The front face of the limiter (the plasma-side face) is flat with a central indentation. In addition, the limiter shape is cylindrically symmetric so that the limiter can be rotated for greater heat distribution. This limiter shape accommodates the various power scrape-off distances lambda p, which depend on the parallel velocity, V/sub parallel/, of the impacting particles.

  20. Limiter

    DOEpatents

    Cohen, Samuel A.; Hosea, Joel C.; Timberlake, John R.

    1986-01-01

    A limiter with a specially contoured front face accommodates the various power scrape-off distances .lambda..sub.p, which depend on the parallel velocity, V.sub..parallel., of the impacting particles. The front face of the limiter (the plasma-side face) is flat with a central indentation. In addition, the limiter shape is cylindrically symmetric so that the limiter can be rotated for greater heat distribution.

  1. Independent Verification and Validation Of SAPHIRE 8 Software Acceptance Test Plan Project Number: N6423 U.S. Nuclear Regulatory Commission

    SciTech Connect

    Kent Norris

    2010-03-01

    The purpose of the Independent Verification and Validation (IV&V) role in the evaluation of the SAPHIRE 8 Software Acceptance Test Plan is to assess the approach to be taken for intended testing activities. The plan typically identifies the items to be tested, the requirements being tested, the testing to be performed, test schedules, personnel requirements, reporting requirements, evaluation criteria, and any risks requiring contingency planning. The IV&V team began this endeavor after the software engineering and software development of SAPHIRE had already been in production.

  2. CD25+ natural regulatory T cells are critical in limiting innate and adaptive immunity and resolving disease following respiratory syncytial virus infection.

    PubMed

    Lee, Debbie C P; Harker, James A E; Tregoning, John S; Atabani, Sowsan F; Johansson, Cecilia; Schwarze, Jürgen; Openshaw, Peter J M

    2010-09-01

    Regulatory CD4(+) T cells have been shown to be important in limiting immune responses, but their role in respiratory viral infections has received little attention. Here we observed that following respiratory syncytial virus (RSV) infection, CD4(+) Foxp3(+) CD25(+) natural regulatory T-cell numbers increased in the bronchoalveolar lavage fluid, lung, mediastinal lymph nodes, and spleen. The depletion of CD25(+) natural regulatory T cells prior to RSV infection led to enhanced weight loss with delayed recovery that was surprisingly accompanied by increased numbers of activated natural killer cells in the lung and bronchoalveolar lavage fluid on day 8 postinfection. Increased numbers of neutrophils were also detected within the bronchoalveolar lavage fluid and correlated with elevated levels of myeloperoxidase as well as interleukin-6 (IL-6) and gamma interferon (IFN-gamma). CD25(+) natural regulatory T-cell depletion also led to enhanced numbers of proinflammatory T cells producing IFN-gamma and tumor necrosis factor alpha (TNF-alpha) in the lung. Despite these increases in inflammatory responses and disease severity, the viral load was unaltered. This work highlights a critical role for natural regulatory T cells in regulating the adaptive and innate immune responses during the later stages of lung viral infections.

  3. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Louisiana. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Louisiana Public Service Commission, composed of five members elected by the general electorate and elected for six-year terms. The Commission is charged with regulating all public utilities and has such other regulatory authority as provided by law. The Commission, however, has no power to regulate a public utility owned, operated, or regulated on the effective data of this constitution (1921) by the governing authority of one or more political subdivisions unless the Commission is authorized to regulate these utilities by the electorate of the political subdivision involved. An additional statutory provision excludes all municipally-owned public utilities from Commission regulation. New Orleans has retained the regulatory authority which it held as of the effective date of the Louisiana Constitution. Therefore, the Commission exercises no regulatory powers over investor or municipally-owned utilities in New Orleans. A municipality is empowered to own and operate a revenue-producing public utility within or without its boundaries and it may sell and distribute the commodity or service of the public utility within or without its corporate limits and may establish rates, rules, and regulations with respect to the sale and distribution. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  4. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in California. Preliminary background report

    SciTech Connect

    Feurer, D.A.; Weaver, C.L.; Gallagher, K.C.; Hejna, D.; Rielley, K.J.

    1980-01-01

    The Constitution of the State of California grants to the Legislature control over persons and private corporations that own or operate a line, plant, or system for the production, generation, or transmission of heat, light, water, or power to be furnished either directly or indirectly to or for the public. The Constitution establishes the Public Utilities Commission and grants certain specific powers to the PUC, including the power to fix rates, establish rules and prescribe a uniform system of accounts. The Constitution also recognizes that the Legislature has plenary power to confer additional authority and jurisdiction upon the PUC. The Constitution prohibits regulation by a city, county, or other municipal body of matters over which the Legislature has granted regulatory power to the PUC. This provision does not, however, impair the right of any city to grant franchises for public utilities. The California legislature has enacted the California Public Utilities Code and has designated the PUC as the agency to implement the regulatory provisions of the Code. The Public Utilities Commission consists of five members appointed by the governor and approved by the senate, a majority of the membership concurring, for staggered 6-year terms. Certain limited powers over the conduct of public utilities may still be exercised by municipalities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  5. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Nebraska. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The state agency with principal authority to regulate electric public utilities is the Power Review Board (Board). However, the Board in fact, exercised little regulatory authority over heat and power utilities because all electrical power in Nebraska is currently supplied by public authorities and is not subject to regulation by the Board. Gas and water utilities are also subject to general supervision by municipalities. The Board is compised of five members - an attorney, an engineer, one accountant, two lay - persons appointed by the governor and confirmed by the legislature. All members are appointed to overlapping four-year terms, and none may serve more than two consecutive terms. Decisions by the Board require the approval of a majority of its members. The Public Service Commission of Nebraska is a constitutionally created body. Its powers and duties include the regulation of rates, service, and general control of common carriers as the legislature may provide by law. Other state agencies also possess limited regulatory jurisdiction which may be relevant to an energy facility. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  6. Phase II Fort Ord Landfill Demonstration Task 8 - Refinement of In-line Instrumental Analytical Tools to Evaluate their Operational Utility and Regulatory Acceptance

    SciTech Connect

    Daley, P F

    2006-04-03

    The overall objective of this project is the continued development, installation, and testing of continuous water sampling and analysis technologies for application to on-site monitoring of groundwater treatment systems and remediation sites. In a previous project, an on-line analytical system (OLAS) for multistream water sampling was installed at the Fort Ord Operable Unit 2 Groundwater Treatment System, with the objective of developing a simplified analytical method for detection of Compounds of Concern at that plant, and continuous sampling of up to twelve locations in the treatment system, from raw influent waters to treated effluent. Earlier implementations of the water sampling and processing system (Analytical Sampling and Analysis Platform, A A+RT, Milpitas, CA) depended on off-line integrators that produced paper plots of chromatograms, and sent summary tables to a host computer for archiving. We developed a basic LabVIEW (National Instruments, Inc., Austin, TX) based gas chromatography control and data acquisition system that was the foundation for further development and integration with the ASAP system. Advantages of this integration include electronic archiving of all raw chromatographic data, and a flexible programming environment to support development of improved ASAP operation and automated reporting. The initial goals of integrating the preexisting LabVIEW chromatography control system with the ASAP, and demonstration of a simplified, site-specific analytical method were successfully achieved. However, although the principal objective of this system was assembly of an analytical system that would allow plant operators an up-to-the-minute view of the plant's performance, several obstacles remained. Data reduction with the base LabVIEW system was limited to peak detection and simple tabular output, patterned after commercial chromatography integrators, with compound retention times and peak areas. Preparation of calibration curves, method detection

  7. Proinsulin multi-peptide immunotherapy induces antigen-specific regulatory T cells and limits autoimmunity in a humanized model

    PubMed Central

    Gibson, V B; Nikolic, T; Pearce, V Q; Demengeot, J; Roep, B O; Peakman, M

    2015-01-01

    Peptide immunotherapy (PIT) is a targeted therapeutic approach, involving administration of disease-associated peptides, with the aim of restoring antigen-specific immunological tolerance without generalized immunosuppression. In type 1 diabetes, proinsulin is a primary antigen targeted by the autoimmune response, and is therefore a strong candidate for exploitation via PIT in this setting. To elucidate the optimal conditions for proinsulin-based PIT and explore mechanisms of action, we developed a preclinical model of proinsulin autoimmunity in a humanized HLA-DRB1*0401 transgenic HLA-DR4 Tg mouse. Once proinsulin-specific tolerance is broken, HLA-DR4 Tg mice develop autoinflammatory responses, including proinsulin-specific T cell proliferation, interferon (IFN)-γ and autoantibody production. These are preventable and quenchable by pre- and post-induction treatment, respectively, using intradermal proinsulin-PIT injections. Intradermal proinsulin-PIT enhances proliferation of regulatory [forkhead box protein 3 (FoxP3+)CD25high] CD4 T cells, including those capable of proinsulin-specific regulation, suggesting this as its main mode of action. In contrast, peptide delivered intradermally on the surface of vitamin D3-modulated (tolerogenic) dendritic cells, controls autoimmunity in association with proinsulin-specific IL-10 production, but no change in regulatory CD4 T cells. These studies define a humanized, translational model for in vivo optimization of PIT to control autoimmunity in type 1 diabetes and indicate that dominant mechanisms of action differ according to mode of peptide delivery. PMID:26206289

  8. Cost tradeoffs in consequence management at nuclear power plants: A risk based approach to setting optimal long-term interdiction limits for regulatory analyses

    SciTech Connect

    Mubayi, V.

    1995-05-01

    The consequences of severe accidents at nuclear power plants can be limited by various protective actions, including emergency responses and long-term measures, to reduce exposures of affected populations. Each of these protective actions involve costs to society. The costs of the long-term protective actions depend on the criterion adopted for the allowable level of long-term exposure. This criterion, called the ``long term interdiction limit,`` is expressed in terms of the projected dose to an individual over a certain time period from the long-term exposure pathways. The two measures of offsite consequences, latent cancers and costs, are inversely related and the choice of an interdiction limit is, in effect, a trade-off between these two measures. By monetizing the health effects (through ascribing a monetary value to life lost), the costs of the two consequence measures vary with the interdiction limit, the health effect costs increasing as the limit is relaxed and the protective action costs decreasing. The minimum of the total cost curve can be used to calculate an optimal long term interdiction limit. The calculation of such an optimal limit is presented for each of five US nuclear power plants which were analyzed for severe accident risk in the NUREG-1150 program by the Nuclear Regulatory Commission.

  9. 13 CFR 124.504 - What circumstances limit SBA's ability to accept a procurement for award as an 8(a) contract?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... impact on an individual small business, SBA will consider all relevant factors. (i) In connection with a... impact on other small business programs, SBA will consider all relevant factors, including but not...) procedures. (c) Adverse impact. SBA has made a written determination that acceptance of the procurement for...

  10. Randomized Trial of a Computerized Touch Screen Decision Aid to Increase Acceptance of Colonoscopy Screening in an African American Population with Limited Literacy.

    PubMed

    Ruzek, Sheryl B; Bass, Sarah Bauerle; Greener, Judith; Wolak, Caitlin; Gordon, Thomas F

    2016-10-01

    The goal of this study was to assess the effectiveness of a touch screen decision aid to increase acceptance of colonoscopy screening among African American patients with low literacy, developed and tailored using perceptual mapping methods grounded in Illness Self-Regulation and Information-Communication Theories. The pilot randomized controlled trial investigated the effects of a theory-based intervention on patients' acceptance of screening, including their perceptions of educational value, feelings about colonoscopy, likelihood to undergo screening, and decisional conflict about colonoscopy screening. Sixty-one African American patients with low literacy, aged 50-70 years, with no history of colonoscopy, were randomly assigned to receive a computerized touch screen decision aid (CDA; n = 33) or a literacy appropriate print tool (PT; n = 28) immediately before a primary care appointment in an urban, university-affiliated general internal medicine clinic. Patients rated the CDA significantly higher than the PT on all indicators of acceptance, including the helpfulness of the information for making a screening decision, and reported positive feelings about colonoscopy, greater likelihood to be screened, and lower decisional conflict. Results showed that a touch screen decision tool is acceptable to African American patients with low iteracy and, by increasing intent to screen, may increase rates of colonoscopy screening.

  11. 77 FR 75466 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Designation of a Longer Period...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... for Commission Action on Proposed Rule Change To Clear Western European Sovereign CDS Contracts December 14, 2012. On October 15, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the... proposed rule change was published for comment in the Federal Register on November 2, 2012.\\3\\...

  12. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Virginia. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilties is vested generally in the State Corporation Commission. The Commission is comprised of three members elected by a joint vote of the two houses of the general assembly. Commissioners serve six-year terms. They must be free from any employment or pecuniary interests in any company subject to the supervision and regulation of the Commission. The Commission is charged with the primary responsibility of supervising and regulating public utilities. However, local governments retain the power to grant franchises and otherwise regulate the use of streets and other public property. In addition, municipally-owned utilities are not within the jurisdiction of the Commission to the extent that they operate within corporate limits. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  13. The acceptance of in silico models for REACH: Requirements, barriers, and perspectives

    PubMed Central

    2011-01-01

    In silico models have prompted considerable interest and debate because of their potential value in predicting the properties of chemical substances for regulatory purposes. The European REACH legislation promotes innovation and encourages the use of alternative methods, but in practice the use of in silico models is still very limited. There are many stakeholders influencing the regulatory trajectory of quantitative structure-activity relationships (QSAR) models, including regulators, industry, model developers and consultants. Here we outline some of the issues and challenges involved in the acceptance of these methods for regulatory purposes. PMID:21982269

  14. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in New Mexico. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the New Mexico Public Service Commission. The Commission is composed of three members appointed by the governor with the advice and consent of the senate. Commission members, who are to be competent persons and qualified electors of (New Mexico), are appointed for six year terms. They must be free from any pecuniary or employment interests incompatible with the duties of the Commission. The Commission possesses the exclusive power to regulate public utilities. The Commission, however, exercises no authority over utilities owned by municipal corporations or H class counties (counties under 54 square miles in area) unless the general electorate of the municipality or county elects to bring such utilities within the jurisdiction of the Commission. Municipalities may establish by contract, rates between the municipality and investor-owned utilities. Such contracts are limited to 25 years in duration and are subject to Commission approval. There is no specific procedure for review of local decisions regarding municipally-owned utilities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  15. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Minnesota. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Minnesota Public Service Commission (PSC) in the Department of Public Service is authorized by statute to regulate public utilities. The PSC consists of five members appointed by the governor with the advice and consent of the senate to terms running for six years. Not more than three commissioners are to belong to the same political party. The commissioners are not to derive any significant portion of their income directly or indirectly from any public utility. Municipalities also have a limited role in the regulation of public utilities. If the municipality controls the exercise of a public utility franchise, it is authorized to assist the PSC as amicus curiae in proceedings with respect to the rates, fares, prices, regulation, or control of a utility operating in the municipality. Municipal utilities are exempt from regulation by the PSC because municipal utilities are presently effectively regulated by the residents of the municipalities which own and operate them. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  16. Acceptance speech.

    PubMed

    Yusuf, C K

    1994-01-01

    I am proud and honored to accept this award on behalf of the Government of Bangladesh, and the millions of Bangladeshi children saved by oral rehydration solution. The Government of Bangladesh is grateful for this recognition of its commitment to international health and population research and cost-effective health care for all. The Government of Bangladesh has already made remarkable strides forward in the health and population sector, and this was recognized in UNICEF's 1993 "State of the World's Children". The national contraceptive prevalence rate, at 40%, is higher than that of many developed countries. It is appropriate that Bangladesh, where ORS was discovered, has the largest ORS production capacity in the world. It was remarkable that after the devastating cyclone in 1991, the country was able to produce enough ORS to meet the needs and remain self-sufficient. Similarly, Bangladesh has one of the most effective, flexible and efficient control of diarrheal disease and epidemic response program in the world. Through the country, doctors have been trained in diarrheal disease management, and stores of ORS are maintained ready for any outbreak. Despite grim predictions after the 1991 cyclone and the 1993 floods, relatively few people died from diarrheal disease. This is indicative of the strength of the national program. I want to take this opportunity to acknowledge the contribution of ICDDR, B and the important role it plays in supporting the Government's efforts in the health and population sector. The partnership between the Government of Bangladesh and ICDDR, B has already borne great fruit, and I hope and believe that it will continue to do so for many years in the future. Thank you.

  17. Ubiquitylation activates a peptidase that promotes cleavage and destabilization of its activating E3 ligases and diverse growth regulatory proteins to limit cell proliferation in Arabidopsis

    PubMed Central

    Dong, Hui; Dumenil, Jack; Lu, Fu-Hao; Na, Li; Vanhaeren, Hannes; Naumann, Christin; Klecker, Maria; Prior, Rachel; Smith, Caroline; McKenzie, Neil; Saalbach, Gerhard; Chen, Liangliang; Xia, Tian; Gonzalez, Nathalie; Seguela, Mathilde; Inzé, Dirk; Dissmeyer, Nico; Li, Yunhai; Bevan, Michael W.

    2017-01-01

    The characteristic shapes and sizes of organs are established by cell proliferation patterns and final cell sizes, but the underlying molecular mechanisms coordinating these are poorly understood. Here we characterize a ubiquitin-activated peptidase called DA1 that limits the duration of cell proliferation during organ growth in Arabidopsis thaliana. The peptidase is activated by two RING E3 ligases, Big Brother (BB) and DA2, which are subsequently cleaved by the activated peptidase and destabilized. In the case of BB, cleavage leads to destabilization by the RING E3 ligase PROTEOLYSIS 1 (PRT1) of the N-end rule pathway. DA1 peptidase activity also cleaves the deubiquitylase UBP15, which promotes cell proliferation, and the transcription factors TEOSINTE BRANCED 1/CYCLOIDEA/PCF 15 (TCP15) and TCP22, which promote cell proliferation and repress endoreduplication. We propose that DA1 peptidase activity regulates the duration of cell proliferation and the transition to endoreduplication and differentiation during organ formation in plants by coordinating the destabilization of regulatory proteins. PMID:28167503

  18. Two-component regulatory proteins ResD-ResE are required for transcriptional activation of fnr upon oxygen limitation in Bacillus subtilis.

    PubMed Central

    Nakano, M M; Zuber, P; Glaser, P; Danchin, A; Hulett, F M

    1996-01-01

    Bacillus subtilis can grow anaerobically in the presence of nitrate as a terminal electron acceptor. The two component regulatory proteins, ResD and ResE, and an anaerobic gene regulator, FNR, were previously shown to be indispensable for nitrate respiration in B. subtilis. Unlike Escherichia coli fnr, B. subtilis fnr transcription was shown to be highly induced by oxygen limitation. fnr is transcribed from its own promoter as well as from a promoter located upstream of narK, the first gene in the narK-fnr dicistronic operon. DNA fragments containing the narK promoter, the fnr promoter, and both of the promoters were used to construct three lacZ fusions to examine the transcriptional regulation of the narK-fnr operon. ResDE was found to be required for transcriptional activation of fnr from the fnr-specific promoter, and FNR was required for activation of narK-fnr transcription from the FNR-dependent narK operon promoter under anaerobiosis. In order to determine if the requirement for ResDE in nitrate respiration is solely to activate fnr transcription, fnr was placed under control of the IPTG (isopropyl-beta-D-thiogalactopyranoside)-inducible promoter, Pspac. The observed defect in anaerobic growth of a Pspac-fnr delta resDE mutant in the presence of IPTG indicated that resDE has an additional role in B. subtilis anaerobic gene regulation. PMID:8682783

  19. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Texas. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities in Texas is generally vested in the Public Utilities Commission. The Commission is comprised of three members appointed by the governor, with the advice of at least two-thirds of the senate, for a six-year term. Prior to the passage of the Texas Public Utility Regulatory Act (PURA) in 1975, the power to regulate public utilities was vested almost exclusively in municipalities. Under PURA, municipalities retain exclusive original jurisdiction over all electric, water, and sewer utilities within the municipality. PURA provides that all regulations pertaining to public utilities promulgated by local regulatory agencies remain in effect unless they are superceded by Commission rules. The municipality's governing body is required to exercise its regulatory authority under rules and standards consistent with those promulgated by the Commission. The Commission has exclusive appellate jurisdiction to review orders and ordinances of regulatory municipalities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  20. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Arizona. Preliminary background report

    SciTech Connect

    Feurer, D.A.; Weaver, C.L.; Gallagher, K.C.; Hejna, D.; Rielley, K.J.

    1980-01-01

    This report is one of a series of preliminary reports describing the laws and regulatory programs of the United States and each of the 50 states affecting the siting and operation of energy generating facilities likely to be used in Integrated Community Energy Systems (ICES). Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES. This report describes laws and regulatory programs in Arizona. The Arizona state constitution establishes the Arizona Corporation Commission to regulate public service corporations. Within the area of its jurisdiction, the Commission has exclusive power and may not be interfered with by the legislature except in one narrow instance as described in the case Corporation Commission v. Pacific Greyhound Lines.

  1. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Illinois. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Illinois Commerce Commission, comprised of five members appointed by the governor with the advice and consent of the senate and appointed for five year terms. They must be free from any employment or pecuniary interests in any business subject to regulation by the Commission. Local governments may exercise a large degree of regulatory authority over public utilities providing services within a municipality. The question of whether a municipality will exercise regulatory control over local public utilities must be put to the voters of the city. If the proposition is approved by a majority of the voters, the municipality may regulate services and rates and exercise most of the regulatory functions otherwise assigned to the Commission. If any public utility is dissatisfied with any action of a municipality, the utility is entitled to apply to the Commission for review of the action. On review, the Commission may take any determination which it deems just and reasonable. In addition, municipally-owned utilities are excluded specifically from the definition of public utility. These utilities are not within the jurisdiction of the Commission and are regulated locally. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  2. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Kentucky. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    Until April 1, 1979, the Public Service Commission had been vested with exclusive jurisdiction over the regulation of rates and service of utilities. As of that date two new agencies, the Energy Regulatory Commission (ERC) and the Utility Regulatory Commission (URC), have replaced the Public Service Commission. The ERC consists of three full-time members appointed by the governor for four year terms and is responsible for enforcing the provisions of the Kentucky statutes relating to electric and gas utilities. The three-member URC is responsible for enforcing the provisions relating to non-energy utilities such as telephone, sewer, and water utilities. The statutes vest all regulatory authority over public utilities in either the ERC or the URC. Local governments retain only the power to grant local franchises. However, it should be noted, that any utility owned or operated by a political subdivision of the state is exempt from regulation. Thus, local government has complete authority over utilities which are self-owned. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  3. "Visually clean" as a sole acceptance criterion for cleaning validation protocols.

    PubMed

    LeBlanc, Destin A

    2002-01-01

    The role of visual examination as the sole acceptance criterion in cleaning validation protocols is explored, including the proper definition of "visual limit" for a given residue. Such a visual limit is specific to the surface the residue is on, and is further defined by viewing conditions, such as lighting, distance, and angle of viewing. A visually clean standard may only be properly utilized if the visual limit is below any scientifically calculated residue limit, such as that determined by a traditional dose-based limit determination. While such an approach, properly applied, has scientific justification and appears to be accepted by the proposed Annex 15 to the European GMPs, the approach is still untested with regulatory authorities.

  4. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Wyoming. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested in the Wyoming Public Service Commission. The Commission is comprised of three members appointed by the Governor with the advice and consent of the state senate. Each member of the Commission serves a six-year term and no more than two members may be from the same political party. The Commission has exclusive regulatory authority over public utilities. The statutory definition of public utility, however, does not include municipally-owned and operated utility systems to the extent they provide services within the municipality. Such utilities are regulated locally. The Commission reviews no documentation of rates or services of municipallyy-owned systems. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  5. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Hawaii. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities in Hawaii is vested in the Public Utilities Commission. The Commission is composed of three members appointed by the Governor. Commissioners serve for six year terms, must be independent of the companies they regulate and must not possess or acquire an interest in any public utility. The regulatory authority of the Commission preempts that of any other state agency. Local governments have no authority over public utilities. Chapter 196 of the Hawaii statutes establishes the position of the Energy Resources Coordinator; the role of the coordinator, however, is merely to develop, review, and recommend programs for the optimum development of Hawaii's energy resources. The Commission has jurisdiction over all public utilities located in the state. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  6. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Utah. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Utah Public Service Commission comprised of three members appointed by the governor with the consent of the State Senate. Commission members are appointed for six-year terms and must be free from employment and pecuniary interests incompatible with the duties of the Commission. The Commission is charged with the general supervision of public utilities, but its authority does not extend to municipally-owned utilities. Local governments are forbidden from exercising any regulatory powers over public utilities unless the utility is municipally-owned. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  7. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in West Virginia. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the West Virginia Public Service Commission, comprised of three members appointed by the governor with the advice and consent of the state senate. Commissioners are appointed for six year terms. They must be free from any pecuniary or employment interest in public utilities. The Commission possesses the exclusive authority to regulate public utilities. While local governments retain the power to control the use of their streets and to grant franchises to public utilities, they cannot use this power to infringe on the exercise of regulatory power by the Commission. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  8. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Indiana. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Public Service Commission of Indiana. The Commission is comprised of three members appointed by the governor. Commissioners are appointed for four-year terms. They must be free from any employment or pecuniary interest in any public utility. Indiana courts have stated that the Commission was created and vested with regulatory authority over public utilities in order to relieve these utilities from local regulation. Local governments do, however, have specific statutory authority to determine, by contract or ordinance, the quality and character of service to be provided by public utilities within the municipality. Local governments may also regulate the use of streets and other public property by public utilities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  9. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Georgia. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Public Service Commission. The Commission is composed of five members elected to six-year terms by the general electorate. Commissioners must be free of employment or pecuniary interests which are incompatible with the duties of the Commission. The Commission is the only agency that may exert regulatory control over public utilities. The legislature has delegated no regulatory authority to local government. Except for the powers incident to granting a franchise and its normal police powers, municipal corporations do not have any role in the supervision of public utilities. The Commission's general supervisory authority does not extend to public utilities owned or operated by municipal corporations. The jurisdiction of the Commission extends to several specific public utilities, including gas or electric light and power companies. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  10. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in New York. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the New York Public Service Commission. The Commission is composed of five members appointed by the governor with the advice and consent of the senate. Commissioners are appointed for six-year terms. Commissioners may not have any pecuniary or financial interest in any public utility. Local governing bodies are authorized to exercise such power, jurisdiction and authority in enforcing the laws of the state and the orders, rules, and regulations of the commission as may be prescribed by statute or by the commission with respect to public utilities. A Commission spokesman confirmed that no statutes have been passed pursuant to this provision and the Commission has not ceded any of its regulatory powers to local governments. With the exception of the granting of franchises and permits to use public ways, local governments exercise no regulatory powers over public utilities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  11. Rationales for regulatory activity

    SciTech Connect

    Perhac, R.M.

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  12. Sonic boom acceptability studies

    NASA Technical Reports Server (NTRS)

    Shepherd, Kevin P.; Sullivan, Brenda M.; Leatherwood, Jack D.; Mccurdy, David A.

    1992-01-01

    The determination of the magnitude of sonic boom exposure which would be acceptable to the general population requires, as a starting point, a method to assess and compare individual sonic booms. There is no consensus within the scientific and regulatory communities regarding an appropriate sonic boom assessment metric. Loudness, being a fundamental and well-understood attribute of human hearing was chosen as a means of comparing sonic booms of differing shapes and amplitudes. The figure illustrates the basic steps which yield a calculated value of loudness. Based upon the aircraft configuration and its operating conditions, the sonic boom pressure signature which reaches the ground is calculated. This pressure-time history is transformed to the frequency domain and converted into a one-third octave band spectrum. The essence of the loudness method is to account for the frequency response and integration characteristics of the auditory system. The result of the calculation procedure is a numerical description (perceived level, dB) which represents the loudness of the sonic boom waveform.

  13. Making regulatory sense of bioaccumulation data

    SciTech Connect

    Bridges, T.S.; Moore, D.W.; Word, J.Q.

    1995-12-31

    Evaluating the environmental consequences of contaminant bioaccumulation is a complex technical and regulatory problem. This problem is exacerbated by the high cost of bioaccumulation testing and the lack of explicit regulatory guidance on how bioaccumulation data should be interpreted and used within a regulatory program. The lack of explicit interpretive guidance has resulted in poorly focused attempts to use this data to make decisions about the management of contaminated sediments. Technical advances in the ability to detect very small quantities of toxicant within the tissues of organisms should reinforce the importance of understanding the relationship between toxicant dose and biological response. Not all detected toxicants will produce adverse effects. Absent specific information about toxicant dose and associated biological effects (e.g. reduced survival, growth, reproduction in animals, cancer risk in humans), it is difficult if not impossible from a regulatory standpoint to objectively determine what level of bioaccumulation constitutes an acceptable adverse effect. To facilitate objective interpretation of bioaccumulation test data they have developed a species-specific residue-effects database using published residue-effects information. Along with guidance on the proper use and limitations of such data, this database should result in more effective management of contaminated sediments.

  14. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Maryland. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities in Maryland is vested in the Public Service Commission under the authority of the Public Service Commission Law. The Commission consists of five commissioners who are appointed by the governor with the advice and consent of the Senate. Commissioners must be or become citizens of Maryland, at least three are to serve full time, and one of the commissioners is to be nominated as chairman. The tenure of each commissioner is six years and their terms are on a staggered schedule. Commissioners are eligible for reappointment. The Public Service Commission Law provides that the Commission's powers an jurisdiction shall extend to the full extent permitted by the Constitution and laws of the United States. Local governments in Maryland are not given regulatory power over public service companies. The only power that local governments have over the operations of utilities is the power to grant franchises. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  15. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Ohio. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Public Utilities Commission (PUCO) is a body created by the Ohio State legislature to administer the provisions of the Ohio Public Utilities Act. It is composed of three commissioners appointed by the governor with the advice and consent of the senate. Once appointed, a commissioner serves for a six-year period. The PUCO is vested with the power and jurisdiction to supervise and regulate public utilities and railroads... . The term public utility includes every corporation, company, co-partnership, person or association, their lessees, trustees, or receivers, as defined in the Ohio Code. Among the various services enumerated in the Code under the definition of public utility are an electric light company; a gas company; a pipeline company transporting gas, oil or coal; a waterworks company; a heating or cooling company. The power to regulate public utilities is shared by the PUCO and municipal governments. The municipal regulatory authority is derived from the Ohio Constitution, statutory provisions, and municipal franchising authority. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  16. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Iowa. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Iowa State Commerce Commission. The Commission is comprised of three members appointed by the governor with the approval of two-thirds of the senate. Commissioners are appointed for six-year terms. They must be free from employment or pecuniary interests in any public utility. Although the right to grant franchises is specifically reserved for municipalities, local governments exercise no regulatory authority over the provision of utility services by public utilities. Municipally-owned utilities, however, are specifically excepted from rate regulation by the Commission. The regulation of rates charged by municipally-owned utilities is the responsibility of local governments. The Commission is given no authority to review decisions of local governments with respect to rates. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  17. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in South Carolina. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    Pursuant to constitutional South Carolina mandate the General Assembly has created the Public Service Commission. The Commission is composed of seven members elected to four year terms by the General Assembly. One commissioner is elected from each of seven districts corresponding to the congressional districts as they existed as of January 1, 1930. The commissioners elect one of their members as chairman. The South Carolina statutes contain separate chapters dealing with the regulation of public utilities and electric utilities. Public utility includes the furnishing of gas or heat (other than by means of electricity) to the public. While the Commission is granted general supervisory and regulatory powers over public utilities and electric utilities, total governments retain some control over electrical utilities. All municipality's have the power to grant exclusive franchises to such utilities for the furnishing of light to the municipality and its inhabitants. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  18. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... Federal Motor Carrier Safety Administration Regulatory Guidance Concerning Electronic Signatures and... guidance. SUMMARY: FMCSA issues regulatory guidance concerning the use of electronic signatures and... information regarding FMCSA's acceptance of electronic signature on documents required by the Federal...

  19. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Florida. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Florida Public Service Commission. The Commission is comprised of five members appointed by the governor with the approval of the senate. The governor must choose his appointees from a list of persons recommended by the nine-person Florida Public Service Commission Nominating Council. Commissioners serve either three- or four-year terms. They must be free from any employment or pecuniary interests in any utility subject to the jurisdiction of the Commission. Within the purview of its powers, the authority of the Commission supersedes that of local governments. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  20. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Tennessee. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Tennessee Public Service Commission has been designated by the legislature as the agency primarily responsible for the regulation of public utilities and carriers. The Commission is comprised of three members elected by the voters of the state. Each member of the Commission serves a six-year term. The Commission is given broad supervisory control over public utilities in the public utilities statute. Included under its authority is the power to determine whether a privilege or franchise granted to a public utility by a municipality is necessary and proper for the public convenience. No privilege or franchise is valid until it has been approved by the Commission. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  1. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Missouri. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities in Missouri is vested in the Public Service Commission. The Commission is composed of five members who are appointed by the governor with the advice and consent of the senate. Commissioners are appointed for a term of six years. Commissioners must be free from any employment or pecuniary interests incompatible with the duties of the Commission. The Commission is charged with the general supervision of public utilities. The Public Service Commission Law passed in 1913, makes no provision for the regulation of public utilities by municipalities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  2. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Arkansas. Preliminary background report

    SciTech Connect

    Feurer, D.A.; Weaver, C.L.; Gallagher, K.C.; Hejna, D.; Rielley, K.J.

    1980-01-01

    The Arkansas state constitution contains no provision dealing with public utility regulation. Title 73 of the Arkansas Statutes specifically provides for the regulation of public utilities. The Arkansas Public Service Commission is established by statute as a subagency of the Department of Commerce and is responsible for regulating electric, steam heating, and certain other kinds of utilities. The Commission consists of three members, each appointed by the governor with the approval of the Senate for a term of six years. The Commission has authority over all matters pertaining to the regulation and operation of gas companies, electric companies, and hydro-electric companies among other utilities enumerated in the statute. The role of local governments in the regulation of public utilities has been reduced by recent legislation. Municipal councils formerly had the power to regulate rate-making for investor owned utilities operating within their boundaries. However, as a result of 1977 amendments to the Public Utilities Act, ratemaking for privately owned electric, gas, telephone, and sewer utilities is now within the exclusive jurisdiction of the Public Service Commission. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  3. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Pennsylvania. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is generally vested in the Pennsylvania Public Utility Commission. The Commission is comprised of five members appointed by the governor with the advice and consent of two-thirds of the senate. Commission members are appointed for 10 year terms. They must be free from any employment which is incompatible with the duties of the Commission, and are subject to a statutory code of ethics. The Commission is charged with responsibility for enforcing the Public Utility Law. Within the purview of its powers, the authority of the Commission supersedes that of local governments. The Commission, for example, may grant exemptions from local zoning requirements, and has approving authority over privileges or franchises granted by municipalities to public utilities. The Commission, however, has no authority over municipally owned utilities operating within municipal boundaries. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  4. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Washington. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Washinton State Constitution grants authority to the legislature to regulate railroads and other common carriers as well as telegraph and telephone companies in the state. No section of the constitution expressly provides for the regulation of electric, gas, water, or heating utilities. The authority to regulate public utilities is vested generally in the Utilities and Transportation Commission, formerly designated at the Public Service Commission. The Commission is composed of three members appointed by the governor, with the consent of the senate. The term of office for commissioners is six years. Recently enacted legislation provides for the implementation of tax incentives to encourage the development of cogeneration facilities in the state. This plan is to be administered by the Department of Revenue in conjunction with the Energy Office. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  5. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in New Jersey. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate the operations of public utilities in New Jersey is generally vested in the Board of Public Utilities. The Board is subsumed within the Department of Energy for administrative purposes, but functions largely independently of supervision or control by that agency. The Board is composed of three members who serve for six-year terms. They are appointed by the governor with the advice and consent of the senate. Within the purview of its powers, the authority of the Board supersedes that of local governments. The Board, for example, may grant exemptions from local zoning provisions, and has approving authority over privileges or franchises granted by municipalities to public utilities. The Board, however, cannot override the refusal of a municipality to grant consent to the initiation of operations by a public utility. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  6. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in South Dakota. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The South Dakota Public Utilities Commission is authorized by statute to regulate gas and electric utilities. The Commission consists of three elected commissioners each of whom serves for a six year term. The Commissioners are elected by district and each must, at the time of election, be a resident of the district from which he has been elected. Each Commissioner must reside in the state capital and devote his entire time to the duties of his office. The Commission is part of the Department of Commerce and Consumer Protection. Municipal power to regulate privately owned electric and gas public utilities was terminated in 1975. A municipally-owned electric utility has the authority to regulate the sale, use, and rates of electric power and energy which it provides. The Commission has no authority to regulate steam, heat, and refrigeration systems; that power resides in cities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  7. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in North Carolina. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    Under the Public Utilities Act of 1965, utilities in North Carolina are regulated by the State's Utility Commission. The Commission consists of seven members who are appointed by the governor, subject to confirmation by the General Assembly sitting in joint session. The Commissioners serve eight year terms and the governor designates one of the commissioners as chairman. The Commission has an office of the executive director, who is appointed to a six year term by the governor subject to confirmaion by the General Assembly. The executive director heads the Commission's public staff. The public staff's duties include reviewing, investigating, and making recommendations on utility rates and services and intervention on behalf of the public in proceedings affecting consumer rates and generating plant certification. The Commission has the same power to regulate the operation of privately-owned public utilities within municipalities as it has to control those ouside. The only power over privately-owned utilities reserved to the municipalities is the power to grant franchises. A municipality may maintain its own utility systems, and such systems are not subject to the control and jurisdiction of the Commission. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  8. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Oklahoma. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Oklahoma Corporation Commission was created by the state constitution, for the purpose of regulating transportation and transmission companies. The Constitution also provides that the Commission may be vested with such additional powers, and charged with such other duties (not inconsistent with this Constitution). Pursuant to this power to regulate the legislature has given the Commission the power to regulate certain public utilities, including electric, gas, and steam. The Commission is composed of three members who are elected to staggered, six-year terms. A commissioner may not have any interests incompatible with the duties of the Commission. The Commission is charged with the general supervision of public utilities. Local governments have no role in the regulation of public utilities although municipalities do have the power to grant franchises. The constitution allows the legislature to pass laws giving cities, towns, and counties the right to regulate the rates and services of their franchises operating within the boundaries of the city, town, or county, although there are no such laws in effect at the present time. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  9. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Rhode Island. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Rhode Island statutes vest in the Public Utility Commission and the Division of Public Utilities the exclusive power and authority to regulate public utility companies in that state. Both bodies have been established within the Department of Business Regulation but are independent of the Department's director and are not under his jurisdiction. The jurisdiction to regulate utilities is shared by the Commission and the Division. The Commission serves as a quasi-judicial tribunal with jurisdiction, powers, and duties to hold investigations and hearings involving rates, sufficiency and resonableness of facilities, gas, electric, water, and pipeline public utilities. The administrator, who is chief executive officer of the Division, is responsible for exercising the jurisdiction, supervision, powers, and duties not specifically assigned to the Commission. By virtue of his office, the chairman of the Commission serves also as the administrator and he supervises and directs the execution of all laws relating to public utilities and carriers and all regulations and orders of the Commission governing the conduct and charges of public utilities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  10. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Nevada. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate the operatons of public utilities in Nevada is vested generally in the Public Service Commission. The Commission is comprised of three members appointed by the governor to four year terms. One of the members is designated by the governor to act as chairman and serves in that capacity at the pleasure of the governor. Commissioners must be free from employment or pecuniary interests which are incompatible with the duties of the Commission. Within the purview of its powers, the authority of the Commission supercedes that of local governments. Local governments play a role in regulating public utilities only through the exercise of their zoning and franchising powers. In addition, municipally-owned utilities are totally exempt from Commission control. No specific procedure is provided by which the decisions of local governments regarding utilities may be reviewed by the Commission. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  11. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in North Dakota. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The North Dakota Public Service Commission (PSC) is a constitutional body responsible for the regulation of all public utilities. The PSC is composed of three elected commissioners who serve for six year terms. Section 83 of the state's Constitution gives the legislature the power to prescribe the powers and duties of the PCS. Pursuant to this authorization, the legislature adopted Title 49 of the North Dakota Century Code prescribing the jurisdiction as well as the powers and duties of the PSC. It also prescribes various rules and regulations pertaining to electric, gas, and other public utilities. All authority over public utilities is vested in the PSC. Local governments, except for the powers inherent in their franchising and zoning authority, are not given any control over utility regulation. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  12. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Michigan. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Michigan Public Service Commission. The Commission is composed of three members appointed by the Governor with the advice and consent of the senate. Commission members are appointed for six-year terms. They must be free from pecuniary and employment interests incompatible with the duties of the Commission. The Commission is vested with complete power and jurisdiction to regulate all public utilities in the state except any municipally-owned utility. The Commission may not change any rates fixed in or regulated by a franchise granted by a municipality. Upon submission to the Commission by the municipality and the public utility operating in the municipality, the Commission may investigate and fix rates and establish rules and conditions of service. The jurisdiction of the Commission extends to all public utilities except municipally-owned utilities. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  13. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Kansas. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The Kansas legislature has created the State Corporation Commission and given the Commission full power, authority, and jurisdiction to supervise and control public utilities. The Commission is empowered to do all things necessary and convenient for the exercise of such power, authority and jurisdiction. The Commission is composed of three members, appointed by the governor by and with the consent of the senate. The Commissioners' appointment is for a four year term. The Commission elects one of its members as chairperson. The Kansas statutes provides that the power and authority to control and regulate all public utilities and common carriers situated and operated wholly or principally within any city or principally operated for the benefit of such city or its people, shall be vested exclusively in such city. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  14. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Massachusetts. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities is vested generally in the Department of Public Utilities. The Department is under the supervision and control of a commission consisting of three members appointed by the governor for terms of four years. No more than two of the commissioners may be members of the same political party. Commissioners must be freee from any employment or financial interests which are incompatible with the duties of the Department. The Department is responsible for regulating public utilities. The Department is specifically granted general supervisory authority over all gas and electric companies. Specific provisions for the appeal of local decisions exist only in the case of a municipality's approval or disapproval of new operaions by an electric or gas company in a municipality already being served by another such utility. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  15. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Mississippi. Preliminary background report

    SciTech Connect

    Feurer, D A; Weaver, C L; Gallagher, K C; Hejna, D; Rielley, K J

    1980-01-01

    The authority to regulate public utilities in Mississippi is vested generally in the Public Service Commission, composed of three members elected for four year terms from separate districts of the state. Within the purview of its powers, the authority of the Commission supersedes that of local governments. It is empowered to amend municipal franchises that contain provisions conflicting with its exclusive jurisdiction over the rates and standards of service of public utilities. Local governments play a role in regulating public utilities only through the exercise of their zoning and franchising powers. They may also operate their own utilities which are totally exempt from Commission control, unless they provide services more than one mile beyond their corporate boundaries. Other than a procedure in which certain provisions in municipal franchises may be subject to modification by the Commission, there is no process by which the decisions of local government respecting utilities are reviewed by the Commission. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.

  16. 78 FR 53483 - Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 3

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... COMMISSION Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 3 AGENCY: Nuclear Regulatory Commission. ACTION: Determination of inspections, tests, analyses, and..., tests, and analyses have been successfully completed, and that the specified acceptance criteria are...

  17. 78 FR 53484 - Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 4

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... COMMISSION Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 4 AGENCY: Nuclear Regulatory Commission. ACTION: Determination of inspections, tests, analyses, and..., tests, and analyses have been successfully completed, and that the specified acceptance criteria are...

  18. Offer/Acceptance Ratio.

    ERIC Educational Resources Information Center

    Collins, Mimi

    1997-01-01

    Explores how human resource professionals, with above average offer/acceptance ratios, streamline their recruitment efforts. Profiles company strategies with internships, internal promotion, cooperative education programs, and how to get candidates to accept offers. Also discusses how to use the offer/acceptance ratio as a measure of program…

  19. Regulation of negative affect in schizophrenia: the effectiveness of acceptance versus reappraisal and suppression.

    PubMed

    Perry, Yael; Henry, Julie D; Nangle, Matthew R; Grisham, Jessica R

    2012-01-01

    Although general emotion coping difficulties are well documented in schizophrenia, there has been limited study of specific regulatory strategies such as suppression, reappraisal, and acceptance. In the present study, clinical and control participants were asked to watch video clips selected to elicit negative affect while engaging in one of these three different emotion regulation strategies (counterbalanced), versus a passive viewing condition. The experiential and expressive components of emotion were quantified using self-report and facial electromyography, respectively. A major finding was that, in contrast to control participants, individuals with schizophrenia did not report a greater willingness to reexperience negative emotion after engaging in acceptance. These data are discussed in the context of evidence highlighting the potentially important role of acceptance in understanding affective abnormalities in clinical conditions such as schizophrenia.

  20. Defining acceptable conditions in wilderness

    NASA Astrophysics Data System (ADS)

    Roggenbuck, J. W.; Williams, D. R.; Watson, A. E.

    1993-03-01

    The limits of acceptable change (LAC) planning framework recognizes that forest managers must decide what indicators of wilderness conditions best represent resource naturalness and high-quality visitor experiences and how much change from the pristine is acceptable for each indicator. Visitor opinions on the aspects of the wilderness that have great impact on their experience can provide valuable input to selection of indicators. Cohutta, Georgia; Caney Creek, Arkansas; Upland Island, Texas; and Rattlesnake, Montana, wilderness visitors have high shared agreement that littering and damage to trees in campsites, noise, and seeing wildlife are very important influences on wilderness experiences. Camping within sight or sound of other people influences experience quality more than do encounters on the trails. Visitors’ standards of acceptable conditions within wilderness vary considerably, suggesting a potential need to manage different zones within wilderness for different clientele groups and experiences. Standards across wildernesses, however, are remarkably similar.

  1. Yersinia pseudotuberculosis supports Th17 differentiation and limits de novo regulatory T cell induction by directly interfering with T cell receptor signaling.

    PubMed

    Pasztoi, Maria; Bonifacius, Agnes; Pezoldt, Joern; Kulkarni, Devesha; Niemz, Jana; Yang, Juhao; Teich, René; Hajek, Janina; Pisano, Fabio; Rohde, Manfred; Dersch, Petra; Huehn, Jochen

    2017-04-04

    Adaptive immunity critically contributes to control acute infection with enteropathogenic Yersinia pseudotuberculosis; however, the role of CD4(+) T cell subsets in establishing infection and allowing pathogen persistence remains elusive. Here, we assessed the modulatory capacity of Y. pseudotuberculosis on CD4(+) T cell differentiation. Using in vivo assays, we report that infection with Y. pseudotuberculosis resulted in enhanced priming of IL-17-producing T cells (Th17 cells), whereas induction of Foxp3(+) regulatory T cells (Tregs) was severely disrupted in gut-draining mesenteric lymph nodes (mLNs), in line with altered frequencies of tolerogenic and proinflammatory dendritic cell (DC) subsets within mLNs. Additionally, by using a DC-free in vitro system, we could demonstrate that Y. pseudotuberculosis can directly modulate T cell receptor (TCR) downstream signaling within naïve CD4(+) T cells and Tregs via injection of effector molecules through the type III secretion system, thereby affecting their functional properties. Importantly, modulation of naïve CD4(+) T cells by Y. pseudotuberculosis resulted in an enhanced Th17 differentiation and decreased induction of Foxp3(+) Tregs in vitro. These findings shed light to the adjustment of the Th17-Treg axis in response to acute Y. pseudotuberculosis infection and highlight the direct modulation of CD4(+) T cell subsets by altering their TCR downstream signaling.

  2. On Maximum FODO Acceptance

    SciTech Connect

    Batygin, Yuri Konstantinovich

    2014-12-24

    This note illustrates maximum acceptance of FODO quadrupole focusing channel. Acceptance is the largest Floquet ellipse of a matched beam: A = $\\frac{a^2}{β}$$_{max}$ where a is the aperture of the channel and βmax is the largest value of beta-function in the channel. If aperture of the channel is restricted by a circle of radius a, the s-s acceptance is available for particles oscillating at median plane, y=0. Particles outside median plane will occupy smaller phase space area. In x-y plane, cross section of the accepted beam has a shape of ellipse with truncated boundaries.

  3. A Negative Regulatory Mechanism Involving 14-3-3ζ Limits Signaling Downstream of ROCK to Regulate Tissue Stiffness in Epidermal Homeostasis.

    PubMed

    Kular, Jasreen; Scheer, Kaitlin G; Pyne, Natasha T; Allam, Amr H; Pollard, Anthony N; Magenau, Astrid; Wright, Rebecca L; Kolesnikoff, Natasha; Moretti, Paul A; Wullkopf, Lena; Stomski, Frank C; Cowin, Allison J; Woodcock, Joanna M; Grimbaldeston, Michele A; Pitson, Stuart M; Timpson, Paul; Ramshaw, Hayley S; Lopez, Angel F; Samuel, Michael S

    2015-12-21

    ROCK signaling causes epidermal hyper-proliferation by increasing ECM production, elevating dermal stiffness, and enhancing Fak-mediated mechano-transduction signaling. Elevated dermal stiffness in turn causes ROCK activation, establishing mechano-reciprocity, a positive feedback loop that can promote tumors. We have identified a negative feedback mechanism that limits excessive ROCK signaling during wound healing and is lost in squamous cell carcinomas (SCCs). Signal flux through ROCK was selectively tuned down by increased levels of 14-3-3ζ, which interacted with Mypt1, a ROCK signaling antagonist. In 14-3-3ζ(-/-) mice, unrestrained ROCK signaling at wound margins elevated ECM production and reduced ECM remodeling, increasing dermal stiffness and causing rapid wound healing. Conversely, 14-3-3ζ deficiency enhanced cutaneous SCC size. Significantly, inhibiting 14-3-3ζ with a novel pharmacological agent accelerated wound healing 2-fold. Patient samples of chronic non-healing wounds overexpressed 14-3-3ζ, while cutaneous SCCs had reduced 14-3-3ζ. These results reveal a novel 14-3-3ζ-dependent mechanism that negatively regulates mechano-reciprocity, suggesting new therapeutic opportunities.

  4. Newbery Medal Acceptance.

    ERIC Educational Resources Information Center

    Freedman, Russell

    1988-01-01

    Presents the Newbery Medal acceptance speech of Russell Freedman, writer of children's nonfiction. Discusses the place of nonfiction in the world of children's literature, the evolution of children's biographies, and the author's work on "Lincoln." (ARH)

  5. USEPA SITE PROGRAM APPROACH TO TECHNOLOGY TRANSFER AND REGULATORY ACCEPTANCE

    EPA Science Inventory

    The SITE Program was created to meet the increased demand for innovative technologies for hazardous waste treatment. To accomplish this mission, the program seeks to advance the development, implementation and commercialization of innovative technologies for hazardous waste chara...

  6. USEPA SITE PROGRAM APPROACH TO TECHNOLOGY TRANSFER AND REGULATORY ACCEPTANCE

    EPA Science Inventory

    The USEPA's SITE program was created to meet the demand for innovative technologies for hazardous waste treatment. The primary mission of the SITe Program is to expedite the cleanup of sites on the NPL. These sites often have multiple contaminants in soil and groundwater, and few...

  7. Alternatives to animal testing: research, trends, validation, regulatory acceptance.

    PubMed

    Huggins, Jane

    2003-01-01

    Current trends and issues in the development of alternatives to the use of animals in biomedical experimentation are discussed in this position paper. Eight topics are considered and include refinement of acute toxicity assays; eye corrosion/irritation alternatives; skin corrosion/irritation alternatives; contact sensitization alternatives; developmental/reproductive testing alternatives; genetic engineering (transgenic) assays; toxicogenomics; and validation of alternative methods. The discussion of refinement of acute toxicity assays is focused primarily on developments with regard to reduction of the number of animals used in the LD(50) assay. However, the substitution of humane endpoints such as clinical signs of toxicity for lethality in these assays is also evaluated. Alternative assays for eye corrosion/irritation as well as those for skin corrosion/irritation are described with particular attention paid to the outcomes, both successful and unsuccessful, of several validation efforts. Alternative assays for contact sensitization and developmental/reproductive toxicity are presented as examples of methods designed for the examination of interactions between toxins and somewhat more complex physiological systems. Moreover, genetic engineering and toxicogenomics are discussed with an eye toward the future of biological experimentation in general. The implications of gene manipulation for research animals, specifically, are also examined. Finally, validation methods are investigated as to their effectiveness, or lack thereof, and suggestions for their standardization and improvement, as well as implementation are reviewed.

  8. Public Acceptance of Plant Biotechnology and GM Crops.

    PubMed

    Lucht, Jan M

    2015-07-30

    A wide gap exists between the rapid acceptance of genetically modified (GM) crops for cultivation by farmers in many countries and in the global markets for food and feed, and the often-limited acceptance by consumers. This review contrasts the advances of practical applications of agricultural biotechnology with the divergent paths-also affecting the development of virus resistant transgenic crops-of political and regulatory frameworks for GM crops and food in different parts of the world. These have also shaped the different opinions of consumers. Important factors influencing consumer's attitudes are the perception of risks and benefits, knowledge and trust, and personal values. Recent political and societal developments show a hardening of the negative environment for agricultural biotechnology in Europe, a growing discussion-including calls for labeling of GM food-in the USA, and a careful development in China towards a possible authorization of GM rice that takes the societal discussions into account. New breeding techniques address some consumers' concerns with transgenic crops, but it is not clear yet how consumers' attitudes towards them will develop. Discussions about agriculture would be more productive, if they would focus less on technologies, but on common aims and underlying values.

  9. Public Acceptance of Plant Biotechnology and GM Crops

    PubMed Central

    Lucht, Jan M.

    2015-01-01

    A wide gap exists between the rapid acceptance of genetically modified (GM) crops for cultivation by farmers in many countries and in the global markets for food and feed, and the often-limited acceptance by consumers. This review contrasts the advances of practical applications of agricultural biotechnology with the divergent paths—also affecting the development of virus resistant transgenic crops—of political and regulatory frameworks for GM crops and food in different parts of the world. These have also shaped the different opinions of consumers. Important factors influencing consumer’s attitudes are the perception of risks and benefits, knowledge and trust, and personal values. Recent political and societal developments show a hardening of the negative environment for agricultural biotechnology in Europe, a growing discussion—including calls for labeling of GM food—in the USA, and a careful development in China towards a possible authorization of GM rice that takes the societal discussions into account. New breeding techniques address some consumers’ concerns with transgenic crops, but it is not clear yet how consumers’ attitudes towards them will develop. Discussions about agriculture would be more productive, if they would focus less on technologies, but on common aims and underlying values. PMID:26264020

  10. Hunter perceptions and acceptance of alternative deer management regulations

    USGS Publications Warehouse

    Cornicelli, L.; Fulton, D.C.; Grund, M.D.; Fieberg, J.

    2011-01-01

    Wildlife managers are often confronted with a policy paradox where a majority of the public supports an outcome, but there is no agreement on specific management strategies to achieve this outcome. Previous research has also reported a link between regulatory acceptance, hunter satisfaction, and hunter participation rates. Thus, human dimensions research aimed at understanding hunter motivations and behavior is needed for effective management. In 2005, we surveyed Minnesota (USA) deer hunters (n = 6,000; 59% response) to evaluate attitudes regarding alternative deer (Odocoileus virginianus) harvest regulations. We also conducted a series of forced choice experiments in which respondents were asked to select an option from a list of representative regulations that might be adopted to achieve a particular deer management goal. Specifically, we modeled 5 deer population scenarios ranging from low populations with high buck-harvest rates to populations 50% over goal density. Our results indicate that hunters preferred different regulations depending on the population scenario, but generally preferred antler-point restrictions and disliked limiting buck licenses through a lottery. We also found consistency among scenarios, in that a small percentage of respondents indicated they would not hunt if regulations were changed. The results from this study should help wildlife managers design deer harvest regulations that are both acceptable to hunters and achieve management objectives. ?? 2011 The Wildlife Society.

  11. Accepting space radiation risks.

    PubMed

    Schimmerling, Walter

    2010-08-01

    The human exploration of space inevitably involves exposure to radiation. Associated with this exposure are multiple risks, i.e., probabilities that certain aspects of an astronaut's health or performance will be degraded. The management of these risks requires that such probabilities be accurately predicted, that the actual exposures be verified, and that comprehensive records be maintained. Implicit in these actions is the fact that, at some point, a decision has been made to accept a certain level of risk. This paper examines ethical and practical considerations involved in arriving at a determination that risks are acceptable, roles that the parties involved may play, and obligations arising out of reliance on the informed consent paradigm seen as the basis for ethical radiation risk acceptance in space.

  12. Current limiters

    SciTech Connect

    Loescher, D.H.; Noren, K.

    1996-09-01

    The current that flows between the electrical test equipment and the nuclear explosive must be limited to safe levels during electrical tests conducted on nuclear explosives at the DOE Pantex facility. The safest way to limit the current is to use batteries that can provide only acceptably low current into a short circuit; unfortunately this is not always possible. When it is not possible, current limiters, along with other design features, are used to limit the current. Three types of current limiters, the fuse blower, the resistor limiter, and the MOSFET-pass-transistor limiters, are used extensively in Pantex test equipment. Detailed failure mode and effects analyses were conducted on these limiters. Two other types of limiters were also analyzed. It was found that there is no best type of limiter that should be used in all applications. The fuse blower has advantages when many circuits must be monitored, a low insertion voltage drop is important, and size and weight must be kept low. However, this limiter has many failure modes that can lead to the loss of over current protection. The resistor limiter is simple and inexpensive, but is normally usable only on circuits for which the nominal current is less than a few tens of milliamperes. The MOSFET limiter can be used on high current circuits, but it has a number of single point failure modes that can lead to a loss of protective action. Because bad component placement or poor wire routing can defeat any limiter, placement and routing must be designed carefully and documented thoroughly.

  13. Regulatory ozone modeling: status, directions, and research needs.

    PubMed Central

    Georgopoulos, P G

    1995-01-01

    The Clean Air Act Amendments (CAAA) of 1990 have established selected comprehensive, three-dimensional, Photochemical Air Quality Simulation Models (PAQSMs) as the required regulatory tools for analyzing the urban and regional problem of high ambient ozone levels across the United States. These models are currently applied to study and establish strategies for meeting the National Ambient Air Quality Standard (NAAQS) for ozone in nonattainment areas; State Implementation Plans (SIPs) resulting from these efforts must be submitted to the U.S. Environmental Protection Agency (U.S. EPA) in November 1994. The following presentation provides an overview and discussion of the regulatory ozone modeling process and its implications. First, the PAQSM-based ozone attainment demonstration process is summarized in the framework of the 1994 SIPs. Then, following a brief overview of the representation of physical and chemical processes in PAQSMs, the essential attributes of standard modeling systems currently in regulatory use are presented in a nonmathematical, self-contained format, intended to provide a basic understanding of both model capabilities and limitations. The types of air quality, emission, and meteorological data needed for applying and evaluating PAQSMs are discussed, as well as the sources, availability, and limitations of existing databases. The issue of evaluating a model's performance in order to accept it as a tool for policy making is discussed, and various methodologies for implementing this objective are summarized. Selected interim results from diagnostic analyses, which are performed as a component of the regulatory ozone modeling process for the Philadelphia-New Jersey region, are also presented to provide some specific examples related to the general issues discussed in this work. Finally, research needs related to a) the evaluation and refinement of regulatory ozone modeling, b) the characterization of uncertainty in photochemical modeling, and c

  14. Why was Relativity Accepted?

    NASA Astrophysics Data System (ADS)

    Brush, S. G.

    Historians of science have published many studies of the reception of Einstein's special and general theories of relativity. Based on a review of these studies, and my own research on the role of the light-bending prediction in the reception of general relativity, I discuss the role of three kinds of reasons for accepting relativity (1) empirical predictions and explanations; (2) social-psychological factors; and (3) aesthetic-mathematical factors. According to the historical studies, acceptance was a three-stage process. First, a few leading scientists adopted the special theory for aesthetic-mathematical reasons. In the second stage, their enthusiastic advocacy persuaded other scientists to work on the theory and apply it to problems currently of interest in atomic physics. The special theory was accepted by many German physicists by 1910 and had begun to attract some interest in other countries. In the third stage, the confirmation of Einstein's light-bending prediction attracted much public attention and forced all physicists to take the general theory of relativity seriously. In addition to light-bending, the explanation of the advance of Mercury's perihelion was considered strong evidence by theoretical physicists. The American astronomers who conducted successful tests of general relativity became defenders of the theory. There is little evidence that relativity was `socially constructed' but its initial acceptance was facilitated by the prestige and resources of its advocates.

  15. UGV acceptance testing

    NASA Astrophysics Data System (ADS)

    Kramer, Jeffrey A.; Murphy, Robin R.

    2006-05-01

    With over 100 models of unmanned vehicles now available for military and civilian safety, security or rescue applications, it is important to for agencies to establish acceptance testing. However, there appears to be no general guidelines for what constitutes a reasonable acceptance test. This paper describes i) a preliminary method for acceptance testing by a customer of the mechanical and electrical components of an unmanned ground vehicle system, ii) how it has been applied to a man-packable micro-robot, and iii) discusses the value of testing both to ensure that the customer has a workable system and to improve design. The test method automated the operation of the robot to repeatedly exercise all aspects and combinations of components on the robot for 6 hours. The acceptance testing process uncovered many failures consistent with those shown to occur in the field, showing that testing by the user does predict failures. The process also demonstrated that the testing by the manufacturer can provide important design data that can be used to identify, diagnose, and prevent long-term problems. Also, the structured testing environment showed that sensor systems can be used to predict errors and changes in performance, as well as uncovering unmodeled behavior in subsystems.

  16. Approaches to acceptable risk

    SciTech Connect

    Whipple, C.

    1997-04-30

    Several alternative approaches to address the question {open_quotes}How safe is safe enough?{close_quotes} are reviewed and an attempt is made to apply the reasoning behind these approaches to the issue of acceptability of radiation exposures received in space. The approaches to the issue of the acceptability of technological risk described here are primarily analytical, and are drawn from examples in the management of environmental health risks. These include risk-based approaches, in which specific quantitative risk targets determine the acceptability of an activity, and cost-benefit and decision analysis, which generally focus on the estimation and evaluation of risks, benefits and costs, in a framework that balances these factors against each other. These analytical methods tend by their quantitative nature to emphasize the magnitude of risks, costs and alternatives, and to downplay other factors, especially those that are not easily expressed in quantitative terms, that affect acceptance or rejection of risk. Such other factors include the issues of risk perceptions and how and by whom risk decisions are made.

  17. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... request, electronic fund transfer (EFT) payment of a regulatory fee may be made as follows: (1)(i) The... directly from the payor's bank account. (2) No EFT payment of a regulatory fee will be accepted unless...

  18. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... request, electronic fund transfer (EFT) payment of a regulatory fee may be made as follows: (1)(i) The... directly from the payor's bank account. (2) No EFT payment of a regulatory fee will be accepted unless...

  19. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... request, electronic fund transfer (EFT) payment of a regulatory fee may be made as follows: (1)(i) The... directly from the payor's bank account. (2) No EFT payment of a regulatory fee will be accepted unless...

  20. 76 FR 50796 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and..., 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and... limit increase will remedy this situation to the benefit of large as well as retail traders,...

  1. Nutrient limitation is the main regulatory factor for carotenoid accumulation and for Psy and Pds steady state transcript levels in Dunaliella salina (Chlorophyta) exposed to high light and salt stress.

    PubMed

    Coesel, Sacha Nicole; Baumgartner, Alexandra Cordeiro; Teles, Licia Marlene; Ramos, Ana Alexandra; Henriques, Nuno Miguel; Cancela, Leonor; Varela, João Carlos Serafim

    2008-01-01

    Dunaliella salina (Dunal) Teodoresco (1905) is a green unicellular alga able to withstand severe salt, light, and nutrient stress, adaptations necessary to grow in harsh environments such as salt ponds. In response to such growth conditions, this microalga accumulates high amounts of beta-carotene in its single chloroplast. In this study, we show that carotenoid accumulation is consistently inhibited in cells grown in nutrient-supplemented media and exposed either to high-light or medium-low-light conditions. Likewise, carotenogenesis in cells shifted to higher salinity (up to 27% NaCl) under medium-low-light conditions is inhibited by the presence of nutrients. The steady-state levels of transcripts encoding phytoene synthase and phytoene desaturase increased substantially in D. salina cells shifted to high light or high salt under nutrient-limiting conditions, whereas the presence of nutrients inhibited this response. The regulatory effect of nutrient availability on the accumulation of carotenoids and messenger RNA levels of the first two enzymes committed to carotenoid biosynthesis is discussed.

  2. Regulatory Forum.

    PubMed

    Peden, W Michael

    2016-12-01

    Revision of the International Council for Harmonization (ICH) S1 guidance for rat carcinogenicity studies to be more selective of compounds requiring a 2-year rat carcinogenicity study has been proposed following extensive evaluation of rat carcinogenicity and chronic toxicity studies by industry and drug regulatory authorities. To inform the ICH S1 expert working group in their potential revision of ICH S1, a prospective evaluation study was initiated in 2013, in which sponsors would assess the pharmacologic and toxicologic findings present in the chronic toxicity studies and predict a positive or negative carcinogenicity outcome using a weight of evidence argument (a carcinogenicity assessment document [CAD]). The Scientific and Regulatory Policy Committee was asked by the Society of Toxicology Pathology (STP) executive committee to track these changes with ICH S1 and inform the STP membership of status changes. This commentary is intended to provide a brief summary of recent changes to the CAD guidance and highlight the importance of STP membership participation in the process of CAD submissions.

  3. Acceptability of human risk.

    PubMed

    Kasperson, R E

    1983-10-01

    This paper has three objectives: to explore the nature of the problem implicit in the term "risk acceptability," to examine the possible contributions of scientific information to risk standard-setting, and to argue that societal response is best guided by considerations of process rather than formal methods of analysis. Most technological risks are not accepted but are imposed. There is also little reason to expect consensus among individuals on their tolerance of risk. Moreover, debates about risk levels are often at base debates over the adequacy of the institutions which manage the risks. Scientific information can contribute three broad types of analyses to risk-setting deliberations: contextual analysis, equity assessment, and public preference analysis. More effective risk-setting decisions will involve attention to the process used, particularly in regard to the requirements of procedural justice and democratic responsibility.

  4. Acceptability of human risk.

    PubMed Central

    Kasperson, R E

    1983-01-01

    This paper has three objectives: to explore the nature of the problem implicit in the term "risk acceptability," to examine the possible contributions of scientific information to risk standard-setting, and to argue that societal response is best guided by considerations of process rather than formal methods of analysis. Most technological risks are not accepted but are imposed. There is also little reason to expect consensus among individuals on their tolerance of risk. Moreover, debates about risk levels are often at base debates over the adequacy of the institutions which manage the risks. Scientific information can contribute three broad types of analyses to risk-setting deliberations: contextual analysis, equity assessment, and public preference analysis. More effective risk-setting decisions will involve attention to the process used, particularly in regard to the requirements of procedural justice and democratic responsibility. PMID:6418541

  5. Acceptance Test Plan.

    DTIC Science & Technology

    2014-09-26

    7 RD-Ai507 154 CCEPTANCE TEST PLN(U) WESTINGHOUSE DEFENSE ND i/i ELECTRO ICS CENTER BALTIMORE MD DEVELOPMENT AND OPERATIONS DIY D C KRRiJS 28 JUN...Ln ACCEPTANCE TEST PLAN FOR SPECIAL RELIABILITY TESTS FOR BROADBAND MICROWAVE AMPLIFIER PANEL David C. Kraus, Reliability Engineer WESTINGHOUSE ...ORGANIZATION b. OFFICE SYMBOL 7g& NAME OF MONITORING ORGANIZATION tIf appdeg ble) WESTINGHOUSE ELECTRIC CORP. - NAVAL RESEARCH LABORATORY e. AOORES$ (Ci7t

  6. Age and Acceptance of Euthanasia.

    ERIC Educational Resources Information Center

    Ward, Russell A.

    1980-01-01

    Study explores relationship between age (and sex and race) and acceptance of euthanasia. Women and non-Whites were less accepting because of religiosity. Among older people less acceptance was attributable to their lesser education and greater religiosity. Results suggest that quality of life in old age affects acceptability of euthanasia. (Author)

  7. Regulatory Anatomy

    PubMed Central

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of “safety” produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape. PMID:26139952

  8. Regulatory Physiology

    NASA Technical Reports Server (NTRS)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  9. High acceptance recoil polarimeter

    SciTech Connect

    The HARP Collaboration

    1992-12-05

    In order to detect neutrons and protons in the 50 to 600 MeV energy range and measure their polarization, an efficient, low-noise, self-calibrating device is being designed. This detector, known as the High Acceptance Recoil Polarimeter (HARP), is based on the recoil principle of proton detection from np[r arrow]n[prime]p[prime] or pp[r arrow]p[prime]p[prime] scattering (detected particles are underlined) which intrinsically yields polarization information on the incoming particle. HARP will be commissioned to carry out experiments in 1994.

  10. Baby-Crying Acceptance

    NASA Astrophysics Data System (ADS)

    Martins, Tiago; de Magalhães, Sérgio Tenreiro

    The baby's crying is his most important mean of communication. The crying monitoring performed by devices that have been developed doesn't ensure the complete safety of the child. It is necessary to join, to these technological resources, means of communicating the results to the responsible, which would involve the digital processing of information available from crying. The survey carried out, enabled to understand the level of adoption, in the continental territory of Portugal, of a technology that will be able to do such a digital processing. It was used the TAM as the theoretical referential. The statistical analysis showed that there is a good probability of acceptance of such a system.

  11. Information capacity of genetic regulatory elements

    NASA Astrophysics Data System (ADS)

    Tkačik, Gašper; Callan, Curtis G., Jr.; Bialek, William

    2008-07-01

    Changes in a cell’s external or internal conditions are usually reflected in the concentrations of the relevant transcription factors. These proteins in turn modulate the expression levels of the genes under their control and sometimes need to perform nontrivial computations that integrate several inputs and affect multiple genes. At the same time, the activities of the regulated genes would fluctuate even if the inputs were held fixed, as a consequence of the intrinsic noise in the system, and such noise must fundamentally limit the reliability of any genetic computation. Here we use information theory to formalize the notion of information transmission in simple genetic regulatory elements in the presence of physically realistic noise sources. The dependence of this “channel capacity” on noise parameters, cooperativity and cost of making signaling molecules is explored systematically. We find that, in the range of parameters probed by recent in vivo measurements, capacities higher than one bit should be achievable. It is of course generally accepted that gene regulatory elements must, in order to function properly, have a capacity of at least one bit. The central point of our analysis is the demonstration that simple physical models of noisy gene transcription, with realistic parameters, can indeed achieve this capacity: it was not self-evident that this should be so. We also demonstrate that capacities significantly greater than one bit are possible, so that transcriptional regulation need not be limited to simple “on-off” components. The question whether real systems actually exploit this richer possibility is beyond the scope of this investigation.

  12. 77 FR 281 - Green Mountain Power Corporation; Notice of Application Accepted for Filing, Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-04

    ... Federal Energy Regulatory Commission Green Mountain Power Corporation; Notice of Application Accepted for...: Green Mountain Power Corporation. e. Name of Projects: Waterbury Hydroelectric Project. f. Location.... h. Applicant Contact: Mr. Jason Lisai, Green Mountain Power Corporation, 163 Acorn Lane,...

  13. 76 FR 7838 - Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted.... On December 30, 2010, Mahoning Hydropower, LLC filed an application for a preliminary...

  14. 76 FR 6459 - Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted.... On December 30, 2010, Mahoning Hydropower, LLC filed an application for a preliminary...

  15. 75 FR 8320 - Coastal Hydropower LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Coastal Hydropower LLC; Notice of Preliminary Permit Application Accepted.... On November 5, 2009, Coastal Hydropower LLC filed an application for a preliminary permit,...

  16. 76 FR 1613 - Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications January 4,...

  17. 78 FR 60268 - City of Holyoke Gas & Electric Department; Notice of Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... Energy Regulatory Commission City of Holyoke Gas & Electric Department; Notice of Application Accepted...; Supplemented: September 24, 2013. d. Applicant: City of Holyoke Gas & Electric Department. e. Name of Project... of Holyoke Gas & Electric Department, 99 Suffolk Street, Holyoke, Massachusetts, 01040,...

  18. 75 FR 33853 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-15

    ... date. Although a time limit is given, comments and suggestions in connection with items for inclusion... Commission. Andrea D. Valentin, Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P...

  19. 76 FR 27924 - Draft Regulatory Guide, Guidance for ITAAC Closure

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING.... Although a time limit is given, comments and suggestions in connection with items for inclusion in...

  20. 76 FR 2726 - Withdrawal of Regulatory Guide 1.154

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... Regulatory Guide 1.154, ``Format and Content of Plant-Specific Pressurized Thermal Shock Safety Analysis... Regulatory Guide (RG) 1.154, ``Format and Content of Plant-Specific Pressurized Thermal Shock Safety Analysis... format and content acceptable to the NRC staff for plant-specific pressurized thermal shock (PTS)...

  1. The Regulatory Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] #7; #7; The Regulatory Plan #7; #7; ] OPEN GOVERNMENT AND EVIDENCE-BASED REGULATION There is a close connection, even an inextricable relationship, between open government and evidence- based regulation. If regulatory choices are based on careful analysis of...

  2. A survey of physicians' acceptance of telemedicine.

    PubMed

    Sheng, O R; Hu, P J; Chau, P Y; Hjelm, N M; Tam, K Y; Wei, C P; Tse, J

    1998-01-01

    Physicians' acceptance of telemedicine is an important managerial issue facing health-care organizations that have adopted, or are about to adopt, telemedicine. Most previous investigations of the acceptance of telemedicine have lacked theoretical foundation and been of limited scope. We examined technology acceptance and usage among physicians and specialists from 49 clinical departments at eight public tertiary hospitals in Hong Kong. Out of the 1021 questionnaires distributed, 310 were completed and returned, a 30% response rate. The preliminary findings suggested that use of telemedicine among clinicians in Hong Kong was moderate. While 18% of the respondents were using some form of telemedicine for patient care and management, it accounted for only 6.3% of the services provided. The intensity of their technology usage was also low, accounting for only 6.8% of a typical telemedicine-assisted service. These preliminary findings have managerial implications.

  3. 10 CFR 26.111 - Checking the acceptability of the urine specimen.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Checking the acceptability of the urine specimen. 26.111 Section 26.111 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.111 Checking the acceptability of the urine specimen. (a) Immediately after the...

  4. 10 CFR 26.111 - Checking the acceptability of the urine specimen.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Checking the acceptability of the urine specimen. 26.111 Section 26.111 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.111 Checking the acceptability of the urine specimen. (a) Immediately after the...

  5. 10 CFR 26.111 - Checking the acceptability of the urine specimen.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Checking the acceptability of the urine specimen. 26.111 Section 26.111 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.111 Checking the acceptability of the urine specimen. (a) Immediately after the...

  6. 10 CFR 26.111 - Checking the acceptability of the urine specimen.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Checking the acceptability of the urine specimen. 26.111 Section 26.111 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.111 Checking the acceptability of the urine specimen. (a) Immediately after the...

  7. 10 CFR 26.111 - Checking the acceptability of the urine specimen.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Checking the acceptability of the urine specimen. 26.111 Section 26.111 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.111 Checking the acceptability of the urine specimen. (a) Immediately after the...

  8. Treatment Acceptability of Healthcare Services for Children with Cerebral Palsy

    ERIC Educational Resources Information Center

    Dahl, Norm; Tervo, Raymond; Symons, Frank J.

    2007-01-01

    Background: Although treatment acceptability scales in intellectual and developmental disabilities research have been used in large- and small-scale applications, large-scale application has been limited to analogue (i.e. contrived) investigations. This study extended the application of treatment acceptability by assessing a large sample of care…

  9. Increasing Our Acceptance as Parents of Children with Special Needs

    ERIC Educational Resources Information Center

    Loewenstein, David

    2007-01-01

    Accepting the limitations of a child whose life was supposed to be imbued with endless possibilities requires parents to come to terms with expectations of themselves and the world around them. In this article, the author offers some helpful strategies for fostering acceptance and strengthening family relationships: (1) Remember that parenting is…

  10. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86...

  11. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86...

  12. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86...

  13. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86...

  14. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  15. Despite regulatory changes, hospitals cautious in helping physicians purchase electronic medical records.

    PubMed

    Grossman, Joy M; Cohen, Genna

    2008-09-01

    While hospitals are evaluating strategies to help physicians purchase electronic medical records (EMRs) following recent federal regulatory changes, they are proceeding cautiously, according to findings from the Center for Studying Health System Change's (HSC) 2007 site visits to 12 nationally representative metropolitan communities. Hospital strategies to aid physician EMR adoption include offering direct financial subsidies, extending the hospital's ambulatory EMR vendor discounts and providing technical support. Two key factors driving hospital interest in supporting physician EMR adoption are improving the quality and efficiency of care and aligning physicians more closely with the hospital. A few hospitals have begun small-scale, phased rollouts of subsidized EMRs, but the burden of other hospital information technology projects, budget limitations and lack of physician interest are among the factors impeding hospital action. While it is too early to assess whether the regulatory changes will spur greater physician EMR adoption, the outcome will depend both on hospitals' willingness to provide support and physicians' acceptance of hospital assistance.

  16. Acceptance of tinnitus: validation of the tinnitus acceptance questionnaire.

    PubMed

    Weise, Cornelia; Kleinstäuber, Maria; Hesser, Hugo; Westin, Vendela Zetterqvist; Andersson, Gerhard

    2013-01-01

    The concept of acceptance has recently received growing attention within tinnitus research due to the fact that tinnitus acceptance is one of the major targets of psychotherapeutic treatments. Accordingly, acceptance-based treatments will most likely be increasingly offered to tinnitus patients and assessments of acceptance-related behaviours will thus be needed. The current study investigated the factorial structure of the Tinnitus Acceptance Questionnaire (TAQ) and the role of tinnitus acceptance as mediating link between sound perception (i.e. subjective loudness of tinnitus) and tinnitus distress. In total, 424 patients with chronic tinnitus completed the TAQ and validated measures of tinnitus distress, anxiety, and depression online. Confirmatory factor analysis provided support to a good fit of the data to the hypothesised bifactor model (root-mean-square-error of approximation = .065; Comparative Fit Index = .974; Tucker-Lewis Index = .958; standardised root mean square residual = .032). In addition, mediation analysis, using a non-parametric joint coefficient approach, revealed that tinnitus-specific acceptance partially mediated the relation between subjective tinnitus loudness and tinnitus distress (path ab = 5.96; 95% CI: 4.49, 7.69). In a multiple mediator model, tinnitus acceptance had a significantly stronger indirect effect than anxiety. The results confirm the factorial structure of the TAQ and suggest the importance of a general acceptance factor that contributes important unique variance beyond that of the first-order factors activity engagement and tinnitus suppression. Tinnitus acceptance as measured with the TAQ is proposed to be a key construct in tinnitus research and should be further implemented into treatment concepts to reduce tinnitus distress.

  17. Targeting regulatory T cells.

    PubMed

    Ménétrier-Caux, Christine; Curiel, Tyler; Faget, Julien; Manuel, Manuarii; Caux, Christophe; Zou, Weiping

    2012-03-01

    Cancers express tumor-associated antigens that should elicit immune response to antagonize the tumor growth, but spontaneous immune rejection of established cancer is rare, suggesting an immunosuppressive environment hindering host antitumor immunity. Among the specific and active tumor-mediated mechanisms, CD4(+)CD25(high) T regulatory cells (Treg) are important mediators of active immune evasion in cancer. In this review, we will discuss Treg subpopulations and the mechanisms of their suppressive functions. Treg depletion improves endogenous antitumor immunity and the efficacy of active immunotherapy in animal models for cancer, suggesting that inhibiting Treg function could also improve the limited successes of human cancer immunotherapy. We will also discuss specific strategies for devising effective cancer immunotherapy targeting Treg.

  18. The Regulatory Framework for Privacy and Security

    NASA Astrophysics Data System (ADS)

    Hiller, Janine S.

    The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

  19. Cone penetrometer acceptance test report

    SciTech Connect

    Boechler, G.N.

    1996-09-19

    This Acceptance Test Report (ATR) documents the results of acceptance test procedure WHC-SD-WM-ATR-151. Included in this report is a summary of the tests, the results and issues, the signature and sign- off ATP pages, and a summarized table of the specification vs. ATP section that satisfied the specification.

  20. 77 FR 70515 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Establish a Limited Waiver of the TRACE Professional Real-Time Data Display Fee on a...

  1. 78 FR 60003 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Extend the Limited Waiver of the TRACE Professional Real-Time Data Display Fee...

  2. Public acceptance of wildlife trapping in Colorado

    USGS Publications Warehouse

    Manfredo, M.J.; Pierce, C.L.; Fulton, D.; Pate, J.; Gill, B.R.

    1999-01-01

    In November 1994, the Colorado Division of Wildlife (CDOW) initiated a stakeholder process to develop trapping regulations that would seek to achieve compromise among divergent interests. A telephone survey was conducted to provide stakeholders with information about the Colorado public's acceptance of trapping. A random sample of 900 residents, stratified by geographic region, indicated that the public would vote to ban trapping and that they believed the ban would eliminate a cruel activity and help to preserve endangered wildlife. Most, however, agreed that trapping was acceptable to prevent spread of disease and to protect livestock, but unacceptable on the basis of providing recreation or making money. Beliefs about trapping were found to be rooted in a protection versus use value orientation about wildlife. The regulations subsequently adopted by the CDOW were consistent with survey findings; however, the regulatory process was bypassed by legislative action, giving trapping authority to the Colorado Department of Agriculture. In response, citizen activists succeeded in placing a ballot initiative before voters. In 1996, the ballot initiative passed, banning trapping in Colorado.

  3. Extending the Technology Acceptance Model: Policy Acceptance Model (PAM)

    NASA Astrophysics Data System (ADS)

    Pierce, Tamra

    There has been extensive research on how new ideas and technologies are accepted in society. This has resulted in the creation of many models that are used to discover and assess the contributing factors. The Technology Acceptance Model (TAM) is one that is a widely accepted model. This model examines people's acceptance of new technologies based on variables that directly correlate to how the end user views the product. This paper introduces the Policy Acceptance Model (PAM), an expansion of TAM, which is designed for the analysis and evaluation of acceptance of new policy implementation. PAM includes the traditional constructs of TAM and adds the variables of age, ethnicity, and family. The model is demonstrated using a survey of people's attitude toward the upcoming healthcare reform in the United States (US) from 72 survey respondents. The aim is that the theory behind this model can be used as a framework that will be applicable to studies looking at the introduction of any new or modified policies.

  4. Quality control for federal clean water act and safe drinking water act regulatory compliance.

    PubMed

    Askew, Ed

    2013-01-01

    QC sample results are required in order to have confidence in the results from analytical tests. Some of the AOAC water methods include specific QC procedures, frequencies, and acceptance criteria. These are considered to be the minimum controls needed to perform the method successfully. Some regulatory programs, such as those in 40 CFR Part 136.7, require additional QC or have alternative acceptance limits. Essential QC measures include method calibration, reagent standardization, assessment of each analyst's capabilities, analysis of blind check samples, determination of the method's sensitivity (method detection level or quantification limit), and daily evaluation of bias, precision, and the presence of laboratory contamination or other analytical interference. The details of these procedures, their performance frequency, and expected ranges of results are set out in this manuscript. The specific regulatory requirements of 40 CFR Part 136.7 for the Clean Water Act, the laboratory certification requirements of 40 CFR Part 141 for the Safe Drinking Water Act, and the ISO 17025 accreditation requirements under The NELAC Institute are listed.

  5. A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.

    PubMed

    Hayes, Eileen P; Jolly, Robert A; Faria, Ellen C; Barle, Ester Lovsin; Bercu, Joel P; Molnar, Lance R; Naumann, Bruce D; Olson, Michael J; Pecquet, Alison M; Sandhu, Reena; Shipp, Bryan K; Sussman, Robert G; Weideman, Patricia A

    2016-08-01

    A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products on December 1st, 2015. This guideline centers around the use of the Acceptable Daily Exposure (ADE) [synonymous with the Permitted Daily Exposure (PDE)] and operational considerations associated with implementation are outlined here. The EU guidance states that all active pharmaceutical ingredients (API) require an ADE; however, other substances such as starting materials, process intermediates, and cleaning agents may benefit from an ADE. Problems in setting ADEs for these additional substances typically relate to toxicological data limitations precluding the ability to establish a formal ADE. Established methodologies such as occupational exposure limits or bands (OELs or OEBs) and the threshold of toxicological concern (TTC) can be used or adjusted for use as interim ADEs when only limited data are available and until a more formal ADE can be established. Once formal ADEs are derived, it is important that the documents are routinely updated and that these updates are communicated to appropriate stakeholders. Another key operational consideration related to data-poor substances includes the use of maximum daily dose (MDD) in setting cross-contamination limits. The MDD is an important part of the maximum allowable/safe concentration (MAC/MSC) calculation and there are important considerations for its use and definition. Finally, other considerations discussed include operational aspects of setting ADEs for pediatrics, considerations for large molecules, and risk management in shared facilities.

  6. Staff Acceptance of Tele-ICU Coverage

    PubMed Central

    Chan, Paul S.; Cram, Peter

    2011-01-01

    Background: Remote coverage of ICUs is increasing, but staff acceptance of this new technology is incompletely characterized. We conducted a systematic review to summarize existing research on acceptance of tele-ICU coverage among ICU staff. Methods: We searched for published articles pertaining to critical care telemedicine systems (aka, tele-ICU) between January 1950 and March 2010 using PubMed, Cumulative Index to Nursing and Allied Health Literature, Global Health, Web of Science, and the Cochrane Library and abstracts and presentations delivered at national conferences. Studies were included if they provided original qualitative or quantitative data on staff perceptions of tele-ICU coverage. Studies were imported into content analysis software and coded by tele-ICU configuration, methodology, participants, and findings (eg, positive and negative staff evaluations). Results: Review of 3,086 citations yielded 23 eligible studies. Findings were grouped into four categories of staff evaluation: overall acceptance level of tele-ICU coverage (measured in 70% of studies), impact on patient care (measured in 96%), impact on staff (measured in 100%), and organizational impact (measured in 48%). Overall acceptance was high, despite initial ambivalence. Favorable impact on patient care was perceived by > 82% of participants. Staff impact referenced enhanced collaboration, autonomy, and training, although scrutiny, malfunctions, and contradictory advice were cited as potential barriers. Staff perceived the organizational impact to vary. An important limitation of available studies was a lack of rigorous methodology and validated survey instruments in many studies. Conclusions: Initial reports suggest high levels of staff acceptance of tele-ICU coverage, but more rigorous methodologic study is required. PMID:21051386

  7. Market Acceptance of Smart Growth

    EPA Pesticide Factsheets

    This report finds that smart growth developments enjoy market acceptance because of stability in prices over time. Housing resales in smart growth developments often have greater appreciation than their conventional suburban counterparts.

  8. L-286 Acceptance Test Record

    SciTech Connect

    HARMON, B.C.

    2000-01-14

    This document provides a detailed account of how the acceptance testing was conducted for Project L-286, ''200E Area Sanitary Water Plant Effluent Stream Reduction''. The testing of the L-286 instrumentation system was conducted under the direct supervision

  9. Canadian regulatory perspectives on genome engineered crops.

    PubMed

    Smyth, Stuart J

    2017-01-02

    New breeding techniques in plant agriculture exploded upon the scene about two years ago, in 2014. While these innovative plant breeding techniques, soon to be led by CRISPR/Cas9, initially appear to hold tremendous promise for plant breeding, if not a revolution for the industry, the question of how the products of these technologies will be regulated is rapidly becoming a key aspect of the technology's future potential. Regulation of innovative technologies and products has always lagged that of the science, but in the past decade, regulatory systems in many jurisdictions have become gridlocked as they try to regulate genetically modified (GM) crops. This regulatory incapability to efficiently assess and approve innovative new agricultural products is particularly important for new plant breeding techniques as if these techniques are classified as genetically modified breeding techniques, then their acceptance and future will diminish considerably as they will be rejected by the European Union. Conversely, if the techniques are accepted as conventional plant breeding, then the future is blindingly bright. This article examines the international debate about the regulation of new plant breeding techniques and then assesses how the Canadian regulatory system has approached the regulation of these technologies through two more public product approvals, GM apples and GM potatoes, then discusses other crop variety approval and those in the regulatory pipeline.

  10. Tracking of time-varying genomic regulatory networks with a LASSO-Kalman smoother

    PubMed Central

    2014-01-01

    It is widely accepted that cellular requirements and environmental conditions dictate the architecture of genetic regulatory networks. Nonetheless, the status quo in regulatory network modeling and analysis assumes an invariant network topology over time. In this paper, we refocus on a dynamic perspective of genetic networks, one that can uncover substantial topological changes in network structure during biological processes such as developmental growth. We propose a novel outlook on the inference of time-varying genetic networks, from a limited number of noisy observations, by formulating the network estimation as a target tracking problem. We overcome the limited number of observations (small n large p problem) by performing tracking in a compressed domain. Assuming linear dynamics, we derive the LASSO-Kalman smoother, which recursively computes the minimum mean-square sparse estimate of the network connectivity at each time point. The LASSO operator, motivated by the sparsity of the genetic regulatory networks, allows simultaneous signal recovery and compression, thereby reducing the amount of required observations. The smoothing improves the estimation by incorporating all observations. We track the time-varying networks during the life cycle of the Drosophila melanogaster. The recovered networks show that few genes are permanent, whereas most are transient, acting only during specific developmental phases of the organism. PMID:24517200

  11. Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning.

    PubMed

    Olson, Michael J; Faria, Ellen C; Hayes, Eileen P; Jolly, Robert A; Barle, Ester Lovsin; Molnar, Lance R; Naumann, Bruce D; Pecquet, Alison M; Shipp, Bryan K; Sussman, Robert G; Weideman, Patricia A

    2016-08-01

    This manuscript centers on communication with key stakeholders of the concepts and program goals involved in the application of health-based pharmaceutical cleaning limits. Implementation of health-based cleaning limits, as distinct from other standards such as 1/1000th of the lowest clinical dose, is a concept recently introduced into regulatory domains. While there is a great deal of technical detail in the written framework underpinning the use of Acceptable Daily Exposures (ADEs) in cleaning (for example ISPE, 2010; Sargent et al., 2013), little is available to explain how to practically create a program which meets regulatory needs while also fulfilling good manufacturing practice (GMP) and other expectations. The lack of a harmonized approach for program implementation and communication across stakeholders can ultimately foster inappropriate application of these concepts. Thus, this period in time (2014-2017) could be considered transitional with respect to influencing best practice related to establishing health-based cleaning limits. Suggestions offered in this manuscript are intended to encourage full and accurate communication regarding both scientific and administrative elements of health-based ADE values used in pharmaceutical cleaning practice. This is a large and complex effort that requires: 1) clearly explaining key terms and definitions, 2) identification of stakeholders, 3) assessment of stakeholders' subject matter knowledge, 4) formulation of key messages fit to stakeholder needs, 5) identification of effective and timely means for communication, and 6) allocation of time, energy, and motivation for initiating and carrying through with communications.

  12. 75 FR 71613 - Mandatory Reliability Standards for Interconnection Reliability Operating Limits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-24

    ... Energy Regulatory Commission 18 CFR Part 40 Mandatory Reliability Standards for Interconnection Reliability Operating Limits November 18, 2010. AGENCY: Federal Energy Regulatory Commission. ACTION: Notice... Regulatory Commission proposes to approve three new Interconnection Reliability Operations and...

  13. The Nuclear Energy Option for the U.S.--How Far Are We from Public Acceptance?

    SciTech Connect

    Biedscheid, J.A.; Devarakonda, M.

    2004-10-03

    The recent rise of oil and gasoline prices accompanied by reluctant acknowledgement that traditional sources of energy are limited has renewed public interest in renewable energy sources. This perspective on energy is focusing attention on and facilitating acceptance of alternative energy concepts, such as solar, wind, and biomass. The nuclear energy alternative, while clean with potentially abundant fuel supplies and associated with low costs, is burdened with the frequently negative public opinion reserved for things nuclear. Coincident with the heightened examination of alternative energy concepts, 2004 marks the 25-year anniversary of the Three Mile Island accident. Since this pivotal accident in 1979, no new reactor licenses have been granted in the U.S. The resolution of the issues of nuclear waste management and disposition are central to and may advance public discussions of the future use of nuclear energy. The U.S. Department of Energy (DOE) is currently preparing the licensing application for Yucca Mountain, which was designated in 2003 as the site for a high-level waste and spent nuclear fuel repository in the U.S. The DOE also has been operating a deep geologic repository for the permanent disposal of transuranic (TRU) waste since 1999. The operational status of the Waste Isolation Pilot Plant (WIPP) as a repository for TRU waste was successfully realized along with the lesson learned that stakeholder trust and acceptance are as critical to the success of a repository program as the resolution of technical issues and obtaining regulatory approvals. For the five years of its operation and for decades prior, the challenge of attaining public acceptance of the WIPP has persisted for reasons aligned with the opposition to nuclear energy. Due to this commonality, the nuclear waste approach to public acceptance, with its pros and cons, provides a baseline for the examination of an approach for the public acceptance of nuclear energy in the U.S. This paper

  14. The physiological basis for spacecraft environmental limits

    NASA Technical Reports Server (NTRS)

    Waligora, J. M. (Compiler)

    1979-01-01

    Limits for operational environments are discussed in terms of acceptable physiological changes. The environmental factors considered are pressure, contaminants, temperature, acceleration, noise, rf radiation, and weightlessness.

  15. Data Quality Objectives for WTP Feed Acceptance Criteria - 12043

    SciTech Connect

    Arakali, Aruna V.; Benson, Peter A.; Duncan, Garth; Johnston, Jill C.; Lane, Thomas A.; Matis, George; Olson, John W.; Banning, Davey L.; Greer, Daniel A.; Seidel, Cary M.; Thien, Michael G.

    2012-07-01

    . Data quality requirements for sample collection and analysis of all WAC parameters were specified during the DQO process. There were eighteen key parameters identified with action limits to ensure the feed transfer and receipt would not exceed plant design, safety, permitting, and processing requirements. The remaining WAC parameters were grouped in the category for obtaining data according to WTP contract specifications, regulatory reporting requirements, and for developing the feed campaign processing sequence. (authors)

  16. Willingness-To-Accept Pharmaceutical Retail Inconvenience: Evidence from a Contingent Choice Experiment

    PubMed Central

    Finlay, Keith; Stoecker, Charles; Cunningham, Scott

    2015-01-01

    Objectives Restrictions on retail purchases of pseudoephedrine are one regulatory approach to reduce the social costs of methamphetamine production and use, but may impose costs on legitimate users of nasal decongestants. This is the first study to evaluate the costs of restricting access to medications on consumer welfare. Our objective was to measure the inconvenience cost consumers place on restrictions for cold medication purchases including identification requirements, purchase limits, over-the-counter availability, prescription requirements, and the active ingredient. Methods We conducted a contingent choice experiment with Amazon Mechanical Turk workers that presented participants with randomized, hypothetical product prices and combinations of restrictions that reflect the range of public policies. We used a conditional logit model to calculate willingness-to-accept each restriction. Results Respondents’ willingness-to-accept prescription requirements was $14.17 ($9.76–$18.58) and behind-the-counter restrictions was $9.68 ($7.03–$12.33) per box of pseudoephedrine product. Participants were willing to pay $4.09 ($1.66–$6.52) per box to purchase pseudoephedrine-based products over phenylephrine-based products. Conclusions Restricting access to medicines as a means of reducing the social costs of non-medical use can imply large inconvenience costs for legitimate consumers. These results are relevant to discussions of retail access restrictions on other medications. PMID:26024444

  17. Regulatory RNAs in Planarians.

    PubMed

    Pawlicka, Kamila; Perrigue, Patrick M; Barciszewski, Jan

    2016-01-01

    The full scope of regulatory RNA evolution and function in epigenetic processes is still not well understood. The development of planarian flatworms to be used as a simple model organism for research has shown a great potential to address gaps in the knowledge in this field of study. The genomes of planarians encode a wide array of regulatory RNAs that function in gene regulation. Here, we review planarians as a suitable model organism for the identification and function of regulatory RNAs.

  18. Regulatory Information By Sector

    EPA Pesticide Factsheets

    Find environmental regulatory, compliance, & enforcement information for various business, industry and government sectors, listed by NAICS code. Sectors include agriculture, automotive, petroleum manufacturing, oil & gas extraction & other manufacturing

  19. Vibration safety limits for magnetic resonance elastography.

    PubMed

    Ehman, E C; Rossman, P J; Kruse, S A; Sahakian, A V; Glaser, K J

    2008-02-21

    Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within a tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit, and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans.

  20. Vibration safety limits for magnetic resonance elastography

    NASA Astrophysics Data System (ADS)

    Ehman, E. C.; Rossman, P. J.; Kruse, S. A.; Sahakian, A. V.; Glaser, K. J.

    2008-02-01

    Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within a tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit, and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans.

  1. From requirements to acceptance tests

    NASA Technical Reports Server (NTRS)

    Baize, Lionel; Pasquier, Helene

    1993-01-01

    From user requirements definition to accepted software system, the software project management wants to be sure that the system will meet the requirements. For the development of a telecommunication satellites Control Centre, C.N.E.S. has used new rules to make the use of tracing matrix easier. From Requirements to Acceptance Tests, each item of a document must have an identifier. A unique matrix traces the system and allows the tracking of the consequences of a change in the requirements. A tool has been developed, to import documents into a relational data base. Each record of the data base corresponds to an item of a document, the access key is the item identifier. Tracing matrix is also processed, providing automatically links between the different documents. It enables the reading on the same screen of traced items. For example one can read simultaneously the User Requirements items, the corresponding Software Requirements items and the Acceptance Tests.

  2. To accept, or not to accept, that is the question: citizen reactions to rationing

    PubMed Central

    Broqvist, Mari; Garpenby, Peter

    2014-01-01

    Abstract Background  The publicly financed health service in Sweden has come under increasing pressure, forcing policy makers to consider restrictions. Objective  To describe different perceptions of rationing, in particular, what citizens themselves believe influences their acceptance of having to stand aside for others in a public health service. Design  Qualitative interviews, analysed by phenomenography, describing perceptions by different categories. Setting and participants  Purposeful sample of 14 Swedish citizens, based on demographic criteria and attitudes towards allocation in health care. Results  Participants expressed high awareness of limitations in public resources and the necessity of rationing. Acceptance of rationing could increase or decrease, depending on one’s (i) awareness that healthcare resources are limited, (ii) endorsement of universal health care, (iii) knowledge and acceptance of the principles guiding rationing and (iv) knowledge about alternatives to public health services. Conclusions  This study suggests that decision makers should be more explicit in describing the dilemma of resource limitations in a publicly funded healthcare system. Openness enables citizens to gain the insight to make informed decisions, i.e. to use public services or to ‘opt out’ of the public sector solution if they consider rationing decisions unacceptable. PMID:22032636

  3. 10 CFR 26.91 - Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use. 26.91 Section 26.91 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.91 Acceptable devices for conducting...

  4. 10 CFR 26.91 - Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use. 26.91 Section 26.91 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.91 Acceptable devices for conducting...

  5. 10 CFR 26.91 - Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use. 26.91 Section 26.91 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.91 Acceptable devices for conducting...

  6. 10 CFR 26.91 - Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use. 26.91 Section 26.91 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.91 Acceptable devices for conducting...

  7. 10 CFR 26.91 - Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use. 26.91 Section 26.91 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting Specimens for Testing § 26.91 Acceptable devices for conducting...

  8. Further Conceptualization of Treatment Acceptability

    ERIC Educational Resources Information Center

    Carter, Stacy L.

    2008-01-01

    A review and extension of previous conceptualizations of treatment acceptability is provided in light of progress within the area of behavior treatment development and implementation. Factors including legislation, advances in research, and service delivery models are examined as to their relationship with a comprehensive conceptualization of…

  9. Acceptance and Commitment Therapy: Introduction

    ERIC Educational Resources Information Center

    Twohig, Michael P.

    2012-01-01

    This is the introductory article to a special series in Cognitive and Behavioral Practice on Acceptance and Commitment Therapy (ACT). Instead of each article herein reviewing the basics of ACT, this article contains that review. This article provides a description of where ACT fits within the larger category of cognitive behavior therapy (CBT):…

  10. Nitrogen trailer acceptance test report

    SciTech Connect

    Kostelnik, A.J.

    1996-02-12

    This Acceptance Test Report documents compliance with the requirements of specification WHC-S-0249. The equipment was tested according to WHC-SD-WM-ATP-108 Rev.0. The equipment being tested is a portable contained nitrogen supply. The test was conducted at Norco`s facility.

  11. Imaginary Companions and Peer Acceptance

    ERIC Educational Resources Information Center

    Gleason, Tracy R.

    2004-01-01

    Early research on imaginary companions suggests that children who create them do so to compensate for poor social relationships. Consequently, the peer acceptance of children with imaginary companions was compared to that of their peers. Sociometrics were conducted on 88 preschool-aged children; 11 had invisible companions, 16 had personified…

  12. Euthanasia Acceptance: An Attitudinal Inquiry.

    ERIC Educational Resources Information Center

    Klopfer, Fredrick J.; Price, William F.

    The study presented was conducted to examine potential relationships between attitudes regarding the dying process, including acceptance of euthanasia, and other attitudinal or demographic attributes. The data of the survey was comprised of responses given by 331 respondents to a door-to-door interview. Results are discussed in terms of preferred…

  13. Helping Our Children Accept Themselves.

    ERIC Educational Resources Information Center

    Gamble, Mae

    1984-01-01

    Parents of a child with muscular dystrophy recount their reactions to learning of the diagnosis, their gradual acceptance, and their son's resistance, which was gradually lessened when he was provided with more information and treated more normally as a member of the family. (CL)

  14. 78 FR 44279 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Regulatory Flexibility Act, 5 U.S.C. sections 601 to 612 (1988). FOR FURTHER INFORMATION CONTACT: Robert... mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602... regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely...

  15. Comparative studies of gene regulatory mechanisms.

    PubMed

    Pai, Athma A; Gilad, Yoav

    2014-12-01

    It has become increasingly clear that changes in gene regulation have played an important role in adaptive evolution both between and within species. Over the past five years, comparative studies have moved beyond simple characterizations of differences in gene expression levels within and between species to studying variation in regulatory mechanisms. We still know relatively little about the precise chain of events that lead to most regulatory adaptations, but we have taken significant steps towards understanding the relative importance of changes in different mechanisms of gene regulatory evolution. In this review, we first discuss insights from comparative studies in model organisms, where the available experimental toolkit is extensive. We then focus on a few recent comparative studies in primates, where the limited feasibility of experimental manipulation dictates the approaches that can be used to study gene regulatory evolution.

  16. DREM 2.0: Improved reconstruction of dynamic regulatory networks from time-series expression data

    PubMed Central

    2012-01-01

    Background Modeling dynamic regulatory networks is a major challenge since much of the protein-DNA interaction data available is static. The Dynamic Regulatory Events Miner (DREM) uses a Hidden Markov Model-based approach to integrate this static interaction data with time series gene expression leading to models that can determine when transcription factors (TFs) activate genes and what genes they regulate. DREM has been used successfully in diverse areas of biological research. However, several issues were not addressed by the original version. Results DREM 2.0 is a comprehensive software for reconstructing dynamic regulatory networks that supports interactive graphical or batch mode. With version 2.0 a set of new features that are unique in comparison with other softwares are introduced. First, we provide static interaction data for additional species. Second, DREM 2.0 now accepts continuous binding values and we added a new method to utilize TF expression levels when searching for dynamic models. Third, we added support for discriminative motif discovery, which is particularly powerful for species with limited experimental interaction data. Finally, we improved the visualization to support the new features. Combined, these changes improve the ability of DREM 2.0 to accurately recover dynamic regulatory networks and make it much easier to use it for analyzing such networks in several species with varying degrees of interaction information. Conclusions DREM 2.0 provides a unique framework for constructing and visualizing dynamic regulatory networks. DREM 2.0 can be downloaded from: www.sb.cs.cmu.edu/drem. PMID:22897824

  17. Media Discourse on the Social Acceptability of Fecal Transplants.

    PubMed

    Chuong, Kim H; O'Doherty, Kieran C; Secko, David M

    2015-10-01

    Advances in human microbiome research have generated considerable interest in elucidating the role of bacteria in health and the application of microbial ecosystem therapies and probiotics. Fecal transplants involve the introduction of gut microbes from a healthy donor's stool to the patient and have been documented as effective for treating Clostridium difficile infections (CDIs) and some other gastrointestinal disorders. However, the treatment has encountered regulatory hurdles preventing widespread uptake. We examined dominant representations of fecal transplants in Canadian media and found that fecal transplants are often represented as being inherently disgusting or distasteful (the "ick factor"). This "ick factor" is used to construct different messages about the treatment's social acceptability and legitimacy. We conclude that an over-emphasis on the "ick factor" constrains public discourse from a more nuanced discussion of the social challenges, scientific concerns, and regulatory issues surrounding the treatment.

  18. Acceptance criteria for urban dispersion model evaluation

    NASA Astrophysics Data System (ADS)

    Hanna, Steven; Chang, Joseph

    2012-05-01

    The authors suggested acceptance criteria for rural dispersion models' performance measures in this journal in 2004. The current paper suggests modified values of acceptance criteria for urban applications and tests them with tracer data from four urban field experiments. For the arc-maximum concentrations, the fractional bias should have a magnitude <0.67 (i.e., the relative mean bias is less than a factor of 2); the normalized mean-square error should be <6 (i.e., the random scatter is less than about 2.4 times the mean); and the fraction of predictions that are within a factor of two of the observations (FAC2) should be >0.3. For all data paired in space, for which a threshold concentration must always be defined, the normalized absolute difference should be <0.50, when the threshold is three times the instrument's limit of quantification (LOQ). An overall criterion is then applied that the total set of acceptance criteria should be satisfied in at least half of the field experiments. These acceptance criteria are applied to evaluations of the US Department of Defense's Joint Effects Model (JEM) with tracer data from US urban field experiments in Salt Lake City (U2000), Oklahoma City (JU2003), and Manhattan (MSG05 and MID05). JEM includes the SCIPUFF dispersion model with the urban canopy option and the urban dispersion model (UDM) option. In each set of evaluations, three or four likely options are tested for meteorological inputs (e.g., a local building top wind speed, the closest National Weather Service airport observations, or outputs from numerical weather prediction models). It is found that, due to large natural variability in the urban data, there is not a large difference between the performance measures for the two model options and the three or four meteorological input options. The more detailed UDM and the state-of-the-art numerical weather models do provide a slight improvement over the other options. The proposed urban dispersion model acceptance

  19. 77 FR 43620 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-25

    ... Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to the Handling of Stop and Stop Limit Orders July 19, 2012. On May 24, 2012, Financial Industry Regulatory Authority, Inc... change to amend FINRA's rules relating to the handling of stop and stop limit orders. The proposed...

  20. Regulatory guidance document

    SciTech Connect

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM`s evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7.

  1. Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?

    PubMed

    Flanagan, Talia; Van Peer, Achiel; Lindahl, Anders

    2016-08-25

    Regulatory interactions are an important part of the drug development and licensing process. A survey on the use of biopharmaceutical tools for regulatory purposes has been carried out within the industry community of the EU project OrBiTo within Innovative Medicines Initiative (IMI). The aim was to capture current practice and experience in using in vitro and in silico biopharmaceutics tools at various stages of development, what barriers exist or are perceived, and to understand the current gaps in regulatory biopharmaceutics. The survey indicated that biorelevant dissolution testing and physiologically based modelling and simulation are widely applied throughout development to address a number of biopharmaceutics issues. However, data from these in vitro and in silico predictive biopharmaceutics tools are submitted to regulatory authorities far less often than they are used for internal risk assessment and decision making. This may prevent regulators from becoming familiar with these tools and how they are applied in industry, and limits the opportunities for biopharmaceutics scientists working in industry to understand the acceptability of these tools in the regulatory environment. It is anticipated that the advanced biopharmaceutics tools and understanding delivered in the next years by OrBiTo and other initiatives in the area of predictive tools will also be of value in the regulatory setting, and provide a basis for more informed and confident biopharmaceutics risk assessment and regulatory decision making. To enable the regulatory potential of predictive biopharmaceutics tools to be realized, further scientific dialogue is needed between industry, regulators and scientists in academia, and more examples need to be published to demonstrate the applicability of these tools.

  2. Acceptability of reactors in space

    SciTech Connect

    Buden, D.

    1981-01-01

    Reactors are the key to our future expansion into space. However, there has been some confusion in the public as to whether they are a safe and acceptable technology for use in space. The answer to these questions is explored. The US position is that when reactors are the preferred technical choice, that they can be used safely. In fact, it does not appear that reactors add measurably to the risk associated with the Space Transportation System.

  3. Acceptability of reactors in space

    SciTech Connect

    Buden, D.

    1981-04-01

    Reactors are the key to our future expansion into space. However, there has been some confusion in the public as to whether they are a safe and acceptable technology for use in space. The answer to these questions is explored. The US position is that when reactors are the preferred technical choice, that they can be used safely. In fact, it dies not appear that reactors add measurably to the risk associated with the Space Transportation System.

  4. 75 FR 13599 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ...: Notice of issuance and availability of Draft Regulatory Guide, DG-8040, ``Health Physics Surveys During... acceptable occupational health physics program that are closely related to surveys: (1) The number and qualification of the health physics staff, (2) instrumentation, including types, numbers of...

  5. The voices acceptance and action scale (VAAS): Pilot data.

    PubMed

    Shawyer, Frances; Ratcliff, Kirk; Mackinnon, Andrew; Farhall, John; Hayes, Steven C; Copolov, David

    2007-06-01

    Acceptance and mindfulness methods that emphasise the acceptance rather than control of symptoms are becoming more central to behavioural and cognitive therapies. Acceptance and Commitment Therapy (ACT) is the most developed of these methods; recent applications of ACT to psychosis suggest it to be a promising therapeutic approach. However, investigation of the mechanisms of therapy within this domain is difficult because there are no acceptance-based measures available specifically for psychotic symptoms. This paper describes the preliminary evaluation of a self-report instrument designed to assess acceptance-based attitudes and actions in relation to auditory and command hallucinations. Following initial scale development, a 56-item version of the Voices Acceptance and Action Scale (VAAS) was administered to 43 participants with command hallucinations as part of their baseline assessment in a larger trial. Measures of symptoms, quality of life, and depression were also administered. The scale was examined for reliability using corrected item total statistics. Based on this method, 31 items were retained. Internal consistency and test-retest reliability for the 31-item VAAS were acceptable. Subsequent examination of construct validity showed the VAAS to correlate significantly in the expected directions with depression, quality of life, and coping with command hallucinations. It also discriminated compliance from non-compliance with harmful command hallucinations. Although these results are preliminary and subject to a number of limitations, the VAAS shows promise as a useful aid in the assessment of the psychological impact of voices.

  6. 78 FR 55117 - Ultimate Heat Sink for Nuclear Power Plants; Draft Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... Nuclear Power Plants.'' This regulatory guide (RG) describes methods and procedures acceptable to the NRC staff that nuclear power plant facility licensees and applicants may use to implement general design... COMMISSION Ultimate Heat Sink for Nuclear Power Plants; Draft Regulatory Guide AGENCY: Nuclear...

  7. 78 FR 14870 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Order...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-07

    ... COMMISSION Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Order Granting Accelerated Approval of Proposed Rule Change Regarding Acceptance of Additional Interest Rate...). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of...

  8. 77 FR 22825 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Order...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-17

    ... COMMISSION Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Order Granting Accelerated Approval of Proposed Rule Change Regarding Acceptance of Additional Interest Rate... basis. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement...

  9. 76 FR 79731 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ... COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing and Immediate.... Self-Regulatory Organization's Statement of Terms of Substance of the Proposed Rule Change The proposed... OCC's acceptance or ``novation'' of exchange transactions in order to provide clearing members...

  10. Dealing efficiently with emotions: acceptance-based coping with negative emotions requires fewer resources than suppression.

    PubMed

    Alberts, Hugo J E M; Schneider, Francine; Martijn, Carolien

    2012-01-01

    Previous studies have consistently shown that changing or avoiding emotions requires resources and therefore leads to impaired performance on a subsequent self-control task. The aim of the present study was to investigate the extent to which acceptance-based coping requires regulatory resources. Participants who accepted their emotions during exposure to a sad video performed better on a subsequent self-control task than participants who were instructed to suppress their emotions and a control group who received no instructions. These findings suggest that acceptance is an efficient strategy in terms of resources.

  11. Task 2 - Limits for High-Frequency Conducted Susceptibility Testing - CS114 (NRC-HQ-60-14-D-0015)

    SciTech Connect

    Wood, Richard Thomas; Ewing, Paul D.; Moses, Rebecca J.

    2015-09-01

    A principal focus of Task 2 under this project was for ORNL to evaluate the basis for susceptibility testing against high-frequency conducted interference and to establish recommendations to resolve concerns about the severity of test limits for the conducted susceptibility (CS) test, CS114, from MIL-STD-461. The primary concern about the test limit has been characterized by the EPRI EMI Working Group in the following terms: Demonstrating compliance with the CS114 test limits recommended in TR-102323 has proven to be problematic, even for components that have been tested to commercial standards and demonstrated proper operation in industrial applications [6]. Specifically, EPRI notes that the CS114 limits approved in regulatory documents are significantly higher than those invoked by the US military and similar commercial standards in the frequency range below 200 kHz. For this task, ORNL evaluated the original approach to establishing the test limit, EPRI technical findings from a review of the limit, and the regulatory basis through which the currently approved limits were accepted. Based on this analysis, strategies have been developed regarding changes to the CS114 limit that can resolve the technical concerns raised by the industry. Guided by the principles that reasonable assurance of safety must not be compromised but excessive conservatism should be reduced, recommendations on a suitable basis for a revised limit have been developed and can be incorporated into the planned Revision 2 of RG 1.180.

  12. The social acceptance of artificial photosynthesis: towards a conceptual framework

    PubMed Central

    Sovacool, Benjamin K.; Gross, Allan

    2015-01-01

    Advancements in artificial photosynthesis have the potential to radically transform how societies convert and use energy. Their successful development, however, hinges not only on technical breakthroughs, but also acceptance and adoption by energy users. This article introduces a conceptual framework enabling analysts, planners and even investors to determine environments where artificial photosynthesis may thrive, and those where it may struggle. Drawn from work looking at the barriers and acceptance of solar photovoltaic and wind energy systems, the article proposes that social acceptance has multiple dimensions—socio-political, community and market—that must be met holistically in order for investors and users to embrace new technologies. The article argues that any future market acceptance for artificial photosynthesis will depend upon the prevalence of nine factors, which create conducive environments; the lack of the conditions engenders environments where they will likely be rejected. The conditions are (i) strong institutional capacity; (ii) political commitment; (iii) favourable legal and regulatory frameworks; (iv) competitive installation and/or production costs; (v) mechanisms for information and feedback; (vi) access to financing; (vii) prolific community and/or individual ownership and use; (viii) participatory project siting; and (ix) recognition of externalities or positive public image. PMID:26052424

  13. 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.

  14. Regulatory T cell memory

    PubMed Central

    Rosenblum, Michael D.; Way, Sing Sing; Abbas, Abul K.

    2016-01-01

    Memory for antigen is a defining feature of adaptive immunity. Antigen-specific lymphocyte populations show an increase in number and function after antigen encounter and more rapidly re-expand upon subsequent antigen exposure. Studies of immune memory have primarily focused on effector B cells and T cells with microbial specificity, using prime challenge models of infection. However, recent work has also identified persistently expanded populations of antigen-specific regulatory T cells that protect against aberrant immune responses. In this Review, we consider the parallels between memory effector T cells and memory regulatory T cells, along with the functional implications of regulatory memory in autoimmunity, antimicrobial host defence and maternal fetal tolerance. In addition, we discuss emerging evidence for regulatory T cell memory in humans and key unanswered questions in this rapidly evolving field. PMID:26688349

  15. 3 CFR - Regulatory Compliance

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... protecting the air we breathe and the water we drink. Consistent regulatory enforcement also levels the... can lead the Government to hold itself more accountable, encouraging agencies to identify and...

  16. 3 CFR - Regulatory Review

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... in general—should be revisited. I therefore direct the Director of OMB, in consultation with... delay; clarify the role of the behavioral sciences in formulating regulatory policy; and identify...

  17. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... basis in accordance with Generally Accepted Accounting Principles (GAAP) as promulgated by the Financial... set forth in FASB Statement of Financial Accounting Standards No. 15, Accounting by Debtors and... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Regulatory accounting-What are...

  18. Assessing the regulatory picture

    SciTech Connect

    Not Available

    1994-02-01

    This article addresses the safety of the nation's drinking water supply and discusses compliance of the Clean Water Act. Right now, the shape of the regulatory future is uncertain. The results of the D-DBP regulatory negotiation are imminent. Congress is ready to begin debating reauthorization of the Safe Drinking Water Act, and utilities are trying to comply with the regulations while trying not to price water out of the reach of some of their customers.

  19. NRC regulatory initiatives

    SciTech Connect

    Johnson, T.C.

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  20. 75 FR 58444 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ...: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1244, ``Availability of Electric Power.... The draft regulatory guide (DG), entitled, ``Availability of Electric Power Sources'' temporarily... electric power sources are less than the number of sources required by the limiting conditions...

  1. 75 FR 13270 - Ute Water Conservancy District; Notice of Application Accepted for Filing and Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-19

    ... would be located on the Plateau Creek Pipeline at the Rapid Creek Water Treatment Plant, in Mesa County... Rapid Creek Water Treatment Plant; and (2) appurtenant facilities. The project would have an estimated... Energy Regulatory Commission Ute Water Conservancy District; Notice of Application Accepted for...

  2. 76 FR 9339 - Village of Swanton, VT; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ... Energy Regulatory Commission Village of Swanton, VT; Notice of Preliminary Permit Application Accepted..., 2011, the Village of Swanton, Vermont (Swanton) filed an application for a preliminary permit, pursuant... Dam Hydroelectric Project to be located on the Missisquoi River in the Village of Swanton,...

  3. 77 FR 20808 - Black Bear Hydro Partners, LLC; Notice of Application Accepted for Filing, Ready for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Energy Regulatory Commission Black Bear Hydro Partners, LLC; Notice of Application Accepted for Filing... October 7, 2011, January 20, 2012, and March 14, 2012. d. Applicant: Black Bear Hydro Partners, LLC. e...: Federal Power Act, 16 U.S.C. 791a-825r. h. Applicant Contact: Mr. Scott D. Hall, Black Bear Hydro...

  4. 75 FR 22122 - Gibson Dam Hydroelectric Company, LLC; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... Energy Regulatory Commission Gibson Dam Hydroelectric Company, LLC; Notice of Application Accepted for... Application: Major Project--Existing Dam. b. Project No.: P-12478-003. c. Date filed: August 28, 2009. d. Applicant: Gibson Dam Hydroelectric Company, LLC. e. Name of Project: Gibson Dam Hydroelectric Project....

  5. 77 FR 35369 - Silt Water Conservancy District; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... requirements under 18 CFR 4.38(c). On September 1 and 23, and October 28, 2011, the Colorado Water Quality Control Division, the Colorado Division of Water Resources, and the U.S. Fish and Wildlife Service... Energy Regulatory Commission Silt Water Conservancy District; Notice of Application Accepted for...

  6. 77 FR 35367 - Silt Water Conservancy District; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... November 22 and 28, 2011, the Colorado Water Quality Control Division, the Colorado Division of Water... Energy Regulatory Commission Silt Water Conservancy District; Notice of Application Accepted for Filing.... Date filed: January 5, 2012. d. Applicant: Silt Water Conservancy District. e. Name of Project:...

  7. 75 FR 28596 - Bryant Mountain LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... Energy Regulatory Commission Bryant Mountain LLC; Notice of Preliminary Permit Application Accepted for..., 2010, Bryant Mountain LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Bryant Mountain Hydroelectric...

  8. 78 FR 38313 - Kings River Conservation District; Notice of Preliminary Permit Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... Energy Regulatory Commission Kings River Conservation District; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To Intervene On June 3, 2013, the Kings River... study the feasibility of the Gould Weir Hydroelectric Project, to be located on the Kings River,...

  9. 77 FR 58375 - Inglis Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... Energy Regulatory Commission Inglis Hydropower, LLC; Notice of Preliminary Permit Application Accepted..., Inglis Hydropower, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project located at the...

  10. 75 FR 24937 - Northern Illinois Hydropower, LLC; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-06

    ... Energy Regulatory Commission Northern Illinois Hydropower, LLC; Notice of Application Accepted for Filing...: Northern Illinois Hydropower, LLC. e. Name of Project: Brandon Road Hydroelectric Project. f. Location: U.S... Zdunich, Northern Illinois Hydropower, LLC, 801 Oakland Avenue, Joliet, IL 60435, (312) 320-1610. i....

  11. 75 FR 18193 - Northern Illinois Hydropower, LLC; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... Energy Regulatory Commission Northern Illinois Hydropower, LLC; Notice of Application Accepted for Filing...: Northern Illinois Hydropower, LLC. e. Name of Project: Dresden Island Project. f. Location: U.S. Army Corps... Zdunich, Northern Illinois Hydropower, LLC, 801 Oakland Avenue, Joliet, IL 60435, (312) 320-1610. i....

  12. 75 FR 40801 - Wilkesboro Hydropower, LLC; Notice of Application Accepted for Filing and Soliciting Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Wilkesboro Hydropower, LLC; Notice of Application Accepted for Filing and...: Wilkesboro Hydroelectric Company, LLC. e. Name of Project: W. Kerr Scott Hydropower Project. f. Location:...

  13. 75 FR 59707 - Coastal Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... Energy Regulatory Commission Coastal Hydropower, LLC; Notice of Preliminary Permit Application Accepted..., 2010. On February 9, 2010, and supplemented on July 16, 2010, Coastal Hydropower, LLC filed an...-hours. Applicant Contact: Neil Anderson, Coastal Hydropower, LLC, Key Centre, 601 108th Avenue,...

  14. 78 FR 69080 - Houtama Hydropower LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... Energy Regulatory Commission Houtama Hydropower LLC; Notice of Preliminary Permit Application Accepted..., 2013, Houtama Hydropower LLC filed an application for a preliminary permit, pursuant to section 4(f) of... Contact: Mr. William C. Hampton, CEO, Houtama Hydropower ] LLC, 1044 NW 12th Drive, Pendleton, OR...

  15. 78 FR 35618 - Three Valleys Municipal Water District; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Three Valleys Municipal Water District; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, Protests, Recommendations, and Terms and Conditions Take notice that the...

  16. 78 FR 72668 - Goodwin Power, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... Energy Regulatory Commission Goodwin Power, LLC; Notice of Preliminary Permit Application Accepted for..., Goodwin Power, LLC filed an application for a successive preliminary permit, pursuant to section 4(f) of... the Goodwin Dam Project, located on the Stanislaus River in Tuolumne and Calaveras...

  17. 18 CFR Appendix A to Part 2 - Guidance for Determining the Acceptable Construction Area for Replacements

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Guidance for Determining the Acceptable Construction Area for Replacements A Appendix A to Part 2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES GENERAL...

  18. 76 FR 21891 - Seneca Nation of Indians; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-19

    ... Energy Regulatory Commission Seneca Nation of Indians; Notice of Preliminary Permit Application Accepted..., 2011, the Seneca Nation of Indians filed an application for a preliminary permit, pursuant to section 4... owners' express permission. The Seneca Nation of Indians proposed project would consist of the...

  19. 75 FR 50752 - El Dorado Irrigation District; Notice of Application Accepted for Filing and Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... Energy Regulatory Commission El Dorado Irrigation District; Notice of Application Accepted for Filing and...-000. c. Date filed: April 19, 2010. d. Applicant: El Dorado Irrigation District. e. Name of Project... Project would be located on the Pleasant Oak main pipeline at the Tank 7 storage tank in El Dorado...

  20. 75 FR 5076 - Fred Coleman; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Fred Coleman; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications January 22, 2010. On November 13, 2009, Fred Coleman filed...

  1. 77 FR 27767 - Milford Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... Energy Regulatory Commission Milford Hydro, LLC; Notice of Preliminary Permit Application Accepted for..., Milford Hydro, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Milford Dam Hydroelectric Project, which would...

  2. 18 CFR Appendix A to Part 2 - Guidance for Determining the Acceptable Construction Area for Replacements

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Guidance for Determining the Acceptable Construction Area for Replacements A Appendix A to Part 2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES GENERAL...

  3. 18 CFR Appendix A to Part 2 - Guidance for Determining the Acceptable Construction Area for Replacements

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Guidance for Determining the Acceptable Construction Area for Replacements A Appendix A to Part 2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES GENERAL...

  4. 18 CFR Appendix A to Part 2 - Guidance for Determining the Acceptable Construction Area for Replacements

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Guidance for Determining the Acceptable Construction Area for Replacements A Appendix A to Part 2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES GENERAL...

  5. 76 FR 7183 - Verdant Power, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    .... d. Applicant: Verdant Power, LLC. e. Name of Project: Roosevelt Island Tidal Energy (RITE) Project f... Energy Regulatory Commission Verdant Power, LLC; Notice of Application Accepted for Filing, Soliciting... not affect federal lands. g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-828c. h....

  6. 76 FR 25320 - Hawthorn Water LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Hawthorn Water LLC; Notice of Preliminary Permit Application Accepted for..., Hawthorn Water LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing...

  7. 77 FR 3754 - Boise Project Board of Control; Notice of Application Accepted for Filing, Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... Energy Regulatory Commission Boise Project Board of Control; Notice of Application Accepted for Filing..., 2011. d. Applicant: Boise Project Board of Control. e. Name of Project: Fargo Drop No. 1 Hydroelectric.... Applicant Contact: Paul Deveau, Manager, Boise Project Board of Control, 2465 Overland Road, Boise, ID...

  8. 78 FR 37212 - Portland General Electric Company; Notice of Application Accepted for Filing, Soliciting Motions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... Energy Regulatory Commission Portland General Electric Company; Notice of Application Accepted for Filing....: 2195-088. c. Date Filed: April 10, 2013. d. Applicant: Portland General Electric Company. e. Name of... Power Act, 16 U.S.C. 791a-825r. h. Applicant Contact: Julie A. Keil, Director of Hydro Licensing...

  9. 75 FR 30012 - Hydrodynamics, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ... Energy Regulatory Commission Hydrodynamics, Inc.; Notice of Preliminary Permit Application Accepted for..., 2010, Hydrodynamics, Inc. filed an application for a preliminary permit, pursuant to section 4(f) of... project is 1.7 gigawatt hours. Applicant Contact: Jason M. Cohn, Project Engineer, Hydrodynamics,...

  10. 77 FR 58820 - Grand River Dam Authority; Notice of Application Accepted for Filing, Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ... Energy Regulatory Commission Grand River Dam Authority; Notice of Application Accepted for Filing.... Applicant: Grand River Dam Authority. e. Name of Project: Pensacola Hydroelectric Project. f. Location: The.... Jahnke, Assistant General Counsel, Grand River Dam Authority, P.O. Box 409, Vinita, Oklahoma......

  11. 77 FR 15749 - Twin Lakes Canal Company; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ... Energy Regulatory Commission Twin Lakes Canal Company; Notice of Preliminary Permit Application Accepted..., Twin Lakes Canal Company filed an application for a successive preliminary permit, pursuant to section... gigawatt-hours, which would be sold to a local utility. Applicant Contact: Mr. Clair Boesen, Twin...

  12. 77 FR 70424 - Pacific Gas and Electric Company; Notice of Application Accepted for Filing, Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... Energy Regulatory Commission Pacific Gas and Electric Company; Notice of Application Accepted for Filing...: Amendment of License. b. Project No.: 1121-112. c. Date Filed: November 13, 2012. d. Applicant: Pacific Gas... Coordinator, Pacific Gas and Electric Company, 245 Market Street, San Francisco, CA 94105. Tel: (415)...

  13. 78 FR 11903 - Acceptability of Corrective Action Programs for Fuel Cycle Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... COMMISSION Acceptability of Corrective Action Programs for Fuel Cycle Facilities AGENCY: Nuclear Regulatory... Fuel Cycle Facilities.'' The draft NUREG provides guidance to the NRC staff on how to determine whether a Corrective Action Plan (CAP) submitted by the licensee of a fuel cycle facility is...

  14. 75 FR 35007 - Portland Water Bureau; Notice of Application Accepted for Filing and Soliciting Comments, Motions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Portland Water Bureau; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, Protests, Recommendations, and Terms and Conditions June 15, 2010. Take notice that the...

  15. 78 FR 38702 - Brenda Wirkkala See; Notice of Application Accepted for Filing, Soliciting Comments, Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... Energy Regulatory Commission Brenda Wirkkala See; Notice of Application Accepted for Filing, Soliciting... Wirkkala See. e. Name of Project: Burnham Creek Hydroelectric Project. f. Location: Burnham Creek, just.... Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r. h. Applicant Contact: Ms. Brenda Wirkkala...

  16. 76 FR 25321 - Wild Flower Water LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Wild Flower Water LLC; Notice of Preliminary Permit Application Accepted for..., Wild Flower Water LLC filed an application, pursuant to section 4(f) of the Federal Power...

  17. 76 FR 51024 - Gay & Robinson, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... Energy Regulatory Commission Gay & Robinson, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On July 1, 2011, Gay... would be 20.5 gigawatt-hours. Applicant Contact: Mr. Charles Okamoto, President, Gay & Robinson, Inc.,...

  18. 10 CFR 32.110 - Acceptance sampling procedures under certain specific licenses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Acceptance sampling procedures under certain specific licenses. 32.110 Section 32.110 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Quality Control Sampling Procedures §...

  19. 78 FR 30297 - Alabama Power Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Alabama Power Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests Take notice that the following hydroelectric application has been filed with the Commission...

  20. 76 FR 11240 - Qualified Hydro 34, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Qualified Hydro 34, LLC; Notice of Preliminary Permit Application Accepted..., 2010, Qualified Hydro 34, LLC filed an application for a preliminary permit, pursuant to section...

  1. 75 FR 49929 - Music Mountain Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... Energy Regulatory Commission Music Mountain Hydro, LLC; Notice of Preliminary Permit Application Accepted.... On May 18, 2010, Music Mountain Hydro, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Music ] Mountain...

  2. 76 FR 28766 - Black Canyon Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... Energy Regulatory Commission Black Canyon Hydro, LLC; Notice of Preliminary Permit Application Accepted..., Black Canyon Hydro, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Black Canyon Hydroelectric...

  3. 78 FR 7770 - Boyce Hydro Power, LLC; Notice of Application Accepted for Filing, Soliciting Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... Energy Regulatory Commission Boyce Hydro Power, LLC; Notice of Application Accepted for Filing.... Applicant Contact: Lee W. Mueller, Boyce Hydro Power, LLC, 6000 S. M-30, Edenville, MI 48620, (989) 689-3161...: Amendment to License. b. Project No: 2785-081. c. Date Filed: September 11, 2012. d. Applicant: Boyce...

  4. 76 FR 52648 - Konohiki Hydro Power, Inc.; Notice of Application Accepted for Filing and Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... Energy Regulatory Commission Konohiki Hydro Power, Inc.; Notice of Application Accepted for Filing and...: May 9, 2011, and supplemented August 4, 2011. d. Applicant: Konohiki Hydro Power, Inc. e. Name of.... h. Applicant Contact: Mrs. Pamela Miller, Konohiki Hydro Power, Inc., P.O. Box 261, Anahola,...

  5. 75 FR 65625 - Osprey II, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Osprey II, LLC; Notice of Preliminary Permit Application Accepted for Filing.... The proposed project would consist of: (1) A new intake structure with trash racks; (2) a new...

  6. 75 FR 57768 - Hydrodynamics, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Hydrodynamics, Inc.; Notice of Preliminary Permit Application Accepted for...-wide, one-foot-thick diversion structure with a flood gate and trash rack; (2) a 2,020-foot-long,...

  7. 77 FR 71190 - Henry County, Iowa; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Henry County, Iowa; Notice of Preliminary Permit Application Accepted for... turbine bay and receiving water via a concrete conduit structure equipped with trash racks; (4) a...

  8. 77 FR 8251 - John B. Crockett; Notice of Preliminary Permit Application Accepted for Filingand Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission John B. Crockett; Notice of Preliminary Permit Application Accepted for... the East Fork Ditch with a trash rack and steel stand pipe; (2) 11,150-foot-long,...

  9. 76 FR 51024 - Percheron Power, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Percheron Power, LLC; Notice of Preliminary Permit Application Accepted for... trash rack; (2) an approximately 65-foot-long, 20-foot-wide powerhouse containing four low-head...

  10. 75 FR 70221 - City of Upland Public Works Department; Notice of Application Accepted for Filing, Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Energy Regulatory Commission City of Upland Public Works Department; Notice of Application Accepted for.... Applicant: City of Upland Public Works Department. e. Name of Project: Upland Hydrogeneration Project... Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r. h. Applicant Contact: Mr. Anthony M. La, Public...

  11. 78 FR 10615 - Westfield Water Resources Department; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... Hydroelectric Project would be located on a water supply pipeline entering the Sackett Filtration Plant in... Energy Regulatory Commission Westfield Water Resources Department; Notice of Application Accepted for.... Date filed: January 22, 2013. d. Applicant: Westfield Water Resources Department. e. Name of...

  12. 76 FR 2370 - Mount Storm Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... Energy Regulatory Commission Mount Storm Hydro, LLC; Notice of Preliminary Permit Application Accepted.... On October 14, 2010, Mount Storm Hydro, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Mount...

  13. 75 FR 39678 - Bishop Tungsten Development, LLC; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-12

    ... Energy Regulatory Commission Bishop Tungsten Development, LLC; Notice of Application Accepted for Filing....: 13163-000. c. Date filed: April 3, 2008. d. Applicant: Bishop Tungsten Development, LLC. e. Name of.... Hicks, Bishop Tungsten Development, LLC, 9050 Pine Creek Road, Bishop, CA 93514, phone (760) 387-2080....

  14. 78 FR 79427 - Greenwood County; Notice of Application Accepted for Filing and Soliciting Comments, Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Greenwood County; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests Take notice that the following hydroelectric application has been filed with the Commission and...

  15. 75 FR 71106 - Deer Creek Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... Energy Regulatory Commission Deer Creek Hydro, LLC; Notice of Preliminary Permit Application Accepted for... October 14, 2010, Deer Creek Hydro, LLC (Deer Creek Hydro) filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the...

  16. 77 FR 76026 - Tlingit-Haida Regional Electric Authority; Notice of Preliminary Permit Application Accepted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Tlingit-Haida Regional Electric Authority; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To Intervene On June 12, 2012,...

  17. 76 FR 63917 - Ocean Renewable Power Company, LLC; Notice of Application Accepted for Filing, Soliciting Motions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... Federal Energy Regulatory Commission Ocean Renewable Power Company, LLC; Notice of Application Accepted.... d. Applicant: Ocean Renewable Power Company, LLC. e. Name of Project: Cobscook Bay Tidal Energy...)-828(c). h. Applicant Contact: Christopher R. Sauer, Ocean Renewable Power Company, LLC, 120...

  18. 76 FR 43680 - Onyx Specialty Papers, Inc.; Notice of Application Accepted for Filing, Soliciting Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Energy Regulatory Commission Onyx Specialty Papers, Inc.; Notice of Application Accepted for Filing... License. b. Project No.: 2985-008. c. Date Filed: June 1, 2010. d. Applicant: Onyx Specialty Papers, Inc... Clements, Counsel for Onyx Specialty Papers, Inc., Van Ness Feldman, PC, 1050 Jefferson Street, NW.,...

  19. 77 FR 70433 - Resolute Marine Energy, Inc.; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Resolute Marine Energy, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On July 25, 2012, Resolute Marine Energy, Inc....

  20. 78 FR 27962 - Archon Energy 1, Inc.; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Archon Energy 1, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On February 11, 2013, the Archon Energy 1, Inc., filed...

  1. 75 FR 47808 - Verde Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ... Energy Regulatory Commission Verde Hydro, LLC; Notice of Preliminary Permit Application Accepted for... 21, 2010, Verde Hydro, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Verde Hydroelectric Project,...

  2. 78 FR 75553 - Cedar Rapids Water Board; Notice of Application Accepted for Filing, Soliciting Comments, Motions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Cedar Rapids Water Board; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests Take notice that the following hydroelectric application has been filed with the Commission...

  3. Grazing function g and collimation angular acceptance

    SciTech Connect

    Peggs, S.G.; Previtali, V.

    2009-11-02

    The grazing function g is introduced - a synchrobetatron optical quantity that is analogous (and closely connected) to the Twiss and dispersion functions {beta}, {alpha}, {eta}, and {eta}'. It parametrizes the rate of change of total angle with respect to synchrotron amplitude for grazing particles, which just touch the surface of an aperture when their synchrotron and betatron oscillations are simultaneously (in time) at their extreme displacements. The grazing function can be important at collimators with limited acceptance angles. For example, it is important in both modes of crystal collimation operation - in channeling and in volume reflection. The grazing function is independent of the collimator type - crystal or amorphous - but can depend strongly on its azimuthal location. The rigorous synchrobetatron condition g = 0 is solved, by invoking the close connection between the grazing function and the slope of the normalized dispersion. Propagation of the grazing function is described, through drifts, dipoles, and quadrupoles. Analytic expressions are developed for g in perfectly matched periodic FODO cells, and in the presence of {beta} or {eta} error waves. These analytic approximations are shown to be, in general, in good agreement with realistic numerical examples. The grazing function is shown to scale linearly with FODO cell bend angle, but to be independent of FODO cell length. The ideal value is g = 0 at the collimator, but finite nonzero values are acceptable. Practically achievable grazing functions are described and evaluated, for both amorphous and crystal primary collimators, at RHIC, the SPS (UA9), the Tevatron (T-980), and the LHC.

  4. Axelrod model: accepting or discussing

    NASA Astrophysics Data System (ADS)

    Dybiec, Bartlomiej; Mitarai, Namiko; Sneppen, Kim

    2012-10-01

    Agents building social systems are characterized by complex states, and interactions among individuals can align their opinions. The Axelrod model describes how local interactions can result in emergence of cultural domains. We propose two variants of the Axelrod model where local consensus is reached either by listening and accepting one of neighbors' opinion or two agents discuss their opinion and achieve an agreement with mixed opinions. We show that the local agreement rule affects the character of the transition between the single culture and the multiculture regimes.

  5. Acceptable knowledge summary report for combustible/noncombustible, metallic, and HEPA filter waste resulting from {sup 238}Pu fabrication activities

    SciTech Connect

    Rogers, P.S.Z.; Foxx, C.L.

    1998-02-19

    All transuranic (TRU) waste must be sufficiently characterized and certified before it is shipped to the Waste Isolation Pilot Plant (WIPP). The US Environmental Protection Agency (EPA) allows use of acceptable knowledge (AK) for waste characterization. EPA uses the term AK in its guidance document and defines AK and provides guidelines on how acceptable knowledge should be obtained and documented. This AK package has been prepared in accordance with Acceptable Knowledge Documentation (TWCP-QP-1.1-021,R.2). This report covers acceptable knowledge information for five waste streams generated at TA-55 during operations to fabricate various heat sources using feedstock {sup 238}Pu supplied by the Savannah River Site (SRS). The {sup 238}Pu feedstock itself does not contain quantities of RCRA-regulated constituents above regulatory threshold limits, as known from process knowledge at SRS and as confirmed by chemical analysis. No RCRA-regulated chemicals were used during {sup 238}Pu fabrication activities at TA-55, and all {sup 238}Pu activities were physically separated from other plutonium processing activities. Most of the waste generated from the {sup 238}Pu fabrication activities is thus nonmixed waste, including waste streams TA-55-43, 45, and 47. The exceptions are waste streams TA-55-44, which contains discarded lead-lined rubber gloves used in the gloveboxes that contained the {sup 238}Pu material, and TA-55-46, which may contain pieces of discarded lead. These waste streams have been denoted as mixed because of the presence of the lead-containing material.

  6. Acceptance and Commitment Therapy (ACT) as a Career Counselling Strategy

    ERIC Educational Resources Information Center

    Hoare, P. Nancey; McIlveen, Peter; Hamilton, Nadine

    2012-01-01

    Acceptance and commitment therapy (ACT) has potential to contribute to career counselling. In this paper, the theoretical tenets of ACT and a selection of its counselling techniques are overviewed along with a descriptive case vignette. There is limited empirical research into ACT's application in career counselling. Accordingly, a research agenda…

  7. Acceptance of Online Degrees by Undergraduate Mexican Students

    ERIC Educational Resources Information Center

    Padilla Rodriguez, Brenda Cecilia; Adams, Jonathan

    2014-01-01

    The quality and acceptance of online degree programs are still controversial issues. In Mexico, where access to technology is limited, there are few studies on the matter. Undergraduate students (n = 104) answered a survey that aimed to evaluate their knowledge of virtual education, their likelihood of enrollment in an online degree program, and…

  8. Acceptance-Enhanced Behavior Therapy for Trichotillomania in Adolescents

    ERIC Educational Resources Information Center

    Fine, Kathi M.; Walther, Michael R.; Joseph, Jessica M.; Robinson, Jordan; Ricketts, Emily J.; Bowe, William E.; Woods, Douglas W.

    2012-01-01

    Although several studies have examined the efficacy of Acceptance Enhanced Behavior Therapy (AEBT) for the treatment of trichotillomania (TTM) in adults, data are limited with respect to the treatment of adolescents. Our case series illustrates the use of AEBT for TTM in the treatment of two adolescents. The AEBT protocol (Woods & Twohig, 2008) is…

  9. 75 FR 61530 - Issuance of Regulatory Guides

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Issuance of Regulatory Guides AGENCY: Nuclear Regulatory Commission. ACTION: Notice. SUMMARY:...

  10. Regulatory framework for NORM residues in Belgium

    SciTech Connect

    Pepin, S.; Dehandschutter, B.; Poffijn, A.; Sonck, M.

    2013-07-01

    The Belgian radiation protection authority (Federal Agency for Nuclear Control - FANC) has published in March 2013 a decree regulating the acceptance of NORM residues by nonradioactive waste treatment facilities. This regulation is based on the concept of 'work activities involving natural radiation sources' in the sense of article 40 of the 96/29/EURATOM directive. The disposal or processing facilities which accept NORM residues with an activity concentration above a generic exemption level will be considered as 'work activities' and submitted to declaration according to the Belgian radiation protection regulations. On basis of this declaration, specific acceptance criteria for the different types of processing/ disposal of the residues (disposal on landfill, recycling into building materials, etc.) are imposed. FANC has drafted guidelines for these acceptance criteria. A methodological guide for the operators of the concerned facilities was also published. Moreover, sites where significant quantities of NORM residues are or have been disposed, are subjected to an environmental monitoring in the framework of the national program of radiological surveillance of FANC. FANC also introduced in its regulations the concept of anthropogenic radon-prone areas: e.g. former phosphogypsum stacks have been defined as anthropogenic radon-prone areas, which allows some form of regulatory control of these sites. (authors)

  11. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

    SciTech Connect

    Kisner, Roger A; Wilgen, John B; Ewing, Paul D; Korsah, Kofi; Antonescu, Christina E

    2006-01-01

    Abstract - Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance to licensees and applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects.

  12. Influence of Gender and Computer Teaching Efficacy on Computer Acceptance among Malaysian Student Teachers: An Extended Technology Acceptance Model

    ERIC Educational Resources Information Center

    Wong, Kung-Teck; Teo, Timothy; Russo, Sharon

    2012-01-01

    The purpose of this study is to validate the technology acceptance model (TAM) in an educational context and explore the role of gender and computer teaching efficacy as external variables. From the literature, it appeared that only limited studies had developed models to explain statistically the chain of influence of computer teaching efficacy…

  13. Freeform solar concentrator with a highly asymmetric acceptance cone

    NASA Astrophysics Data System (ADS)

    Wheelwright, Brian; Angel, J. Roger P.; Coughenour, Blake; Hammer, Kimberly

    2014-10-01

    A solar concentrator with a highly asymmetric acceptance cone is investigated. Concentrating photovoltaic systems require dual-axis sun tracking to maintain nominal concentration throughout the day. In addition to collecting direct rays from the solar disk, which subtends ~0.53 degrees, concentrating optics must allow for in-field tracking errors due to mechanical misalignment of the module, wind loading, and control loop biases. The angular range over which the concentrator maintains <90% of on-axis throughput is defined as the optical acceptance angle. Concentrators with substantial rotational symmetry likewise exhibit rotationally symmetric acceptance angles. In the field, this is sometimes a poor match with azimuth-elevation trackers, which have inherently asymmetric tracking performance. Pedestal-mounted trackers with low torsional stiffness about the vertical axis have better elevation tracking than azimuthal tracking. Conversely, trackers which rotate on large-footprint circular tracks are often limited by elevation tracking performance. We show that a line-focus concentrator, composed of a parabolic trough primary reflector and freeform refractive secondary, can be tailored to have a highly asymmetric acceptance angle. The design is suitable for a tracker with excellent tracking accuracy in the elevation direction, and poor accuracy in the azimuthal direction. In the 1000X design given, when trough optical errors (2mrad rms slope deviation) are accounted for, the azimuthal acceptance angle is +/- 1.65°, while the elevation acceptance angle is only +/-0.29°. This acceptance angle does not include the angular width of the sun, which consumes nearly all of the elevation tolerance at this concentration level. By decreasing the average concentration, the elevation acceptance angle can be increased. This is well-suited for a pedestal alt-azimuth tracker with a low cost slew bearing (without anti-backlash features).

  14. Studying Student Teachers' Acceptance of Role Responsibility.

    ERIC Educational Resources Information Center

    Davis, Michael D.; Davis, Concetta M.

    1980-01-01

    There is variance in the way in which student teachers accept responsibility for the teaching act. This study explains why some variables may affect student teachers' acceptance of role responsibilities. (CM)

  15. [Subjective well-being and self acceptance].

    PubMed

    Makino, Y; Tagami, F

    1998-06-01

    The purpose of the present study was to examine the relationship between subjective well-being and self acceptance, and to design a happiness self-writing program to increase self acceptance and subjective well-being of adolescents. In study 1, we examined the relationship between social interaction and self acceptance. In study 2, we created a happiness self-writing program in cognitive behavioral approach, and examined whether the program promoted self acceptance and subjective well-being. Results indicated that acceptance of self-openness, an aspect of self acceptance, was related to subjective well-being. The happiness self-writing program increased subjective well-being, but it was not found to have increased self acceptance. It was discussed why the program could promote subjective well-being, but not self acceptance.

  16. Evolutionary rewiring of bacterial regulatory networks

    PubMed Central

    Taylor, Tiffany B.; Mulley, Geraldine; McGuffin, Liam J.; Johnson, Louise J.; Brockhurst, Michael A.; Arseneault, Tanya; Silby, Mark W.; Jackson, Robert W.

    2015-01-01

    Bacteria have evolved complex regulatory networks that enable integration of multiple intracellular and extracellular signals to coordinate responses to environmental changes. However, our knowledge of how regulatory systems function and evolve is still relatively limited. There is often extensive homology between components of different networks, due to past cycles of gene duplication, divergence, and horizontal gene transfer, raising the possibility of cross-talk or redundancy. Consequently, evolutionary resilience is built into gene networks - homology between regulators can potentially allow rapid rescue of lost regulatory function across distant regions of the genome. In our recent study [Taylor, et al. Science (2015), 347(6225)] we find that mutations that facilitate cross-talk between pathways can contribute to gene network evolution, but that such mutations come with severe pleiotropic costs. Arising from this work are a number of questions surrounding how this phenomenon occurs. PMID:28357301

  17. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  18. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... either— (i) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an...

  19. Older Adults' Acceptance of Information Technology

    ERIC Educational Resources Information Center

    Wang, Lin; Rau, Pei-Luen Patrick; Salvendy, Gavriel

    2011-01-01

    This study investigated variables contributing to older adults' information technology acceptance through a survey, which was used to find factors explaining and predicting older adults' information technology acceptance behaviors. Four factors, including needs satisfaction, perceived usability, support availability, and public acceptance, were…

  20. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 1 2011-10-01 2011-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  1. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 1 2014-10-01 2014-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  2. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 1 2013-10-01 2013-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  3. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 1 2012-10-01 2012-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  4. 46 CFR 28.73 - Accepted organizations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Accepted organizations. 28.73 Section 28.73 Shipping... INDUSTRY VESSELS General Provisions § 28.73 Accepted organizations. An organization desiring to be designated by the Commandant as an accepted organization must request such designation in writing. As...

  5. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... offered have either achieved commercial market acceptance or been satisfactorily supplied to an agency... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance....

  6. 21 CFR 820.86 - Acceptance status.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Acceptance status. 820.86 Section 820.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Acceptance Activities § 820.86 Acceptance status. Each manufacturer...

  7. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... either— (i) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an...

  8. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) 41 U.S...) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an agency under current...

  9. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Market acceptance. 2911.103... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  10. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... either— (i) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an...

  11. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  12. 48 CFR 2911.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Market acceptance. 2911... DESCRIBING AGENCY NEEDS Selecting And Developing Requirements Documents 2911.103 Market acceptance. The... offered have either achieved commercial market acceptance or been satisfactorily supplied to an...

  13. The relation between remembered parental acceptance in childhood and self-acceptance among young Turkish adults.

    PubMed

    Kuyumcu, Behire; Rohner, Ronald P

    2016-05-11

    This study examined the relation between young adults' age and remembrances of parental acceptance in childhood, and their current self-acceptance. The study was based on a sample of 236 young adults in Turkey (139 women and 97 men). The adult version of the Parental Acceptance-Rejection/Control Questionnaire for mothers and fathers along with the Self-Acceptance subscale of the Psychological Well-Being Scale, and the Personal Information Form were used as measures. Results showed that both men and women tended to remember having been accepted in childhood by both their mothers and fathers. Women, however, reported more maternal and paternal acceptance in childhood than did men. Similarly, the level of self-acceptance was high among both men and women. However, women's self-acceptance was higher than men's. Correlational analyses showed that self-acceptance was positively related to remembrances of maternal and paternal acceptance among both women and men. Results indicated that age and remembered paternal acceptance significantly predicted women's self-acceptance. Age and remembered maternal acceptance made significant and independent contributions to men's self-acceptance. Men's remembrances of paternal acceptance in childhood did not make significant contribution to their self-acceptance. Finally, the relation between women's age and self-acceptance was significantly moderated by remembrances of paternal acceptance in childhood.

  14. Advancing technician practice: Deliberations of a regulatory board.

    PubMed

    Adams, Alex J

    2017-02-16

    In 2016, the Idaho State Board of Pharmacy (U.S.) undertook a major rulemaking initiative to advance pharmacy practice by broadening the ability of pharmacists to delegate tasks to pharmacy technicians. The new rules of the Board thus moved the locus of control in technician scope of practice from law to pharmacist delegation. Pharmacist delegation is individualistic and takes into account the individual technician's capabilities, the pharmacist's comfort level, facility policies, and the risk mitigation strategies present at the facility, among other factors. State law limits, by contrast, are rigid and can mean that pharmacists are unable to delegate tasks that are or could otherwise be within the abilities of their technicians. The expanded technician duties are in two domains: 1) medication dispensing support (e.g., tech-check-tech, accepting verbal prescriptions, transferring prescriptions, and performing remote data entry); and 2) technical support for pharmacist clinical services (e.g., administering immunizations). This commentary reviews the evidence behind these expanded duties, as well as the key regulatory decision points for each task. The Board's rules and approach may prove useful to other states and even other governing bodies outside the U.S. as they consider similar issues.

  15. Consumer acceptance of food crops developed by genome editing.

    PubMed

    Ishii, Tetsuya; Araki, Motoko

    2016-07-01

    One of the major problems regarding consumer acceptance of genetically modified organisms (GMOs) is the possibility that their transgenes could have adverse effects on the environment and/or human health. Genome editing, represented by the CRISPR/Cas9 system, can efficiently achieve transgene-free gene modifications and is anticipated to generate a wide spectrum of plants. However, the public attitude against GMOs suggests that people will initially be unlikely to accept these plants. We herein explored the bottlenecks of consumer acceptance of transgene-free food crops developed by genome editing and made some recommendations. People should not pursue a zero-risk bias regarding such crops. Developers are encouraged to produce cultivars with a trait that would satisfy consumer needs. Moreover, they should carefully investigate off-target mutations in resultant plants and initially refrain from agricultural use of multiplex genome editing for better risk-benefit communication. The government must consider their regulatory status and establish appropriate regulations if necessary. The government also should foster communication between the public and developers. If people are informed of the benefits of genome editing-mediated plant breeding and trust in the relevant regulations, and if careful risk-benefit communication and sincere considerations for the right to know approach are guaranteed, then such transgene-free crops could gradually be integrated into society.

  16. The regulatory horizon

    NASA Technical Reports Server (NTRS)

    Cook, ED

    1987-01-01

    The author briefly discusses the FAA's position as it relates to cockpit resource management. For example, if Cockpit Resource Management (CRM) is a positive concept, why isn't everyone required to implement it? The regulatory practice of the FAA is discussed and questions and answers are presented.

  17. Toxicogenomics in Regulatory Ecotoxicology

    EPA Science Inventory

    The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions, and as with any new technology, there is a wide range of opinion. The purpose of this feature article is to consider roles of toxicogenomic...

  18. Full-Scale Cask Testing and Public Acceptance of Spent Nuclear Fuel Shipments - 12254

    SciTech Connect

    Dilger, Fred; Halstead, Robert J.; Ballard, James D.

    2012-07-01

    Full-scale physical testing of spent fuel shipping casks has been proposed by the National Academy of Sciences (NAS) 2006 report on spent nuclear fuel transportation, and by the Presidential Blue Ribbon Commission (BRC) on America's Nuclear Future 2011 draft report. The U.S. Nuclear Regulatory Commission (NRC) in 2005 proposed full-scale testing of a rail cask, and considered 'regulatory limits' testing of both rail and truck casks (SRM SECY-05-0051). The recent U.S. Department of Energy (DOE) cancellation of the Yucca Mountain project, NRC evaluation of extended spent fuel storage (possibly beyond 60-120 years) before transportation, nuclear industry adoption of very large dual-purpose canisters for spent fuel storage and transport, and the deliberations of the BRC, will fundamentally change assumptions about the future spent fuel transportation system, and reopen the debate over shipping cask performance in severe accidents and acts of sabotage. This paper examines possible approaches to full-scale testing for enhancing public confidence in risk analyses, perception of risk, and acceptance of spent fuel shipments. The paper reviews the literature on public perception of spent nuclear fuel and nuclear waste transportation risks. We review and summarize opinion surveys sponsored by the State of Nevada over the past two decades, which show consistent patterns of concern among Nevada residents about health and safety impacts, and socioeconomic impacts such as reduced property values along likely transportation routes. We also review and summarize the large body of public opinion survey research on transportation concerns at regional and national levels. The paper reviews three past cask testing programs, the way in which these cask testing program results were portrayed in films and videos, and examines public and official responses to these three programs: the 1970's impact and fire testing of spent fuel truck casks at Sandia National Laboratories, the 1980's

  19. Regulatory Promotion of Emergent CCS Technology

    SciTech Connect

    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 comprehensive 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.

  20. Acceptability of GM foods among Pakistani consumers.

    PubMed

    Ali, Akhter; Rahut, Dil Bahadur; Imtiaz, Muhammad

    2016-04-02

    In Pakistan majority of the consumers do not have information about genetically modified (GM) foods. In developing countries particularly in Pakistan few studies have focused on consumers' acceptability about GM foods. Using comprehensive primary dataset collected from 320 consumers in 2013 from Pakistan, this study analyzes the determinants of consumers' acceptability of GM foods. The data was analyzed by employing the bivariate probit model and censored least absolute deviation (CLAD) models. The empirical results indicated that urban consumers are more aware of GM foods compared to rural consumers. The acceptance of GM foods was more among females' consumers as compared to male consumers. In addition, the older consumers were more willing to accept GM food compared to young consumers. The acceptability of GM foods was also higher among wealthier households. Low price is the key factor leading to the acceptability of GM foods. The acceptability of the GM foods also reduces the risks among Pakistani consumers.

  1. Probabilistic simulation for flaw acceptance by dye-penetrant inspection

    NASA Technical Reports Server (NTRS)

    Russell, D. A.; Keremes, J. J.

    1990-01-01

    This paper examines the problems encountered in assessing the reliability of dye-penetrant nondestructive inspection (NDI) techniques in preventing failures due to undetected surface flaws, as well as from flaw acceptance (Fitness-For-Purpose). A Monte Carlo simulation procedure which includes the major variables of the problem is presented as a means of quantifying reliability. Some issues associated with distribution selection are examined. A methodology for selecting the penetrant type and flaw acceptance size for the specific components analyzed using the simulation is proposed. Current methodology limitations are discussed along with possible future effort. Penetrant selection and acceptable sizes of detected flaws are based on a probabilistic assessment of the effect of component and dye-penetrant system variables on structural reliability.

  2. Consumer Acceptability of Intramuscular Fat

    PubMed Central

    Frank, Damian; Joo, Seon-Tea

    2016-01-01

    Fat in meat greatly improves eating quality, yet many consumers avoid visible fat, mainly because of health concerns. Generations of consumers, especially in the English-speaking world, have been convinced by health authorities that animal fat, particularly saturated or solid fat, should be reduced or avoided to maintain a healthy diet. Decades of negative messages regarding animal fats has resulted in general avoidance of fatty cuts of meat. Paradoxically, low fat or lean meat tends to have poor eating quality and flavor and low consumer acceptability. The failure of low-fat high-carbohydrate diets to curb “globesity” has prompted many experts to re-evaluate of the place of fat in human diets, including animal fat. Attitudes towards fat vary dramatically between and within cultures. Previous generations of humans sought out fatty cuts of meat for their superior sensory properties. Many consumers in East and Southeast Asia have traditionally valued more fatty meat cuts. As nutritional messages around dietary fat change, there is evidence that attitudes towards animal fat are changing and many consumers are rediscovering and embracing fattier cuts of meat, including marbled beef. The present work provides a short overview of the unique sensory characteristics of marbled beef and changing consumer preferences for fat in meat in general. PMID:28115880

  3. Alternatives to animal experimentation: The regulatory background

    SciTech Connect

    Garthoff, Bernward . E-mail: bernward.garthoff@bayercropscience.com

    2005-09-01

    The framework, in which alternatives to animal experiments can be developed, standardized, respectively formally validated, has to be seen in a global context. The ever increasing demand of testing for hazard and risk assessment in health and environment, exemplified by the EU REACH program, subsequently triggers laboratory animal testing. This holds especially true, if no valid alternative methods agreed to by the regulatory authorities and the scientific community are available. At least for regulatory toxicity testing, the global frame and network are given by institutions such as OECD, ICH, and alike. However, due to the necessity of global consent of states, organizations, and stakeholders, the time gap between availability of a novel alternative test method and its final acceptance by authorities and implementation thereafter is widening. The lack of new technologies or opportunities for alternative method application such as, for example, the broad use of transgenic animals for refinement of existing tests, adds to the problem. The bare existence of certain in vivo tests increases also the gap between public demands for testing versus availability of alternative tests. Industries operating on a worldwide basis support the alternative test development in their respective area of research and operational business. However, a more coordinating approach such as that of the ecopa-organization (European Consensus Platform on Alternatives) is needed to exploit the existing possibilities within the current regulatory framework. This will speed up the process of acceptance and challenge the political worldto feel responsible for the sequels of their demanding more testing, that is, by funding alternative method development in academia and industry.

  4. Alternatives to animal experimentation: the regulatory background.

    PubMed

    Garthoff, Bernward

    2005-09-01

    The framework, in which alternatives to animal experiments can be developed, standardized, respectively formally validated, has to be seen in a global context. The ever increasing demand of testing for hazard and risk assessment in health and environment, exemplified by the EU REACH program, subsequently triggers laboratory animal testing. This holds especially true, if no valid alternative methods agreed to by the regulatory authorities and the scientific community are available. At least for regulatory toxicity testing, the global frame and network are given by institutions such as OECD, ICH, and alike. However, due to the necessity of global consent of states, organizations, and stakeholders, the time gap between availability of a novel alternative test method and its final acceptance by authorities and implementation thereafter is widening. The lack of new technologies or opportunities for alternative method application such as, for example, the broad use of transgenic animals for refinement of existing tests, adds to the problem. The bare existence of certain in vivo tests increases also the gap between public demands for testing versus availability of alternative tests. Industries operating on a worldwide basis support the alternative test development in their respective area of research and operational business. However, a more coordinating approach such as that of the ecopa-organization (European Consensus Platform on Alternatives) is needed to exploit the existing possibilities within the current regulatory framework. This will speed up the process of acceptance and challenge the political world to feel responsible for the sequels of their demanding more testing, that is, by funding alternative method development in academia and industry.

  5. Basic Regulatory Principles of Escherichia coli's Electron Transport Chain for Varying Oxygen Conditions

    PubMed Central

    Henkel, Sebastian G.; Beek, Alexander Ter; Steinsiek, Sonja; Stagge, Stefan; Bettenbrock, Katja; de Mattos, M. Joost Teixeira; Sauter, Thomas; Sawodny, Oliver; Ederer, Michael

    2014-01-01

    For adaptation between anaerobic, micro-aerobic and aerobic conditions Escherichia coli's metabolism and in particular its electron transport chain (ETC) is highly regulated. Although it is known that the global transcriptional regulators FNR and ArcA are involved in oxygen response it is unclear how they interplay in the regulation of ETC enzymes under micro-aerobic chemostat conditions. Also, there are diverse results which and how quinones (oxidised/reduced, ubiquinone/other quinones) are controlling the ArcBA two-component system. In the following a mathematical model of the E. coli ETC linked to basic modules for substrate uptake, fermentation product excretion and biomass formation is introduced. The kinetic modelling focusses on regulatory principles of the ETC for varying oxygen conditions in glucose-limited continuous cultures. The model is based on the balance of electron donation (glucose) and acceptance (oxygen or other acceptors). Also, it is able to account for different chemostat conditions due to changed substrate concentrations and dilution rates. The parameter identification process is divided into an estimation and a validation step based on previously published and new experimental data. The model shows that experimentally observed, qualitatively different behaviour of the ubiquinone redox state and the ArcA activity profile in the micro-aerobic range for different experimental conditions can emerge from a single network structure. The network structure features a strong feed-forward effect from the FNR regulatory system to the ArcBA regulatory system via a common control of the dehydrogenases of the ETC. The model supports the hypothesis that ubiquinone but not ubiquinol plays a key role in determining the activity of ArcBA in a glucose-limited chemostat at micro-aerobic conditions. PMID:25268772

  6. 78 FR 40776 - Issuance of Regulatory Guide 1.124 and Regulatory Guide 1.130

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-08

    ...) Boiler and Pressure Vessel Code (B&PVC). Regulatory Guides 1.124 and 1.130 delineates levels of service... 2008 Addenda of the Boiler and Pressure Vessel Code (ASME B&PV Code), Section III, Division 1 (limited....130 approves for use the 2007 Edition through the 2008 Addenda of the Boiler and Pressure Vessel...

  7. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.

    PubMed

    Wagner, J A; Williams, S A; Webster, C J

    2007-01-01

    A consistent framework for the acceptance and qualification of biomarkers for regulatory use is needed to facilitate innovative and efficient research and subsequent application of biomarkers in drug development. One key activity is biomarker qualification, a graded, "fit-for-purpose" evidentiary process linking a biomarker with biology and clinical end points. A biomarker consortium model will distribute cost and risk, and drive efficient execution of research and ultimately regulatory acceptance of biomarkers for specific indications.

  8. Toxicogenomics and the Regulatory Framework

    EPA Science Inventory

    Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

  9. Acceptance in Romantic Relationships: The Frequency and Acceptability of Partner Behavior Inventory

    ERIC Educational Resources Information Center

    Doss, Brian D.; Christensen, Andrew

    2006-01-01

    Despite the recent emphasis on acceptance in romantic relationships, no validated measure of relationship acceptance presently exists. To fill this gap, the 20-item Frequency and Acceptability of Partner Behavior Inventory (FAPBI; A. Christensen & N. S. Jacobson, 1997) was created to assess separately the acceptability and frequency of both…

  10. 24 CFR 203.202 - Plan acceptability and acceptance renewal criteria-general.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUD acceptance of such change or modification, except that changes mandated by other applicable laws... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Plan acceptability and acceptance... Underwriting Procedures Insured Ten-Year Protection Plans (plan) § 203.202 Plan acceptability and...

  11. Functional footprinting of regulatory DNA

    PubMed Central

    Vierstra, Jeff; Reik, Andreas; Chang, Kai-Hsin; Stehling-Sun, Sandra; Zhou, Yuan-Yue; Hinkley, Sarah J.; Paschon, David E.; Zhang, L.; Psatha, Nikoletta; Bendana, Yuri R.; O'Neill, Colleen M.; Song, Alex H.; Mich, Andrea; Liu, Pei-Qi; Lee, Gary; Bauer, Daniel E.; Holmes, Michael C.; Orkin, Stuart H.; Papayannopoulou, Thalia; Stamatoyannopoulos, George; Rebar, Edward J.; Gregory, Philip D.; Urnov, Fyodor D.; Stamatoyannopoulos, John A.

    2017-01-01

    Regulatory regions harbor multiple transcription factor recognition sites; however, the contribution of individual sites to regulatory function remains challenging to define. We describe a facile approach that exploits the error-prone nature of genome editing-induced double-strand break repair to map functional elements within regulatory DNA at nucleotide resolution. We demonstrate the approach on a human erythroid enhancer, revealing single TF recognition sites that gate the majority of downstream regulatory function. PMID:26322838

  12. Nuclear Regulatory Commission information digest

    SciTech Connect

    None,

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  13. 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.

  14. Cognitive regulatory control therapies.

    PubMed

    Bowins, Brad

    2013-01-01

    Cognitive regulatory control processes play an essential but typically unappreciated role in maintaining mental health. The purpose of the current paper is to identify this role and demonstrate how cognitive-behavioral and related techniques can compensate for impairments. Impaired cognitive regulation contributes to the overly intense emotional states present in anxiety disorders, depression, and personality disorders; progression of adaptive hypomania to mania; expression of psychosis in the conscious and awake state; dominance of immature defense mechanisms in borderline and other personality disorders. A wide variety of standard (monitoring, reappraisal, response inhibition, relaxation training) and more novel (suppression therapy, willful detachment, cost-benefit analysis, normalization, mature defense mechanism training) cognitive-behavioral and related techniques can be applied to compensate for cognitive regulatory control impairments, and their success probably aligns with this capacity.

  15. 77 FR 71023 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... COMMISSION Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate... Order Acceptance Cut-Off Time Cannot Be Past 4:30 p.m. November 21, 2012. Pursuant to Section 19(b)(1... below, which Items have been prepared by the self-regulatory organization. The Commission is...

  16. A regulatory model for clinical laboratories: an empirical evaluation.

    PubMed

    Peddecord, K M

    1989-04-01

    Clinical laboratories in the United States are subject to various regulatory and accreditation programs, which mandate a broad range of requirements regarding personnel, quality-control systems, and analytical proficiency standards. Reported here, for a cross-section of U.S. laboratories, is the degree of compliance with these regulatory requirements, some other laboratory characteristics, and their relation to analytical proficiency. The results suggest that those laboratory characteristics that predict highest proficiency-test performance differ for each laboratory specialty. Regression models are presented that explain from 12% to 35% of the variation in analytical performance and suggest that factors outside of those specified in the regulatory model and other characteristics measured in this research are important. Indeed, the current regulatory approach may not ensure highest performance. Also discussed are the current status, limitations, and prospects for change of the clinical laboratory regulatory system.

  17. Regulatory perspective for prevention of groundwater pollution. [Monograph

    SciTech Connect

    Dotson, L.J.

    1982-01-01

    This paper attempts to establish a regulatory perspective for preventing groundwater pollution, which is a serious problem in many regions of the country. Historically, pollution-control regulations have been haphazard and uncoordinated. Few have been designed to consider the problems unique to this source. The paper outlines important hydrologic factors to establish a basis for an improved regulatory program for groundwater quality protection. Significant factors include the hydrologic role of ground water, the uses and regional importance of groundwater, and groundwater contamination pathways. A review of past and present trends in regulatory protection includes two regulatory approaches that are generally superior and a listing of key factors that planners should consider when designing land-use regulations. The paper concludes with a discussion of some possible problems of implementing an improved regulatory program, such as limits on our technical or enforcement capabilities. 52 references, 7 figures.

  18. Students' Formalising Process of the Limit Concept

    ERIC Educational Resources Information Center

    Kabael, Tangul

    2014-01-01

    The concept of limit is the foundation for many concepts such as the derivative and the integral in advanced mathematics. The limit concept has been a research topic in mathematics education for years and in the literature it is a broadly accepted fact that the limit is a difficult notion for most students. The study presented in this article is a…

  19. Addressing patient safety through the use of 'criteria of acceptability' for medical radiation equipment.

    PubMed

    Gilley, Debbie Bray; Holmberg, Ola

    2013-02-01

    Patient safety should be considered in the use of ionising radiation equipment in medicine. The International Atomic Energy Agency (IAEA) establishes standards of safety and provides for the application of these standards, also in the area of medical use of radiation. Equipment acceptability, as it relates to radiation in medicine, is the need to satisfy the requirements or standards prior to the use of the device in patient imaging or treatment. Through IAEA activities in establishing and developing Safety Standards, Safety Reports and recommendations to regulatory authorities and end-users, it encourages the adoption of acceptability criteria that are relevant to the medical equipment and its use.

  20. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  1. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  2. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  3. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  4. 7 CFR 1207.323 - Acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan National Potato Promotion Board § 1207.323 Acceptance. Each...

  5. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  6. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  7. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  8. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AND ORDERS; FRUITS, VEGETABLES, NUTS), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  9. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AND ORDERS; FRUITS, VEGETABLES, NUTS), DEPARTMENT OF AGRICULTURE OLIVES GROWN IN CALIFORNIA Order Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the...

  10. Acceptance Criteria for Aerospace Structural Adhesives.

    DTIC Science & Technology

    ADHESIVES, *AIRFRAMES, PRIMERS, STRUCTURAL ENGINEERING, CHEMICAL COMPOSITION, MECHANICAL PROPERTIES, INDUSTRIAL PRODUCTION , DATA ACQUISITION , PARTICLE SIZE, ACCEPTANCE TESTS, ELASTOMERS, BONDING, QUALITY CONTROL, .

  11. 2013 SYR Accepted Poster Abstracts.

    PubMed

    2013-01-01

    SYR 2013 Accepted Poster abstracts: 1. Benefits of Yoga as a Wellness Practice in a Veterans Affairs (VA) Health Care Setting: If You Build It, Will They Come? 2. Yoga-based Psychotherapy Group With Urban Youth Exposed to Trauma. 3. Embodied Health: The Effects of a Mind�Body Course for Medical Students. 4. Interoceptive Awareness and Vegetable Intake After a Yoga and Stress Management Intervention. 5. Yoga Reduces Performance Anxiety in Adolescent Musicians. 6. Designing and Implementing a Therapeutic Yoga Program for Older Women With Knee Osteoarthritis. 7. Yoga and Life Skills Eating Disorder Prevention Among 5th Grade Females: A Controlled Trial. 8. A Randomized, Controlled Trial Comparing the Impact of Yoga and Physical Education on the Emotional and Behavioral Functioning of Middle School Children. 9. Feasibility of a Multisite, Community based Randomized Study of Yoga and Wellness Education for Women With Breast Cancer Undergoing Chemotherapy. 10. A Delphi Study for the Development of Protocol Guidelines for Yoga Interventions in Mental Health. 11. Impact Investigation of Breathwalk Daily Practice: Canada�India Collaborative Study. 12. Yoga Improves Distress, Fatigue, and Insomnia in Older Veteran Cancer Survivors: Results of a Pilot Study. 13. Assessment of Kundalini Mantra and Meditation as an Adjunctive Treatment With Mental Health Consumers. 14. Kundalini Yoga Therapy Versus Cognitive Behavior Therapy for Generalized Anxiety Disorder and Co-Occurring Mood Disorder. 15. Baseline Differences in Women Versus Men Initiating Yoga Programs to Aid Smoking Cessation: Quitting in Balance Versus QuitStrong. 16. Pranayam Practice: Impact on Focus and Everyday Life of Work and Relationships. 17. Participation in a Tailored Yoga Program is Associated With Improved Physical Health in Persons With Arthritis. 18. Effects of Yoga on Blood Pressure: Systematic Review and Meta-analysis. 19. A Quasi-experimental Trial of a Yoga based Intervention to Reduce Stress and

  12. 75 FR 61531 - Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... E. Norris, Component Integrity Branch, Division of Engineering, Office of Nuclear Regulatory... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice. SUMMARY:...

  13. In acceptance we trust? Conceptualising acceptance as a viable approach to NGO security management.

    PubMed

    Fast, Larissa A; Freeman, C Faith; O'Neill, Michael; Rowley, Elizabeth

    2013-04-01

    This paper documents current understanding of acceptance as a security management approach and explores issues and challenges non-governmental organisations (NGOs) confront when implementing an acceptance approach to security management. It argues that the failure of organisations to systematise and clearly articulate acceptance as a distinct security management approach and a lack of organisational policies and procedures concerning acceptance hinder its efficacy as a security management approach. The paper identifies key and cross-cutting components of acceptance that are critical to its effective implementation in order to advance a comprehensive and systematic concept of acceptance. The key components of acceptance illustrate how organisational and staff functions affect positively or negatively an organisation's acceptance, and include: an organisation's principles and mission, communications, negotiation, programming, relationships and networks, stakeholder and context analysis, staffing, and image. The paper contends that acceptance is linked not only to good programming, but also to overall organisational management and structures.

  14. Federal Energy Regulatory Commission fiscal year 1997 annual financial statements

    SciTech Connect

    1998-02-24

    This report presents the results of the independent certified public accountants` audit of the Federal Energy Regulatory commission`s statements of financial position, and the related statements of operations and changes in net position. The auditors` work was conducted in accordance with generally accepted government auditing standards. An independent public accounting firm conducted the audit. The auditors` reports on the Commission`s internal control structure and compliance with laws and regulations disclosed no reportable conditions or instances of noncompliance.

  15. 75 FR 60865 - Surety Companies Acceptable on Federal Bonds: Amendment-Allegheny Casualty Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Fiscal Service Surety Companies Acceptable on Federal Bonds: Amendment-- Allegheny Casualty Company... INFORMATION: The underwriting limitation for Allegheny Casualty Company (NAIC 13285), which was listed in...

  16. Factors influencing the acceptance of nature conservation measures--a qualitative study in Switzerland.

    PubMed

    Schenk, Anita; Hunziker, Marcel; Kienast, Felix

    2007-04-01

    Landscapes fulfil a multitude of ecological and social functions. Due to the fact that both traditional and everyday landscapes today face many different threats, regulatory measures have been undertaken in many countries to protect and further sustainable landscape development. They include legislation as well as economic incentives. In recent years, however, it has become clear that just to have a few laws and to spend money on subsidies is not enough. Factors other than legislation are also essential to further the sustainable development of landscapes. One of the basic factors affecting the success or failure of landscape conservation measures is public acceptance of these measures. Our project took this as its starting point. The objective was to determine which conditions and factors influence acceptance positively or negatively. To this end 22 Swiss who are directly affected by nature conservation measures, in particular by mire landscape and dry meadow conservation measures, were interviewed using qualitative interview techniques. It is shown that perception, communication, and possibilities to participate are the most decisive driving factors influencing the formation of a long-lasting acceptance. Furthermore, acceptance may be based mainly on economic criteria, on usefulness, on ecological or even aesthetic aspects. It can be shown that not all of these motivations lead to a long-lasting acceptance. Ecologically based acceptance seems the most promising because it is founded on general convictions. Economic incentives--though important--seem to generate only superficial acceptance and do not seem to be as important as is usually assumed.

  17. TFM-Explorer: mining cis-regulatory regions in genomes

    PubMed Central

    Tonon, Laurie; Varré, Jean-Stéphane

    2010-01-01

    DNA-binding transcription factors (TFs) play a central role in transcription regulation, and computational approaches that help in elucidating complex mechanisms governing this basic biological process are of great use. In this perspective, we present the TFM-Explorer web server that is a toolbox to identify putative TF binding sites within a set of upstream regulatory sequences of genes sharing some regulatory mechanisms. TFM-Explorer finds local regions showing overrepresentation of binding sites. Accepted organisms are human, mouse, rat, chicken and drosophila. The server employs a number of features to help users to analyze their data: visualization of selected binding sites on genomic sequences, and selection of cis-regulatory modules. TFM-Explorer is available at http://bioinfo.lifl.fr/TFM. PMID:20522509

  18. Limitations of proficiency testing under CLIA '67.

    PubMed

    Laessig, R H; Ehrmeyer, S S; Lanphear, B J; Burmeister, B J; Hassemer, D J

    1992-07-01

    Proficiency testing (PT), recognized as a quality-assurance (QA) and quality-improvement tool, also has become the cornerstone of the Health Care Financing Administration's (HCFA) regulatory strategy under the revised Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Use of PT as a regulatory tool corrupts it for things it can do better. PT as a primary regulatory strategy has severe limitations. We explore the nature of these limitations and their implications for clinical laboratories as they impact on the long-term success of HCFA's approved regulatory PT programs in 1991 and beyond, and CLIA '88 PT, which is to be implemented in 1994.

  19. Gaining Acceptance for the use of in vitro Toxicity Assays and QIVIVE in Regulatory Risk Assessment

    EPA Science Inventory

    Testing strategies are anticipated to increasingly rely on in vitro data as a basis to characterize early steps or key events in toxicity at relevant dose levels in human tissues. This requires quantitative in vitro to in vivo extrapolation to characterize dose-response as a bas...

  20. The Effect of Soil Properties on Metal Bioavailability: Field Scale Validation to Support Regulatory Acceptance

    DTIC Science & Technology

    2013-06-01

    bioaccessibility, bioavailability, and toxicity of metals (As, Cd, Cr, Pb) in DoD soils as measured by biological models used to evaluate ecological...bioavailability, and toxicity of metals (Pb, As, Cd, Cr) in DoD soils as measured by biological models used to evaluate ecological risk (e.g., plants...screening tool for estimating in vivo toxic metal bioavailability in DoD soils; (2) To provide DoD with a scientifically and technically sound method for

  1. 75 FR 82130 - Generalized System of Preferences (GSP): Notice Regarding the Acceptance of Petitions To Grant a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-29

    ... (GSP): Notice Regarding the Acceptance of Petitions To Grant a Competitive Need Limitation (CNL) Waiver... competitive need limitations (CNLs) on imports of certain products that are eligible for duty-free...

  2. 76 FR 71967 - Jordan Hydroelectric Limited Partnership; Notice of Availability of Final Environmental Assessment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Jordan Hydroelectric Limited Partnership; Notice of Availability of... Federal Energy Regulatory Commission's regulations, 18 CFR Part 380 (Order No. 486, 52 FR 47897),...

  3. 76 FR 53847 - New International Commission on Radiological Protection; Recommendations on the Annual Dose Limit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... REIRS database (NUREG-0713, ``Occupational Radiation Exposure at Commercial Nuclear Power Reactors and... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY... Annual Dose Limit to the Lens of the Eye AGENCY: Nuclear Regulatory Commission. ACTION: Request...

  4. Heavy Metal, Religiosity, and Suicide Acceptability.

    ERIC Educational Resources Information Center

    Stack, Steven

    1998-01-01

    Reports on data taken from the General Social Survey that found a link between "heavy metal" rock fanship and suicide acceptability. Finds that relationship becomes nonsignificant once level of religiosity is controlled. Heavy metal fans are low in religiosity, which contributes to greater suicide acceptability. (Author/JDM)

  5. Hanford Site liquid waste acceptance criteria

    SciTech Connect

    LUECK, K.J.

    1999-09-11

    This document provides the waste acceptance criteria for liquid waste managed by Waste Management Federal Services of Hanford, Inc. (WMH). These waste acceptance criteria address the various requirements to operate a facility in compliance with applicable environmental, safety, and operational requirements. This document also addresses the sitewide miscellaneous streams program.

  6. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  7. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  8. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  9. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  10. Nevada Test Site Waste Acceptance Criteria (NTSWAC)

    SciTech Connect

    NNSA /NSO Waste Management Project

    2008-06-01

    This document establishes the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, Nevada Test Site Waste Acceptance Criteria (NTSWAC). The NTSWAC provides the requirements, terms, and conditions under which the Nevada Test Site will accept low-level radioactive (LLW) and LLW Mixed Waste (MW) for disposal.

  11. Consumer acceptance of ginseng food products.

    PubMed

    Chung, Hee Sook; Lee, Young-Chul; Rhee, Young Kyung; Lee, Soo-Yeun

    2011-01-01

    Ginseng has been utilized less in food products than in dietary supplements in the United States. Sensory acceptance of ginseng food products by U.S. consumers has not been reported. The objectives of this study were to: (1) determine the sensory acceptance of commercial ginseng food products and (2) assess influence of the addition of sweeteners to ginseng tea and ginseng extract to chocolate on consumer acceptance. Total of 126 consumers participated in 3 sessions for (1) 7 commercial red ginseng food products, (2) 10 ginseng teas varying in levels of sugar or honey, and (3) 10 ginseng milk or dark chocolates varying in levels of ginseng extract. Ginseng candy with vitamin C and ginseng crunchy white chocolate were the most highly accepted, while sliced ginseng root product was the least accepted among the seven commercial products. Sensory acceptance increased in proportion to the content of sugar and honey in ginseng tea, whereas acceptance decreased with increasing content of ginseng extract in milk and dark chocolates. Findings demonstrate that ginseng food product types with which consumers have been already familiar, such as candy and chocolate, will have potential for success in the U.S. market. Chocolate could be suggested as a food matrix into which ginseng can be incorporated, as containing more bioactive compounds than ginseng tea at a similar acceptance level. Future research may include a descriptive analysis with ginseng-based products to identify the key drivers of liking and disliking for successful new product development.

  12. Genres Across Cultures: Types of Acceptability Variation

    ERIC Educational Resources Information Center

    Shaw, Philip; Gillaerts, Paul; Jacobs, Everett; Palermo, Ofelia; Shinohara, Midori; Verckens, J. Piet

    2004-01-01

    One can ask four questions about genre validity across cultures. Does a certain form or configuration occur in the culture in question? Is it acceptable? If acceptable, is it in practice preferred? Is it recommended by prescriptive authorities? This paper reports the results of an attempt to answer these questions empirically by testing the…

  13. 48 CFR 11.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Market acceptance. 11.103... DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 11.103 Market acceptance. (a) Section... may, under appropriate circumstances, require offerors to demonstrate that the items offered— (1)...

  14. 48 CFR 2811.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Market acceptance. 2811.103... Planning DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 2811.103 Market acceptance... offerors to demonstrate that the items offered meet the criteria set forth in FAR 11.103(a)....

  15. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Loan acceptance. 1655.11 Section 1655.11 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.11 Loan acceptance. The TSP record keeper will reject a loan application if: (a) The participant is not qualified to apply...

  16. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Loan acceptance. 1655.11 Section 1655.11 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.11 Loan acceptance. The TSP record keeper will reject a loan application if: (a) The participant is not qualified to apply...

  17. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Loan acceptance. 1655.11 Section 1655.11 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.11 Loan acceptance. The TSP record keeper will reject a loan application if: (a) The participant is not qualified to apply...

  18. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  19. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  20. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  1. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND SECURITY... Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf of the head...

  2. 48 CFR 3011.103 - Market acceptance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Market acceptance. 3011.103 Section 3011.103 Federal Acquisition Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND... Developing Requirements Documents 3011.103 Market acceptance. (a) Contracting officers may act on behalf...

  3. 48 CFR 411.103 - Market acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Market acceptance. 411.103... ACQUISITION PLANNING DESCRIBING AGENCY NEEDS Selecting and Developing Requirements Documents 411.103 Market... accordance with FAR 11.103(a), the market acceptability of their items to be offered. (b) The...

  4. 10 CFR 52.9 - Jurisdictional limits.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Jurisdictional limits. 52.9 Section 52.9 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General Provisions § 52.9 Jurisdictional limits. No permit, license, standard design approval, or standard...

  5. 10 CFR 52.9 - Jurisdictional limits.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Jurisdictional limits. 52.9 Section 52.9 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General Provisions § 52.9 Jurisdictional limits. No permit, license, standard design approval, or standard...

  6. 10 CFR 52.9 - Jurisdictional limits.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Jurisdictional limits. 52.9 Section 52.9 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General Provisions § 52.9 Jurisdictional limits. No permit, license, standard design approval, or standard...

  7. 10 CFR 52.9 - Jurisdictional limits.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Jurisdictional limits. 52.9 Section 52.9 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General Provisions § 52.9 Jurisdictional limits. No permit, license, standard design approval, or standard...

  8. 10 CFR 14.27 - Time limit.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Time limit. 14.27 Section 14.27 Energy NUCLEAR REGULATORY COMMISSION ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT Filing Procedures and Requirements § 14.27 Time limit. The claimant shall furnish evidence and information of the types described in 10 CFR...

  9. 10 CFR 14.27 - Time limit.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Time limit. 14.27 Section 14.27 Energy NUCLEAR REGULATORY COMMISSION ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT Filing Procedures and Requirements § 14.27 Time limit. The claimant shall furnish evidence and information of the types described in 10 CFR...

  10. 10 CFR 14.27 - Time limit.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Time limit. 14.27 Section 14.27 Energy NUCLEAR REGULATORY COMMISSION ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT Filing Procedures and Requirements § 14.27 Time limit. The claimant shall furnish evidence and information of the types described in 10 CFR...

  11. 10 CFR 14.27 - Time limit.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Time limit. 14.27 Section 14.27 Energy NUCLEAR REGULATORY COMMISSION ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT Filing Procedures and Requirements § 14.27 Time limit. The claimant shall furnish evidence and information of the types described in 10 CFR...

  12. 10 CFR 14.27 - Time limit.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Time limit. 14.27 Section 14.27 Energy NUCLEAR REGULATORY COMMISSION ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT Filing Procedures and Requirements § 14.27 Time limit. The claimant shall furnish evidence and information of the types described in 10 CFR...

  13. 10 CFR 52.9 - Jurisdictional limits.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Jurisdictional limits. 52.9 Section 52.9 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General Provisions § 52.9 Jurisdictional limits. No permit, license, standard design approval, or standard...

  14. Public Perceptions of Regulatory Costs, Their Uncertainty and Interindividual Distribution.

    PubMed

    Johnson, Branden B; Finkel, Adam M

    2016-06-01

    Public perceptions of both risks and regulatory costs shape rational regulatory choices. Despite decades of risk perception studies, this article is the first on regulatory cost perceptions. A survey of 744 U.S. residents probed: (1) How knowledgeable are laypeople about regulatory costs incurred to reduce risks? (2) Do laypeople see official estimates of cost and benefit (lives saved) as accurate? (3) (How) do preferences for hypothetical regulations change when mean-preserving spreads of uncertainty replace certain cost or benefit? and (4) (How) do preferences change when unequal interindividual distributions of hypothetical regulatory costs replace equal distributions? Respondents overestimated costs of regulatory compliance, while assuming agencies underestimate costs. Most assumed agency estimates of benefits are accurate; a third believed both cost and benefit estimates are accurate. Cost and benefit estimates presented without uncertainty were slightly preferred to those surrounded by "narrow uncertainty" (a range of costs or lives entirely within a personally-calibrated zone without clear acceptance or rejection of tradeoffs). Certain estimates were more preferred than "wide uncertainty" (a range of agency estimates extending beyond these personal bounds, thus posing a gamble between favored and unacceptable tradeoffs), particularly for costs as opposed to benefits (but even for costs a quarter of respondents preferred wide uncertainty to certainty). Agency-acknowledged uncertainty in general elicited mixed judgments of honesty and trustworthiness. People preferred egalitarian distributions of regulatory costs, despite skewed actual cost distributions, and preferred progressive cost distributions (the rich pay a greater than proportional share) to regressive ones. Efficient and socially responsive regulations require disclosure of much more information about regulatory costs and risks.

  15. Understanding diversity: the importance of social acceptance.

    PubMed

    Chen, Jacqueline M; Hamilton, David L

    2015-04-01

    Two studies investigated how people define and perceive diversity in the historically majority-group dominated contexts of business and academia. We hypothesized that individuals construe diversity as both the numeric representation of racial minorities and the social acceptance of racial minorities within a group. In Study 1, undergraduates' (especially minorities') perceptions of campus diversity were predicted by perceived social acceptance on a college campus, above and beyond perceived minority representation. Study 2 showed that increases in a company's representation and social acceptance independently led to increases in perceived diversity of the company among Whites. Among non-Whites, representation and social acceptance only increased perceived diversity of the company when both qualities were high. Together these findings demonstrate the importance of both representation and social acceptance to the achievement of diversity in groups and that perceiver race influences the relative importance of these two components of diversity.

  16. Heavy metal, religiosity, and suicide acceptability.

    PubMed

    Stack, S

    1998-01-01

    There has been little work at the national level on the subject of musical subcultures and suicide acceptability. The present work explores the link between "heavy metal" rock fanship and suicide acceptability. Metal fanship is thought to elevate suicide acceptability through such means as exposure to a culture of personal and societal chaos marked by hopelessness, and through its associations with demographic risk factors such as gender, socioeconomic status, and education. Data are taken from the General Social Survey. A link between heavy metal fanship and suicide acceptability is found. However, this relationship becomes nonsignificant once level of religiosity is controlled. Metal fans are low in religiosity, which contributes, in turn, to greater suicide acceptability.

  17. Monte Carlo determination of Phoswich Array acceptance

    SciTech Connect

    Costales, J.B.; E859 Collaboration

    1992-07-01

    The purpose of this memo is to describe the means by which the acceptance of the E859 Phoswich Array is determined. By acceptance, two things are meant: first, the geometrical acceptance (the angular size of the modules); second, the detection acceptance (the probability that a particle of a given 4-momentum initially in the detector line-of-sight is detected as such). In particular, this memo will concentrate on those particles for which the energy of the particle can be sufficiently measured; that is to say, protons, deuterons and tritons. In principle, the phoswich array can measure the low end of the pion energy spectrum, but with a poor resolution. The detection acceptance of pions and baryon clusters heavier than tritons will be neglected in this memo.

  18. Beam-limiting and radiation-limiting interlocks

    SciTech Connect

    Macek, R.J.

    1996-04-01

    This paper reviews several aspects of beam-limiting and radiation- limiting interlocks used for personnel protection at high-intensity accelerators. It is based heavily on the experience at the Los Alamos Neutron Science Center (LANSCE) where instrumentation-based protection is used extensively. Topics include the need for ``active`` protection systems, system requirements, design criteria, and means of achieving and assessing acceptable reliability. The experience with several specific devices (ion chamber-based beam loss interlock, beam current limiter interlock, and neutron radiation interlock) designed and/or deployed to these requirements and criteria is evaluated.

  19. Regulatory T Cells and Their Role in Animal Disease.

    PubMed

    Veiga-Parga, T

    2016-07-01

    In humans and mouse models, Foxp3(+) regulatory T cells are known to control all aspects of immune responses. However, only limited information exists on these cells' role in diseases of other animals. In this review, we cover the most important features and different types of regulatory T cells, which include those that are thymus-derived and peripherally induced, the mechanisms by which they control immune responses by targeting effector T cells and antigen-presenting cells, and most important, their role in animal health and diseases including cancer, infections, and other conditions such as hypersensitivities and autoimmunity. Although the literature regarding regulatory T cells in domestic animal species is still limited, multiple articles have recently emerged and are discussed. Moreover, we also discuss the evidence suggesting that regulatory T cells might limit the magnitude of effector responses, which can have either a positive or negative result, depending on the context of animal and human disease. In addition, the issue of plasticity is discussed because plasticity in regulatory T cells can result in the loss of their protective function in some microenvironments during disease. Lastly, the manipulation of regulatory T cells is discussed in assessing the possibility of their use as a treatment in the future.

  20. On Limits

    NASA Technical Reports Server (NTRS)

    Holzmann, Gerard J.

    2008-01-01

    In the last 3 decades or so, the size of systems we have been able to verify formally with automated tools has increased dramatically. At each point in this development, we encountered a different set of limits -- many of which we were eventually able to overcome. Today, we may have reached some limits that may be much harder to conquer. The problem I will discuss is the following: given a hypothetical machine with infinite memory that is seamlessly shared among infinitely many CPUs (or CPU cores), what is the largest problem size that we could solve?

  1. Opportunities and limitations of molecular methods for quantifying microbial compliance parameters in EU bathing waters.

    PubMed

    Oliver, David M; van Niekerk, Melanie; Kay, David; Heathwaite, A Louise; Porter, Jonathan; Fleming, Lora E; Kinzelman, Julie L; Connolly, Elaine; Cummins, Andy; McPhail, Calum; Rahman, Amanna; Thairs, Ted; de Roda Husman, Ana Maria; Hanley, Nick D; Dunhill, Ian; Globevnik, Lidija; Harwood, Valerie J; Hodgson, Chris J; Lees, David N; Nichols, Gordon L; Nocker, Andreas; Schets, Ciska; Quilliam, Richard S

    2014-03-01

    The debate over the suitability of molecular biological methods for the enumeration of regulatory microbial parameters (e.g. Faecal Indicator Organisms [FIOs]) in bathing waters versus the use of traditional culture-based methods is of current interest to regulators and the science community. Culture-based methods require a 24-48hour turn-around time from receipt at the laboratory to reporting, whilst quantitative molecular tools provide a more rapid assay (approximately 2-3h). Traditional culturing methods are therefore often viewed as slow and 'out-dated', although they still deliver an internationally 'accepted' evidence-base. In contrast, molecular tools have the potential for rapid analysis and their operational utility and associated limitations and uncertainties should be assessed in light of their use for regulatory monitoring. Here we report on the recommendations from a series of international workshops, chaired by a UK Working Group (WG) comprised of scientists, regulators, policy makers and other stakeholders, which explored and interrogated both molecular (principally quantitative polymerase chain reaction [qPCR]) and culture-based tools for FIO monitoring under the European Bathing Water Directive. Through detailed analysis of policy implications, regulatory barriers, stakeholder engagement, and the needs of the end-user, the WG identified a series of key concerns that require critical appraisal before a potential shift from culture-based approaches to the employment of molecular biological methods for bathing water regulation could be justified.

  2. 77 FR 59608 - Go Green Go Hydro LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

    ... Energy Regulatory Commission Go Green Go Hydro LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On June 20, 2012, Go Green Go Hydro LLC (Go Green or applicant) filed an application for a preliminary permit, pursuant...

  3. 78 FR 2989 - PayneBridge, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission PayneBridge, LLC; Notice of Preliminary Permit Application Accepted for..., PayneBridge, LLC filed an application for a successive preliminary permit under section 4(f) of...

  4. 76 FR 9612 - GE Hitachi Nuclear Energy; Acceptance for Docketing of an Application for Renewal of the U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION GE Hitachi Nuclear Energy; Acceptance for Docketing of an Application for Renewal of the U.S. Advanced Boiling Water Reactor Design Certification On December 7, 2010, GE Hitachi Nuclear Energy...

  5. 76 FR 2359 - Great River Hydropower, LLC; Notice of Application Accepted for Filing and Soliciting Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... Federal Energy Regulatory Commission Great River Hydropower, LLC; Notice of Application Accepted for...: Great River Hydropower, LLC. e. Name of Project: Upper Mississippi River Lock & Dam No. 21 Hydroelectric... following facilities: (1) A new 796-foot-long by 46-foot-wide by 25-foot-high concrete hydropower...

  6. 76 FR 66710 - Erie Boulevard Hydropower, L.P.; Notice of Application Accepted for Filing, Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Erie Boulevard Hydropower, L.P.; Notice of Application Accepted for Filing...: Erie Boulevard Hydropower, L.P. (dba Brookfield Renewable Power). e. Name of Projects: Oswego...

  7. 78 FR 32644 - Las Vegas Wash Hydro LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... Energy Regulatory Commission Las Vegas Wash Hydro LLC; Notice of Preliminary Permit Application Accepted..., 2012, Las Vegas Wash Hydro LLC, filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Las Vegas...

  8. 18 CFR Appendix A to Part 2 - Guidance for Determining the Acceptable Construction Area for Auxiliary and Replacement Facilities

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Guidance for Determining the Acceptable Construction Area for Auxiliary and Replacement Facilities A Appendix A to Part 2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY...

  9. 78 FR 44110 - FFP Project 124, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Energy Regulatory Commission FFP Project 124, LLC; Notice of Preliminary Permit Application Accepted for... Project 124, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project to be located at the US...

  10. 78 FR 35020 - FFP Project 56, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Energy Regulatory Commission FFP Project 56, LLC; Notice of Preliminary Permit Application Accepted for... Project 56, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project located at the U.S....

  11. 76 FR 48847 - FFP Project 49 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Energy Regulatory Commission FFP Project 49 LLC; Notice of Preliminary Permit Application Accepted for... Project 49 LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to study... Kentucky and Mississippi County, Missouri. The sole purpose of a preliminary permit, if issued, is to...

  12. 76 FR 48846 - FFP Project 125 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Energy Regulatory Commission FFP Project 125 LLC; Notice of Preliminary Permit Application Accepted for... Project 125 LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to... and near Vidalia, in Concordia Parish, Louisiana. The sole purpose of a preliminary permit, if...

  13. 78 FR 44110 - FFP Project 130, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Energy Regulatory Commission FFP Project 130, LLC; Notice of Preliminary Permit Application Accepted for... Project 130, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project to be located at the US...

  14. 78 FR 30917 - FFP Project 116, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... Energy Regulatory Commission FFP Project 116, LLC; Notice of Preliminary Permit Application Accepted for... Project 116, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project at the Kentucky River...

  15. 78 FR 35019 - FFP Project 132, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Energy Regulatory Commission FFP Project 132, LLC; Notice of Preliminary Permit Application Accepted for... Project 132, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal... Project (Allegheny 7 Project or project) to be located at the U.S. Army Corps of Engineers'...

  16. 78 FR 30916 - FFP Project 117, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... Energy Regulatory Commission FFP Project 117, LLC; Notice of Preliminary Permit Application Accepted for... Project 117, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project at the Kentucky River...

  17. 76 FR 48844 - FFP Project 11 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Energy Regulatory Commission FFP Project 11 LLC; Notice of Preliminary Permit Application Accepted for... Project 11 LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to study... Parishes, Louisiana. The sole purpose of a preliminary permit, if issued, is to grant the permit...

  18. 77 FR 31610 - FFP Project 110, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-29

    ... Energy Regulatory Commission FFP Project 110, LLC; Notice of Preliminary Permit Application Accepted for... Project 110, LLC filed an application for a preliminary permit under section 4(f) of the Federal Power Act proposing to study the feasibility of the proposed Mississippi River Lock and Dam 25--Project No. 14403,...

  19. 78 FR 44111 - FFP Project 123, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Energy Regulatory Commission FFP Project 123, LLC; Notice of Preliminary Permit Application Accepted for... Project 123, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project to be located at the US...

  20. 78 FR 35021 - FFP Project 119, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Energy Regulatory Commission FFP Project 119, LLC; Notice of Preliminary Permit Application Accepted for... Project 119, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project located at the U.S....

  1. 78 FR 35016 - FFP Project 118, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Energy Regulatory Commission FFP Project 118, LLC; Notice of Preliminary Permit Application Accepted for... Project 118, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project located at the U.S....

  2. 76 FR 48849 - FFP Project 46 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Energy Regulatory Commission FFP Project 46 LLC; Notice of Preliminary Permit Application Accepted for... Project 46 LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to study... County, Missouri and Lake County Tennessee. The sole purpose of a preliminary permit, if issued, is...

  3. 76 FR 48852 - FFP Project 42 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Federal Energy Regulatory Commission FFP Project 42 LLC; Notice of Preliminary Permit Application Accepted..., 2011, FFP Project 42 LLC filed an application, pursuant to section 4(f) of the Federal Power Act..., Tennessee and near West Memphis, in Crittenden County Arkansas. The sole purpose of a preliminary permit,...

  4. 76 FR 48851 - FFP Project 50 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Energy Regulatory Commission FFP Project 50 LLC; Notice of Preliminary Permit Application Accepted for... Project 50 LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to study... and in Mississippi County Missouri. The sole purpose of a preliminary permit, if issued, is to...

  5. 78 FR 44109 - FFP Project 131, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Energy Regulatory Commission FFP Project 131, LLC; Notice of Preliminary Permit Application Accepted for... Project 131, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project to be located at the US...

  6. 76 FR 48844 - FFP Project 29 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Energy Regulatory Commission FFP Project 29 LLC; Notice of Preliminary Permit Application Accepted for... Project 29 LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to study..., Louisiana. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority...

  7. 78 FR 35020 - FFP Project 55, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Energy Regulatory Commission FFP Project 55, LLC; Notice of Preliminary Permit Application Accepted for... Project 55, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project located at the U.S....

  8. 78 FR 35019 - FFP Project 58, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Energy Regulatory Commission FFP Project 58, LLC; Notice of Preliminary Permit Application Accepted for... Project 58, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project at the Kentucky River...

  9. 76 FR 48845 - FFP Project 5 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Energy Regulatory Commission FFP Project 5 LLC; Notice of Preliminary Permit Application Accepted for... Project 5 LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to study... St. Bernard Parishes, Louisiana. The sole purpose of a preliminary permit, if issued, is to grant...

  10. 78 FR 30917 - FFP Project 115, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... Energy Regulatory Commission FFP Project 115, LLC; Notice of Preliminary Permit Application Accepted for... Project 115, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project at the Kentucky River...

  11. 75 FR 30389 - City of Santa Fe, NM; Notice of Application Accepted for Filing and Soliciting Comments, Motions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... Energy Regulatory Commission City of Santa Fe, NM; Notice of Application Accepted for Filing and.... Date filed: May 10, 2010. d. Applicant: City of Santa Fe, New Mexico. e. Name of Project: Santa Fe Canyon Hydroelectric Project. f. Location: The proposed Santa Fe Canyon Hydroelectric Project would...

  12. Acceptance Factors Influencing Adoption of National Institute of Standards and Technology Information Security Standards: A Quantitative Study

    ERIC Educational Resources Information Center

    Kiriakou, Charles M.

    2012-01-01

    Adoption of a comprehensive information security governance model and security controls is the best option organizations may have to protect their information assets and comply with regulatory requirements. Understanding acceptance factors of the National Institute of Standards and Technology (NIST) Risk Management Framework (RMF) comprehensive…

  13. 77 FR 60421 - FFP Project 68 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission FFP Project 68 LLC; Notice of Preliminary Permit Application Accepted for..., FFP Project 68, LLC filed an application for a preliminary permit, pursuant to section 4(f) of...

  14. 77 FR 24941 - Vantage Wind Energy LLC; Order Accepting Updated Market Power Analysis and Providing Direction on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... Energy Regulatory Commission Vantage Wind Energy LLC; Order Accepting Updated Market Power Analysis and... analysis filed by Vantage Wind Energy LLC (Vantage Wind). As discussed below, the Commission concludes that Vantage Wind continues to satisfy the Commission's standards for market-based rate authority. Vantage...

  15. 76 FR 4891 - Blue Heron Hydro LLC; Notice of Application Accepted for Filing and Soliciting Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-27

    ... Energy Regulatory Commission Blue Heron Hydro LLC; Notice of Application Accepted for Filing and... Heron Hydro LLC. e. Name of Project: Townshend Dam Hydroelectric Project. f. Location: U.S. Army Corps... Heron Hydro LLC, 113 Bartlett Road, Plainfield, Vermont 05667. (802) 454-1874. i. FERC Contact:...

  16. 76 FR 5147 - Blue Heron Hydro LLC; Notice of Application Accepted for Filing and Soliciting Motions To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-28

    ... Energy Regulatory Commission Blue Heron Hydro LLC; Notice of Application Accepted for Filing and... Heron Hydro LLC. e. Name of Project: Ball Mountain Dam Hydroelectric Project. f. Location: U.S. Army..., Blue Heron Hydro LLC, 113 Bartlett Road, Plainfield, Vermont 05667. (802) 454 1874. i. FERC Contact:...

  17. 77 FR 64973 - Don W. Gilbert Hydro Power, LLC; Notice of Application Accepted for Filing With the Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... Energy Regulatory Commission Don W. Gilbert Hydro Power, LLC; Notice of Application Accepted for Filing.... Date filed: May 30, 2012. d. Applicant: Don W. Gilbert Hydro Power, LLC. e. Name of Project: Gilbert...Ann G. Somonich, Don W. Gilbert Hydro Power, LLC, 1805 Grace Power Plant Road, Grace, Idaho...

  18. 77 FR 38043 - Great Lakes Hydro America, LLC; Notice of Application Accepted for Filing and Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ... Energy Regulatory Commission Great Lakes Hydro America, LLC; Notice of Application Accepted for Filing.... Applicant: Great Lakes Hydro America, LLC. e. Name of Project: Penobscot Mills. f. Location: North Twin development, West Branch Penobscot River, Maine. g. Filed Pursuant to: Federal Power Act, 16 U.S.C....

  19. 76 FR 62060 - NortHydro, LLC.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... Energy Regulatory Commission NortHydro, LLC.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On July 29, 2011, NortHydro, LLC (NortHydro or applicant) filed an application for a preliminary permit, pursuant to section...

  20. 76 FR 62060 - NortHydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... Energy Regulatory Commission NortHydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On July 29, 2011, NortHydro, LLC (NortHydro or applicant) filed an application for a preliminary permit, pursuant to section...