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

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

    Carrington, Clark D.; Bolger, P. Michael, E-mail: mike.bolger@fda.hhs.go

    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 standardsmore » 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.« less

  3. 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

  4. 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 PROCEDURE...

  5. 10 CFR 2.643 - Acceptance and docketing of application for limited work authorization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Acceptance and docketing of application for limited work authorization. 2.643 Section 2.643 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR DOMESTIC LICENSING... Construct Certain Utilization Facilities; and Advance Issuance of Limited Work Authorizations Phased...

  6. Pain acceptance, psychological functioning, and self-regulatory fatigue in temporomandibular disorder.

    PubMed

    Eisenlohr-Moul, Tory A; Burris, Jessica L; Evans, Daniel R

    2013-12-01

    A growing body of evidence suggests that chronic pain patients suffer from chronic self-regulatory fatigue: difficulty controlling thoughts, emotions, and behavior. Pain acceptance, which involves responding to pain and related experiences without attempts to control or avoid them (pain willingness), and pursuit of valued life activities regardless of pain (activity engagement) has been associated with various favorable outcomes in chronic pain patients, including better psychological functioning. The study presented here tested the hypotheses that pain acceptance is associated with less psychological distress, higher psychological well-being, and reduced self-regulatory fatigue in temporomandibular disorder (TMD) patients, particularly for those with longer pain duration. Cross-sectional data were provided by 135 TMD patients during an initial evaluation at a university-based tertiary orofacial pain clinic. Results of hierarchical linear regression models indicated that, controlling for pain severity, pain willingness is associated with less psychological distress and lower self-regulatory fatigue, and activity engagement is associated with greater psychological well-being. Furthermore, the effect of pain willingness on psychological distress was moderated by pain duration such that pain willingness was more strongly associated with less psychological distress in patients with longer pain duration; this moderating effect was fully mediated by self-regulatory fatigue. These findings suggest pain willingness may buffer against self-regulatory fatigue in those with longer pain duration, and such conservation of self-regulatory resources may protect against psychological symptoms.

  7. Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust.

    PubMed

    Cazap, Eduardo; Jacobs, Ira; McBride, Ali; Popovian, Robert; Sikora, Karol

    2018-05-16

    Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics. Biosimilar approval pathways in many major regulatory regions worldwide are, to a broad degree, scientifically aligned. However, owing to regional differences in health care priorities, policies, and resources, some important regulatory inconsistencies are evident. Acceptance of biosimilars by health care systems, health care professionals, and patients will be a key factor in the uptake of these therapies, and such regulatory variations could contribute to confusion and diminished confidence regarding the quality, efficacy, and reliability of these agents. Furthermore, the need for manufacturers to account for regulatory inconsistencies introduces inefficiencies and delays into biosimilar development programs. These issues should be addressed if biosimilars are to attain their maximal global potential. This review summarizes the evolution of the global biosimilar landscape and provides examples of inconsistencies between regulatory requirements in different regions. In addition, we review ongoing efforts to improve regulatory alignment and highlight the importance of education as a crucial factor in generating trust in, and acceptance of, biosimilars on a worldwide scale. Biosimilars of monoclonal antibody anticancer therapies are beginning to emerge, and more are likely to become available for clinical use in the near future. The extent to which biosimilars

  8. Prediction of adaptive self-regulatory responses to arthritis pain anxiety in exercising adults: does pain acceptance matter?

    PubMed

    Cary, Miranda Ashley; Gyurcsik, Nancy C; Brawley, Lawrence R

    2015-01-01

    Exercising for ≥ 150 min/week is a recommended strategy for self-managing arthritis. However, exercise nonadherence is a problem. Arthritis pain anxiety may interfere with regular exercise. According to the fear-avoidance model, individuals may confront their pain anxiety by using adaptive self-regulatory responses (eg, changing exercise type or duration). Furthermore, the anxiety-self-regulatory responses relationship may vary as a function of individuals' pain acceptance levels. To investigate pain acceptance as a moderator of the pain anxiety-adaptive self-regulatory responses relationship. The secondary objective was to examine whether groups of patients who differed in meeting exercise recommendations also differed in pain-related and self-regulatory responses. Adults (mean [± SD] age 49.75 ± 13.88 years) with medically diagnosed arthritis completed online measures of arthritis pain-related variables and self-regulatory responses at baseline, and exercise participation two weeks later. Individuals meeting (n=87) and not meeting (n=49) exercise recommendations were identified. Hierarchical multiple regression analysis revealed that pain acceptance moderated the anxiety-adaptive self-regulatory responses relationship. When pain anxiety was lower, greater pain acceptance was associated with less frequent use of adaptive responses. When anxiety was higher, adaptive responses were used regardless of pain acceptance level. MANOVA findings revealed that participants meeting the recommended exercise dose reported significantly lower pain and pain anxiety, and greater pain acceptance (P<0.05) than those not meeting the dose. Greater pain acceptance may help individuals to focus their efforts to adapt to their pain anxiety only when it is higher, leaving self-regulatory capacity to cope with additional challenges to exercise adherence (eg, busy schedule).

  9. Prediction of adaptive self-regulatory responses to arthritis pain anxiety in exercising adults: Does pain acceptance matter?

    PubMed Central

    Cary, Miranda A; Gyurcsik, Nancy C; Brawley, Lawrence R

    2015-01-01

    BACKGROUND: Exercising for ≥150 min/week is a recommended strategy for self-managing arthritis. However, exercise nonadherence is a problem. Arthritis pain anxiety may interfere with regular exercise. According to the fear-avoidance model, individuals may confront their pain anxiety by using adaptive self-regulatory responses (eg, changing exercise type or duration). Furthermore, the anxiety-self-regulatory responses relationship may vary as a function of individuals’ pain acceptance levels. OBJECTIVES: To investigate pain acceptance as a moderator of the pain anxiety-adaptive self-regulatory responses relationship. The secondary objective was to examine whether groups of patients who differed in meeting exercise recommendations also differed in pain-related and self-regulatory responses. METHODS: Adults (mean [± SD] age 49.75±13.88 years) with medically diagnosed arthritis completed online measures of arthritis pain-related variables and self-regulatory responses at baseline, and exercise participation two weeks later. Individuals meeting (n=87) and not meeting (n=49) exercise recommendations were identified. RESULTS: Hierarchical multiple regression analysis revealed that pain acceptance moderated the anxiety-adaptive self-regulatory responses relationship. When pain anxiety was lower, greater pain acceptance was associated with less frequent use of adaptive responses. When anxiety was higher, adaptive responses were used regardless of pain acceptance level. MANOVA findings revealed that participants meeting the recommended exercise dose reported significantly lower pain and pain anxiety, and greater pain acceptance (P<0.05) than those not meeting the dose. CONCLUSIONS: Greater pain acceptance may help individuals to focus their efforts to adapt to their pain anxiety only when it is higher, leaving self-regulatory capacity to cope with additional challenges to exercise adherence (eg, busy schedule). PMID:25621990

  10. The regulatory acceptance of alternatives in the European Union.

    PubMed

    Warbrick, E Vicky; Evans, Peter F

    2004-06-01

    Recently, progress has been made toward the regulatory acceptance of replacements in the European Union (EU), particularly with the introduction of in vitro methods for the prediction of skin corrosivity, dermal penetration, phototoxicity and embryotoxicity. In vitro genotoxicity tests are well established, and testing for this endpoint can be completed without animals, provided that clear negative outcomes are obtained. Tiered approaches including in vitro tests can also be used to address skin and eye irritation endpoints. Reductions and/or refinements in animal use are being achieved following the replacement of the oral LD50 test with alternative methods and the adoption of reduced test packages for materials, such as closed-system intermediates and certain polymers. Furthermore, the use of a "read-across" approach has reduced animal testing. Substantial gains in refinement will also be made with the recent acceptance of the local lymph node assay for skin sensitisation and the development of an acute inhalation toxicity method that avoids lethality as the endpoint. For the future, under the proposed EU Registration, Evaluation and Authorisation of Chemicals (REACH) scheme, it is envisaged that, where suitable in vitro methods exist, these should be used to support registration of substances produced at up to ten tonnes per annum. This proposal can only accelerate the further development, validation and regulatory acceptance of such alternative methods.

  11. Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

    PubMed

    Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

    2017-10-01

    The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  12. The regulatory function of self-esteem: testing the epistemic and acceptance signaling systems.

    PubMed

    Stinson, Danu Anthony; Logel, Christine; Holmes, John G; Wood, Joanne V; Forest, Amanda L; Gaucher, Danielle; Fitzsimons, Grainné M; Kath, Jennifer

    2010-12-01

    The authors draw on sociometer theory (e.g., Leary, 2004) and self-verification theory (e.g., Swann, 1997) to propose an expanded model of the regulatory function of self-esteem. The model suggests that people not only possess an acceptance signaling system that indicates whether relational value is high or low but also possess an epistemic signaling system that indicates whether social feedback is consistent or inconsistent with chronic perceived relational value (i.e., global self-esteem). One correlational study and 5 experiments, with diverse operationalizations of social feedback, demonstrated that the epistemic signaling system responds to self-esteem consistent or inconsistent relational-value feedback with increases or deceases in epistemic certainty. Moreover, Studies 3-6 demonstrated that the acceptance and epistemic signaling systems respond uniquely to social feedback. Finally, Studies 5 and 6 provide evidence that the epistemic signaling system is part of a broader self-regulatory system: Self-esteem inconsistent feedback caused cognitive efforts to decrease the discrepancy between self-views and feedback and caused depleted self-regulatory capacity on a subsequent self-control task. PsycINFO Database Record (c) 2010 APA, all rights reserved.

  13. Determination and evaluation of acceptable force limits in single-digit tasks.

    PubMed

    Nussbaum, Maury A; Johnson, Hope

    2002-01-01

    Acceptable limits derived from psychophysical methodologies have been proposed, measured, and employed in a range of applications. There is little existing work, however, on such limits for single-digit exertions and relatively limited evidence on several fundamental issues related to data collection and processing of a sequence of self-regulated exertion levels. An experimental study was conducted using 14 male and 10 female participants (age range 18-31 years) from whom maximal voluntary exertions and maximal acceptable limits (MALs) were obtained using the index finger and thumb. Moderate to high levels of consistency were found for both measures between sessions separated by one day. Single MAL values, determined from a time series of exertions, were equivalent across three divergent processing methods and between values obtained from 5- and 25-min samples. A critical interpretation of these and earlier results supports continued use of acceptable limits but also suggests that they should be used with some caution and not equated with safe limits. This research can be applied toward future development of exertion limits based on perceived acceptability.

  14. Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: expert opinions on the state of affairs and the way forward.

    PubMed

    Schiffelers, Marie-Jeanne W A; Blaauboer, Bas J; Bakker, Wieger E; Beken, Sonja; Hendriksen, Coenraad F M; Koëter, Herman B W M; Krul, Cyrille

    2014-06-01

    Pharmaceuticals and chemicals are subjected to regulatory safety testing accounting for approximately 25% of laboratory animal use in Europe. This testing meets various objections and has led to the development of a range of 3R models to Replace, Reduce or Refine the animal models. However, these models must overcome many barriers before being accepted for regulatory risk management purposes. This paper describes the barriers and drivers and options to optimize this acceptance process as identified by two expert panels, one on pharmaceuticals and one on chemicals. To untangle the complex acceptance process, the multilevel perspective on technology transitions is applied. This perspective defines influences at the micro-, meso- and macro level which need alignment to induce regulatory acceptance of a 3R model. This paper displays that there are many similar mechanisms within both sectors that prevent 3R models from becoming accepted for regulatory risk assessment and management. Shared barriers include the uncertainty about the value of the new 3R models (micro level), the lack of harmonization of regulatory requirements and acceptance criteria (meso level) and the high levels of risk aversion (macro level). In optimizing the process commitment, communication, cooperation and coordination are identified as critical drivers. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Setting limits for acceptable change in sediment particle size composition following marine aggregate dredging.

    PubMed

    Cooper, Keith M

    2012-08-01

    In the UK, Government policy requires marine aggregate extraction companies to leave the seabed in a similar physical condition after the cessation of dredging. This measure is intended to promote recovery, and the return of a similar faunal community to that which existed before dredging. Whilst the policy is sensible, and in line with the principles of sustainable development, the use of the word 'similar' is open to interpretation. There is, therefore, a need to set quantifiable limits for acceptable change in sediment composition. Using a case study site, it is shown how such limits could be defined by the range of sediment particle size composition naturally found in association with the faunal assemblages in the wider region. Whilst the approach offers a number of advantages over the present system, further testing would be required before it could be recommended for use in the regulatory context. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  16. Satiated with belongingness? Effects of acceptance, rejection, and task framing on self-regulatory performance.

    PubMed

    DeWall, C Nathan; Baumeister, Roy F; Vohs, Kathleen D

    2008-12-01

    Seven experiments showed that the effects of social acceptance and social exclusion on self-regulatory performance depend on the prospect of future acceptance. Excluded participants showed decrements in self-regulation, but these decrements were eliminated if the self-regulation task was ostensibly a diagnostic indicator of the ability to get along with others. No such improvement was found when the task was presented as diagnostic of good health. Accepted participants, in contrast, performed relatively poorly when the task was framed as a diagnostic indicator of interpersonally attractive traits. Furthermore, poor performance among accepted participants was not due to self-handicapping or overconfidence. Offering accepted participants a cash incentive for self-regulating eliminated the self-regulation deficits. These findings provide evidence that the need to belong fits standard motivational patterns: Thwarting the drive intensifies it, whereas satiating it leads to temporary reduction in drive. Accepted people are normally good at self-regulation but are unwilling to exert the effort to self-regulate if self-regulation means gaining the social acceptance they have already obtained.

  17. Satiated with Belongingness? Effects of Acceptance, Rejection, and Task Framing on Self-Regulatory Performance

    PubMed Central

    DeWall, C. Nathan; Baumeister, Roy F.; Vohs, Kathleen D.

    2008-01-01

    Seven experiments showed that the effects of social acceptance and social exclusion on self-regulatory performance depend on the prospect of future acceptance. Excluded participants showed decrements in self-regulation, but these decrements were eliminated if the self-regulation task was ostensibly a diagnostic indicator of the ability to get along with others. No such improvement was found when the task was presented as diagnostic of good health. Accepted participants, in contrast, performed relatively poorly when the task was framed as a diagnostic indicator of interpersonally attractive traits. Furthermore, poor performance among accepted participants was not due to self-handicapping or overconfidence. Offering accepted participants a cash incentive for self-regulating eliminated the self-regulation deficits. These findings provide evidence that the need to belong fits standard motivational patterns: thwarting the drive intensifies it, whereas satiating it leads to temporary reduction in drive. Accepted people are normally good at self-regulation but are unwilling to exert the effort to self-regulate if self-regulation means gaining the social acceptance they have already obtained. PMID:19025289

  18. 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. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. 10 CFR 2.643 - Acceptance and docketing of application for limited work authorization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... § 2.101(a)(9) is incomplete and not acceptable for processing, the Director of New Reactors or the Director of Nuclear Reactor Regulation will inform the applicant of this determination and the respects in... authorization. 2.643 Section 2.643 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR DOMESTIC LICENSING...

  20. Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

    PubMed

    Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

    2014-01-01

    International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

  1. 78 FR 28896 - Design Limits and Loading Combinations for Metal Primary Reactor Containment System Components

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0095] Design Limits and Loading Combinations for Metal... Regulatory Guide (RG) 1.57, ``Design Limits and Loading Combinations for Metal Primary Reactor Containment... the NRC staff considers acceptable for design limits and loading combinations for metal primary...

  2. The limits of acceptable change process: modifications and clarifications

    Treesearch

    David N. Cole; Stephen F. McCool

    1997-01-01

    Limits of Acceptable Change (LAC) was originally formulated to deal with the issue of recreation carrying capacity in wilderness. Enthusiasm for the process has led to questions about its applicability to a broad range of natural resource issues—both within and outside of protected areas. This paper uses a generic version of the LAC process to identify situations where...

  3. Beyond wilderness: Broadening the applicability of limits of acceptable change

    Treesearch

    Mark W. Brunson

    1977-01-01

    The Limits of Acceptable Change (LAC) process helps managers preserve wilderness attributes along with recreation opportunities. Ecosystem management likewise requires managers to balance societal and ecosystem needs. Both are more likely to succeed through collaborative planning. Consequently, LAC can offer a conceptual framework for achieving sustainable solutions...

  4. 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

  5. Factors Influencing Acceptability and Perceived Impacts of a Mandatory ePortfolio Implemented by an Occupational Therapy Regulatory Organization.

    PubMed

    Vachon, Brigitte; Foucault, Marie-Lyse; Giguère, Charles-Édouard; Rochette, Annie; Thomas, Aliki; Morel, Martine

    2018-01-01

    The use of ePortfolios has been implemented in several regulatory organizations to encourage clinicians' engagement in continuing professional development (CPD). However, their use has achieved mixed success, and multiple personal and contextual factors can influence their impacts on practice change. The aim of this study was to identify which factors influence the acceptability and perceived impacts of an ePortfolio implemented by an occupational therapy regulatory organization in one Canadian province. A cross-sectional online survey design was used. The survey was sent to registered occupational therapists in Quebec. Multiple regression analyses were conducted to identify factors influencing acceptability and outcomes: ease of use, satisfaction, impact on implementation of the CPD plan, and competence improvement. The survey was fully completed by 546 participants. Factors significantly influencing the ePortfolio acceptability and perceived impacts were attitude toward and familiarity with the portfolio, confidence in reflective skills, engagement in the CPD plan, and desire for feedback. Time spent completing the ePortfolio and the fact of completing it in teams were negatively associated with the outcomes. Shaping more favorable user attitudes, helping users recognize and experience the tool's benefits for their practice, and fostering confidence in their reflective skills are important factors that can be addressed to improve ePortfolio acceptability and outcomes. Contextual factors, such as time spent completing the ePortfolio and completing it in teams, seem to reflect greater difficulty with using the tool. Study findings can contribute to improving ePortfolio implementation in the CPD context.

  6. Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

    PubMed

    Schechtman, Leonard M

    2002-01-01

    Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also

  7. 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.

  8. Developing acceptance limits for measured bearing wear of the Space Shuttle Main Engine high pressure oxidizer turbopump

    NASA Technical Reports Server (NTRS)

    Genge, Gary G.

    1991-01-01

    The probabilistic design approach currently receiving attention for structural failure modes has been adapted for obtaining measured bearing wear limits in the Space Shuttle Main Engine high-pressure oxidizer turbopump. With the development of the shaft microtravel measurements to determine bearing health, an acceptance limit was neeed that protects against all known faiure modes yet is not overly conservative. This acceptance criteria limit has been successfully determined using probabilistic descriptions of preflight hardware geometry, empirical bearing wear data, mission requirements, and measurement tool precision as an input for a Monte Carlo simulation. The result of the simulation is a frequency distribution of failures as a function of preflight acceptance limits. When the distribution is converted into a reliability curve, a conscious risk management decision is made concerning the acceptance limit.

  9. Defining fire and wilderness objectives: Applying limits of acceptable change

    Treesearch

    David N. Cole

    1995-01-01

    The Limits of Acceptable Change (LAC) planning process was developed to help define objectives for recreation management in wilderness. This process can be applied to fire in wilderness if its conceptual foundation is broadened. LAC would lead decision makers to identify a compromise between the goal of allowing fire to play its natural role in wilderness and various...

  10. 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

    ...\\ directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70464; File No. SR-ICEEU-2013-11] Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change Related To Enhanced...

  11. Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products.

    PubMed

    van der Laan, Jan Willem; Brightwell, John; McAnulty, Peter; Ratky, Joszef; Stark, Claudia

    2010-01-01

    As part of the RETHINK European FP6 Project an overview of the acceptability and usefulness of minipigs has been carried out in the regulatory arenas of human and veterinary pharmaceuticals, food additives, cosmetics, biocides and agrochemicals, chemicals and medical devices. The safety of new pharmaceuticals for human use should be tested in non-rodents, but the regulatory world is not too prescriptive regarding the choice of species. The choice is most often dogs through long tradition. When dogs are not appropriate, in many cases non-human primates are chosen as an alternative. From information in the public domain as well as literature from the EMA and FDA, it is clear that minipigs have already been identified as suitable to take the role of non-rodent species in toxicity testing of pharmaceutical products. In the field of foodstuffs, the pig is used more extensively because of the apparent similarity in the omnivorous food pattern and digestive tract between humans and pigs. The extensive use of pigs in this field provides historical data. In the field of medical devices the ISO Guidelines indicate that the pig is regarded as a suitable animal model because of its haematological and cardiovascular similarities to man. The pig is also mentioned as suitable for testing local effects after implantation. Political and societal support for using nonhuman primates is decreasing, and it is an appropriate time to consider the role of the minipig. We have reviewed the costs of testing in minipigs, and these are not significantly higher than the costs for a study in dogs. Economical reasons should therefore not be used to argue against the use of minipigs instead of dogs or monkeys. For most purposes, minipigs may be considered an acceptable choice as non-rodent species, provided adequate justification for this choice is made. Copyright © 2010 Elsevier Inc. All rights reserved.

  12. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

    PubMed

    Kemp, Robert; Prasad, Vinay

    2017-07-21

    Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to measure than clinically meaningful outcomes. The use of surrogates as an endpoint in clinical trials and basis for regulatory approval is common, and frequently exceeds the guidance given by regulatory bodies. In this article, we demonstrate that the use of surrogates in oncology is widespread and increasing. At the same time, the strength of association between the surrogates used and clinically meaningful outcomes is often unknown or weak. Attempts to validate surrogates are rarely undertaken. When this is done, validation relies on only a fraction of available data, and often concludes that the surrogate is poor. Post-marketing studies, designed to ensure drugs have meaningful benefits, are often not performed. Alternatively, if a drug fails to improve quality of life or overall survival, market authorization is rarely revoked. We suggest this reliance on surrogates, and the imprecision surrounding their acceptable use, means that numerous drugs are now approved based on small yet statistically significant increases in surrogates of questionable reliability. In turn, this means the benefits of many approved drugs are uncertain. This is an unacceptable situation for patients and professionals, as prior experience has shown that such uncertainty can be associated with significant harm. The use of surrogate outcomes should be limited to situations where a surrogate has demonstrated robust ability to predict meaningful benefits, or where cases are dire, rare or with few treatment options. In both cases, surrogates must be used only when continuing studies examining hard endpoints have been fully recruited.

  13. 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).

  14. 21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  15. 21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  16. 21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  17. 21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  18. 21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  19. 21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  20. 21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL General Provisions § 509.4 Establishment of tolerances... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  1. 21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL General Provisions § 109.4 Establishment of tolerances... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  2. 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.

  3. 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.

  4. 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. Copyright © 2010 S. Karger AG, Basel.

  5. Fatigue acceptance test limit criterion for larger diameter rolled thread fasteners

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

    Kephart, A.R.

    1997-05-01

    This document describes a fatigue lifetime acceptance test criterion by which studs having rolled threads, larger than 1.0 inches in diameter, can be assured to meet minimum quality attributes associated with a controlled rolling process. This criterion is derived from a stress dependent, room temperature air fatigue database for test studs having a 0.625 inch diameter threads of Alloys X-750 HTH and direct aged 625. Anticipated fatigue lives of larger threads are based on thread root elastic stress concentration factors which increase with increasing thread diameters. Over the thread size range of interest, a 30% increase in notch stress ismore » equivalent to a factor of five (5X) reduction in fatigue life. The resulting diameter dependent fatigue acceptance criterion is normalized to the aerospace rolled thread acceptance standards for a 1.0 inch diameter, 0.125 inch pitch, Unified National thread with a controlled Root radius (UNR). Testing was conducted at a stress of 50% of the minimum specified material ultimate strength, 80 Ksi, and at a stress ratio (R) of 0.10. Limited test data for fastener diameters of 1.00 to 2.25 inches are compared to the acceptance criterion. Sensitivity of fatigue life of threads to test nut geometry variables was also shown to be dependent on notch stress conditions. Bearing surface concavity of the compression nuts and thread flank contact mismatch conditions can significantly affect the fastener fatigue life. Without improved controls these conditions could potentially provide misleading acceptance data. Alternate test nut geometry features are described and implemented in the rolled thread stud specification, MIL-DTL-24789(SH), to mitigate the potential effects on fatigue acceptance data.« less

  6. 21 CFR 509.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a food additive, may be established to define a level of contamination at which a food may be... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Establishment of tolerances, regulatory limits, and action levels. 509.4 Section 509.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  7. 21 CFR 109.4 - Establishment of tolerances, regulatory limits, and action levels.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a food additive, may be established to define a level of contamination at which a food may be... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Establishment of tolerances, regulatory limits, and action levels. 109.4 Section 109.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  8. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of Proposed... given that on August 20, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities..., which Items have been prepared primarily by ICE Clear Europe. ICE Clear Europe filed the proposal...

  9. 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

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

  10. Historical development of limits of acceptable change: conceptual clarifications and possible extensions

    Treesearch

    David N. Cole; George H. Stankey

    1997-01-01

    The Limits of Acceptable Change (LAC) process was developed to deal with the issue of recreational carrying capacity. For that purpose, the LAC process sought to explicitly define a compromise between resource/visitor experience protection and recreation use goals. The most critical and unique element of the process is the specification of LAC standards that define...

  11. Experiencing limits of acceptable change: some thoughts after a decade of implementation

    Treesearch

    Stephen F. McCool; David N. Cole

    1997-01-01

    Wilderness managers and researchers have experienced implementation of the Limits of Acceptable Change planning system for over a decade. In a sense, implementation of LAC has been a broad scale experiment in planning, with the hypothesis being that LAC processes are more effective approaches to deal with questions of recreation management in protected areas than the...

  12. Institutional barriers and opportunities in application of the limits of acceptable change

    Treesearch

    George H. Stankey

    1997-01-01

    Although the Limits of Acceptable Change (LAC) process has been in use since the mid-1980’s and has contributed to improved wilderness management, significant barriers and challenges remain. Formal and informal institutional barriers are the principal constraint to more effective implementation. Although grounded in a traditional management-by-objectives model, the LAC...

  13. 78 FR 58576 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Clear Contracts Traded on ICE Endex September 18, 2013. Pursuant to Section 19(b)(1) of... that on September 18, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities...

  14. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Delivery Procedures To Reflect the Clearing Relationship for ICE Futures U.S. Inc... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on December 19, 2012, ICE Clear Europe Limited...

  15. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Delivery Procedures To Reflect the Clearing Relationship for ICE Futures Europe... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 24, 2013, ICE Clear Europe Limited...

  16. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change to Provide for a T+1 Settlement of the Initial Payment Related to the CDS Contracts Cleared by ICE Clear Europe Limited April 26, 2012. I. Introduction On March 6, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the...

  17. Limits of acceptable change as tool for tourism development sustainability in Pangandaran West Java

    NASA Astrophysics Data System (ADS)

    Komsary, K. C.; Tarigan, W. P.; Wiyana, T.

    2018-03-01

    Pangandaran since 2006 has become a model of sustainable tourism development. A program aimed to empower local communities to prepare work plans and activities to enrich the various potential development of sustainable tourism. By empowering local community, business competition has led to the undesired development of the tourism sector. This becomes the concern of the negative impact of physical changes in the area. This study aims to identify and measure the acceptable changes (limits of acceptable change-LAC) of tourism development in Pangandaran to remain adaptable as a tourist attraction. This study considers how to determine acceptable levels of impact that occurs in the Pangandaran area. This method involves stakeholders in determining the values, issues, and concerns the acceptable levels of impact for this region. The result of acceptance rate then compared with the effects of the current state. Through review and analysis methods used in this study, the LAC situation in Pangandaran outlined. Results from this study are expected to identify indicators of sustainable development of tourism sector through LAC approach.

  18. 76 FR 23845 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make... approach that the staff of the NRC considers acceptable for use in developing an appropriate surveillance... steel. The recommendations described in this draft regulatory guide are an approach acceptable to the...

  19. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Withdrawal of Proposed Rule Change Regarding Central Counterparty Resolution and Recovery Procedures April 22, 2013. On March 7, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission...

  20. 78 FR 7844 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Withdrawal of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Withdrawal of Proposed Rule Change To Clear Western European Sovereign CDS Contracts January 29, 2013. On October 15, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange Commission (``Commission''), pursuant to...

  1. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing Proposed Rule Changes Regarding Central..., 2013, 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 the...

  2. Proceedings - Limits of Acceptable Change and related planning processes: Progress and future directions

    Treesearch

    Stephen F. McCool; David N. Cole

    1997-01-01

    Experience with Limits of Acceptable Change (LAC) and related planning processes has accumulated since the mid-1980's. These processes were developoed as a means of dealing with recreation carrying capacity issues in wilderness and National Parks. These processes clearly also have application outside of protected areas and to issues other than recreation...

  3. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting Accelerated Approval... \\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. The...

  4. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting Accelerated Approval...\\ notice is hereby given that on February 28, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed... Items I and II below, which Items have been prepared primarily by ICE Clear Europe. The Commission is...

  5. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting Accelerated Approval... thereunder,\\2\\ notice is hereby given that on September 25, 2012, ICE Clear Europe Limited (``ICE Clear... described in Items I and II below, which items have been prepared primarily by ICE Clear Europe. The...

  6. The Technology Acceptance Model for Resource-Limited Settings (TAM-RLS): A Novel Framework for Mobile Health Interventions Targeted to Low-Literacy End-Users in Resource-Limited Settings.

    PubMed

    Campbell, Jeffrey I; Aturinda, Isaac; Mwesigwa, Evans; Burns, Bridget; Santorino, Data; Haberer, Jessica E; Bangsberg, David R; Holden, Richard J; Ware, Norma C; Siedner, Mark J

    2017-11-01

    Although mobile health (mHealth) technologies have shown promise in improving clinical care in resource-limited settings (RLS), they are infrequently brought to scale. One limitation to the success of many mHealth interventions is inattention to end-user acceptability, which is an important predictor of technology adoption. We conducted in-depth interviews with 43 people living with HIV in rural Uganda who had participated in a clinical trial of a short messaging system (SMS)-based intervention designed to prompt return to clinic after an abnormal laboratory test. Interviews focused on established features of technology acceptance models, including perceived ease of use and perceived usefulness, and included open-ended questions to gain insight into unexplored issues related to the intervention's acceptability. We used conventional (inductive) and direct content analysis to derive categories describing use behaviors and acceptability. Interviews guided development of a proposed conceptual framework, the technology acceptance model for resource-limited settings (TAM-RLS). This framework incorporates both classic technology acceptance model categories as well as novel factors affecting use in this setting. Participants described how SMS message language, phone characteristics, and experience with similar technologies contributed to the system's ease of use. Perceived usefulness was shaped by the perception that the system led to augmented HIV care services and improved access to social support from family and colleagues. Emergent themes specifically related to mHealth acceptance among PLWH in Uganda included (1) the importance of confidentiality, disclosure, and stigma, and (2) the barriers and facilitators downstream from the intervention that impacted achievement of the system's target outcome. The TAM-RLS is a proposed model of mHealth technology acceptance based upon end-user experiences in rural Uganda. Although the proposed model requires validation, the TAM

  7. 'You're repulsive': Limits to acceptable drunken comportment for young adults.

    PubMed

    MacLean, Sarah; Pennay, Amy; Room, Robin

    2018-03-01

    Researchers have described a 'culture of intoxication' among young people. Yet drunkenness remains a socially risky practice with potential to evoke emotions of irritation and even disgust. We consider intoxicated practices that young adults in Melbourne, Australia, described as distasteful, to identify contemporary cultural forces that constrain intoxication and limit how it is enacted. Interviews were conducted with 60 participants in Melbourne, Australia, each with recent drinking experience. Participants were asked to provide accounts of moments when they regarded their own or others' drunken comportment as unsociable or unpleasant. Transcripts were analysed to identify recurrent themes. Despite amusement when recounting drunken antics, almost everyone in the study identified some discomfort at their own or other's drunkenness. We describe four interacting domains where lines delineating acceptable comportment appear be drawn. The first concerns intoxicated practices. Unpleasant drunken comportment often entailed a sense that the drunk person had disturbed others through an overflow of the self - extruding intimacy, sexuality, violence or bodily fluids. The second domain was gendering, with women vulnerable to being regarded as sexually inappropriate, and men as threatening. Third, the settings where intoxicated behaviour occurred influenced whether intoxicated people risked censure. Finally, the relationships between the drunk person and others, including their respective social positions and drinking patterns, shaped how they were perceived. The capacity of alcohol to render people more open to the world is both sought and reviled. It is important to recognise that there remain limits on acceptable drunken comportment, although these are complex and contingent. These limits are enforced via people's affective responses to drunkenness. This is form of alcohol harm reduction that occurs outside of public health intervention. Thus, cultures that constrain

  8. 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

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66911; File No. SR-ICEEU-2012-05] 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 Calculation and Payment of Interest on Mark-To-Market Margin on...

  9. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Proposed Rule Change To Revise Rules 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 (``Commission'') the proposed...

  10. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change Related to... August 14, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange... been prepared primarily by ICE Clear Europe. The Commission is publishing this notice to solicit...

  11. 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.

  12. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Designation of a Longer Period for Commission... October 15, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange...-day time period. \\5\\ 15 U.S.C. 78s(b)(2). The proposed rule change would permit ICE Clear Europe to...

  13. 78 FR 38411 - Vogtle Electric Generating Plant, Unit 4; Inspections, Tests, Analyses, and Acceptance Criteria

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... Plant, Unit 4; Inspections, Tests, Analyses, and Acceptance Criteria AGENCY: Nuclear Regulatory Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

  14. 77 FR 16105 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change To Provide for a T+1 Settlement of the Initial Payment Related to the CDS Contracts Cleared by ICE Clear Europe...\\ and Rule 19b-4 thereunder \\2\\ notice is hereby given that on March 6, 2012, ICE Clear Europe Limited...

  15. Limits of acceptable change planning in the Selway-Bitterroot Wilderness: 1985 to 1997 (FIDL)

    Treesearch

    Dan Ritter

    1997-01-01

    In 1985 the Forest Supervisors and staff of the Bitterroot, Clearwater, and Nez Perce National Forests met and agreed to an action plan for implementing a Limits of Acceptable Change (LAC) planning process for the Selway-Bitterroot Wilderness (SBW). The process, which was to include a citizens task force, was to produce a completed management plan in 2 years. Eight...

  16. Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.

    PubMed

    Paini, Alicia; Leonard, Jeremy A; Kliment, Tomas; Tan, Yu-Mei; Worth, Andrew

    2017-11-01

    Physiologically based kinetic (PBK) models are used widely throughout a number of working sectors, including academia and industry, to provide insight into the dosimetry related to observed adverse health effects in humans and other species. Use of these models has increased over the last several decades, especially in conjunction with emerging alternative methods to animal testing, such as in vitro studies and data-driven in silico quantitative-structure-activity-relationship (QSAR) predictions. Experimental information derived from these new approach methods can be used as input for model parameters and allows for increased confidence in models for chemicals that did not have in vivo data for model calibration. Despite significant advancements in good modelling practice (GMP) for model development and evaluation, there remains some reluctance among regulatory agencies to use such models during the risk assessment process. Here, the results of a survey disseminated to the modelling community are presented in order to inform the frequency of use and applications of PBK models in science and regulatory submission. Additionally, the survey was designed to identify a network of investigators involved in PBK modelling and knowledgeable of GMP so that they might be contacted in the future for peer review of PBK models, especially in regards to vetting the models to such a degree as to gain a greater acceptance for regulatory purposes. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  17. 78 FR 35335 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Amendment No. 2 to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Amendment No. 2 to Proposed Rule...\\ notice is hereby given that on June 4, 2013, ICE Clear Europe Limited (``ICE Clear Europe'') filed with... proposed rule changes to implement a clearing relationship in which ICE Clear Europe will clear contracts...

  18. Time to Reject the Linear-No Threshold Hypothesis and Accept Thresholds and Hormesis: A Petition to the U.S. Nuclear Regulatory Commission.

    PubMed

    Marcus, Carol S

    2015-07-01

    On February 9, 2015, I submitted a petition to the U.S. Nuclear Regulatory Commission (NRC) to reject the linear-no threshold (LNT) hypothesis and ALARA as the bases for radiation safety regulation in the United States, using instead threshold and hormesis evidence. In this article, I will briefly review the history of LNT and its use by regulators, the lack of evidence supporting LNT, and the large body of evidence supporting thresholds and hormesis. Physician acceptance of cancer risk from low dose radiation based upon federal regulatory claims is unfortunate and needs to be reevaluated. This is dangerous to patients and impedes good medical care. A link to my petition is available: http://radiationeffects.org/wp-content/uploads/2015/03/Hormesis-Petition-to-NRC-02-09-15.pdf, and support by individual physicians once the public comment period begins would be extremely important.

  19. 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

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Order Granting Accelerated Approval...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on May 5, 2012, ICE Clear Europe... such as the FSA, CFTC, SEC, Banque de France, Bundesbank, Bundesanstalt f[uuml]r...

  20. Gaining Regulator Acceptance of Natural Attenuation as a Remediation Tool

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

    Hughes, M.B.

    Monitored natural attenuation (MNA) makes use of biological degradation, chemical reactions with natural materials, and other processes to clean up contaminated soils and groundwater. In the past, the regulatory community has been slow to accept natural attenuation due to a misperception that natural attenuation is a ''do nothing'' approach. Recently however, regulators have been more open to considering MNA as part of an overall clean-up plan that includes active treatment technologies to remove or contain the source of contamination at a site. MNA is currently being implemented at the Savannah River Site for remediation of selected contaminants. The South Carolinamore » Department of Health and Environmental Control, who has regulatory authority over these actions, has accepted this process. Significant overall cost savings are forecast. Additionally, there will be less disruption to the ecosystem, compared with engineered technologies. This paper describes the monitored natural attenuation concept as well as the process of constructive engagement with the regulators to achieve acceptance. Application to DOE, DOD, and commercial sites, as well as acceptability to other regulatory bodies, will be discussed with an emphasis on strategies to prevent false starts in the negotiation process and inventing options that result in mutual gains for all parties.« less

  1. 29 CFR 1926.29 - Acceptable certifications.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Acceptable certifications. (a) Pressure vessels. Current and valid certification by an insurance company or... by an insurance company or regulatory authority attesting to the safe installation, inspection, and... types of pressure vessels and similar equipment are contained in subparts F and O of this part. ...

  2. 77 FR 51880 - Requirements for Maintenance of Inspections, Tests, Analyses, and Acceptance Criteria

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Maintenance of Inspections, Tests, Analyses, and Acceptance Criteria AGENCY: Nuclear Regulatory Commission... construction activities through inspections, tests, analyses, and acceptance criteria (ITAAC) under a combined... inspections, tests, or analyses were performed as required, or that acceptance criteria are met, and to notify...

  3. 20 CFR 404.780 - Evidence of “good cause” for exceeding time limits on accepting proof of support or application...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... accepting proof of support or application for a lump-sum death payment. (a) When evidence of good cause is... death payment. You may be asked for evidence of good cause for these delays if— (1) You are the insured... limits on accepting proof of support or application for a lump-sum death payment. 404.780 Section 404.780...

  4. Rationales for regulatory activity

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

    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.

  5. Embracing equifinality with efficiency: Limits of Acceptability sampling using the DREAM(LOA) algorithm

    NASA Astrophysics Data System (ADS)

    Vrugt, Jasper A.; Beven, Keith J.

    2018-04-01

    This essay illustrates some recent developments to the DiffeRential Evolution Adaptive Metropolis (DREAM) MATLAB toolbox of Vrugt (2016) to delineate and sample the behavioural solution space of set-theoretic likelihood functions used within the GLUE (Limits of Acceptability) framework (Beven and Binley, 1992, 2014; Beven and Freer, 2001; Beven, 2006). This work builds on the DREAM(ABC) algorithm of Sadegh and Vrugt (2014) and enhances significantly the accuracy and CPU-efficiency of Bayesian inference with GLUE. In particular it is shown how lack of adequate sampling in the model space might lead to unjustified model rejection.

  6. A cross-cultural study of perceived benefit versus risk as mediators in the trust-acceptance relationship.

    PubMed

    Bronfman, Nicolás C; Vázquez, Esperanza López

    2011-12-01

    Several recent studies have identified the significant role social trust in regulatory organizations plays in the public acceptance of various technologies and activities. In a cross-cultural investigation, the current work explores empirically the relationship between social trust in management authorities and the degree of public acceptability of hazards for individuals residing in either developed or emerging Latin American economies using confirmatory rather than exploratory techniques. Undergraduates in Mexico, Brazil, and Chile and the United States and Spain assessed trust in regulatory authorities, public acceptance, personal knowledge, and the risks and benefits for 23 activities and technological hazards. Four findings were encountered. (i) In Latin American nations trust in regulatory entities was strongly and significantly (directly as well as indirectly) linked with the public's acceptance of any activity or technology. In developed countries trust and acceptability are essentially linked indirectly (through perceived risk and perceived benefit). (ii) Lack of knowledge strengthened the magnitude and statistical significance of the trust-acceptability relationship in both developed and developing countries. (iii) For high levels of claimed knowledge, the impact on the trust-acceptability relationship varied depending upon the origin of the sample. (iv) Confirmatory analysis revealed the relative importance of perceived benefit over perceived risk in meditating the trust-acceptability causal chain. © 2011 Society for Risk Analysis.

  7. 77 FR 43620 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-25

    ... self-regulatory organization consents, the Commission shall either approve the proposed rule change...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to the Handling of Stop and Stop Limit...

  8. 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 donor...

  9. 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 donor...

  10. 76 FR 40412 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... a more limited application by their terms. For more information about the rulebook consolidation...

  11. 75 FR 45171 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555...-3040. This guide describes some engineering practices and methods generally considered by the NRC to be... they reflect the latest general engineering approaches that are acceptable to the NRC staff. If future...

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

    PubMed

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

    2015-10-01

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

  13. 12 CFR 562.2 - Regulatory reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting... limited to, the accounting instructions provided in the TFR, guidance contained in OTS regulations...

  14. 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

  15. 78 FR 11903 - Acceptability of Corrective Action Programs for Fuel Cycle Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... Cycle Facilities AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for public comment... ``Acceptability of Corrective Action Programs for Fuel Cycle Facilities.'' The draft NUREG provides guidance to... a fuel cycle facility is acceptable. DATES: Comments may be submitted by April 22, 2013. Comments...

  16. 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.

  17. 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

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66629; File No. SR-ICEEU-2012-05] 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 Calculation and Payment of Interest on Mark-To-Market Margin on CDS...

  18. 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

  19. Radio-frequency electromagnetic field (RF-EMF) exposure levels in different European outdoor urban environments in comparison with regulatory limits.

    PubMed

    Urbinello, Damiano; Joseph, Wout; Huss, Anke; Verloock, Leen; Beekhuizen, Johan; Vermeulen, Roel; Martens, Luc; Röösli, Martin

    2014-07-01

    Concerns of the general public about potential adverse health effects caused by radio-frequency electromagnetic fields (RF-EMFs) led authorities to introduce precautionary exposure limits, which vary considerably between regions. It may be speculated that precautionary limits affect the base station network in a manner that mean population exposure unintentionally increases. The objectives of this multicentre study were to compare mean exposure levels in outdoor areas across four different European cities and to compare with regulatory RF-EMF exposure levels in the corresponding areas. We performed measurements in the cities of Amsterdam (the Netherlands, regulatory limits for mobile phone base station frequency bands: 41-61 V/m), Basel (Switzerland, 4-6 V/m), Ghent (Belgium, 3-4.5 V/m) and Brussels (Belgium, 2.9-4.3 V/m) using a portable measurement device. Measurements were conducted in three different types of outdoor areas (central and non-central residential areas and downtown), between 2011 and 2012 at 12 different days. On each day, measurements were taken every 4s for approximately 15 to 30 min per area. Measurements per urban environment were repeated 12 times during 1 year. Arithmetic mean values for mobile phone base station exposure ranged between 0.22 V/m (Basel) and 0.41 V/m (Amsterdam) in all outdoor areas combined. The 95th percentile for total RF-EMF exposure varied between 0.46 V/m (Basel) and 0.82 V/m (Amsterdam) and the 99th percentile between 0.81 V/m (Basel) and 1.20 V/m (Brussels). All exposure levels were far below international reference levels proposed by ICNIRP (International Commission on Non-Ionizing Radiation Protection). Our study did not find indications that lowering the regulatory limit results in higher mobile phone base station exposure levels. Copyright © 2014 Elsevier Ltd. All rights reserved.

  20. Department of Defense Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U... the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because... Flexibility Act. Printing of these entries is limited to fields that contain information required by the...

  1. 18 CFR 50.8 - Acceptance/rejection of applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... applications. 50.8 Section 50.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT APPLICATIONS FOR PERMITS TO SITE INTERSTATE ELECTRIC TRANSMISSION FACILITIES § 50.8 Acceptance/rejection of applications. (a) Applications will be...

  2. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... basis in accordance with Generally Accepted Accounting Principles (GAAP) as promulgated by the Financial Accounting Standards Board (FASB), supplemented by Regulatory Accounting Principles (RAP) as identified by... set forth in FASB Statement of Financial Accounting Standards No. 15, Accounting by Debtors and...

  3. Understanding the Factors Limiting the Acceptability of Online Courses and Degrees

    ERIC Educational Resources Information Center

    Adams, Jonathan

    2008-01-01

    This study examines prior research conducted on the acceptability of online degrees in hiring situations. In a national survey, a questionnaire was developed for assessing the importance of objections to accepting job candidates with online degrees and sent to university search committee chairs in institutions advertising open faculty positions…

  4. ReNE: A Cytoscape Plugin for Regulatory Network Enhancement

    PubMed Central

    Politano, Gianfranco; Benso, Alfredo; Savino, Alessandro; Di Carlo, Stefano

    2014-01-01

    One of the biggest challenges in the study of biological regulatory mechanisms is the integration, americanmodeling, and analysis of the complex interactions which take place in biological networks. Despite post transcriptional regulatory elements (i.e., miRNAs) are widely investigated in current research, their usage and visualization in biological networks is very limited. Regulatory networks are commonly limited to gene entities. To integrate networks with post transcriptional regulatory data, researchers are therefore forced to manually resort to specific third party databases. In this context, we introduce ReNE, a Cytoscape 3.x plugin designed to automatically enrich a standard gene-based regulatory network with more detailed transcriptional, post transcriptional, and translational data, resulting in an enhanced network that more precisely models the actual biological regulatory mechanisms. ReNE can automatically import a network layout from the Reactome or KEGG repositories, or work with custom pathways described using a standard OWL/XML data format that the Cytoscape import procedure accepts. Moreover, ReNE allows researchers to merge multiple pathways coming from different sources. The merged network structure is normalized to guarantee a consistent and uniform description of the network nodes and edges and to enrich all integrated data with additional annotations retrieved from genome-wide databases like NCBI, thus producing a pathway fully manageable through the Cytoscape environment. The normalized network is then analyzed to include missing transcription factors, miRNAs, and proteins. The resulting enhanced network is still a fully functional Cytoscape network where each regulatory element (transcription factor, miRNA, gene, protein) and regulatory mechanism (up-regulation/down-regulation) is clearly visually identifiable, thus enabling a better visual understanding of its role and the effect in the network behavior. The enhanced network produced by Re

  5. A Regulatory Framework for Nanotechnology

    DTIC Science & Technology

    informed by a map of the regulatory landscape of nanotechnology and a review of the regulatory frameworks for the aviation and biotechnology industries...aviation and biotechnology and maps the regulatory landscape in the United States by examining stakeholders, regulatory entities, and applicable legislation...state of nanotechnology if the limitations of technical expertise are addressed. This expertise can be provided by advisory committees of technical

  6. 78 FR 65007 - Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 3

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 052-00026; NRC-2008-0252] Inspections, Tests, Analyses... Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

  7. 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

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 052-00026; NRC-2008-0252] Inspections, Tests, Analyses... Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria (ITAAC) completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

  8. 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

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 052-00025; NRC-2008-0252] Inspections, Tests, Analyses... Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria (ITAAC) completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

  9. 17 CFR 1.52 - Self-regulatory organization adoption and surveillance of minimum financial requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements... accounting and auditing firm that is acceptable to the Commission; and (2) Self-regulatory organization means...

  10. 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

  11. 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.

  12. 12 CFR 7.1007 - Acceptances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 1 2011-01-01 2011-01-01 false Acceptances. 7.1007 Section 7.1007 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY BANK ACTIVITIES AND OPERATIONS Bank Powers § 7.1007 Acceptances. A national bank is not limited in the character of acceptances it may make in...

  13. Canadian regulatory perspectives on genome engineered crops

    PubMed Central

    Smyth, Stuart J.

    2017-01-01

    ABSTRACT 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. PMID:27858499

  14. Challenges in international medicine: ethical dilemmas, unanticipated consequences, and accepting limitations.

    PubMed

    Iserson, Kenneth V; Biros, Michelle H; James Holliman, C

    2012-06-01

    While personal and organizational challenges occur in every area of health care, practitioners of international medicine face unique problems and dilemmas that are rarely discussed in training programs. Health professions schools, residency and fellowship programs, nongovernmental organizations (NGOs), and government programs have a responsibility to make those new to international medicine aware of the special circumstances that they may face and to provide methods for understanding and dealing with these circumstances. Standard "domestic" approaches to such challenges may not work in international medicine, even though these challenges may appear to be similar to those faced in other clinical settings. How should organizations ensure that well-meaning health intervention efforts do not cause adverse unintended sequelae? How should an individual balance respect for cultural uniqueness and local mores that may profoundly differ from his or her own beliefs, with the need to remain a moral agent true to one's self? When is acceptance the appropriate response to situations in which limitations of resources seem to preclude any good solution? Using a case-based approach, the authors discuss issues related to the four major international medicine domains: clinical practice (postdisaster response, resource limitations, standards of care), medical systems and systems development (prehospital care, wartime casualties, sustainable change, cultural awareness), teaching (instruction and local resources, professional preparation), and research (questionable funded studies, clinical trials, observational studies). It is hoped that this overview may help prepare those involved with international medicine for the challenges and dilemmas they may face and help frame their responses to these situations. © 2012 by the Society for Academic Emergency Medicine.

  15. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., since the making of acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller... under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance...

  16. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., since the making of acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller... under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance...

  17. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., since the making of acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller... under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance...

  18. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller's manual 7.7420. Therefore, national banks are authorized by the Comptroller to make acceptances under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of...

  19. 12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller's manual 7.7420. Therefore, national banks are authorized by the Comptroller to make acceptances under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of...

  20. 75 FR 27606 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-17

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Trade Reporting Facility Limited Liability Company...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 27, 2010, the Financial Industry...

  1. Consumer acceptance of irradiated chicken and produce in the U.S.A.

    NASA Astrophysics Data System (ADS)

    Cottee, Jim; Kunstadt, Peter; Fraser, Frank

    1995-02-01

    There is a demonstrated dichotomy between perceived consumer acceptance of irradiated foods, and the consumers' choice of food in grocery stores. Indeed the perception has been that most consumers were against irradiated foods and that massive educational campaigns would be needed to change their minds. Meanwhile, some initial sales of irradiated foods have been unexpectedly brisk when supported by limited, point-of-sale information. There is strong agreement between recent studies, with respect to consumers willing to buy irradiated foods once the benefits are explained. A large segment of approximately 50% of all respondents indicate that they would buy irradiated foods. Consumers have also shown that they put a great deal of trust in their grocers and in regulatory bodies.

  2. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    PubMed

    Gonçalves, Joana P; Aires, Ricardo S; Francisco, Alexandre P; Madeira, Sara C

    2012-01-01

    Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules) under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1) apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2) ignore local patterns, abundant in most interesting cases of transcriptional activity; (3) neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4) limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots). Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in functionally enriched

  3. Regulatory Snapshots: Integrative Mining of Regulatory Modules from Expression Time Series and Regulatory Networks

    PubMed Central

    Gonçalves, Joana P.; Aires, Ricardo S.; Francisco, Alexandre P.; Madeira, Sara C.

    2012-01-01

    Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules) under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1) apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2) ignore local patterns, abundant in most interesting cases of transcriptional activity; (3) neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4) limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots). Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in functionally enriched

  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. Expert opinions on the acceptance of alternative methods in food safety evaluations: Formulating recommendations to increase acceptance of non-animal methods for kinetics.

    PubMed

    Punt, Ans; Bouwmeester, Hans; Schiffelers, Marie-Jeanne W A; Peijnenburg, Ad A C M

    2018-02-01

    Inclusion of alternative methods that replace, reduce, or refine (3R) animal testing within regulatory safety evaluations of chemicals generally faces many hurdles. The goal of the current work is to i) collect responses from key stakeholders involved in food safety evaluations on what they consider the most relevant factors that influence the acceptance and use of 3R methods and to ii) use these responses to formulate activities needed to increase the acceptance and use of 3R methods, particularly for kinetics. The stakeholders were contacted by e-mail for their opinions, asking the respondents to write down three barriers and/or drivers and scoring these by distributing 5 points over the three factors. The main barriers that obtained the highest aggregated scores were i) uncertain predictability 3R methods/lack of validation, ii) insufficient guidance regulators/industry and iii) insufficient harmonization of legislation. The major driver identified was the possibility of 3R methods to provide more mechanistic information. Based on the results, recommendations are given to enhance the acceptance and application of 3R toxicokinetic methods in food safety evaluations. These include steering of regulatory data requirements as well as creating (funding) opportunities for development and validation of alternative methods for kinetics and development of guidances. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  6. 10 CFR 32.110 - Acceptance sampling procedures under certain specific licenses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 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 § 32...

  7. 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 § 32...

  8. Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study.

    PubMed

    Vitry, Agnes; Nguyen, Tuan; Entwistle, Vikky; Roughead, Elizabeth

    2015-01-01

    Withdrawal of conditional regulatory approval or subsidization of new medicines when subsequent evidence does not confirm early trial results may not be well understood or accepted by the public. We present a case study of the US Food and Drug Administration (FDA)'s decision to withdraw the indication of bevacizumab for the treatment of advanced breast cancer and include an analysis of the reactions of stakeholders with a view to identifying opportunities for improving risk management for new medicines with conditional approval or funding. We drew on a range of information sources, including FDA documents, medical journals and media reports, to describe the evidentiary basis of the FDA decisions. We analysed the reactions and perspectives of the stakeholders. In 2008 bevacizumab was granted conditional approval for treatment of advanced breast cancer by the FDA pending submission of supplementary satisfactory evidence. In 2011 the FDA decision to withdraw the indication was met with a hostile reaction from many clinicians and cancer survivors. There were different interpretations of the therapeutic value of bevacizumab with strong beliefs among cancer survivors that the medicine was effective and potential harm was manageable. High expectations of the public may have been encouraged by overly positive media reports and limited understanding by the public of the complexity of the scientific evaluation of new medicines and of the regulatory processes. Improving understanding and acceptance of approval or coverage schemes conditional to evidence development may require the development of risk management plans by regulatory and funding institutions. They may include a range of strategies such as requirements for formal patient acknowledgment of the conditional availability of the medicine, 'black-triangle' equivalent labels that identify full approval is based on pending evidence, and ongoing communication with the media, public and health professionals.

  9. 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.

  10. A future scenario of the global regulatory landscape regarding genome-edited crops

    PubMed Central

    Araki, Motoko

    2017-01-01

    ABSTRACT The global agricultural landscape regarding the commercial cultivation of genetically modified (GM) crops is mosaic. Meanwhile, a new plant breeding technique, genome editing is expected to make genetic engineering-mediated crop breeding more socially acceptable because it can be used to develop crop varieties without introducing transgenes, which have hampered the regulatory review and public acceptance of GM crops. The present study revealed that product- and process-based concepts have been implemented to regulate GM crops in 30 countries. Moreover, this study analyzed the regulatory responses to genome-edited crops in the USA, Argentina, Sweden and New Zealand. The findings suggested that countries will likely be divided in their policies on genome-edited crops: Some will deregulate transgene-free crops, while others will regulate all types of crops that have been modified by genome editing. These implications are discussed from the viewpoint of public acceptance. PMID:27960622

  11. 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..., the collector shall measure the temperature of the specimen. The temperature-measuring device used...

  12. 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..., the collector shall measure the temperature of the specimen. The temperature-measuring device used...

  13. 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..., the collector shall measure the temperature of the specimen. The temperature-measuring device used...

  14. International regulatory requirements for skin sensitization testing.

    PubMed

    Daniel, Amber B; Strickland, Judy; Allen, David; Casati, Silvia; Zuang, Valérie; Barroso, João; Whelan, Maurice; Régimbald-Krnel, M J; Kojima, Hajime; Nishikawa, Akiyoshi; Park, Hye-Kyung; Lee, Jong Kwon; Kim, Tae Sung; Delgado, Isabella; Rios, Ludmila; Yang, Ying; Wang, Gangli; Kleinstreuer, Nicole

    2018-06-01

    Skin sensitization test data are required or considered by chemical regulation authorities around the world. These data are used to develop product hazard labeling for the protection of consumers or workers and to assess risks from exposure to skin-sensitizing chemicals. To identify opportunities for regulatory uses of non-animal replacements for skin sensitization tests, the needs and uses for skin sensitization test data must first be clarified. Thus, we reviewed skin sensitization testing requirements for seven countries or regions that are represented in the International Cooperation on Alternative Test Methods (ICATM). We noted the type of skin sensitization data required for each chemical sector and whether these data were used in a hazard classification, potency classification, or risk assessment context; the preferred tests; and whether alternative non-animal tests were acceptable. An understanding of national and regional regulatory requirements for skin sensitization testing will inform the development of ICATM's international strategy for the acceptance and implementation of non-animal alternatives to assess the health hazards and risks associated with potential skin sensitizers. Copyright © 2018 Elsevier Inc. All rights reserved.

  15. The challenges of modelling phosphorus in a headwater catchment: Applying a 'limits of acceptability' uncertainty framework to a water quality model

    NASA Astrophysics Data System (ADS)

    Hollaway, M. J.; Beven, K. J.; Benskin, C. McW. H.; Collins, A. L.; Evans, R.; Falloon, P. D.; Forber, K. J.; Hiscock, K. M.; Kahana, R.; Macleod, C. J. A.; Ockenden, M. C.; Villamizar, M. L.; Wearing, C.; Withers, P. J. A.; Zhou, J. G.; Barber, N. J.; Haygarth, P. M.

    2018-03-01

    There is a need to model and predict the transfer of phosphorus (P) from land to water, but this is challenging because of the large number of complex physical and biogeochemical processes involved. This study presents, for the first time, a 'limits of acceptability' approach of the Generalized Likelihood Uncertainty Estimation (GLUE) framework to the Soil and Water Assessment Tool (SWAT), in an application to a water quality problem in the Newby Beck catchment (12.5 km2), Cumbria, United Kingdom (UK). Using high frequency outlet data (discharge and P), individual evaluation criteria (limits of acceptability) were assigned to observed discharge and P loads for all evaluation time steps, identifying where the model was performing well/poorly and to infer which processes required improvement in the model structure. Initial limits of acceptability were required to be relaxed by a substantial amount (by factors of between 5.3 and 6.7 on a normalized scale depending on the evaluation criteria used) in order to gain a set of behavioral simulations (1001 and 1016, respectively out of 5,000,000). Of the 39 model parameters tested, the representation of subsurface processes and associated parameters, were consistently shown as critical to the model not meeting the evaluation criteria, irrespective of the chosen evaluation metric. It is therefore concluded that SWAT is not an appropriate model to guide P management in this catchment. This approach highlights the importance of high frequency monitoring data for setting robust model evaluation criteria. It also raises the question as to whether it is possible to have sufficient input data available to drive such models so that we can have confidence in their predictions and their ability to inform catchment management strategies to tackle the problem of diffuse pollution from agriculture.

  16. 78 FR 45983 - Acceptability of Corrective Action Programs for Fuel Cycle Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... Programs for Fuel Cycle Facilities AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; withdrawal... withdrawing draft NUREG-2154, ``Acceptability of Corrective Action Programs for Fuel Cycle Facilities,'' based... determine whether a submittal for a Corrective Action Program (CAP), voluntarily submitted by fuel cycle...

  17. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 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 preclinical...

  18. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 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 preclinical...

  19. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 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 preclinical...

  20. 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 preclinical...

  1. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 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 preclinical...

  2. 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.

  3. 75 FR 80854 - Toshiba Corporation; Acceptance for Docketing of an Application for Renewal of the U.S. Advanced...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 52-044; NRC-2010-0361] Toshiba Corporation; Acceptance for Docketing of an Application for Renewal of the U.S. Advanced Boiling Water Reactor Design Certification On November 2, 2010, Toshiba Corporation (Toshiba) submitted an application to the U.S. Nuclear Regulatory Commission (NRC) for a design...

  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 initial...

  5. 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 initial...

  6. 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 initial...

  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 initial...

  8. 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 initial...

  9. 75 FR 16202 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ..., Revision 2, ``An Acceptable Model and Related Statistical Methods for the Analysis of Fuel Densification.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing guide in the... nuclear power reactors. To meet these objectives, the guide describes statistical methods related to...

  10. Regulatory T cells in the control of host-microorganism interactions (*).

    PubMed

    Belkaid, Yasmine; Tarbell, Kristin

    2009-01-01

    Each microenvironment requires a specific set of regulatory elements that are finely and constantly tuned to maintain local homeostasis. Various populations of regulatory T cells contribute to the maintenance of this equilibrium and establishment of controlled immune responses. In particular, regulatory T cells limit the magnitude of effector responses, which may result in failure to adequately control infection. However, regulatory T cells also help limit collateral tissue damage caused by vigorous antimicrobial immune responses against pathogenic microbes as well as commensals. In this review, we describe various situations in which the balance between regulatory T cells and effector immune functions influence the outcome of host-microorganism coexistence and discuss current hypotheses and points of polemic associated with the origin, target, and antigen specificity of both endogenous and induced regulatory T cells during these interactions.

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

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

    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, EPRImore » 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.« less

  12. Acceptability of donated breast milk in a resource limited South African setting.

    PubMed

    Coutsoudis, Irene; Petrites, Alissa; Coutsoudis, Anna

    2011-02-22

    The importance of breast milk for infants' growth, development and overall health is widely recognized. In situations where women are not able to provide their infants with sufficient amounts of their own breast milk, donor breast milk is the next preferred option. Although there is considerable research on the safety and scientific aspects of donor milk, and the motivations and experiences of donors, there is limited research addressing the attitudes and experiences of the women and families whose infants receive this milk. This study therefore examined attitudes towards donated breast milk among mothers, families and healthcare providers of potential recipient infants. The study was conducted at a public hospital and nearby clinic in Durban, South Africa. The qualitative data was derived from eight focus group discussions which included four groups with mothers; one with male partners; and one with grandmothers, investigating attitudes towards receiving donated breast milk for infants. There was also one group each with nurses and doctors about their attitudes towards donated breast milk and its use in the hospital. The focus groups were conducted in September and October 2009 and each group had between four and eleven participants, leading to a total of 48 participants. Although breast milk was seen as important to child health there were concerns about undermining of breast milk because of concerns about HIV and marketing and promotion of formula milks. In addition there were concerns about the safety of donor breast milk and discomfort about using another mother's milk. Participants believed that education on the importance of breast milk and transparency on the processes involved in sourcing and preparing donor milk would improve the acceptability. This study has shown that there are obstacles to the acceptability of donor milk, mainly stemming from lack of awareness/familiarity with the processes around donor breast milk and that these could be readily

  13. Willingness-to-accept pharmaceutical retail inconvenience: evidence from a contingent choice experiment.

    PubMed

    Finlay, Keith; Stoecker, Charles; Cunningham, Scott

    2015-01-01

    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. 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. 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. 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.

  14. 77 FR 33253 - Regulatory Guide 8.24, Revision 2, Health Physics Surveys During Enriched Uranium-235 Processing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

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

  15. Basic regulatory principles of Escherichia coli's electron transport chain for varying oxygen conditions.

    PubMed

    Henkel, Sebastian G; Ter Beek, Alexander; 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.

  16. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

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

    Kisner, Roger A; Wilgen, John B; Ewing, Paul D

    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 tomore » 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.« less

  17. Regulatory guidance for lightning protection in nuclear power plants

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

    Kisner, R. A.; Wilgen, J. B.; Ewing, P. D.

    2006-07-01

    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 andmore » 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. (authors)« less

  18. 75 FR 74697 - Central Oregon Irrigation District; Notice of Competing Preliminary Permit Application Accepted...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13858-000] Central Oregon Irrigation District; Notice of Competing Preliminary Permit Application Accepted for Filing and Soliciting Comments and Interventions November 22, 2010. On October 6, 2010, Central Oregon Irrigation District filed...

  19. Searching for statistically significant regulatory modules.

    PubMed

    Bailey, Timothy L; Noble, William Stafford

    2003-10-01

    The regulatory machinery controlling gene expression is complex, frequently requiring multiple, simultaneous DNA-protein interactions. The rate at which a gene is transcribed may depend upon the presence or absence of a collection of transcription factors bound to the DNA near the gene. Locating transcription factor binding sites in genomic DNA is difficult because the individual sites are small and tend to occur frequently by chance. True binding sites may be identified by their tendency to occur in clusters, sometimes known as regulatory modules. We describe an algorithm for detecting occurrences of regulatory modules in genomic DNA. The algorithm, called mcast, takes as input a DNA database and a collection of binding site motifs that are known to operate in concert. mcast uses a motif-based hidden Markov model with several novel features. The model incorporates motif-specific p-values, thereby allowing scores from motifs of different widths and specificities to be compared directly. The p-value scoring also allows mcast to only accept motif occurrences with significance below a user-specified threshold, while still assigning better scores to motif occurrences with lower p-values. mcast can search long DNA sequences, modeling length distributions between motifs within a regulatory module, but ignoring length distributions between modules. The algorithm produces a list of predicted regulatory modules, ranked by E-value. We validate the algorithm using simulated data as well as real data sets from fruitfly and human. http://meme.sdsc.edu/MCAST/paper

  20. Aversion to injection limits acceptability of extended-release naltrexone among homeless, alcohol-dependent patients.

    PubMed

    Friedmann, Peter D; Mello, Dawn; Lonergan, Sean; Bourgault, Claire; O'Toole, Thomas P

    2013-01-01

    Ending homelessness is a major priority of the Department of Veteran Affairs (VA), and alcohol use can be a barrier to stable housing. Clinical trials suggest that depot extended-release naltrexone (XR-NTX) is efficacious in reducing alcohol consumption among alcohol-dependent subjects. An open-label, randomized pilot study sought to examine the feasibility and effectiveness of XR-NTX versus oral naltrexone to improve alcohol consumption and housing stability among homeless, alcohol-dependent veterans at the Providence Veteran Affairs Medical Center. Of 215 potential candidates approached over a 16-month recruitment period, only 15 agreed to consider study entry and 7 were randomized. The primary reasons given for refusal were not wanting an injection; fear of needles; and not wanting to change drinking habits. Only 1 participant in the XR-NTX group returned after the first injection. Three participants in the oral naltrexone group attended all 7 visits and had good outcomes. Although XR-NTX has demonstrated efficacy in reducing heavy drinking, limited acceptance of the injection might reduce its effectiveness among homeless, alcohol-dependent patients.

  1. 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.

  2. Vibration safety limits for magnetic resonance elastography

    PubMed Central

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

    2010-01-01

    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 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. PMID:18263949

  3. Regulatory Promotion of Emergent CCS Technology

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

    Davies, Lincoln; Uchitel, Kirsten; Johnson, David

    2014-01-01

    Despite the growing inevitability of climate change and the attendant need for mitigation strategies, carbon capture and sequestration (CCS) has yet to gain much traction in the United States. Recent regulatory proposals by the U.S. Environmental Protection Agency (EPA), limited in scope to new-build power plants, represent the only significant policy initiative intended to mandate diffusion of CCS technology. Phase I of this Project assessed barriers to CCS deployment as prioritized by the CCS community. That research concluded that there were four primary barriers: (1) cost, (2) lack of a carbon price, (3) liability, and (4) lack of a comprehensivemore » regulatory regime. Phase II of this Project, as presented in this Report, assesses potential regulatory models for CCS and examines where those models address the hurdles to diffusing CCS technology identified in Phase I. It concludes (1) that a CCS-specific but flexible standard, such as a technology performance standard or a very particular type of market-based regulation, likely will promote CCS diffusion, and (2) that these policies cannot work alone, but rather, should be combined with other measures, such as liability limits and a comprehensive CCS regulatory regime.« less

  4. [Regulatory policies and public opinion: the case of smoking].

    PubMed

    Saltó, Esteve; Joan R, Villalbí; Valverde, Araceli; Baranda, Lucía; Plasencia, Antoni

    2006-01-01

    Collecting and disseminating information about the public opinion on a regulatory process gives visibility to the silent social support and facilitates the process, which often confronts resistance from interest groups. This paper presents a survey about a proposed legislation on tobacco in its final stages and its results, and some considerations on the use of this sort of information in change processes. Cross sectional descriptive study. In December 2005 a brief telephone survey was made to a population sample of 18 and more years of age (N=830) in Catalonia (Spain). The questionnaire explored opinions on the proposed regulations under discussion. We present the degree of support and the rating of nine regulatory measures, stratified by the respondents use of tobacco. Daily smokers are 26.3% of the surveyed population. Awareness and general support for tobacco regulation are very high. Aspects with wider support include bans on sales to minors (97.3%), smoking in enclosed public places (92.8%) and workplaces (89%), and publicity (90.8%). The aspect with less social support is banning smoking in bars and cafes (80.2%). The population supports widely tobacco regulation. This reinforces the process and weakens the arguments of those against it. Although smokers are less supportive, most of them accept the regulations, except for limitations in bars and cafes.

  5. Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.

    PubMed

    Solomon, Howard M; Makris, Susan L; Alsaid, Hasan; Bermudez, Oscar; Beyer, Bruce K; Chen, Antong; Chen, Connie L; Chen, Zhou; Chmielewski, Gary; DeLise, Anthony M; de Schaepdrijver, Luc; Dogdas, Belma; French, Julian; Harrouk, Wafa; Helfgott, Jonathan; Henkelman, R Mark; Hesterman, Jacob; Hew, Kok-Wah; Hoberman, Alan; Lo, Cecilia W; McDougal, Andrew; Minck, Daniel R; Scott, Lelia; Stewart, Jane; Sutherland, Vicki; Tatiparthi, Arun K; Winkelmann, Christopher T; Wise, L David; Wood, Sandra L; Ying, Xiaoyou

    2016-06-01

    During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies. Implementing these technologies into the Good Laboratory Practice environment requires rigorous testing, validation, and documentation to ensure the reproducibility of data. A workshop on current practices and regulatory requirements was held with the goal of defining minimal criteria for the proper implementation of these technologies and subsequent submission to regulatory agencies. Micro-computed tomography (micro-CT) is especially well suited for high-throughput evaluations, and is gaining popularity to evaluate fetal skeletons to assess the potential developmental toxicity of test agents. This workshop was convened to help scientists in the developmental toxicology field understand and apply micro-CT technology to nonclinical toxicology studies and facilitate the regulatory acceptance of imaging data. Presentations and workshop discussions covered: (1) principles of micro-CT fetal imaging; (2) concordance of findings with conventional skeletal evaluations; and (3) regulatory requirements for validating the system. Establishing these requirements for micro-CT examination can provide a path forward for laboratories considering implementing this technology and provide regulatory agencies with a basis to consider the acceptability of data generated via this technology. Published by Elsevier Inc.

  6. 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. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. 75 FR 7469 - Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-19

    ...-Stream Energy Conversion Devices (TISEC devices) to transmit the electricity from the turbines to the... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13605-000] Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

  8. 75 FR 26208 - Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12731-004] Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting... April 7, 2010, Natural Currents Energy Services, LLC, filed an application for a preliminary permit...

  9. 75 FR 34725 - Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-18

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13795-000] Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications; Mahoning Hydropower, LLC June 10, 2010. On May 25, 2010, Mahoning Hydropower, LLC filed an...

  10. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13877-000] Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications January 4, 2011. On November 4, 2010, Mahoning Hydro, LLC...

  11. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13618-000] Coastal Hydropower LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications February 18, 2010. On November 5, 2009, Coastal Hydropower...

  12. Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

    PubMed

    Seabroke, Suzie; Wise, Lesley; Waller, Patrick

    2013-10-01

    The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

  13. 18 CFR 5.22 - Notice of acceptance and ready for environmental analysis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Notice of acceptance and ready for environmental analysis. 5.22 Section 5.22 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS § 5.22 Notice o...

  14. ResDE Two-Component Regulatory System Mediates Oxygen Limitation-Induced Biofilm Formation by Bacillus amyloliquefaciens SQR9.

    PubMed

    Zhou, Xuan; Zhang, Nan; Xia, Liming; Li, Qing; Shao, Jiahui; Shen, Qirong; Zhang, Ruifu

    2018-04-15

    Efficient biofilm formation and root colonization capabilities facilitate the ability of beneficial plant rhizobacteria to promote plant growth and antagonize soilborne pathogens. Biofilm formation by plant-beneficial Bacillus strains is triggered by environmental cues, including oxygen deficiency, but the pathways that sense these environmental signals and regulate biofilm formation have not been thoroughly elucidated. In this study, we showed that the ResDE two-component regulatory system in the plant growth-promoting rhizobacterium Bacillus amyloliquefaciens strain SQR9 senses the oxygen deficiency signal and regulates biofilm formation. ResE is activated by sensing the oxygen limitation-induced reduction of the NAD + /NADH pool through its PAS domain, stimulating its kinase activity, and resulting in the transfer of a phosphoryl group to ResD. The phosphorylated ResD directly binds to the promoter regions of the qoxABCD and ctaCDEF operons to improve the biosynthesis of terminal oxidases, which can interact with KinB to activate biofilm formation. These results not only revealed the novel regulatory function of the ResDE two-component system but also contributed to the understanding of the complicated regulatory network governing Bacillus biofilm formation. This research may help to enhance the root colonization and the plant-beneficial efficiency of SQR9 and other Bacillus rhizobacteria used in agriculture. IMPORTANCE Bacillus spp. are widely used as bioinoculants for plant growth promotion and disease suppression. The exertion of their plant-beneficial functions is largely dependent on their root colonization, which is closely related to their biofilm formation capabilities. On the other hand, Bacillus is the model bacterium for biofilm study, and the process and molecular network of biofilm formation are well characterized (B. Mielich-Süss and D. Lopez, Environ Microbiol 17:555-565, 2015, https://doi.org/10.1111/1462-2920.12527; L. S. Cairns, L. Hobley, and

  15. 75 FR 53962 - Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13823-000] Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting... Currents Energy Services, LLC filed an application for a preliminary permit, pursuant to section 4(f) of...

  16. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13954-000] Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments... Hydropower, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power...

  17. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13953-000] Mahoning Hydropower, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments... Hydropower, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power...

  18. 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

  19. Functional Evolution of a cis-Regulatory Module

    PubMed Central

    Palsson, Arnar; Alekseeva, Elena; Bergman, Casey M; Nathan, Janaki; Kreitman, Martin

    2005-01-01

    Lack of knowledge about how regulatory regions evolve in relation to their structure–function may limit the utility of comparative sequence analysis in deciphering cis-regulatory sequences. To address this we applied reverse genetics to carry out a functional genetic complementation analysis of a eukaryotic cis-regulatory module—the even-skipped stripe 2 enhancer—from four Drosophila species. The evolution of this enhancer is non-clock-like, with important functional differences between closely related species and functional convergence between distantly related species. Functional divergence is attributable to differences in activation levels rather than spatiotemporal control of gene expression. Our findings have implications for understanding enhancer structure–function, mechanisms of speciation and computational identification of regulatory modules. PMID:15757364

  20. 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 B 1 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 B 1 . 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.

  1. 75 FR 7467 - Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-19

    ... of 300 kW; (3) one or more clusters of Tidal In-Stream Energy Conversion Devices (TISEC devices) to... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13606-000] Natural Currents Energy Services, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

  2. Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

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

    Kostova, M.; Howard, D.; Elder, P.

    2013-07-01

    The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined asmore » low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)« less

  3. 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%.

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

    PubMed

    Sovacool, Benjamin K; Gross, Allan

    2015-06-06

    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.

  5. 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

  6. The relationship of state Medicaid coverage to Medicaid acceptance among substance abuse providers in the United States.

    PubMed

    Andrews, Christina M

    2014-10-01

    The Affordable Care Act will dramatically increase the number of Americans with Medicaid coverage for substance abuse treatment (SAT). Currently, few SAT providers accept Medicaid, and consequently, there is concern that newly-eligible Medicaid enrollees will have difficulty finding SAT providers willing to serve them. However, little is known about why few SAT providers accept Medicaid. In response, this study examines how features of state Medicaid coverage for SAT, including benefits, eligibility, and oversight, are associated with Medicaid acceptance among SAT providers. Medicaid acceptance was positively associated with the number of SAT services covered, and the number of optional categorical expansions implemented by the state. Requirements for physician involvement were associated with lower odds of acceptance. The results suggest that more generous Medicaid coverage may encourage SAT providers to accept Medicaid, but regulatory policies may inhibit their ability to do so.

  7. A Survey of Social-Regulatory Practices in Selected Michigan Community Colleges.

    ERIC Educational Resources Information Center

    Hollander, Martin Elliot

    This study surveyed social-regulatory practices of selected community colleges in Michigan to find out: origin and extent of written social-regulatory policies and the provisions for change; types of rules of conduct; and communication and enforcement of social-regulatory practices and rules. The study was limited to commuter-type publicly…

  8. 75 FR 61479 - Kendall Head Tidal Energy Project; Notice of Preliminary Permit Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13801-000] Kendall Head Tidal Energy Project; Notice of Preliminary Permit Application Accepted for Filing and Soliciting... Federal Power Act, proposing to study the feasibility of the Kendall Head Tidal Energy Project, located in...

  9. 75 FR 78235 - Dodge Mill Realty, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13890-000] Dodge Mill Realty, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications December 8, 2010. On December 3, 2010, Dodge Mill Realty...

  10. 76 FR 25322 - Oklahoma Rose Water LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13854-000] Oklahoma Rose Water LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On September 30, 2010, Oklahoma Rose Water LLC filed an...

  11. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13842-000] Wild Flower Water LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On September 23, 2010, Wild Flower Water LLC filed an...

  12. 75 FR 2128 - Basin Farm Renewable, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... the feasibility of the Basin Farm Renewable Energy Project, to be located on Saxtons River, in... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13640-000] Basin Farm Renewable, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments...

  13. 75 FR 2127 - Basin Farm Renewable, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... the feasibility of the Basin Farm Renewable Energy Project Project, to be located on Saxtons River, in... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13643-000] Basin Farm Renewable, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments...

  14. 76 FR 45252 - Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14125-000] Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On March 25, 2011, Reliable Storage 1 LLC, filed an...

  15. 76 FR 45251 - Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14121-000] Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On March 25, 2011, Reliable Storage 1 LLC, filed an...

  16. 76 FR 45252 - Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14122-000] Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On March 25, 2011, Reliable Storage 1 LLC, filed an...

  17. 76 FR 45251 - Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14124-000] Reliable Storage 1 LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On March 25, 2011, Reliable Storage 1 LLC, filed an...

  18. 75 FR 65312 - Vortex Hydro Energy, LLC; Notice of Competing Preliminary Permit Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-22

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13831-000] Vortex Hydro Energy, LLC; Notice of Competing Preliminary Permit Application Accepted for Filing and Soliciting Comments and Interventions October 15, 2010. On August 9, 2010, Vortex Hydro Energy, LLC filed an...

  19. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13346-002] PayneBridge, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On November 1, 2012, PayneBridge, LLC filed an application for a...

  20. 75 FR 36710 - The Texas Engineering Experiment Station/Texas A&M University System; Notice of Acceptance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... for the Nuclear Science Center Reactor and Order Imposing Procedures for Access To Safeguards Information and Sensitive Unclassified Non- Safeguards Information AGENCY: Nuclear Regulatory Commission. ACTION: Notice of acceptance for docketing. FOR FURTHER INFORMATION CONTACT: Christian Cowdrey, Project...

  1. 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. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  2. 76 FR 9340 - Mill Town Power Project; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13995-000] Mill Town Power Project; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On January 4, 2011, Mill Town Power Project filed an application for a...

  3. 75 FR 18190 - New Jersey Water Supply Authority; Notice of Preliminary Permit Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... Contact: Edward Buss, P.E., New Jersey Water Supply Authority, 1851 State Hwy. 31, Clinton, NJ 08800, (908... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13399-000] New Jersey Water Supply Authority; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments...

  4. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 5984-063] Erie Boulevard Hydropower, L.P.; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and....: 5984-063. c. Date Filed: May 10, 2011. d. Applicant: Erie Boulevard Hydropower, L.P. (dba Brookfield...

  5. 78 FR 59919 - Pershing County Water Conservation District; Notice of Application Accepted for Filing With the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14327-000] Pershing County Water Conservation District; Notice of Application Accepted for Filing With the Commission, Intent to Waive Scoping, Soliciting Motions to Intervene and Protests, Ready For Environmental Analysis, and Soliciting Comments, Terms and Conditions,...

  6. Emerging regulatory paradigms in glutathione metabolism

    PubMed Central

    Liu, Yilin; Hyde, Annastasia S.; Simpson, Melanie A.; Barycki, Joseph J.

    2015-01-01

    One of the hallmarks of cancer is the ability to generate and withstand unusual levels of oxidative stress. In part, this property of tumor cells is conferred by elevation of the cellular redox buffer glutathione. Though enzymes of the glutathione synthesis and salvage pathways have been characterized for several decades, we still lack a comprehensive understanding of their independent and coordinate regulatory mechanisms. Recent studies have further revealed that overall central metabolic pathways are frequently altered in various tumor types, resulting in significant increases in biosynthetic capacity, and feeding into glutathione synthesis. In this review, we will discuss the enzymes and pathways affecting glutathione flux in cancer, and summarize current models for regulating cellular glutathione through both de novo synthesis and efficient salvage. In addition, we examine the integration of glutathione metabolism with other altered fates of intermediary metabolites, and highlight remaining questions about molecular details of the accepted regulatory modes. PMID:24974179

  7. 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.

  8. 75 FR 21773 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U... the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because... Flexibility Act. Printing of these entries is limited to fields that contain information required by the...

  9. The regulatory network analysis of long noncoding RNAs in human colorectal cancer.

    PubMed

    Zhang, Yuwei; Tao, Yang; Li, Yang; Zhao, Jinshun; Zhang, Lina; Zhang, Xiaohong; Dong, Changzheng; Xie, Yangyang; Dai, Xiaoyu; Zhang, Xinjun; Liao, Qi

    2018-05-01

    Colorectal cancer (CRC) is among one of the most prevalent and lethiferous diseases worldwide. Long noncoding RNAs (lncRNAs) are commonly accepted to function as a key regulatory factor in human cancer, but the potential regulatory mechanisms of CRC-associated lncRNA are largely obscure. Here, we integrated several expression profiles to obtain 55 differentially expressed (DE) lncRNAs. We first detected lncRNA interactions with transcription factors, microRNAs, mRNAs, and RNA-binding proteins to construct a regulatory network and then create functional enrichment analyses for them using bioinformatics approaches. We found the upregulated genes in the regulatory network are enriched in cell cycle and DNA damage response, while the downregulated genes are enriched in cell differentiation, cellular response, and cell signaling. We then employed module-based methods to mine several intriguing modules from the overall network, which helps to classify the functions of genes more specifically. Next, we confirmed the validity of our network by comparisons with a randomized network using computational method. Finally, we attempted to annotate lncRNA functions based on the regulatory network, which indicated its potential application. Our study of the lncRNA regulatory network provided significant clues to unveil lncRNAs potential regulatory mechanisms in CRC and laid a foundation for further experimental investigation.

  10. Neural indicators of emotion regulation via acceptance vs reappraisal in remitted major depressive disorder

    PubMed Central

    Keng, Shian-Ling; Ji, Jie Lisa; Moore, Tyler; Minkel, Jared; Dichter, Gabriel S.

    2015-01-01

    Mood disorders are characterized by impaired emotion regulation abilities, reflected in alterations in frontolimbic brain functioning during regulation. However, little is known about differences in brain function when comparing regulatory strategies. Reappraisal and emotional acceptance are effective in downregulating negative affect, and are components of effective depression psychotherapies. Investigating neural mechanisms of reappraisal vs emotional acceptance in remitted major depressive disorder (rMDD) may yield novel mechanistic insights into depression risk and prevention. Thirty-seven individuals (18 rMDD, 19 controls) were assessed during a functional magnetic resonance imaging task requiring reappraisal, emotional acceptance or no explicit regulation while viewing sad images. Lower negative affect was reported following reappraisal than acceptance, and was lower following acceptance than no explicit regulation. In controls, the acceptance > reappraisal contrast revealed greater activation in left insular cortex and right prefrontal gyrus, and less activation in several other prefrontal regions. Compared with controls, the rMDD group had greater paracingulate and right midfrontal gyrus (BA 8) activation during reappraisal relative to acceptance. Compared with reappraisal, acceptance is associated with activation in regions linked to somatic and emotion awareness, although this activation is associated with less reduction in negative affect. Additionally, a history of MDD moderated these effects. PMID:25617820

  11. Meanings and implications of acceptability judgements for wilderness use impacts

    Treesearch

    Amy F. Hoss; Mark W. Brunson

    2000-01-01

    While the concept of “acceptability” is central to the Limits of Acceptable Change (LAC) framework, there is inadequate understanding of how “acceptability” is judged and how unacceptable conditions affect visitor experiences. To address this knowledge gap, visitors to nine wilderness areas were interviewed. Judgments of social and environmental conditions fell into...

  12. 7 CFR 42.133 - Portion of production acceptance criteria.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CONTAINER REGULATIONS STANDARDS FOR CONDITION OF FOOD CONTAINERS On-Line Sampling and Inspection Procedures... determined by comparing the calculated CuSum value with the acceptance limit (“L”) for the specified AQL. (b) A portion of production is acceptable if the CuSum value, calculated from the subgroup representing...

  13. 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. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. Building sustainable communities using sense of place indicators in three Hudson River Valley, NY, tourism destinations: An application of the limits of acceptable change process

    Treesearch

    Laura E. Sullivan; Rudy M. Schuster; Diane M. Kuehn; Cheryl S. Doble; Duarte Morais

    2010-01-01

    This study explores whether measures of residents' sense of place can act as indicators in the Limits of Acceptable Change (LAC) process to facilitate tourism planning and management. Data on community attributes valued by residents and the associated values and meanings were collected through focus groups with 27 residents in three Hudson River Valley, New York,...

  15. 77 FR 10503 - Fall River Community Hydro Project; Notice of Preliminary Permit Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14216-000] Fall River Community Hydro Project; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On June 27, 2011, Fall River Valley Community Service District, California, filed an...

  16. 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 POLICY...

  17. 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 POLICY...

  18. 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 POLICY...

  19. 75 FR 47586 - New York Tidal Energy Company; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ...) 50 to 150 Tidal In Stream Energy Conversion (TISEC) devices consisting of, (2) rotating propeller... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13730-000] New York Tidal Energy Company; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments...

  20. 76 FR 74783 - American River Power II, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14325-000] American River Power II, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions to Intervene, and Competing Applications On November 10, 2011, American River Power II, LLC (AMP...

  1. 77 FR 14516 - Lock+ Hydro Friends Fund VII; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14339-000] Lock+ Hydro Friends Fund VII; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On December 22, 2011, Lock+ Hydro Friends Fund VII filed...

  2. 75 FR 38799 - Reedsport OPT Wave Park, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-06

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13666-000] Reedsport OPT Wave Park, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications June 24, 2010. Reedsport OPT Wave Park, LLC filed on...

  3. 77 FR 7143 - Green Wave Mendocino Wave Park; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14291-000] Green Wave Mendocino Wave Park; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments... (FPA), proposing to study the feasibility of the Green Wave Mendocino Wave Park (Mendocino Wave Project...

  4. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

    PubMed

    McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

    2012-07-01

    There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

  5. Regulatory Fit and Equal Opportunity/Diversity: Implications for DEOMI

    DTIC Science & Technology

    2013-01-01

    than demographic diversity ( Ivancevich & Gilbert, 2000); the goal of equality is to create and manage a heterogeneous mix of abilities, skills, ideas...accepted. Recruiting of minorities and women are not seen as violations of EO laws (Kravitz, 2008; Newman & Lyon , 2009; Pyburn, et al., 2008). Similarly...209-213. REGULATORY FIT AND EQUAL OPPORTUNITY/DIVERSITY 23 Ivancevich , J. M. & Gilbert, J. A. (2000). Diversity management: Time for a new approach

  6. 77 FR 21551 - New York City Department of Environmental Protection; Notice of Application Accepted for filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13287-004] New York City Department of Environmental Protection; Notice of Application Accepted for filing And Soliciting Motions To Intervene and Protests Take notice that the following hydroelectric application has been filed with the Commission and is available for public...

  7. 77 FR 101 - Rumford Falls Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Comments, Motions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2333-078] Rumford Falls Hydro, LLC; 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 and is available for public inspection: a. Types...

  8. 78 FR 78355 - San Diego County Water Authority; Notice of Preliminary Permit Application Accepted For Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12747-002] San Diego County Water Authority; Notice of Preliminary Permit Application Accepted For Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On July 1, 2013, the San Diego County Water Authority filed an application for a preliminary...

  9. 75 FR 47586 - New York Tidal Energy Company; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12665-004] New York Tidal Energy Company; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications July 30, 2010. On May 12, 2010, New York Tidal Energy...

  10. 76 FR 35201 - Jersey Central Power and Light; PSEG Fossil LLC; Notice of Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-16

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2309-019] Jersey Central Power and Light; PSEG Fossil LLC; Notice of Application Accepted for Filing, Soliciting Motions To...: Jersey Central Power and Light and PSEG Fossil LLC. e. Name of Project: Yards Creek Pumped Storage...

  11. 76 FR 34071 - Lock Hydro Friends Fund I; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14107-000] Lock Hydro Friends Fund I; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On March 4, 2011, Lock Hydro Friends Fund I, filed an...

  12. 76 FR 18755 - Lock Hydro Friends Fund LII; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13810-000] Lock Hydro Friends Fund LII; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On July 12, 2010, Lock Hydro Friends Fund LII, filed an...

  13. 75 FR 27769 - Lock+ Hydro Friends Fund VII; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13711-000] Lock+ Hydro Friends Fund VII; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications May 11, 2010. On April 13, 2010 Lock+ Hydro Friends Fund...

  14. 76 FR 18755 - Lock Hydro Friends Fund LI; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13818-000] Lock Hydro Friends Fund LI; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On July 16, 2010, Lock Hydro Friends Fund LI, filed an...

  15. 75 FR 27770 - Lock+ Hydro Friends Fund VIII; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13710-000] Lock+ Hydro Friends Fund VIII; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications May 11, 2010. On April 13, 2010 Lock+ Hydro Friends Fund...

  16. 76 FR 54765 - Lock+ Hydro Friends Fund IV; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-02

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14253-000] Lock+ Hydro Friends Fund IV; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On August 10, 2011, the Lock+ Hydro Friends Fund IV filed...

  17. 76 FR 34975 - U.S. Farmers, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14102-000] U.S. Farmers, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On February 22, 2011, U.S. Farmers, LLC filed an application for a...

  18. 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…

  19. Anxiety sensitivity and affect regulatory strategies: individual and interactive risk factors for anxiety-related symptoms.

    PubMed

    Kashdan, Todd B; Zvolensky, Michael J; McLeish, Alison C

    2008-01-01

    Studies have shown that anxiety sensitivity (AS) is a risk factor in the development of pathological anxiety. Recent theoretical models emphasize the additional importance of how people handle their anxious experiences. The present study examined whether high AS and being fixated on the control and regulation of unwanted anxious feelings or being unable to properly modulate affect as needed lead to particularly problematic outcomes. We examined the interactive influence of AS and affect regulatory strategies on the frequency and intensity of anxiety symptoms. Questionnaires were completed by 248 young adults in the community. Results showed a general pattern with anxiety symptoms being the most severe when high AS was paired with affect regulatory difficulties. Of participants high in AS, anxious arousal and worry were heightened in the presence of less acceptance of emotional distress; anxious arousal, worry, and agoraphobic cognitions were heightened when fewer resources were available to properly modulate affect; and agoraphobic cognitions were heightened in the presence of high emotion expressiveness. As evidence of construct specificity, an alternative model with anhedonic depressive symptoms as a main effect and interaction effect (with regulatory strategies) failed to predict anxiety symptoms. However, anxiety sensitivity and less acceptance of emotional distress were associated with greater anhedonia. Results are discussed in the context of how and when affect regulatory behavior shifts individuals from normative anxiety to pathology.

  20. Workplace violence: managing a culture of acceptance.

    PubMed

    Fredrick, Marie

    2014-01-01

    The cultural acceptance of workplace violence is changing. Management has become more educated on regulatory issues around its tolerance of workplace violence. Events around the country in a variety of settings have aided in raising awareness of this issue. Healthcare professionals are not immune to workplace violence, including those working in the imaging profession. Healthcare workers, historically, have given care despite the demeanor of patients, often putting up with aggressive behavior including sexual harassment and physical assault. Management needs to take all possible measures to ensure employees feel safe at work. It is essential to have well thought out policies and procedures to mitigate workplace violence; keeping in mind that a goal of eliminating workplace violence is unrealistic.

  1. An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

    PubMed Central

    Beaver, Julia A.; Tzou, Abraham; Blumenthal, Gideon M.; McKee, Amy E.; Kim, Geoffrey; Pazdur, Richard; Philip, Reena

    2016-01-01

    As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this article, we will describe the potential benefit of complex signatures and their unique regulatory challenges including analytical performance validation, complex signature simulation, and clinical performance evaluation. We also will review the potential regulatory pathways for clearance, approval, or acceptance of complex signatures by the U.S. Food and Drug Administration (FDA). These regulatory pathways include regulations applicable to in vitro diagnostic devices, including companion diagnostic devices, the potential for labeling as a complementary diagnostic, and the biomarker qualification program. PMID:27993967

  2. 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. © 2016 Society for Risk Analysis.

  3. Incorporating patient-preference evidence into regulatory decision making.

    PubMed

    Ho, Martin P; Gonzalez, Juan Marcos; Lerner, Herbert P; Neuland, Carolyn Y; Whang, Joyce M; McMurry-Heath, Michelle; Hauber, A Brett; Irony, Telba

    2015-10-01

    Patients have a unique role in deciding what treatments should be available for them and regulatory agencies should take their preferences into account when making treatment approval decisions. This is the first study designed to obtain quantitative patient-preference evidence to inform regulatory approval decisions by the Food and Drug Administration Center for Devices and Radiological Health. Five-hundred and forty United States adults with body mass index (BMI) ≥ 30 kg/m(2) evaluated tradeoffs among effectiveness, safety, and other attributes of weight-loss devices in a scientific survey. Discrete-choice experiments were used to quantify the importance of safety, effectiveness, and other attributes of weight-loss devices to obese respondents. A tool based on these measures is being used to inform benefit-risk assessments for premarket approval of medical devices. Respondent choices yielded preference scores indicating their relative value for attributes of weight-loss devices in this study. We developed a tool to estimate the minimum weight loss acceptable by a patient to receive a device with a given risk profile and the maximum mortality risk tolerable in exchange for a given weight loss. For example, to accept a device with 0.01 % mortality risk, a risk tolerant patient will require about 10 % total body weight loss lasting 5 years. Patient preference evidence was used make regulatory decision making more patient-centered. In addition, we captured the heterogeneity of patient preferences allowing market approval of effective devices for risk tolerant patients. CDRH is using the study tool to define minimum clinical effectiveness to evaluate new weight-loss devices. The methods presented can be applied to a wide variety of medical products. This study supports the ongoing development of a guidance document on incorporating patient preferences into medical-device premarket approval decisions.

  4. Indirect presentation in the thymus limits naive and regulatory T-cell differentiation by promoting deletion of self-reactive thymocytes.

    PubMed

    Yap, Jin Yan; Wirasinha, Rushika C; Chan, Anna; Howard, Debbie R; Goodnow, Christopher C; Daley, Stephen R

    2018-02-07

    Acquisition of T-cell central tolerance involves distinct pathways of self-antigen presentation to thymocytes. One pathway termed indirect presentation requires a self-antigen transfer step from thymic epithelial cells (TECs) to bone marrow-derived cells before the self-antigen is presented to thymocytes. The role of indirect presentation in central tolerance is context-dependent, potentially due to variation in self-antigen expression, processing and presentation in the thymus. Here, we report experiments in mice in which TECs expressed a membrane-bound transgenic self-antigen, hen egg lysozyme (HEL), from either the insulin (insHEL) or thyroglobulin (thyroHEL) promoter. Intrathymic HEL expression was less abundant and more confined to the medulla in insHEL mice compared with thyroHEL mice. When indirect presentation was impaired by generating mice lacking MHC class II expression in bone marrow-derived antigen-presenting cells, insHEL-mediated thymocyte deletion was abolished, whereas thyroHEL-mediated deletion occurred at a later stage of thymocyte development and Foxp3 + regulatory T-cell differentiation increased. Indirect presentation increased the strength of T-cell receptor signalling that both self-antigens induced in thymocytes, as assessed by Helios expression. Hence, indirect presentation limits the differentiation of naive and regulatory T cells by promoting deletion of self-reactive thymocytes. © 2018 John Wiley & Sons Ltd.

  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. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Regulatory immune cells and functions in autoimmunity and transplantation immunology.

    PubMed

    Papp, Gabor; Boros, Peter; Nakken, Britt; Szodoray, Peter; Zeher, Margit

    2017-05-01

    In physiological circumstances, various tolerogenic mechanisms support the protection of self-structures during immune responses. However, quantitative and/or qualitative changes in regulatory immune cells and mediators can evoke auto-reactive immune responses, and upon susceptible genetic background, along with the presence of other concomitant etiological factors, autoimmune disease may develop. In transplant immunology, tolerogenic mechanisms are also critical, since the balance between of alloantigen-reactive effector cells and the regulatory immune cells will ultimately determine whether a graft is accepted or rejected. Better understanding of the immunological tolerance and the potential modulations of immune regulatory processes are crucial for developing effective therapies in autoimmune diseases as well as in organ transplantation. In this review, we focus on the novel insights regarding the impaired immune regulation and other relevant factors contributing to the development of auto-reactive and graft-reactive immune responses in autoimmune diseases and transplant rejection, respectively. We also address some promising approaches for modification of immune-regulatory processes and tolerogenic mechanisms in autoimmunity and solid organ transplantation, which may be beneficial in future therapeutic strategies. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. 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

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 4344-011] 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 and is available for public inspection: a. Type o...

  8. 77 FR 63302 - San Gabriel Valley Water Company dba, Fontana Water Company; Notice of Application Accepted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14428-000] San Gabriel Valley Water Company dba, Fontana Water Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, Protests, Recommendations, and Terms and Conditions October 10, 2012. Take notice that the following hydroelectric...

  9. 76 FR 51962 - Oregon Department of Fish and Wildlife; Notice of Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14235-000] Oregon Department of Fish and Wildlife; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, Protests, Recommendations, and Terms and Conditions Take notice that the following hydroelectric application has been filed with the...

  10. US EPA - A*Star Partnership - Accelerating the Acceptance of ...

    EPA Pesticide Factsheets

    The path for incorporating new alternative methods and technologies into quantitative chemical risk assessment poses a diverse set of scientific challenges. Some of these challenges include development of relevant and predictive test systems and computational models to integrate and extrapolate experimental data, and rapid characterization and acceptance of these systems and models. The series of presentations will highlight a collaborative effort between the U.S. Environmental Protection Agency (EPA) and the Agency for Science, Technology and Research (A*STAR) that is focused on developing and applying experimental and computational models for predicting chemical-induced liver and kidney toxicity, brain angiogenesis, and blood-brain-barrier formation. In addressing some of these challenges, the U.S. EPA and A*STAR collaboration will provide a glimpse of what chemical risk assessments could look like in the 21st century. Presentation on US EPA – A*STAR Partnership at international symposium on Accelerating the acceptance of next-generation sciences and their application to regulatory risk assessment in Singapore.

  11. Neural indicators of emotion regulation via acceptance vs reappraisal in remitted major depressive disorder.

    PubMed

    Smoski, Moria J; Keng, Shian-Ling; Ji, Jie Lisa; Moore, Tyler; Minkel, Jared; Dichter, Gabriel S

    2015-09-01

    Mood disorders are characterized by impaired emotion regulation abilities, reflected in alterations in frontolimbic brain functioning during regulation. However, little is known about differences in brain function when comparing regulatory strategies. Reappraisal and emotional acceptance are effective in downregulating negative affect, and are components of effective depression psychotherapies. Investigating neural mechanisms of reappraisal vs emotional acceptance in remitted major depressive disorder (rMDD) may yield novel mechanistic insights into depression risk and prevention. Thirty-seven individuals (18 rMDD, 19 controls) were assessed during a functional magnetic resonance imaging task requiring reappraisal, emotional acceptance or no explicit regulation while viewing sad images. Lower negative affect was reported following reappraisal than acceptance, and was lower following acceptance than no explicit regulation. In controls, the acceptance > reappraisal contrast revealed greater activation in left insular cortex and right prefrontal gyrus, and less activation in several other prefrontal regions. Compared with controls, the rMDD group had greater paracingulate and right midfrontal gyrus (BA 8) activation during reappraisal relative to acceptance. Compared with reappraisal, acceptance is associated with activation in regions linked to somatic and emotion awareness, although this activation is associated with less reduction in negative affect. Additionally, a history of MDD moderated these effects. © The Author (2015). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

  12. [Acceptance and Commitment Therapy: Theoretical background and practice].

    PubMed

    Eisenbeck, Nikolett; Schlosser, Károly Kornél; Szondy, Máté; Szabó-Bartha, Anett

    The Acceptance and Commitment Therapy (ACT) is one of the modern, so-called third-wave behavioural therapies. Among them the most successful is ACT, both in the number of therapists and respective scientific research. ACT's theoretical and philosophical background is described explicitly and its therapeutic interventions were developed according to this philosophy. Its psychopathological model is based on the idea that mainly the person's regulatory efforts of their own thoughts and feelings lead to psychological problems. That is, the source of human suffering and various psychological problems is the so called psychological inflexibility: control attempts of private events instead of living a life based on personal values and long-term goals. Therefore, clinical work in ACT focuses on the acceptance and defusion of the unwanted inner experiences and on the development of a meaningful life. The present article aims to provide a comprehensive description of ACT in Hungarian: its theoretical background, clinical techniques, and efficacy. At the end of the article, the state of ACT in Hungary will also be briefly discussed.

  13. Application of Regulatory Focus Theory to Search Advertising

    PubMed Central

    Mowle, Elyse N.; Georgia, Emily J.; Doss, Brian D.; Updegraff, John A.

    2015-01-01

    Purpose The purpose of this paper is to test the utility of regulatory focus theory principles in a real-world setting; specifically, Internet hosted text advertisements. Effect of compatibility of the ad text with the regulatory focus of the consumer was examined. Design/methodology/approach Advertisements were created using Google AdWords. Data were collected for the number of views and clicks each ad received. Effect of regulatory fit was measured using logistic regression. Findings Logistic regression analyses demonstrated that there was a strong main effect for keyword, such that users were almost six times as likely to click on a promotion advertisement as a prevention advertisement, as well as a main effect for compatibility, such that users were twice as likely to click on an advertisement with content that was consistent with their keyword. Finally, there was a strong interaction of these two variables, such that the effect of consistent advertisements was stronger for promotion searches than for prevention searches. Research limitations/implications The effect of ad compatibility had medium to large effect sizes, suggesting that individuals’ state may have more influence on advertising response than do individuals’ traits (e.g. personality traits). Measurement of regulatory fit was limited by the constraints of Google AdWords. Practical implications The results of this study provide a possible framework for ad creation for Internet advertisers. Originality/value This paper is the first study to demonstrate the utility of regulatory focus theory in online advertising. PMID:26430293

  14. 78 FR 37217 - Ted P. Sorenson; Notice of Preliminary Permit Application Accepted for Filing and Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14519-000] Ted P. Sorenson; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On May 1, 2013, Ted P. Sorenson filed an application for a preliminary permit, pursuant to section 4(f) of the...

  15. 78 FR 34360 - Public Utility District No. 2 of Grant County, Washington; Notice of Application Accepted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2114-209] Public Utility District No. 2 of Grant County, Washington; 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 is...

  16. Intrinsic limits to gene regulation by global crosstalk

    NASA Astrophysics Data System (ADS)

    Friedlander, Tamar; Prizak, Roshan; Guet, Calin; Barton, Nicholas H.; Tkacik, Gasper

    Gene activity is mediated by the specificity of binding interactions between special proteins, called transcription factors, and short regulatory sequences on the DNA, where different protein species preferentially bind different DNA targets. Limited interaction specificity may lead to crosstalk: a regulatory state in which a gene is either incorrectly activated due to spurious interactions or remains erroneously inactive. Since each protein can potentially interact with numerous DNA targets, crosstalk is inherently a global problem, yet has previously not been studied as such. We construct a theoretical framework to analyze the effects of global crosstalk on gene regulation, using statistical mechanics. We find that crosstalk in regulatory interactions puts fundamental limits on the reliability of gene regulation that are not easily mitigated by tuning proteins concentrations or by complex regulatory schemes proposed in the literature. Our results suggest that crosstalk imposes a previously unexplored global constraint on the functioning and evolution of regulatory networks, which is qualitatively distinct from the known constraints that act at the level of individual gene regulatory elements. The research leading to these results has received funding from the People Programme (Marie Curie Actions) of the European Union's Seventh Framework Programme (FP7/2007-2013) under REA Grant agreement Nr. 291734 (T.F.) and ERC Grant Nr. 250152 (N.B.).

  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 Nebraska. Preliminary background report

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

    Feurer, D A; Weaver, C L; Gallagher, K C

    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, andmore » 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.« less

  18. Local tolerance testing under REACH: Accepted non-animal methods are not on equal footing with animal tests.

    PubMed

    Sauer, Ursula G; Hill, Erin H; Curren, Rodger D; Raabe, Hans A; Kolle, Susanne N; Teubner, Wera; Mehling, Annette; Landsiedel, Robert

    2016-07-01

    In general, no single non-animal method can cover the complexity of any given animal test. Therefore, fixed sets of in vitro (and in chemico) methods have been combined into testing strategies for skin and eye irritation and skin sensitisation testing, with pre-defined prediction models for substance classification. Many of these methods have been adopted as OECD test guidelines. Various testing strategies have been successfully validated in extensive in-house and inter-laboratory studies, but they have not yet received formal acceptance for substance classification. Therefore, under the European REACH Regulation, data from testing strategies can, in general, only be used in so-called weight-of-evidence approaches. While animal testing data generated under the specific REACH information requirements are per se sufficient, the sufficiency of weight-of-evidence approaches can be questioned under the REACH system, and further animal testing can be required. This constitutes an imbalance between the regulatory acceptance of data from approved non-animal methods and animal tests that is not justified on scientific grounds. To ensure that testing strategies for local tolerance testing truly serve to replace animal testing for the REACH registration 2018 deadline (when the majority of existing chemicals have to be registered), clarity on their regulatory acceptance as complete replacements is urgently required. 2016 FRAME.

  19. 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

    ... Rule Change Relating to the Acceptance of Letters of Credit or Pass-Through Letters of Credit Deposits... accept Letters of Credit as permitted cover for certain clearing members for cleared energy futures. As part of the update to the Permitted Cover, ICE Clear Europe will consider new requests to use Letters...

  20. 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

  1. Impaired function of CD4+/CD25+ T regulatory lymphocytes characterizes the self-limited hepatitis A virus infection.

    PubMed

    Perrella, Alessandro; Vitiello, Laura; Atripaldi, Luigi; Sbreglia, Costanza; Grattacaso, Stella; Bellopede, Pasquale; Patarino, Tommaso; Morelli, Giuseppe; Altamura, Simona; Racioppi, Luigi; Perrella, Oreste

    2008-07-01

    Hepatitis A virus (HAV) causes a transient illness leaving permanent protection against reinfection. Few data are available on the regulatory mechanisms involved in the CD4+ T helper activation. We aimed to investigate the frequency and function of CD3+/CD4+/CD25+ T cells with regulatory function (Tregs) during acute HAV infection. We enrolled 35 consecutive patients and 15 healthy donors, enumerated Tregs by flow cytometry assay and evaluated, after immunomagnetical sorting with magnetic beads, their ability to inhibit the proliferation of CD4+/CD25- T lymphocytes at different ratios (1:1, 1:10, 1:20). All patients had the usual course of infection. Our immunological analysis showed Tregs frequency in these patients (6.5% [range, 5-8.8%]; 36 [range, 10-87] cells) did not have any statistical difference compared with healthy donors (6% [range, 5-8%]; 48 (range, 23-71) cells), while their ability to suppress CD4+/CD25- was drastically reduced at different ratios (Mann-Whitney U-test; ratio 1:1, 93% vs 72%, z = -3.34, P < 0.0001; ratio 1:10, 86% vs 51%, z = -4.04, P < 0.001; ratio 1:20, 56% vs 30%, z = -3.43, P < 0.0001). After the seroconversion, CD4+/CD25+ frequency and function in HAV-infected patients did not differ from healthy individuals. CD4+/CD25+ T cells seem to be impaired in their function during the HAV acute infection. This evidence might help to determine an optimal T helper cell immune network that is a predisposing factor for a self-limiting disease.

  2. 78 FR 41398 - City of Berlin, Berlin Water Works; Notice of Preliminary Permit Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14529-000] City of Berlin, Berlin Water Works; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On June 19, 2013, the City of Berlin, Berlin Water Works, filed an application for a...

  3. 78 FR 19698 - Lucid Energy, Inc., The City of Portland Water Bureau; Notice of Application Accepted for Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14498-000] Lucid Energy, Inc., The City of Portland Water Bureau; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, Protests, Recommendations, and Terms and Conditions Take notice that the following hydroelectric application has been...

  4. Regulatory guidance on soil cover systems

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

    Kane, J.D.

    1991-12-31

    The US Nuclear Regulatory Commission (NRC) in September 1991, completed revisions to 14 sections of the Standard Review Plan (SRP) for the Review of a License Application for a Low-Level Radioactive Waste Disposal Facility. The major purposes of the SRP are to ensure the quality and uniformity of the NRC staff`s safety reviews, and to present a well-defined base from which to evaluate the acceptability of information and data provided in the Safety Analysis Report (SAR) portion of the license application. SRP 3.2, entitled, Design Considerations for Normal and Abnormal/Accident Conditions, was one of the sections that was revised bymore » the NRC staff. This revision was completed to provide additional regulatory guidance on the important considerations that need to be addressed for the proper design and construction of soil cover systems that are to be placed over the LLW. The cover system over the waste is acknowledged to be one of the most important engineered barriers for the long-term stable performance of the disposal facility. The guidance in revised SRP 3.2 summarizes the previous efforts and recommendations of the US Army Corps of Engineers (COE), and a peer review panel on the placement of soil cover systems. NRC published these efforts in NUREG/CR-5432. The discussions in this paper highlight selected recommendations on soil cover issues that the NRC staff considers important for ensuring the safe, long-term performance of the soil cover systems. The development phases to be discussed include: (1) cover design; (2) cover material selection; (3) laboratory and field testing; (4) field placement control and acceptance; and (5) penetrations through the constructed covers.« less

  5. 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…

  6. Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice.

    PubMed

    Cohen, A D; Wu, J J; Puig, L; Chimenti, S; Vender, R; Rajagopalan, M; Romiti, R; de la Cruz, C; Skov, L; Zachariae, C; Young, H S; Foley, P; van der Walt, J M; Naldi, L; Prens, E P; Blauvelt, A

    2017-12-01

    The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies. © 2017 British Association of Dermatologists.

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

    PubMed

    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.

  8. 10 CFR 72.96 - Siting limitations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Siting limitations. 72.96 Section 72.96 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL... high-level radioactive waste that may be stored. This limitation shall prohibit the storage of a...

  9. 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.

  10. Regulatory pathways to enable the licencing of alternatives to antibiotics.

    PubMed

    Ioannou, Faye; Burnsteel, Cindy; Mackay, David K J; Gay, Cyril G

    2018-05-01

    Effective alternatives to antibiotics (ATA) such as vaccines, antibodies, phage therapies, prebiotics, probiotics and herbal medicines can be used in place of traditional antibiotics in a way that does not compromise animal health as means of tackling the growing threat to both animal and human health from antimicrobial resistance (AMR). This paper reflects the key points on the approaches that were discussed during the 2nd International Symposium on ATA between regulatory agencies, veterinary product companies representing largely the pharmaceutical and feed-additive sectors, academia and other stakeholders on regulatory pathways to enable the licensing of alternatives to antibiotics for food producing animals. The need to demonstrate compliance with generally accepted standards for quality, safety and efficacy is considered a pre-requisite for all veterinary medicinal products receiving an authorisation including ATA, irrespective of the region in which they are approved. ATA are often based on novel technologies, with complex mechanisms of action; therefore, early and close communication with regulators is encouraged. In addition, strategic use by ATA applicants of all regulatory tools available to support innovation is highly recommended. The veterinary product manufacturers consider that the regulation of veterinary medicines should evolve to accommodate innovative ATA technologies and incentives from regulatory agencies provided to stimulate further ATA development. Copyright © 2018.

  11. Estimating Acceptability of Financial Health Incentives

    ERIC Educational Resources Information Center

    Bigsby, Elisabeth; Seitz, Holli H.; Halpern, Scott D.; Volpp, Kevin; Cappella, Joseph N.

    2017-01-01

    A growing body of evidence suggests that financial incentives can influence health behavior change, but research on the public acceptability of these programs and factors that predict public support have been limited. A representative sample of U.S. adults (N = 526) were randomly assigned to receive an incentive program description in which the…

  12. Promoting Adoption of the 3Rs through Regulatory Qualification.

    PubMed

    Walker, Elizabeth Gribble; Baker, Amanda F; Sauer, John-Michael

    2016-12-01

    One mechanism to advance the application of novel safety assessment methodologies in drug development, including in silico or in vitro approaches that reduce the use of animals in toxicology studies, is regulatory qualification. Regulatory qualification, a formal process defined at the the U. S. Food and Drug Administration and the European Medicines Agency, hinges on a central concept of stating an appropriate "context of use" for a novel drug development tool (DDT) that precisely defines how that DDT can be used to support decision making in a regulated drug development setting. When accumulating the data to support a particular "context-of-use," the concept of "fit-for-purpose" often guides assay validation, as well as the type and amount of data or evidence required to evaluate the tool. This paper will review pathways for regulatory acceptance of novel DDTs and discuss examples of safety projects considered for regulatory qualification. Key concepts to be considered when defining the evidence required to formally adopt and potentially replace animal-intensive traditional safety assessment methods using qualified DDTs are proposed. Presently, the use of qualified translational kidney safety biomarkers can refine and reduce the total numbers of animals used in drug development. We propose that the same conceptual regulatory framework will be appropriate to assess readiness of new technologies that may eventually replace whole animal models. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  13. 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 GENERAL...

  14. Pesticide regulations for agriculture: Chemically flawed regulatory practice.

    PubMed

    Gamble, Donald S; Bruccoleri, Aldo G

    2016-08-02

    Two categories of pesticide soil models now exist. Government regulatory agencies use pesticide fate and transport hydrology models, including versions of PRZM.gw. They have good descriptions of pesticide transport by water flow. Their descriptions of chemical mechanisms are unrealistic, having been postulated using the universally accepted but incorrect pesticide soil science. The objective of this work is to report experimental tests of a pesticide soil model in use by regulatory agencies and to suggest possible improvements. Tests with experimentally based data explain why PRZM.gw predictions can be wrong by orders of magnitude. Predictive spreadsheet models are the other category. They are experimentally based, with chemical stoichiometry applied to integral kinetic rate laws for sorption, desorption, intra-particle diffusion, and chemical reactions. They do not account for pesticide transport through soils. Each category of models therefore lacks what the other could provide. They need to be either harmonized or replaced. Some preliminary tests indicate that an experimental mismatch between the categories of models will have to be resolved. Reports of pesticides in the environment and the medical problems that overlap geographically indicate that government regulatory practice needs to account for chemical kinetics and mechanisms. Questions about possible cause and effect links could then be investigated.

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

    PubMed

    Carré, Clément; Mas, André; Krouk, Gabriel

    2017-01-01

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

  16. 77 FR 2103 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-13

    ... Institutional Brokers utilize an acceptable, integrated order management system. Proposed Rule 5(a) provides a... purposes of the Act. The Exchange believes that its provision of an order management system for certain of... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66118; File No. SR-CHX-2011-33] Self-Regulatory...

  17. Genome-wide analysis of the regulatory function mediated by the small regulatory psm-mec RNA of methicillin-resistant Staphylococcus aureus.

    PubMed

    Cheung, Gordon Y C; Villaruz, Amer E; Joo, Hwang-Soo; Duong, Anthony C; Yeh, Anthony J; Nguyen, Thuan H; Sturdevant, Daniel E; Queck, S Y; Otto, M

    2014-07-01

    Several methicillin resistance (SCCmec) clusters characteristic of hospital-associated methicillin-resistant Staphylococcus aureus (MRSA) strains harbor the psm-mec locus. In addition to encoding the cytolysin, phenol-soluble modulin (PSM)-mec, this locus has been attributed gene regulatory functions. Here we employed genome-wide transcriptional profiling to define the regulatory function of the psm-mec locus. The immune evasion factor protein A emerged as the primary conserved and strongly regulated target of psm-mec, an effect we show is mediated by the psm-mec RNA. Furthermore, the psm-mec locus exerted regulatory effects that were more moderate in extent. For example, expression of PSM-mec limited expression of mecA, thereby decreasing methicillin resistance. Our study shows that the psm-mec locus has a rare dual regulatory RNA and encoded cytolysin function. Furthermore, our findings reveal a specific mechanism underscoring the recently emerging concept that S. aureus strains balance pronounced virulence and high expression of antibiotic resistance. Published by Elsevier GmbH.

  18. 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 14.23...

  19. 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 14.23...

  20. 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 14.23...

  1. Proposed Activities to Address Regulatory Gaps and Challenges for Licensing Advanced Reactors Using Seismic Isolation

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

    Coleman, Justin Leigh; Kammerer, Annie M.; Whittaker, Andrew S.

    Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report thatmore » investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, “Seismic Analysis of Safety Related Nuclear Structures.” The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design approach

  2. Switching between nitrogen and glucose limitation: Unraveling transcriptional dynamics in Escherichia coli.

    PubMed

    Löffler, Michael; Simen, Joana Danica; Müller, Jan; Jäger, Günter; Laghrami, Salaheddine; Schäferhoff, Karin; Freund, Andreas; Takors, Ralf

    2017-09-20

    Transcriptional control under nitrogen and carbon-limitation conditions have been well analyzed for Escherichia coli. However, the transcriptional dynamics that underlie the shift in regulatory programs from nitrogen to carbon limitation is not well studied. In the present study, cells were cultivated at steady state under nitrogen (ammonia)-limited conditions then shifted to carbon (glucose) limitation to monitor changes in transcriptional dynamics. Nitrogen limitation was found to be dominated by sigma 54 (RpoN) and sigma 38 (RpoS), whereas the "housekeeping" sigma factor 70 (RpoD) and sigma 38 regulate cellular status under glucose limitation. During the transition, nitrogen-mediated control was rapidly redeemed and mRNAs that encode active uptake systems, such as ptsG and manXYZ, were quickly amplified. Next, genes encoding facilitators such as lamB were overexpressed, followed by high affinity uptake systems such as mglABC and non-specific porins such as ompF. These regulatory programs are complex and require well-equilibrated and superior control. At the metabolome level, 2-oxoglutarate is the likely component that links carbon- and nitrogen-mediated regulation by interacting with major regulatory elements. In the case of dual glucose and ammonia limitation, sigma 24 (RpoE) appears to play a key role in orchestrating these complex regulatory networks. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Evolution of chemical-specific adjustment factors (CSAF) based on recent international experience; increasing utility and facilitating regulatory acceptance.

    PubMed

    Bhat, Virunya S; Meek, M E Bette; Valcke, Mathieu; English, Caroline; Boobis, Alan; Brown, Richard

    2017-10-01

    The application of chemical-specific toxicokinetic or toxicodynamic data to address interspecies differences and human variability in the quantification of hazard has potential to reduce uncertainty and better characterize variability compared with the use of traditional default or categorically-based uncertainty factors. The present review summarizes the state-of-the-science since the introduction of the World Health Organization/International Programme on Chemical Safety (WHO/IPCS) guidance on chemical-specific adjustment factors (CSAF) in 2005 and the availability of recent applicable guidance including the WHO/IPCS guidance on physiologically-based pharmacokinetic (PBPK) modeling in 2010 as well as the U.S. EPA guidance on data-derived extrapolation factors in 2014. A summary of lessons learned from an analysis of more than 100 case studies from global regulators or published literature illustrates the utility and evolution of CSAF in regulatory decisions. Challenges in CSAF development related to the adequacy of, or confidence in, the supporting data, including verification or validation of PBPK models. The analysis also identified issues related to adequacy of CSAF documentation, such as inconsistent terminology and often limited and/or inconsistent reporting, of both supporting data and/or risk assessment context. Based on this analysis, recommendations for standardized terminology, documentation and relevant interdisciplinary research and engagement are included to facilitate the continuing evolution of CSAF development and guidance.

  4. 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.

  5. How regulatory T cells work

    PubMed Central

    Vignali, Dario A. A.; Collison, Lauren W.; Workman, Creg J.

    2009-01-01

    Regulatory T (Treg) cells are essential for maintaining peripheral tolerance, preventing autoimmune diseases and limiting chronic inflammatory diseases. However, they also limit beneficial responses by suppressing sterilizing immunity and limiting anti-tumour immunity. Given that Treg cells can have both beneficial and deleterious effects, there is considerable interest in determining their mechanisms of action. In this Review, we discuss the basic mechanisms used by Treg cells to mediate suppression, and discuss whether one or many of these mechanisms are likely to be crucial for Treg-cell function. In addition, we present the hypothesis that effector T cells may not be ‘innocent’ parties in this suppressive process and might in fact potentiate Treg-cell function. PMID:18566595

  6. 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.

  7. 10 CFR 20.1207 - Occupational dose limits for minors.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Occupational dose limits for minors. 20.1207 Section 20.1207 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1207 Occupational dose limits for minors. The annual occupational dose limits for minors are...

  8. 10 CFR 20.1207 - Occupational dose limits for minors.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Occupational dose limits for minors. 20.1207 Section 20.1207 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1207 Occupational dose limits for minors. The annual occupational dose limits for minors are...

  9. 10 CFR 20.1207 - Occupational dose limits for minors.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Occupational dose limits for minors. 20.1207 Section 20.1207 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1207 Occupational dose limits for minors. The annual occupational dose limits for minors are...

  10. 10 CFR 20.1207 - Occupational dose limits for minors.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Occupational dose limits for minors. 20.1207 Section 20.1207 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1207 Occupational dose limits for minors. The annual occupational dose limits for minors are...

  11. 10 CFR 20.1207 - Occupational dose limits for minors.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Occupational dose limits for minors. 20.1207 Section 20.1207 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1207 Occupational dose limits for minors. The annual occupational dose limits for minors are...

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

    PubMed

    Adams, Alex J

    2018-01-01

    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. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. 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

  14. Bridging the Gap between Social Acceptance and Ethical Acceptability.

    PubMed

    Taebi, Behnam

    2017-10-01

    New technology brings great benefits, but it can also create new and significant risks. When evaluating those risks in policymaking, there is a tendency to focus on social acceptance. By solely focusing on social acceptance, we could, however, overlook important ethical aspects of technological risk, particularly when we evaluate technologies with transnational and intergenerational risks. I argue that good governance of risky technology requires analyzing both social acceptance and ethical acceptability. Conceptually, these two notions are mostly complementary. Social acceptance studies are not capable of sufficiently capturing all the morally relevant features of risky technologies; ethical analyses do not typically include stakeholders' opinions, and they therefore lack the relevant empirical input for a thorough ethical evaluation. Only when carried out in conjunction are these two types of analysis relevant to national and international governance of risky technology. I discuss the Rawlsian wide reflective equilibrium as a method for marrying social acceptance and ethical acceptability. Although the rationale of my argument is broadly applicable, I will examine the case of multinational nuclear waste repositories in particular. This example will show how ethical issues may be overlooked if we focus only on social acceptance, and will provide a test case for demonstrating how the wide reflective equilibrium can help to bridge the proverbial acceptance-acceptability gap. © 2016 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

  15. Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance.

    PubMed

    Jena, G B; Chavan, Sapana

    2017-10-01

    The principles of Good Laboratory Practices (GLPs) are mainly intended for the laboratories performing studies for regulatory compliances. However, today GLP can be applied to broad disciplines of science to cater to the needs of the experimental objectives, generation of quality data and assay reproducibility. Considering its significance, it can now be applied in academics; industries as well as government set ups throughout the world. GLP is the best way to promote the reliability, reproducibility of the test data and hence facilitates the international acceptability. Now it is high time to translate and implement the concept of GLP beyond regulatory studies. Thus, it can pave the way for better understanding of scientific problems and help to maintain a good human and environmental health. Through this review, we have made an attempt to explore the uses of GLP principles in different fields of science and its acceptability as well as looking for its future perspectives. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. USE OF METHOD DETECTION LIMITS IN ENVIRONMENTAL MEASUREMENTS

    EPA Science Inventory

    Environmental measurements often produce values below the method detection limit (MDL). Because low or zero values may be used in determining compliance with regulatory limits, in determining emission factors (typical concentrations emitted by a given type of source), or in model...

  17. Examining the Moderating Effect of Individual-Level Cultural Values on Users' Acceptance of E-Learning in Developing Countries: A Structural Equation Modeling of an Extended Technology Acceptance Model

    ERIC Educational Resources Information Center

    Tarhini, Ali; Hone, Kate; Liu, Xiaohui; Tarhini, Takwa

    2017-01-01

    In this study, we examine the effects of individual-level culture on the adoption and acceptance of e-learning tools by students in Lebanon using a theoretical framework based on the Technology Acceptance Model (TAM). To overcome possible limitations of using TAM in developing countries, we extend TAM to include "subjective norms" (SN)…

  18. Preliminary evaluation of an analog procedure to assess acceptability of intimate partner violence against women: the Partner Violence Acceptability Movie Task

    PubMed Central

    Gracia, Enrique; Rodriguez, Christina M.; Lila, Marisol

    2015-01-01

    Acceptability of partner violence against women is a risk factor linked to its perpetration, and to public, professionals’ and victims’ responses to this behavior. Research on the acceptability of violence in intimate partner relationships is, however, limited by reliance solely on self-reports that often provide distorted or socially desirable accounts that may misrepresent respondents’ attitudes. This study presents data on the development and initial validation of a new analog task assessing respondents’ acceptability of physical violence toward women in intimate relationships: the Partner Violence Acceptability Movie Task (PVAM). This new analog task is intended to provide a more implicit measure of the acceptability of partner violence against women. For this analog task, clips were extracted from commercially available films (90-s segments) portraying partner violence. Two independent samples were used to develop and evaluate the PVAM: a sample of 245 undergraduate students and a sample of 94 male intimate partner violence offenders. This new analog task demonstrated acceptable internal consistency. Results also indicated adequate construct validity. Both perpetrators and undergraduates scoring high in the PVAM also scored higher in self-reported justifications of partner abuse. Perpetrators of partner violence scored significantly higher in acceptability of partner violence than the undergraduate sample (both male and female students), and male students scored higher than females. These preliminary results suggest that the PVAM may be a promising tool to assess the acceptability of violence in intimate partner relationships, highlighting the need to consider alternatives to self-report to evaluate potential beliefs about partner violence. PMID:26528220

  19. Predictive factors of telemedicine service acceptance and behavioral intention of physicians.

    PubMed

    Rho, Mi Jung; Choi, In Young; Lee, Jaebeom

    2014-08-01

    Despite the proliferation of telemedicine technology, telemedicine service acceptance has been slow in actual healthcare settings. The purpose of this research is to develop a theoretical model for explaining the predictive factors influencing physicians' willingness to use telemedicine technology to provide healthcare services. We developed the Telemedicine Service Acceptance model based on the technology acceptance model (TAM) with the inclusion of three predictive constructs from the previously published telemedicine literature: (1) accessibility of medical records and of patients as clinical factors, (2) self-efficacy as an individual factor and (3) perceived incentives as regulatory factors. A survey was conducted, and structural equation modeling was applied to evaluate the empirical validity of the model and causal relationships within the model using the data collected from 183 physicians. Our results confirmed the validity of the original TAM constructs: the perceived usefulness of telemedicine directly impacted the behavioral intention to use it, and the perceived ease of use directly impacted both the perceived usefulness and the behavioral intention to use it. In addition, new predictive constructs were found to have ramifications on TAM variables: the accessibility of medical records and of patients directly impacted the perceived usefulness of telemedicine, self-efficacy had a significant positive effect on both the perceived ease of use and the perceived usefulness of telemedicine, and perceived incentives were found to be important with respect to the intention to use telemedicine technology. This study demonstrated that the Telemedicine Service Acceptance model was feasible and could explain the acceptance of telemedicine services by physicians. These results identified important factors for increasing the involvement of physicians in telemedicine practice. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. 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

  1. Cis-regulatory Elements and Human Evolution

    PubMed Central

    Siepel, Adam

    2014-01-01

    Modification of gene regulation has long been considered an important force in human evolution, particularly through changes to cis-regulatory elements (CREs) that function in transcriptional regulation. For decades, however, the study of cis-regulatory evolution was severely limited by the available data. New data sets describing the locations of CREs and genetic variation within and between species have now made it possible to study CRE evolution much more directly on a genome-wide scale. Here, we review recent research on the evolution of CREs in humans based on large-scale genomic data sets. We consider inferences based on primate divergence, human polymorphism, and combinations of divergence and polymorphism. We then consider “new frontiers” in this field stemming from recent research on transcriptional regulation. PMID:25218861

  2. 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

    ... Regulations or other official interpretations thereunder (collectively ``FATCA''). II. Self-Regulatory... changes allow ICE Clear Europe to be in compliance with FATCA Regulations. \\8\\ 15 U.S.C. 78q-1. B. Self... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70283; File No. SR-ICEEU-2013-08] Self...

  3. A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports.

    PubMed

    Hoffman, Keith B; Dimbil, Mo; Tatonetti, Nicholas P; Kyle, Robert F

    2016-06-01

    Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with millions of potential drug-AE pairs to analyze, the issue of focus is daunting. Our objective was to develop a signaling platform that focuses on AEs with historically demonstrated regulatory interest and to analyze such AEs with a disproportional reporting method that offers broad signal detection and acceptable false-positive rates. We analyzed over 1500 US FDA regulatory actions (safety communications and drug label changes) from 2008 to 2015 to construct a list of eligible signal AEs. The FDA Adverse Event Reporting System (FAERS) was used to evaluate disproportional reporting rates, constrained by minimum case counts and confidence interval limits, of these selected AEs for 109 training drugs. This step led to 45 AEs that appeared to have a low likelihood of being added to a label by FDA, so they were removed from the signal eligible list. We measured disproportional reporting for the final group of eligible AEs on a test group of 29 drugs that were not used in either the eligible list construction or the training steps. In a group of 29 test drugs, our model reduced the number of potential drug-AE signals from 41,834 to 97 and predicted 73 % of individual drug label changes. The model also predicted at least one AE-drug pair label change in 66 % of all the label changes for the test drugs. By concentrating on AE types with already demonstrated interest to FDA, we constructed a signaling system that provided focus regarding drug-AE pairs and suitable accuracy with regard to the issuance of FDA labeling changes. We suggest that focus on historical regulatory actions may increase the utility of pharmacovigilance signaling systems.

  4. 77 FR 7930 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries... section 610 of the Regulatory Flexibility Act. Printing of these entries is limited to fields that contain...D Intelligence Interrogations, Detainee Debriefings, and Tactical Questioning. This rule only...

  5. 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…

  6. Virtual online consultations: advantages and limitations (VOCAL) study.

    PubMed

    Greenhalgh, Trisha; Vijayaraghavan, Shanti; Wherton, Joe; Shaw, Sara; Byrne, Emma; Campbell-Richards, Desirée; Bhattacharya, Satya; Hanson, Philippa; Ramoutar, Seendy; Gutteridge, Charles; Hodkinson, Isabel; Collard, Anna; Morris, Joanne

    2016-01-29

    Remote video consultations between clinician and patient are technically possible and increasingly acceptable. They are being introduced in some settings alongside (and occasionally replacing) face-to-face or telephone consultations. To explore the advantages and limitations of video consultations, we will conduct in-depth qualitative studies of real consultations (microlevel) embedded in an organisational case study (mesolevel), taking account of national context (macrolevel). The study is based in 2 contrasting clinical settings (diabetes and cancer) in a National Health Service (NHS) acute trust in London, UK. Main data sources are: microlevel--audio, video and screen capture to produce rich multimodal data on 45 remote consultations; mesolevel--interviews, ethnographic observations and analysis of documents within the trust; macrolevel--key informant interviews of national-level stakeholders and document analysis. Data will be analysed and synthesised using a sociotechnical framework developed from structuration theory. City Road and Hampstead NHS Research Ethics Committee, 9 December 2014, reference 14/LO/1883. We plan outputs for 5 main audiences: (1) academics: research publications and conference presentations; (2) service providers: standard operating procedures, provisional operational guidance and key safety issues; (3) professional bodies and defence societies: summary of relevant findings to inform guidance to members; (4) policymakers: summary of key findings; (5) patients and carers: 'what to expect in your virtual consultation'. The research literature on video consultations is sparse. Such consultations offer potential advantages to patients (who are spared the cost and inconvenience of travel) and the healthcare system (eg, they may be more cost-effective), but fears have been expressed that they may be clinically risky and/or less acceptable to patients or staff, and they bring significant technical, logistical and regulatory challenges. We

  7. Grassland productivity limited by multiple nutrients

    USDA-ARS?s Scientific Manuscript database

    Limitation of aboveground net primary productivity (ANPP) by nitrogen (N) is widely accepted, but the roles of phosphorus (P), potassium (K) and their combinations remain unclear. Thus we may underestimate nutrient limitation of primary productivity. We conducted standardized sampling of ANPP and ...

  8. An acceptable role for computers in the aircraft design process

    NASA Technical Reports Server (NTRS)

    Gregory, T. J.; Roberts, L.

    1980-01-01

    Some of the reasons why the computerization trend is not wholly accepted are explored for two typical cases: computer use in the technical specialties and computer use in aircraft synthesis. The factors that limit acceptance are traced in part, to the large resources needed to understand the details of computer programs, the inability to include measured data as input to many of the theoretical programs, and the presentation of final results without supporting intermediate answers. Other factors are due solely to technical issues such as limited detail in aircraft synthesis and major simplifying assumptions in the technical specialties. These factors and others can be influenced by the technical specialist and aircraft designer. Some of these factors may become less significant as the computerization process evolves, but some issues, such as understanding large integrated systems, may remain issues in the future. Suggestions for improved acceptance include publishing computer programs so that they may be reviewed, edited, and read. Other mechanisms include extensive modularization of programs and ways to include measured information as part of the input to theoretical approaches.

  9. Facing the malpractice crisis: academic physicians' willingness to accept quick fix solutions.

    PubMed

    Levine, Rachel B; Kravet, Steven J; Reed, Darcy A; Windish, Donna M; Wolfe, Leah; Wright, Scott M

    2006-12-01

    We sought to determine the willingness of academic physicians to accept strategies to contain institutional malpractice costs. We surveyed all 270 Department of Medicine physicians at a large academic center. Respondents were asked about their knowledge regarding malpractice premiums, willingness to reduce patient-care activities and accept decreases in compensation. The response rate was 80%. Respondents estimated the annual increase in malpractice premiums from 2004 to 2005 to be 29%. The true increase was 28% (P = 0.55). Almost all opposed eliminating patient care (95%) or providing patient care every other year at double effort and withdrawing from patient care on alternate years (97%). Seventy percent would limit their clinical procedures. Most physicians opposed salary reduction (97%) or decreases in fringe benefits (99%). Few academic physicians are willing to limit patient care or accept decreases in compensation to recoup institutional malpractice costs.

  10. 39 CFR 3010.21 - Calculation of annual limitation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Calculation of annual limitation. 3010.21 Section 3010.21 Postal Service POSTAL REGULATORY COMMISSION PERSONNEL REGULATION OF RATES FOR MARKET DOMINANT PRODUCTS Rules for Applying the Price Cap § 3010.21 Calculation of annual limitation. (a) The calculation...

  11. 78 FR 79055 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 71158; File No. SR-NASDAQ-2013-158] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Acceptable Trade Range December 20, 2013. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act''),\\1...

  12. Beyond regulatory compression: confronting the liminal spaces of health research regulation

    PubMed Central

    Taylor-Alexander, Samuel; Dove, Edward S.; Fletcher, Isabel; Ganguli Mitra, Agomoni; McMillan, Catriona; Laurie, Graeme

    2016-01-01

    ABSTRACT Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this ‘regulatory turn’ by drawing on the anthropological concept of liminality. We offer the term ‘regulatory compression’ to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the ‘in-between’, liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of ‘processual regulation’, a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation. PMID:28058061

  13. Methodology Used to Assess Acceptability of Oral Pediatric Medicines: A Systematic Literature Search and Narrative Review.

    PubMed

    Mistry, Punam; Batchelor, Hannah

    2017-06-01

    Regulatory guidelines require that any new medicine designed for a pediatric population must be demonstrated as being acceptable to that population. There is currently no guidance on how to conduct or report on acceptability testing. Our objective was to undertake a review of the methods used to assess the acceptability of medicines within a pediatric population and use this review to propose the most appropriate methodology. We used a defined search strategy to identify literature reports of acceptability assessments of medicines conducted within pediatric populations and extracted information about the tools used in these studies for comparison across studies. In total, 61 articles were included in the analysis. Palatability was the most common (54/61) attribute measured when evaluating acceptability. Simple scale methods were most commonly used, with visual analog scales (VAS) and hedonic scales used both separately and in combination in 34 of the 61 studies. Hedonic scales alone were used in 14 studies and VAS alone in just five studies. Other tools included Likert scales; forced choice or preference; surveys or questionnaires; observations of facial expressions during administration, ease of swallowing, or ability to swallow the dosage; prevalence of complaints or refusal to take the medicine; and time taken for a nurse to administer the medicine. The best scale in terms of validity, reliability, feasibility, and preference to use when assessing acceptability remains unclear. Further work is required to select the most appropriate method to justify whether a medicine is acceptable to a pediatric population.

  14. The Benefits and Limitations of Hydraulic Modeling for Ordinary High Water Mark Delineation

    DTIC Science & Technology

    2016-02-01

    ER D C/ CR RE L TR -1 6- 1 Wetland Regulatory Assistance Program (WRAP) The Benefits and Limitations of Hydraulic Modeling for Ordinary...client/default. Wetland Regulatory Assistance Program (WRAP) ERDC/CRREL TR-16-1 February 2016 The Benefits and Limitations of Hydraulic Modeling...Approved for public release; distribution is unlimited. Prepared for Headquarters, U.S. Army Corps of Engineers Washington, DC 20314-1000 Under Wetlands

  15. Intrinsic limits to gene regulation by global crosstalk

    PubMed Central

    Friedlander, Tamar; Prizak, Roshan; Guet, Călin C.; Barton, Nicholas H.; Tkačik, Gašper

    2016-01-01

    Gene regulation relies on the specificity of transcription factor (TF)–DNA interactions. Limited specificity may lead to crosstalk: a regulatory state in which a gene is either incorrectly activated due to noncognate TF–DNA interactions or remains erroneously inactive. As each TF can have numerous interactions with noncognate cis-regulatory elements, crosstalk is inherently a global problem, yet has previously not been studied as such. We construct a theoretical framework to analyse the effects of global crosstalk on gene regulation. We find that crosstalk presents a significant challenge for organisms with low-specificity TFs, such as metazoans. Crosstalk is not easily mitigated by known regulatory schemes acting at equilibrium, including variants of cooperativity and combinatorial regulation. Our results suggest that crosstalk imposes a previously unexplored global constraint on the functioning and evolution of regulatory networks, which is qualitatively distinct from the known constraints that act at the level of individual gene regulatory elements. PMID:27489144

  16. 18 CFR 1b.11 - Limitation on participation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Limitation on participation. 1b.11 Section 1b.11 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.11 Limitation on...

  17. 18 CFR 1b.11 - Limitation on participation.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Limitation on participation. 1b.11 Section 1b.11 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.11 Limitation on...

  18. 18 CFR 1b.11 - Limitation on participation.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Limitation on participation. 1b.11 Section 1b.11 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.11 Limitation on...

  19. 18 CFR 1b.11 - Limitation on participation.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Limitation on participation. 1b.11 Section 1b.11 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.11 Limitation on...

  20. Regulatory Flexibility: An Individual Differences Perspective on Coping and Emotion Regulation.

    PubMed

    Bonanno, George A; Burton, Charles L

    2013-11-01

    People respond to stressful events in different ways, depending on the event and on the regulatory strategies they choose. Coping and emotion regulation theorists have proposed dynamic models in which these two factors, the person and the situation, interact over time to inform adaptation. In practice, however, researchers have tended to assume that particular regulatory strategies are consistently beneficial or maladaptive. We label this assumption the fallacy of uniform efficacy and contrast it with findings from a number of related literatures that have suggested the emergence of a broader but as yet poorly defined construct that we refer to as regulatory flexibility. In this review, we articulate this broader construct and define both its features and limitations. Specifically, we propose a heuristic individual differences framework and review research on three sequential components of flexibility for which propensities and abilities vary: sensitivity to context, availability of a diverse repertoire of regulatory strategies, and responsiveness to feedback. We consider the methodological limitations of research on each component, review questions that future research on flexibility might address, and consider how the components might relate to each other and to broader conceptualizations about stability and change across persons and situations. © The Author(s) 2013.

  1. 76 FR 12101 - Jordan Hydroelectric Limited Partnership; Notice of Environmental Assessment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-04

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Project No. 12737-002] Jordan Hydroelectric Limited Partnership; Notice of Environmental Assessment In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's regulations, 18 CFR part 380 (Order No. 486, 52 FR 447897), the Office of...

  2. Cost-effectiveness acceptability curves revisited.

    PubMed

    Al, Maiwenn J

    2013-02-01

    Since the introduction of the cost-effectiveness acceptability curve (CEAC) in 1994, its use as a method to describe uncertainty around incremental cost-effectiveness ratios (ICERs) has steadily increased. In this paper, first the construction and interpretation of the CEAC is explained, both in the context of modelling studies and in the context of cost-effectiveness (CE) studies alongside clinical trials. Additionally, this paper reviews the advantages and limitations of the CEAC. Many of the perceived limitations can be attributed to the practice of interpreting the CEAC as a decision rule while it was not developed as such. It is argued that the CEAC is still a useful tool in describing and quantifying uncertainty around the ICER, especially in combination with other tools such as plots on the CE plane and value-of-information analysis.

  3. 76 FR 40755 - Impact of Reduced Dose Limits on NRC Licensed Activities; Solicitation of Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0279] Impact of Reduced Dose Limits on NRC Licensed Activities; Solicitation of Public Comment AGENCY: Nuclear Regulatory Commission. ACTION: Solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission) is seeking public...

  4. Improving homogeneity by dynamic speed limit systems.

    PubMed

    van Nes, Nicole; Brandenburg, Stefan; Twisk, Divera

    2010-05-01

    Homogeneity of driving speeds is an important variable in determining road safety; more homogeneous driving speeds increase road safety. This study investigates the effect of introducing dynamic speed limit systems on homogeneity of driving speeds. A total of 46 subjects twice drove a route along 12 road sections in a driving simulator. The speed limit system (static-dynamic), the sophistication of the dynamic speed limit system (basic roadside, advanced roadside, and advanced in-car) and the situational condition (dangerous-non-dangerous) were varied. The homogeneity of driving speed, the rated credibility of the posted speed limit and the acceptance of the different dynamic speed limit systems were assessed. The results show that the homogeneity of individual speeds, defined as the variation in driving speed for an individual subject along a particular road section, was higher with the dynamic speed limit system than with the static speed limit system. The more sophisticated dynamic speed limit system tested within this study led to higher homogeneity than the less sophisticated systems. The acceptance of the dynamic speed limit systems used in this study was positive, they were perceived as quite useful and rather satisfactory. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

  5. Regulatory Aspects of Sabin Type 2 Withdrawal From Trivalent Oral Poliovirus Vaccine: Process and Lessons Learned.

    PubMed

    Decina, Daniela; Fournier-Caruana, Jacqueline; Takane, Marina; Ostad Ali Dehaghi, Razieh; Sutter, Roland

    2017-07-01

    Withdrawal of type 2 oral poliovirus vaccine (OPV) in OPV-using countries required regulatory approval for use of inactivated poliovirus vaccine and bivalent OPV in routine immunization. Worldwide, a variety of mechanisms were used by member states, with some differences in approach observed between inactivated poliovirus vaccine and bivalent OPV. These included acceptance for use of World Health Organization (WHO) prequalified vaccines, registration and licensure pathways, participation in WHO-convened joint reviews of licensing dossiers, as well as pragmatic application of alternatively available mechanisms, when appropriate. Simple but effective tools were used to monitor progress and to record, authenticate, and share information. Essential to achievement of regulatory targets was ongoing communication with key stakeholders, including switch-country national regulatory authorities, vaccine manufacturers, partner organizations, and relevant units within WHO. Understanding of the regulatory environment gained through the OPV switch can be helpful in supporting further stages of the polio end game and other time-sensitive vaccine introduction programs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  6. The regulatory contract and restructuring: A modest proposal

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

    Hartman, R.S.; Tabors, R.

    1996-12-01

    History does not support the notion that the regulatory contract has treated utilities unfairly. But to the extent it is decided, for other reasons, that utilities should receive transition payments as the industry is pushed to a more competitive framework, there are four important principles to keep firmly in mind. To paraphrase the contemporary bumper sticker, `in the economic, social and/or romantic affairs of man and/or woman, unexpected events happen.` A more thoughtful interpretation of this notion would be that in economic and social interrelationships, individuals formulate behavioral plans based upon expectations about the state of the world and/or themore » behavior of other individuals. Should those expectations turn out to be incorrect, the individuals relying upon those expectations and their plans will be frustrated. The frustrated individuals may rail against their fate; they may accept their disappointment stoically. They may `take arms against a sea of troubles, and by opposing end them.` Alternatively and more likely in late twentieth century America, they may litigate (or threaten litigation) for breach of contract, claiming that some implicit or explicit, oral or written contract has been breached and that reliance upon that contract has consequently damaged them. The discussion of assets potentially stranded by the ongoing restructuring of the U.S. electric power industry has been characterized by the latter response. As some utilities have faced the possible economic obsolescence of particular generation assets in light of technological changes and altered regulatory rules, they have invoked the notion of a `regulatory contract` having governed their expectations, behavior and past capital investment. By implication, these utilities argue that they should be fully compensated for all cost incurred under good faith adherence to past regulatory processes and procedures.« less

  7. The regulatory framework for preventing cross-contamination of pharmaceutical products: History and considerations for the future.

    PubMed

    Sargent, Edward V; Flueckiger, Andreas; Barle, Ester Lovsin; Luo, Wendy; Molnar, Lance R; Sandhu, Reena; Weideman, Patricia A

    2016-08-01

    Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact both product safety and quality. This issue has been recognized by regulators and industry for some time, leading to publication of a number of continually evolving guidelines. This manuscript provides a historical overview of the regulatory framework for managing cross-contamination in multi-product facilities to provide context for current approaches. Early guidelines focused on the types of pharmaceuticals for which dedicated facilities and control systems were needed, and stated the requirements for cleaning validation. More recent guidelines have promoted the idea of using Acceptable Daily Exposures (ADEs) to establish cleaning limits for actives and other potentially hazardous substances. The ADE approach is considered superior to previous methods for setting cleaning limits such as using a predetermined general limit (e.g., 10 ppm or a fraction of the median lethal dose (LD50) or therapeutic dose). The ADEs can be used to drive the cleaning process and as part of the overall assessment of whether dedicated production facilities are required. While great strides have been made in using the ADE approach, work remains to update good manufacturing practices (GMPs) to ensure that the approaches are clear, consistent with the state-of-the-science, and broadly applicable yet flexible enough for adaptation to unique products and situations. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. 45 CFR 149.45 - Funding limitation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Funding limitation. 149.45 Section 149.45 Public... Funding limitation. (a) Based on the projected or actual availability of program funding, the Secretary... accepting applications or satisfying reimbursement requests based on the availability of funding is final...

  9. 45 CFR 149.45 - Funding limitation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Funding limitation. 149.45 Section 149.45 Public... Funding limitation. (a) Based on the projected or actual availability of program funding, the Secretary... accepting applications or satisfying reimbursement requests based on the availability of funding is final...

  10. 45 CFR 149.45 - Funding limitation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Funding limitation. 149.45 Section 149.45 Public... Funding limitation. (a) Based on the projected or actual availability of program funding, the Secretary... accepting applications or satisfying reimbursement requests based on the availability of funding is final...

  11. 45 CFR 149.45 - Funding limitation.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Funding limitation. 149.45 Section 149.45 Public... Funding limitation. (a) Based on the projected or actual availability of program funding, the Secretary... accepting applications or satisfying reimbursement requests based on the availability of funding is final...

  12. 45 CFR 149.45 - Funding limitation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Funding limitation. 149.45 Section 149.45 Public... Funding limitation. (a) Based on the projected or actual availability of program funding, the Secretary... accepting applications or satisfying reimbursement requests based on the availability of funding is final...

  13. 75 FR 16516 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ...: R.A. Jervey, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: (301) 251...'' series. This series was developed to describe and make available to the public such information as.... Although a time limit is given, comments and suggestions in connection with items for inclusion in guides...

  14. Fisheries regulatory regimes and resilience to climate change.

    PubMed

    Ojea, Elena; Pearlman, Isaac; Gaines, Steven D; Lester, Sarah E

    2017-05-01

    Climate change is already producing ecological, social, and economic impacts on fisheries, and these effects are expected to increase in frequency and magnitude in the future. Fisheries governance and regulations can alter socio-ecological resilience to climate change impacts via harvest control rules and incentives driving fisher behavior, yet there are no syntheses or conceptual frameworks for examining how institutions and their regulatory approaches can alter fisheries resilience to climate change. We identify nine key climate resilience criteria for fisheries socio-ecological systems (SES), defining resilience as the ability of the coupled system of interacting social and ecological components (i.e., the SES) to absorb change while avoiding transformation into a different undesirable state. We then evaluate the capacity of four fisheries regulatory systems that vary in their degree of property rights, including open access, limited entry, and two types of rights-based management, to increase or inhibit resilience. Our exploratory assessment of evidence in the literature suggests that these regulatory regimes vary widely in their ability to promote resilient fisheries, with rights-based approaches appearing to offer more resilience benefits in many cases, but detailed characteristics of the regulatory instruments are fundamental.

  15. Time perspective and social preference in older and younger adults: Effects of self-regulatory fatigue.

    PubMed

    Segerstrom, Suzanne C; Geiger, Paul J; Combs, Hannah L; Boggero, Ian A

    2016-09-01

    Socioemotional selectivity theory predicts that when perceived time in life is limited, people will prefer emotionally close social partners over less emotionally rewarding partners. Regulating social choices with regard to time perspective can make the best use of time with regard to well-being. However, doing so may depend on the self-regulatory capacity of the individual. Two studies, 1 with younger adults (N = 101) and 1 with younger (N = 42) and older (N = 39) adults, experimentally tested the effects of time perspective and self-regulatory fatigue on preferences for emotionally close partners and knowledgeable partners. In both studies and across younger and older adults, when self-regulatory fatigue was low, the perception of limited time resulted in a greater preference for close social partners relative to knowledgeable social partners. However, this shift was eliminated by self-regulatory fatigue. In Study 2, when fatigued, younger adults preferred close social partners to knowledgeable partners across time perspectives; older adults preferred close and knowledgeable partners more equally across time perspectives. These findings have implications for social decision-making and satisfaction among people who experience chronic self-regulatory fatigue. They also contradict previous suggestions that only younger adults are susceptible to self-regulatory fatigue. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  16. Time Perspective and Social Preference in Older and Younger Adults: Effects of Self-Regulatory Fatigue

    PubMed Central

    Segerstrom, Suzanne C.; Geiger, Paul J.; Combs, Hannah L.; Boggero, Ian A.

    2016-01-01

    Socioemotional selectivity theory predicts that when perceived time in life is limited, people will prefer emotionally close social partners over less emotionally rewarding partners. Regulating social choices with regard to time perspective can make the best use of time with regard to well-being. However, doing so may depend on the self-regulatory capacity of the individual. Two studies, one with younger adults (N = 101) and one with younger (N = 42) and older (N = 39) adults, experimentally tested the effects of time perspective and self-regulatory fatigue on preferences for emotionally close partners and knowledgeable partners. In both studies and across younger and older adults, when self-regulatory fatigue was low, the perception of limited time resulted in a greater preference for close social partners relative to knowledgeable social partners. However, this shift was eliminated by self-regulatory fatigue. In Study 2, when fatigued, younger adults preferred close social partners to knowledgeable partners across time perspectives; older adults preferred close and knowledgeable partners more equally across time perspectives. These findings have implications for social decision-making and satisfaction among people who experience chronic self-regulatory fatigue. They also contradict previous suggestions that only younger adults are susceptible to self-regulatory fatigue. PMID:27243763

  17. Application of Regulatory Focus Theory to Search Advertising.

    PubMed

    Mowle, Elyse N; Georgia, Emily J; Doss, Brian D; Updegraff, John A

    The purpose of this paper is to test the utility of regulatory focus theory principles in a real-world setting; specifically, Internet hosted text advertisements. Effect of compatibility of the ad text with the regulatory focus of the consumer was examined. Advertisements were created using Google AdWords. Data were collected for the number of views and clicks each ad received. Effect of regulatory fit was measured using logistic regression. Logistic regression analyses demonstrated that there was a strong main effect for keyword, such that users were almost six times as likely to click on a promotion advertisement as a prevention advertisement, as well as a main effect for compatibility, such that users were twice as likely to click on an advertisement with content that was consistent with their keyword. Finally, there was a strong interaction of these two variables, such that the effect of consistent advertisements was stronger for promotion searches than for prevention searches. The effect of ad compatibility had medium to large effect sizes, suggesting that individuals' state may have more influence on advertising response than do individuals' traits (e.g. personality traits). Measurement of regulatory fit was limited by the constraints of Google AdWords. The results of this study provide a possible framework for ad creation for Internet advertisers. This paper is the first study to demonstrate the utility of regulatory focus theory in online advertising.

  18. Local immunomodulation with Fas ligand-engineered biomaterials achieves allogeneic islet graft acceptance.

    PubMed

    Headen, Devon M; Woodward, Kyle B; Coronel, María M; Shrestha, Pradeep; Weaver, Jessica D; Zhao, Hong; Tan, Min; Hunckler, Michael D; Bowen, William S; Johnson, Christopher T; Shea, Lonnie; Yolcu, Esma S; García, Andrés J; Shirwan, Haval

    2018-06-04

    Islet transplantation is a promising therapy for type 1 diabetes. However, chronic immunosuppression to control rejection of allogeneic islets induces morbidities and impairs islet function. T effector cells are responsible for islet allograft rejection and express Fas death receptors following activation, becoming sensitive to Fas-mediated apoptosis. Here, we report that localized immunomodulation using microgels presenting an apoptotic form of the Fas ligand with streptavidin (SA-FasL) results in prolonged survival of allogeneic islet grafts in diabetic mice. A short course of rapamycin treatment boosted the immunomodulatory efficacy of SA-FasL microgels, resulting in acceptance and function of allografts over 200 days. Survivors generated normal systemic responses to donor antigens, implying immune privilege of the graft, and had increased CD4 + CD25 + FoxP3 + T regulatory cells in the graft and draining lymph nodes. Deletion of T regulatory cells resulted in acute rejection of established islet allografts. This localized immunomodulatory biomaterial-enabled approach may provide an alternative to chronic immunosuppression for clinical islet transplantation.

  19. 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…

  20. 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. Project HOPE—The People-to-People Health Foundation, Inc.

  1. The Impact of Religiosity on Midshipman Adjustment and Feelings of Acceptance

    DTIC Science & Technology

    2006-06-01

    the military nature , if a midshipman is accepting of homosexuals he is often looked on as strange. Like if you have a gay friend it is looked on...grown exponentially over the past fifty years. Significant growth of religious diversity and religious media support the growing nature of popular...however, is still limited in scope and depth. The covert or personal nature of an individual’s beliefs makes acceptance and tolerance issues more

  2. Statistics of optimal information flow in ensembles of regulatory motifs

    NASA Astrophysics Data System (ADS)

    Crisanti, Andrea; De Martino, Andrea; Fiorentino, Jonathan

    2018-02-01

    Genetic regulatory circuits universally cope with different sources of noise that limit their ability to coordinate input and output signals. In many cases, optimal regulatory performance can be thought to correspond to configurations of variables and parameters that maximize the mutual information between inputs and outputs. Since the mid-2000s, such optima have been well characterized in several biologically relevant cases. Here we use methods of statistical field theory to calculate the statistics of the maximal mutual information (the "capacity") achievable by tuning the input variable only in an ensemble of regulatory motifs, such that a single controller regulates N targets. Assuming (i) sufficiently large N , (ii) quenched random kinetic parameters, and (iii) small noise affecting the input-output channels, we can accurately reproduce numerical simulations both for the mean capacity and for the whole distribution. Our results provide insight into the inherent variability in effectiveness occurring in regulatory systems with heterogeneous kinetic parameters.

  3. 47 CFR 73.6007 - Power limitations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Power limitations. 73.6007 Section 73.6007... Class A Television Broadcast Stations § 73.6007 Power limitations. An application to change the facilities of an existing Class A TV station will not be accepted if it requests an effective radiated power...

  4. 47 CFR 73.6007 - Power limitations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 4 2011-10-01 2011-10-01 false Power limitations. 73.6007 Section 73.6007... Class A Television Broadcast Stations § 73.6007 Power limitations. An application to change the facilities of an existing Class A TV station will not be accepted if it requests an effective radiated power...

  5. Learning portfolio models in health regulatory colleges of Ontario, Canada.

    PubMed

    Tompkins, Marianne; Paquette-Frenette, Denise

    2010-01-01

    Health regulatory colleges promote continued competence by requiring members to submit yearly portfolios that document learning. Previous studies conclude that portfolios can be valuable tools to promote continuous learning in health college members, but portfolios are time-consuming to complete and difficult to evaluate. This exploratory study compares the features of portfolio models in regulatory colleges, as a basis for future studies. Data were collected through a document review of the portfolio models described on the Web sites of 14 Canadian health regulatory colleges. All models contain 3 common components of self-directed learning: (1) self-diagnosis, (2) learning plan and activities, and (3) self-evaluation. Several include member profiles and peer feedback. A broad range of formal, nonformal, and informal activities are accepted as evidence of learning; a few colleges restrict learners' freedom in selecting these activities. There is a dual philosophy of learning in portfolio models that includes both humanist and technical paradigms. Low numbers of members are selected for audit of completed portfolios. The possibility of last-minute preparation and the lack of support to members who struggle with self-directed learning methods are issues to be resolved. Although portfolios are designed to enhance learning and reflection, quality cannot be ensured unless compliance is enforced, and learning outcomes are measured. Professionals should be guided regarding how to complete portfolios. More health regulatory colleges should announce the number of portfolios they audit. In general, the number of portfolios audited by each profession may need to be increased.

  6. 78 FR 13130 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change, as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... already the case for single-name CDS). Recognizing the highly correlated relationship between long-short...' proprietary positions. ICE Clear Europe does not currently clear CDS positions of customers of its Clearing Members, but it plans to introduce customer clearing for CDS upon receipt of applicable regulatory...

  7. Estimating Acceptability of Financial Health Incentives.

    PubMed

    Bigsby, Elisabeth; Seitz, Holli H; Halpern, Scott D; Volpp, Kevin; Cappella, Joseph N

    2017-08-01

    A growing body of evidence suggests that financial incentives can influence health behavior change, but research on the public acceptability of these programs and factors that predict public support have been limited. A representative sample of U.S. adults ( N = 526) were randomly assigned to receive an incentive program description in which the funding source of the program (public or private funding) and targeted health behavior (smoking cessation, weight loss, or colonoscopy) were manipulated. Outcome variables were attitude toward health incentives and allocation of hypothetical funding for incentive programs. Support was highest for privately funded programs. Support for incentives was also higher among ideologically liberal participants than among conservative participants. Demographics and health history differentially predicted attitude and hypothetical funding toward incentives. Incentive programs in the United States are more likely to be acceptable to the public if they are funded by private companies.

  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. Laboratory study of effects of sonic boom shaping on subjective loudness and acceptability

    NASA Technical Reports Server (NTRS)

    Leatherwood, Jack D.; Sullivan, Brenda M.

    1992-01-01

    A laboratory study was conducted to determine the effects of sonic boom signature shaping on subjective loudness and acceptability. The study utilized the sonic boom simulator at the Langley Research Center. A wide range of symmetrical, front-shock-minimized signature shapes were investigated together with a limited number of asymmetrical signatures. Subjective loudness judgments were obtained from 60 test subjects by using an 11-point numerical category scale. Acceptability judgments were obtained using the method of constant stimuli. Results were used to assess the relative predictive ability of several noise metrics, determine the loudness benefits of detailed boom shaping, and derive laboratory sonic boom acceptability criteria. These results indicated that the A-weighted sound exposure level, the Stevens Mark 7 Perceived Level, and the Zwicker Loudness Level metrics all performed well. Significant reductions in loudness were obtained by increasing front-shock rise time and/or decreasing front-shock overpressure of the front-shock minimized signatures. In addition, the asymmetrical signatures were rated to be slightly quieter than the symmetrical front-shock-minimized signatures of equal A-weighted sound exposure level. However, this result was based on a limited number of asymmetric signatures. The comparison of laboratory acceptability results with acceptability data obtained in more realistic situations also indicated good agreement.

  10. 76 FR 53511 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-26

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65184; File No. SR-NYSEAmex-2011-63] Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending NYSE Amex Equities Rule 17(c)(2)(B) To Make Permanent the Pilot Program that Permits the Exchange To Accept Inbound Orders Routed by Archipelago Securities LLC in...

  11. 76 FR 42534 - Mandatory Reliability Standards for Interconnection Reliability Operating Limits; System...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... Reliability Operating Limits; System Restoration Reliability Standards AGENCY: Federal Energy Regulatory... data necessary to analyze and monitor Interconnection Reliability Operating Limits (IROL) within its... Interconnection Reliability Operating Limits, Order No. 748, 134 FERC ] 61,213 (2011). \\2\\ The term ``Wide-Area...

  12. 17 CFR 240.13b2-2 - Representations and conduct in connection with the preparation of required reports and documents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... misleading” include, but are not limited to, actions taken at any time with respect to the professional... material violations of generally accepted accounting principles, generally accepted auditing standards, or other professional or regulatory standards); (ii) Not to perform audit, review or other procedures...

  13. 17 CFR 240.13b2-2 - Representations and conduct in connection with the preparation of required reports and documents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... misleading” include, but are not limited to, actions taken at any time with respect to the professional... material violations of generally accepted accounting principles, generally accepted auditing standards, or other professional or regulatory standards); (ii) Not to perform audit, review or other procedures...

  14. 17 CFR 240.13b2-2 - Representations and conduct in connection with the preparation of required reports and documents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... misleading” include, but are not limited to, actions taken at any time with respect to the professional... material violations of generally accepted accounting principles, generally accepted auditing standards, or other professional or regulatory standards); (ii) Not to perform audit, review or other procedures...

  15. 17 CFR 240.13b2-2 - Representations and conduct in connection with the preparation of required reports and documents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... misleading” include, but are not limited to, actions taken at any time with respect to the professional... material violations of generally accepted accounting principles, generally accepted auditing standards, or other professional or regulatory standards); (ii) Not to perform audit, review or other procedures...

  16. 17 CFR 240.13b2-2 - Representations and conduct in connection with the preparation of required reports and documents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... misleading” include, but are not limited to, actions taken at any time with respect to the professional... material violations of generally accepted accounting principles, generally accepted auditing standards, or other professional or regulatory standards); (ii) Not to perform audit, review or other procedures...

  17. 76 FR 76153 - Allco Renewable Energy Limited v. Massachusetts Electric Company d/b/a National Grid; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-12-000] Allco Renewable Energy Limited v. Massachusetts Electric Company d/b/a National Grid; Notice of Complaint Take notice... Public Utilities Regulatory Policies Act (PURPA), Allco Renewable Energy Limited filed a formal complaint...

  18. Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.

    PubMed

    Woolacott, Nerys; Corbett, Mark; Jones-Diette, Julie; Hodgson, Robert

    2017-10-01

    Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from nonrandomized studies, from small single-arm trials, or from single-center trials; and using surrogate end points. We examined these methodological challenges through a pragmatic review of the available literature. Methods to adjust nonrandomized studies for confounding are imperfect. The relative treatment effect generated from single-arm trials is uncertain and may be optimistic. Single-center trial results may not be generalizable. Surrogate end points, on average, overestimate treatment effects. Current methods for analyzing such data are limited, and effectiveness claims based on these suboptimal forms of evidence are likely to be subject to significant uncertainty. Assessments of cost-effectiveness, based on the modeling of such data, are likely to be subject to considerable uncertainty. This uncertainty must not be underestimated by decision makers: methods for its quantification are required and schemes to protect payers from the cost of uncertainty should be implemented. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  19. Genomic analysis reveals major determinants of cis-regulatory variation in Capsella grandiflora

    PubMed Central

    Steige, Kim A.; Laenen, Benjamin; Reimegård, Johan; Slotte, Tanja

    2017-01-01

    Understanding the causes of cis-regulatory variation is a long-standing aim in evolutionary biology. Although cis-regulatory variation has long been considered important for adaptation, we still have a limited understanding of the selective importance and genomic determinants of standing cis-regulatory variation. To address these questions, we studied the prevalence, genomic determinants, and selective forces shaping cis-regulatory variation in the outcrossing plant Capsella grandiflora. We first identified a set of 1,010 genes with common cis-regulatory variation using analyses of allele-specific expression (ASE). Population genomic analyses of whole-genome sequences from 32 individuals showed that genes with common cis-regulatory variation (i) are under weaker purifying selection and (ii) undergo less frequent positive selection than other genes. We further identified genomic determinants of cis-regulatory variation. Gene body methylation (gbM) was a major factor constraining cis-regulatory variation, whereas presence of nearby transposable elements (TEs) and tissue specificity of expression increased the odds of ASE. Our results suggest that most common cis-regulatory variation in C. grandiflora is under weak purifying selection, and that gene-specific functional constraints are more important for the maintenance of cis-regulatory variation than genome-scale variation in the intensity of selection. Our results agree with previous findings that suggest TE silencing affects nearby gene expression, and provide evidence for a link between gbM and cis-regulatory constraint, possibly reflecting greater dosage sensitivity of body-methylated genes. Given the extensive conservation of gbM in flowering plants, this suggests that gbM could be an important predictor of cis-regulatory variation in a wide range of plant species. PMID:28096395

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

    PubMed Central

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

    2017-01-01

    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. PMID:28193896

  1. 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.

  2. Regulatory Science in Professional Education.

    PubMed

    Akiyama, Hiroshi

    2017-01-01

    In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

  3. A prior-based integrative framework for functional transcriptional regulatory network inference

    PubMed Central

    Siahpirani, Alireza F.

    2017-01-01

    Abstract Transcriptional regulatory networks specify regulatory proteins controlling the context-specific expression levels of genes. Inference of genome-wide regulatory networks is central to understanding gene regulation, but remains an open challenge. Expression-based network inference is among the most popular methods to infer regulatory networks, however, networks inferred from such methods have low overlap with experimentally derived (e.g. ChIP-chip and transcription factor (TF) knockouts) networks. Currently we have a limited understanding of this discrepancy. To address this gap, we first develop a regulatory network inference algorithm, based on probabilistic graphical models, to integrate expression with auxiliary datasets supporting a regulatory edge. Second, we comprehensively analyze our and other state-of-the-art methods on different expression perturbation datasets. Networks inferred by integrating sequence-specific motifs with expression have substantially greater agreement with experimentally derived networks, while remaining more predictive of expression than motif-based networks. Our analysis suggests natural genetic variation as the most informative perturbation for network inference, and, identifies core TFs whose targets are predictable from expression. Multiple reasons make the identification of targets of other TFs difficult, including network architecture and insufficient variation of TF mRNA level. Finally, we demonstrate the utility of our inference algorithm to infer stress-specific regulatory networks and for regulator prioritization. PMID:27794550

  4. Regulatory Fit and Equal Opportunity/Diversity: Implications for the Defense Equal Opportunity Management Institute (DEOMI)

    DTIC Science & Technology

    2013-01-01

    than demographic diversity ( Ivancevich & Gilbert, 2000); the goal of equality is to create and manage a heterogeneous mix of abilities, skills, ideas...accepted. Recruiting of minorities and women are not seen as violations of EO laws (Kravitz, 2008; Newman & Lyon , 2009; Pyburn, et al., 2008). Similarly...209-213. REGULATORY FIT AND EQUAL OPPORTUNITY/DIVERSITY 23 Ivancevich , J. M. & Gilbert, J. A. (2000). Diversity management: Time for a new approach

  5. Are all GMOs the same? Consumer acceptance of cisgenic rice in India.

    PubMed

    Shew, Aaron M; Nalley, Lawton L; Danforth, Diana M; Dixon, Bruce L; Nayga, Rodolfo M; Delwaide, Anne-Cecile; Valent, Barbara

    2016-01-01

    India has more than 215 million food-insecure people, many of whom are farmers. Genetically modified (GM) crops have the potential to alleviate this problem by increasing food supplies and strengthening farmer livelihoods. For this to occur, two factors are critical: (i) a change in the regulatory status of GM crops, and (ii) consumer acceptance of GM foods. There are generally two classifications of GM crops based on how they are bred: cisgenically bred, containing only DNA sequences from sexually compatible organisms; and transgenically bred, including DNA sequences from sexually incompatible organisms. Consumers may view cisgenic foods as more natural than those produced via transgenesis, thus influencing consumer acceptance. This premise was the catalyst for our study--would Indian consumers accept cisgenically bred rice and if so, how would they value cisgenics compared to conventionally bred rice, GM-labelled rice and 'no fungicide' rice? In this willingness-to-pay study, respondents did not view cisgenic and GM rice differently. However, participants were willing-to-pay a premium for any aforementioned rice with a 'no fungicide' attribute, which cisgenics and GM could provide. Although not significantly different (P = 0.16), 76% and 73% of respondents stated a willingness-to-consume GM and cisgenic foods, respectively. © 2015 Society for Experimental Biology, Association of Applied Biologists and John Wiley & Sons Ltd.

  6. Progress, innovation and regulatory science in drug development: the politics of international standard-setting.

    PubMed

    Abraham, John; Reed, Tim

    2002-06-01

    This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.

  7. Acceptance of Tinnitus As an Independent Correlate of Tinnitus Severity.

    PubMed

    Hesser, Hugo; Bånkestad, Ellinor; Andersson, Gerhard

    2015-01-01

    Tinnitus is the experience of sounds without an identified external source, and for some the experience is associated with significant severity (i.e., perceived negative affect, activity limitation, and participation restriction due to tinnitus). Acceptance of tinnitus has recently been proposed to play an important role in explaining heterogeneity in tinnitus severity. The purpose of the present study was to extend previous investigations of acceptance in relation to tinnitus by examining the unique contribution of acceptance in accounting for tinnitus severity, beyond anxiety and depression symptoms. In a cross-sectional study, 362 participants with tinnitus attending an ENT clinic in Sweden completed a standard set of psychometrically examined measures of acceptance of tinnitus, tinnitus severity, and anxiety and depression symptoms. Participants also completed a background form on which they provided information about the experience of tinnitus (loudness, localization, sound characteristics), other auditory-related problems (hearing problems and sound sensitivity), and personal characteristics. Correlational analyses showed that acceptance was strongly and inversely related to tinnitus severity and anxiety and depression symptoms. Multivariate regression analysis, in which relevant patient characteristics were controlled, revealed that acceptance accounted for unique variance beyond anxiety and depression symptoms. Acceptance accounted for more of the variance than anxiety and depression symptoms combined. In addition, mediation analysis revealed that acceptance of tinnitus mediated the direct association between self-rated loudness and tinnitus severity, even after anxiety and depression symptoms were taken into account. Findings add to the growing body of work, supporting the unique and important role of acceptance in tinnitus severity. The utility of the concept is discussed in relation to the development of new psychological models and interventions for

  8. 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).

  9. Regulatory science based approach in development of novel medical devices.

    PubMed

    Sakuma, Ichiro

    2015-08-01

    For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

  10. 77 FR 8724 - Natural Gas Pipelines; Project Cost and Annual Limits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ...] Natural Gas Pipelines; Project Cost and Annual Limits February 9, 2012. AGENCY: Federal Energy Regulatory... limits for natural gas pipelines blanket construction certificates for each calendar year. DATES: This... CFR Part 157 Administrative practice and procedure, Natural gas, Reporting and recordkeeping...

  11. Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

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

    Moe, Wayne L.

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

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

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

    Moe, Wayne Leland

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

  13. Ready for eHealth? Health Professionals' Acceptance and Adoption of eHealth Interventions in Inpatient Routine Care.

    PubMed

    Hennemann, Severin; Beutel, Manfred E; Zwerenz, Rüdiger

    2017-03-01

    eHealth interventions can be effective in treating health problems. However, adoption in inpatient routine care seems limited. The present study therefore aimed to investigate barriers and facilitators to acceptance of eHealth interventions and of online aftercare in particular in health professionals of inpatient treatment. A total of 152 out of 287 health professionals of various professional groups in four inpatient rehabilitation facilities filled out a self-administered web-based questionnaire (response rate: 53%); 128 individuals were eligible for further data analysis. Acceptance and possible predictors were investigated with a complex research model based on the Unified Theory of Acceptance and Use of Technology. Acceptance of eHealth interventions was rather low (M = 2.47, SD = 0.98); however, acceptance of online aftercare was moderate (M = 3.08, SD = 0.96, t(127) = 8.22, p < .001), and eHealth literacy was elevated. Social influence, performance expectancy, and treatment-related internet and mobile use significantly predicted overall acceptance. No differences were found between professional and age groups. Although acceptance of eHealth interventions was limited in health professionals of inpatient treatment, moderate acceptance of online aftercare for work-related stress implies a basis for future implementation. Tailored eHealth education addressing misconceptions about inferiority and incongruity with conventional treatment considering the systemic aspect of acceptance formation are needed.

  14. 78 FR 30384 - Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... SMALL BUSINESS ADMINISTRATION Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory... Regional (Region X) Small Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National... Region X Regulatory Fairness Board must contact Jos[eacute] M[eacute]ndez by May 30, 2013 in writing, by...

  15. Video Game Acceptance: A Meta-Analysis of the Extended Technology Acceptance Model.

    PubMed

    Wang, Xiaohui; Goh, Dion Hoe-Lian

    2017-11-01

    The current study systematically reviews and summarizes the existing literature of game acceptance, identifies the core determinants, and evaluates the strength of the relationships in the extended technology acceptance model. Moreover, this study segments video games into two categories: hedonic and utilitarian and examines player acceptance of these two types separately. Through a meta-analysis of 50 articles, we find that perceived ease of use (PEOU), perceived usefulness (PU), and perceived enjoyment (PE) significantly associate with attitude and behavioral intention. PE is the dominant predictor of hedonic game acceptance, while PEOU and PU are the main determinants of utilitarian game acceptance. Furthermore, we find that respondent type and game platform are significant moderators. Findings of this study provide critical insights into the phenomenon of game acceptance and suggest directions for future research.

  16. Role of antisense RNAs in evolution of yeast regulatory complexity.

    PubMed

    Lin, Chih-Hsu; Tsai, Zing Tsung-Yeh; Wang, Daryi

    2013-01-01

    Antisense RNAs (asRNAs) are known to regulate gene expression. However, a genome-wide mechanism of asRNA regulation is unclear, and there is no good explanation why partial asRNAs are not functional. To explore its regulatory role, we investigated asRNAs using an evolutionary approach, as genome-wide experimental data are limited. We found that the percentage of genes coupling with asRNAs in Saccharomyces cerevisiae is negatively associated with regulatory complexity and evolutionary age. Nevertheless, asRNAs evolve more slowly when their sense genes are under more complex regulation. Older genes coupling with asRNAs are more likely to demonstrate inverse expression, reflecting the role of these asRNAs as repressors. Our analyses provide novel evidence, suggesting a minor contribution of asRNAs in developing regulatory complexity. Although our results support the leaky hypothesis for asRNA transcription, our evidence also suggests that partial asRNAs may have evolved as repressors. Our study deepens the understanding of asRNA regulatory evolution. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Virtual online consultations: advantages and limitations (VOCAL) study

    PubMed Central

    Greenhalgh, Trisha; Vijayaraghavan, Shanti; Wherton, Joe; Shaw, Sara; Byrne, Emma; Campbell-Richards, Desirée; Bhattacharya, Satya; Hanson, Philippa; Ramoutar, Seendy; Gutteridge, Charles; Hodkinson, Isabel; Collard, Anna; Morris, Joanne

    2016-01-01

    Introduction Remote video consultations between clinician and patient are technically possible and increasingly acceptable. They are being introduced in some settings alongside (and occasionally replacing) face-to-face or telephone consultations. Methods To explore the advantages and limitations of video consultations, we will conduct in-depth qualitative studies of real consultations (microlevel) embedded in an organisational case study (mesolevel), taking account of national context (macrolevel). The study is based in 2 contrasting clinical settings (diabetes and cancer) in a National Health Service (NHS) acute trust in London, UK. Main data sources are: microlevel—audio, video and screen capture to produce rich multimodal data on 45 remote consultations; mesolevel—interviews, ethnographic observations and analysis of documents within the trust; macrolevel—key informant interviews of national-level stakeholders and document analysis. Data will be analysed and synthesised using a sociotechnical framework developed from structuration theory. Ethics approval City Road and Hampstead NHS Research Ethics Committee, 9 December 2014, reference 14/LO/1883. Planned outputs We plan outputs for 5 main audiences: (1) academics: research publications and conference presentations; (2) service providers: standard operating procedures, provisional operational guidance and key safety issues; (3) professional bodies and defence societies: summary of relevant findings to inform guidance to members; (4) policymakers: summary of key findings; (5) patients and carers: ‘what to expect in your virtual consultation’. Discussion The research literature on video consultations is sparse. Such consultations offer potential advantages to patients (who are spared the cost and inconvenience of travel) and the healthcare system (eg, they may be more cost-effective), but fears have been expressed that they may be clinically risky and/or less acceptable to patients or staff, and they

  18. 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.

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

    PubMed

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

    2017-07-01

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

  20. The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience.

    PubMed

    Risha, Peter Gasper; Msuya, Zera; Clark, Malcolm; Johnson, Keith; Ndomondo-Sigonda, Margareth; Layloff, Thomas

    2008-08-01

    The Tanzania Food and Drugs Authority piloted the use of Minilab kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Minilab screening techniques, they were stationed at key Ports-of-Entry (POE) to screen the quality of imported medicines. In addition, three non-Ports-of-Entry centres were established to screen samples collected during Post-Marketing-Surveillance. Standard operating procedures (SOPs) were developed to structure and standardize the implementation process. Over 1200 samples were tested using the Minilab outside the central quality control laboratory (QCL), almost doubling the previous testing capacity. The program contributed to increased regulatory reach and visibility of the Authority throughout the country, serving as a deterrent against entry of substandard medicines into market. The use of Minilab for quality screening was inexpensive and provided a high sample throughput. However, it suffers from the limitation that it can reliably detect only grossly substandard or wrong drug samples and therefore, it should not be used as an independent testing resource but in conjunction with a full-service quality control laboratory capable of auditing reported substandard results.

  1. 78 FR 3893 - Enbridge Energy, Limited Partnership; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-17

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. IS13-17-000] Enbridge Energy... Energy, Limited Partnership's proposed revision to its downstream Nomination Verification Procedure. \\1\\ Enbridge Energy, Limited Partnership, 141 FERC ] 61,246 (2012). Take notice that a technical conference...

  2. Mental health service acceptability for the armed forces veteran community.

    PubMed

    Farrand, P; Jeffs, A; Bloomfield, T; Greenberg, N; Watkins, E; Mullan, E

    2018-06-15

    Despite developments in mental health services for armed forces veterans and family members, barriers to access associated with poor levels of acceptability regarding service provision remain. Adapting a Step 2 mental health service based on low-intensity cognitive behavioural therapy (CBT) interventions to represent a familiar context and meet the needs of the armed forces veteran community may serve to enhance acceptability and reduce help-seeking barriers. To examine acceptability of a Step 2 low-intensity CBT mental health service adapted for armed forces veterans and family members provided by a UK Armed Forces charity. Qualitative study using individual semi-structured interviews with armed forces veterans and family members of those injured or becoming unwell while serving in the British Armed Forces. Data analysis was undertaken using thematic alongside disconfirming case analysis. Adapting a Step 2 mental health service for armed forces veterans and family members enhanced acceptability and promoted help-seeking. Wider delivery characteristics associated with Step 2 mental health services within the Improving Access to Psychological Therapies (IAPT) programme also contributed to service acceptability. However, limitations of Step 2 mental health service provision were also identified. A Step 2 mental health service adapted for armed forces veterans and family members enhances acceptability and may potentially overcome help-seeking barriers. However, concerns remain regarding ways to accommodate the treatment of post-traumatic stress disorder and provide support for family members.

  3. 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.

  4. Parental acceptance, postpartum depression, and maternal sensitivity: mediating and moderating processes.

    PubMed

    Crockenberg, Susan C; Leerkes, Esther M

    2003-03-01

    Mothers (n = 92), fathers (n = 84), and their infants (60% male) participated in a longitudinal study of postpartum depression and maternal sensitivity. Mothers completed questionnaire measures of remembered parental acceptance, depressive symptoms, and infant distress to novelty and limits. Mothers and partners reported on marital aggression and avoidance. Maternal sensitivity was observed in the laboratory at 6 months. Characteristics of mothers, partners, and infants combined to predict postpartum depression and maternal sensitivity. Remembered parental rejection predicted postpartum depressive symptoms with prenatal depression controlled; self-esteem mediated this effect. Paternal acceptance buffered against postpartum depression when infants were highly reactive and when partners were aggressive. Paternal acceptance reduced the impact of postpartum depression on maternal sensitivity; having an aggressive marital partner exacerbated the effect.

  5. 78 FR 2988 - Badger Creek Limited; Notice of Petition for Declaratory Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL13-38-000; QF87-120-012] Badger Creek Limited; Notice of Petition for Declaratory Order Take notice that on January 8, 2013....205(c) (2012), Badger Creek Limited filed a petition for declaratory order requesting a limited waiver...

  6. Regulatory Risk Reduction for Advanced Reactor Technologies – FY2016 Status and Work Plan Summary

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

    Moe, Wayne Leland

    2016-08-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy’s (DOE) Advanced Reactor Technologiesmore » (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants« less

  7. 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. © 2013 The Author(s). Journal compilation © Overseas Development Institute, 2013.

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

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

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

    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 largemore » 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

  9. Compartmentalized gene regulatory network of the pathogenic fungus Fusarium graminearum

    USDA-ARS?s Scientific Manuscript database

    Head blight caused by Fusarium graminearum (Fg) is a major limiting factor of wheat production with both yield loss and mycotoxin contamination. Here we report a model for global Fg gene regulatory networks (GRNs) inferred from a large collection of transcriptomic data using a machine-learning appro...

  10. 78 FR 73912 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-09

    ... Rule Change To Extend the Pilot Program That Eliminated the Position and Exercise Limits for Options on... amend its rules to extend the pilot program that eliminated position and exercise limits for physically..., because not all self- regulatory organizations (``SROs'') have adopted similar rules eliminating position...

  11. Taxi Regulatory Revision in Oakland and Berkeley, California : Two Case Studies

    DOT National Transportation Integrated Search

    1983-06-01

    A case study was performed of regulatory changes pertaining to taxicabs in Oakland and neighboring Berkeley, CA. In Oakland rates were approximately doubled and limits on the number of taxi permits removed. Companies were allowed to levy a per-trip s...

  12. 75 FR 63878 - Self-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ...-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of...(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory...

  13. Deciphering RNA Regulatory Elements Involved in the Developmental and Environmental Gene Regulation of Trypanosoma brucei.

    PubMed

    Gazestani, Vahid H; Salavati, Reza

    2015-01-01

    Trypanosoma brucei is a vector-borne parasite with intricate life cycle that can cause serious diseases in humans and animals. This pathogen relies on fine regulation of gene expression to respond and adapt to variable environments, with implications in transmission and infectivity. However, the involved regulatory elements and their mechanisms of actions are largely unknown. Here, benefiting from a new graph-based approach for finding functional regulatory elements in RNA (GRAFFER), we have predicted 88 new RNA regulatory elements that are potentially involved in the gene regulatory network of T. brucei. We show that many of these newly predicted elements are responsive to both transcriptomic and proteomic changes during the life cycle of the parasite. Moreover, we found that 11 of predicted elements strikingly resemble previously identified regulatory elements for the parasite. Additionally, comparison with previously predicted motifs on T. brucei suggested the superior performance of our approach based on the current limited knowledge of regulatory elements in T. brucei.

  14. 43 CFR 46.240 - Establishing time limits for the NEPA process.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...: (1) Set time limits from the start to the finish of the NEPA analysis and documentation, consistent with the requirements of 40 CFR 1501.8 and other legal obligations, including statutory and regulatory timeframes; (2) Consult with cooperating agencies in setting time limits; and (3) Encourage cooperating...

  15. 43 CFR 46.240 - Establishing time limits for the NEPA process.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...: (1) Set time limits from the start to the finish of the NEPA analysis and documentation, consistent with the requirements of 40 CFR 1501.8 and other legal obligations, including statutory and regulatory timeframes; (2) Consult with cooperating agencies in setting time limits; and (3) Encourage cooperating...

  16. 12 CFR 211.12 - Lending limits and capital requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 2 2010-01-01 2010-01-01 false Lending limits and capital requirements. 211.12 Section 211.12 Banks and Banking FEDERAL RESERVE SYSTEM BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM... Lending limits and capital requirements. (a) Acceptances of Edge corporations. (1) Limitations. An Edge...

  17. Attempting to be active: Self-efficacy and barrier limitation differentiate activity levels of working mothers.

    PubMed

    Gierc, Madelaine; Locke, Sean; Jung, Mary; Brawley, Lawrence

    2016-07-01

    Working mothers are less physically active than working women without children and mothers who do not work. The purpose of this study was to examine concurrent self-regulatory efficacy and barriers to physical activity in a sample of working mothers. Women completed a mixed-methods survey which included measures of physical activity, concurrent self-regulatory efficacy, and barriers. Sufficiently active women experienced significantly greater concurrent self-regulatory efficacy and significantly less barrier limitation and frequency. No significant group differences were found for age, domestic duties performed, and children's extracurricular activities. Thematic analysis of barriers revealed six themes of common and unique factors, including limited time and family activities. © The Author(s) 2014.

  18. Regulatory element-based prediction identifies new susceptibility regulatory variants for osteoporosis.

    PubMed

    Yao, Shi; Guo, Yan; Dong, Shan-Shan; Hao, Ruo-Han; Chen, Xiao-Feng; Chen, Yi-Xiao; Chen, Jia-Bin; Tian, Qing; Deng, Hong-Wen; Yang, Tie-Lin

    2017-08-01

    Despite genome-wide association studies (GWASs) have identified many susceptibility genes for osteoporosis, it still leaves a large part of missing heritability to be discovered. Integrating regulatory information and GWASs could offer new insights into the biological link between the susceptibility SNPs and osteoporosis. We generated five machine learning classifiers with osteoporosis-associated variants and regulatory features data. We gained the optimal classifier and predicted genome-wide SNPs to discover susceptibility regulatory variants. We further utilized Genetic Factors for Osteoporosis Consortium (GEFOS) and three in-house GWASs samples to validate the associations for predicted positive SNPs. The random forest classifier performed best among all machine learning methods with the F1 score of 0.8871. Using the optimized model, we predicted 37,584 candidate SNPs for osteoporosis. According to the meta-analysis results, a list of regulatory variants was significantly associated with osteoporosis after multiple testing corrections and contributed to the expression of known osteoporosis-associated protein-coding genes. In summary, combining GWASs and regulatory elements through machine learning could provide additional information for understanding the mechanism of osteoporosis. The regulatory variants we predicted will provide novel targets for etiology research and treatment of osteoporosis.

  19. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD06-6-000] Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC)...

  20. Mouse regulatory DNA landscapes reveal global principles of cis-regulatory evolution.

    PubMed

    Vierstra, Jeff; Rynes, Eric; Sandstrom, Richard; Zhang, Miaohua; Canfield, Theresa; Hansen, R Scott; Stehling-Sun, Sandra; Sabo, Peter J; Byron, Rachel; Humbert, Richard; Thurman, Robert E; Johnson, Audra K; Vong, Shinny; Lee, Kristen; Bates, Daniel; Neri, Fidencio; Diegel, Morgan; Giste, Erika; Haugen, Eric; Dunn, Douglas; Wilken, Matthew S; Josefowicz, Steven; Samstein, Robert; Chang, Kai-Hsin; Eichler, Evan E; De Bruijn, Marella; Reh, Thomas A; Skoultchi, Arthur; Rudensky, Alexander; Orkin, Stuart H; Papayannopoulou, Thalia; Treuting, Piper M; Selleri, Licia; Kaul, Rajinder; Groudine, Mark; Bender, M A; Stamatoyannopoulos, John A

    2014-11-21

    To study the evolutionary dynamics of regulatory DNA, we mapped >1.3 million deoxyribonuclease I-hypersensitive sites (DHSs) in 45 mouse cell and tissue types, and systematically compared these with human DHS maps from orthologous compartments. We found that the mouse and human genomes have undergone extensive cis-regulatory rewiring that combines branch-specific evolutionary innovation and loss with widespread repurposing of conserved DHSs to alternative cell fates, and that this process is mediated by turnover of transcription factor (TF) recognition elements. Despite pervasive evolutionary remodeling of the location and content of individual cis-regulatory regions, within orthologous mouse and human cell types the global fraction of regulatory DNA bases encoding recognition sites for each TF has been strictly conserved. Our findings provide new insights into the evolutionary forces shaping mammalian regulatory DNA landscapes. Copyright © 2014, American Association for the Advancement of Science.

  1. Conception et validation d'un modele d'analyse et de suivi pour une politique energetique durable et acceptable de l'energie eolienne: Une etude comparative France-Quebec

    NASA Astrophysics Data System (ADS)

    Feurtey, Evariste

    In this research, we built a conceptual model of a sustainable and acceptable wind power policy that we tried to validate through the case study of France and Quebec in the wind energy sector. Our qualitative and comparative approach helps us to illustrate the interaction of institutional variables studied, including the national context of emergence, the balance of power between pressure groups, the supranational and exogenous influences, level of political commitment, policy and regulatory instruments, social acceptance and energy policy mechanisms. The research confirms that the neo-corporatism is present in France as in Quebec. With the unfavorable energy context (low cost of electricity tariff, lack of electricity demand, and an already low zero carbon electric mix), it is an important factor explaining : 1) the 20 years delay accumulated by France and Quebec in the development of wind projects or industrial sector; 2) the 10% limited penetration scale given to wind energy. We also demonstrate that the political commitment to develop wind energy fluctuates with the government majority, the energy context or the influence of pressure groups. This manifests itself in a lack of continuity of policies and tariff instruments used. In both national case studies, the results also show that balanced policies and regulations ensure sustainable development of wind energy only if they allow a sufficient market size. The search results also illustrates that the conceptual division made between acceptance of wind sector, acceptance of ownership, local acceptance is very instructive. Social controversies, though multifactorial, are connected to both a critique of the development model too industrial and private, territorial dilemmas (closed environment), energy context (electric surplus in Quebec), or related to strategic planning system and centralized decision. An important issue for a more acceptable wind policy in the future will come to a greater plurality of ownership

  2. 76 FR 12769 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...,\\2\\ notice is hereby given that on February 16, 2011, the Financial Industry Regulatory Authority... CFR 240.19b-4(f)(3). I. Self-Regulatory Organization's Statement of the Terms of Substance of the...

  3. Study of the regulatory issues affecting truck freight movement in the Midwest.

    DOT National Transportation Integrated Search

    2014-12-01

    This project investigated regulatory issues that may affect or limit freight movement in Iowa and other Midwest states: Illinois, Kansas, : Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin. Current state regulations for the following are re...

  4. [Regulatory T cells].

    PubMed

    Marinić, Igor; Gagro, Alenka; Rabatić, Sabina

    2006-12-01

    Regulatory T-cells are a subset of T cells that have beene extensively studied in modern immunology. They are important for the maintenance of peripheral tolerance, and have an important role in various clinical conditions such as allergy, autoimmune disorders, tumors, infections, and in transplant medicine. Basically, this population has a suppressive effect on the neighboring immune cells, thus contributing to the local modulation and control of immune response. There are two main populations of regulatory T cells - natural regulatory T cells, which form a distinct cellular lineage, develop in thymus and perform their modulatory action through direct intercellular contact, along with the secreted cytokines; and inducible regulatory T cells, which develop in the periphery after contact with the antigen that is presented on the antigen presenting cell, and their primary mode of action is through the interleukin 10 (IL-10) and transforming growth factor beta (TGF-alpha) cytokines. Natural regulatory T cells are activated through T cell receptor after contact with specific antigen and inhibit proliferation of other T cells in an antigen independent manner. One of the major difficulties in the research of regulatory T cells is the lack of specific molecular markers that would identify these cells. Natural regulatory T cells constitutively express surface molecule CD25, but many other surface and intracellular molecules (HLA-DR, CD122, CD45RO, CD62, CTLA-4, GITR, PD-1, Notch, FOXP3, etc.) are being investigated for further phenotypic characterization of these cells. Because regulatory T cells have an important role in establishing peripheral tolerance, their importance is manifested in a number of clinical conditions. In the IPEX syndrome (immunodysregulation, polyendocrinopathy and enteropathy, X-linked), which is caused by mutation in Foxp3 gene that influences the development and function of regulatory T cells, patients develop severe autoimmune reactions that

  5. 78 FR 64255 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-28

    ... Amending Commentary .07 to Rule 904 To Extend the Pilot Program That Eliminated the Position Limits for... that eliminated the position limits for options on SPDR S&P 500 ETF (``SPY'') (``SPY Pilot Program...- regulatory organizations (``SROs'') have adopted similar rules eliminating position limits on SPY and market...

  6. An acceptance model for smart glasses based tourism augmented reality

    NASA Astrophysics Data System (ADS)

    Obeidy, Waqas Khalid; Arshad, Haslina; Huang, Jiung Yao

    2017-10-01

    Recent mobile technologies have revolutionized the way people experience their environment. Although, there is only limited research on users' acceptance of AR in the cultural tourism context, previous researchers have explored the opportunities of using augmented reality (AR) in order to enhance user experience. Recent AR research lack works that integrates dimensions which are specific to cultural tourism and smart glass specific context. Hence, this work proposes an AR acceptance model in the context of cultural heritage tourism and smart glasses capable of performing augmented reality. Therefore, in this paper we aim to present an AR acceptance model to understand the AR usage behavior and visiting intention for tourists who use Smart Glass based AR at UNESCO cultural heritage destinations in Malaysia. Furthermore, this paper identifies information quality, technology readiness, visual appeal, and facilitating conditions as external variables and key factors influencing visitors' beliefs, attitudes and usage intention.

  7. 12 CFR 412.13 - Limitations and penalties.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Limitations and penalties. 412.13 Section 412.13 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES ACCEPTANCE OF PAYMENT FROM A NON-FEDERAL SOURCE FOR TRAVEL EXPENSES § 412.13 Limitations and penalties. (a) This part is in addition to and not in...

  8. Acceptable range of speech level in noisy sound fields for young adults and elderly persons.

    PubMed

    Sato, Hayato; Morimoto, Masayuki; Ota, Ryo

    2011-09-01

    The acceptable range of speech level as a function of background noise level was investigated on the basis of word intelligibility scores and listening difficulty ratings. In the present study, the acceptable range is defined as the range that maximizes word intelligibility scores and simultaneously does not cause a significant increase in listening difficulty ratings from the minimum ratings. Listening tests with young adult and elderly listeners demonstrated the following. (1) The acceptable range of speech level for elderly listeners overlapped that for young listeners. (2) The lower limit of the acceptable speech level for both young and elderly listeners was 65 dB (A-weighted) for noise levels of 40 and 45 dB (A-weighted), a level with a speech-to-noise ratio of +15 dB for noise levels of 50 and 55 dB, and a level with a speech-to-noise ratio of +10 dB for noise levels from 60 to 70 dB. (3) The upper limit of the acceptable speech level for both young and elderly listeners was 80 dB for noise levels from 40 to 55 dB and 85 dB or above for noise levels from 55 to 70 dB. © 2011 Acoustical Society of America

  9. Acceptability of Health Care-Related Risks: A Literature Review.

    PubMed

    Quintard, Bruno; Roberts, Tamara; Nitaro, Léa; Quenon, Jean-Luc; Michel, Philippe

    2016-03-01

    Risk management aims at reducing risks associated with hospital care to an acceptable level, both in their frequency and their impact on health. The social acceptability of risk on the part of the general population and of the health-care professionals, faced with regular information about adverse events, is undoubtedly evolving rapidly.In contrast to risk acceptability, the concept of risk perception is of limited interest to risk managers because it does not inform on the behaviors and actions resulting from these perceptions. The aim of this work was to define the concept of social acceptability of risk through an in-depth examination of a wide-ranging and multidisciplinary literature. A 1990-2010 English and French literature review was carried out in medical, epidemiological, and human and social sciences online databases, gray literature, and books. Of the 5931 references retrieved, 203 met the inclusion criteria. We identified contributions from 5 major research fields: economic, sociocognitive, psychometric, sociological/anthropological, and interactionist. When assessing risks, individuals use a variety of psychological and social processes that include their perception not only of a given risk but also of their own personal and social resources. This global perception has a direct impact on the responses and actual behavior of individuals and groups, enabling them to cope with the risk and/or manage it. Social acceptability includes perceptions related to risks and the stated intentions of individual behavior. This concept may therefore be relevant for defining local and national patient safety priorities.

  10. Predicting nurses' use of healthcare technology using the technology acceptance model: an integrative review.

    PubMed

    Strudwick, Gillian

    2015-05-01

    The benefits of healthcare technologies can only be attained if nurses accept and intend to fully use them. One of the most common models utilized to understand user acceptance of technology is the Technology Acceptance Model. This model and modified versions of it have only recently been applied in the healthcare literature among nurse participants. An integrative literature review was conducted on this topic. Ovid/MEDLINE, PubMed, Google Scholar, and CINAHL were searched yielding a total of 982 references. Upon eliminating duplicates and applying the inclusion and exclusion criteria, the review included a total of four dissertations, three symposium proceedings, and 13 peer-reviewed journal articles. These documents were appraised and reviewed. The results show that a modified Technology Acceptance Model with added variables could provide a better explanation of nurses' acceptance of healthcare technology. These added variables to modified versions of the Technology Acceptance Model are discussed, and the studies' methodologies are critiqued. Limitations of the studies included in the integrative review are also examined.

  11. Regulatory Actions - Final Mercury and Air Toxics Standards (MATS) for Power Plants

    EPA Pesticide Factsheets

    The U.S. Environmental Protection Agency (EPA) has proposed Mercury and Air Toxics Standards (MATS) for power plants to limit mercury, acid gases and other toxic pollution from power plants. This page describes Federal regulatory actions.

  12. 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…

  13. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire.

    PubMed

    Bothelius, Kristoffer; Jernelöv, Susanna; Fredrikson, Mats; McCracken, Lance M; Kaldo, Viktor

    2015-11-01

    Acceptance may be an important therapeutic process in sleep medicine, but valid psychometric instruments measuring acceptance related to sleep difficulties are lacking. The purpose of this study was to develop a measure of acceptance in insomnia, and to examine its factor structure as well as construct validity. In a cross-sectional design, a principal component analysis for item reduction was conducted on a first sample (A) and a confirmatory factor analysis on a second sample (B). Construct validity was tested on a combined sample (C). Questionnaire items were derived from a measure of acceptance in chronic pain, and data were gathered through screening or available from pretreatment assessments in four insomnia treatment trials, administered online, via bibliotherapy and in primary care. Adults with insomnia: 372 in sample A and 215 in sample B. Sample C (n = 820) included sample A and B with another 233 participants added. Construct validity was assessed through relations with established acceptance and sleep scales. The principal component analysis presented a two-factor solution with eight items, explaining 65.9% of the total variance. The confirmatory factor analysis supported the solution. Acceptance of sleep problems was more closely related to subjective symptoms and consequences of insomnia than to diary description of sleep, or to acceptance of general private events. The Sleep Problem Acceptance Questionnaire (SPAQ), containing the subscales "Activity Engagement" and "Willingness", is a valid tool to assess acceptance of insomnia. © 2015 Associated Professional Sleep Societies, LLC.

  14. Framing Innovation: Does an Instructional Vision Help Superintendents Gain Acceptance for a Large-Scale Technology Initiative?

    ERIC Educational Resources Information Center

    Flanagan, Gina E.

    2014-01-01

    There is limited research that outlines how a superintendent's instructional vision can help to gain acceptance of a large-scale technology initiative. This study explored how superintendents gain acceptance for a large-scale technology initiative (specifically a 1:1 device program) through various leadership actions. The role of the instructional…

  15. Clinical and regulatory considerations in pharmacogenetic testing.

    PubMed

    Schuck, Robert N; Marek, Elizabeth; Rogers, Hobart; Pacanowski, Michael

    2016-12-01

    Both regulatory science and clinical practice rely on best available scientific data to guide decision-making. However, changes in clinical practice may be driven by numerous other factors such as cost. In this review, we reexamine noteworthy examples where pharmacogenetic testing information was added to drug labeling to explore how the available evidence, potential public health impact, and predictive utility of each pharmacogenetic biomarker impacts clinical uptake. Advances in the field of pharmacogenetics have led to new discoveries about the genetic basis for variability in drug response. The Food and Drug Administration recognizes the value of pharmacogenetic testing strategies and has been proactive about incorporating pharmacogenetic information into the labeling of both new drugs and drugs already on the market. Although some examples have readily translated to routine clinical practice, clinical uptake of genetic testing for many drugs has been limited. Both regulatory science and clinical practice rely on data-driven approaches to guide decision making; however, additional factors are also important in clinical practice that do not impact regulatory decision making, and these considerations may result in heterogeneity in clinical uptake of pharmacogenetic testing. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  16. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

  17. 77 FR 52791 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...The Office of the Comptroller of the Currency (OCC), Board of Governors of the Federal Reserve System (Board), and the Federal Deposit Insurance Corporation (FDIC) (collectively, the agencies) are seeking comment on three Notices of Proposed Rulemaking (NPR) that would revise and replace the agencies' current capital rules. In this NPR, the agencies are proposing to revise their risk-based and leverage capital requirements consistent with agreements reached by the Basel Committee on Banking Supervision (BCBS) in ``Basel III: A Global Regulatory Framework for More Resilient Banks and Banking Systems'' (Basel III). The proposed revisions would include implementation of a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for banking organizations subject to the advanced approaches capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator measure. Additionally, consistent with Basel III, the agencies are proposing to apply limits on a banking organization's capital distributions and certain discretionary bonus payments if the banking organization does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk- based capital requirements. This NPR also would establish more conservative standards for including an instrument in regulatory capital. As discussed in the proposal, the revisions set forth in this NPR are consistent with section 171 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), which requires the agencies to establish minimum risk-based and leverage capital requirements. In connection with the proposed changes to the agencies' capital rules in this NPR, the agencies are also seeking comment on the two related NPRs published elsewhere in today's Federal Register. The two related NPRs are discussed further in the SUPPLEMENTARY INFORMATION.

  18. The Chinese health care regulatory institutions in an era of transition.

    PubMed

    Fang, Jing

    2008-02-01

    The purpose of this paper is to contribute to a better understanding of Chinese health care regulation in an era of transition. It describes the major health care regulatory institutions operating currently in China and analyzes the underlying factors. The paper argues that in the transition from a planned to a market economy, the Chinese government has been employing a hybrid approach where both old and new institutions have a role in the management of emerging markets, including the health care market. This approach is consistent with the incremental reform strategy adopted by the Party-state. Although a health care regulatory framework has gradually taken shape, the framework is incomplete, with a particular lack of emphasis on professional self-regulation. In addition, its effectiveness is limited despite the existence of many regulatory institutions. In poor rural areas, the effectiveness of the regulatory framework is further undermined or distorted by the extremely difficult financial position that local governments find themselves in. The interpretations of the principle of 'rule of law' by policy makers and officials at different levels and the widespread informal network of relations between known individuals (Guanxi) play an important role in the operation of the regulatory framework. The findings of this paper reveal the complex nature of regulating health care in transitional China.

  19. Illness acceptance degree versus intensity of psychopathological symptoms in patients with psoriasis.

    PubMed

    Kostyła, Magdalena; Tabała, Klaudia; Kocur, Józef

    2013-06-01

    Chronic inflammatory skin diseases such as psoriasis have undoubtedly a negative impact on the patients' quality of life. Many of them may face various limitations in their psychosocial lives because of symptoms indicating the presence of psychopathological phenomena. Mental disorders in patients with skin diseases occur much more frequently than in the general population. Studies show that a considerable percentage (30-60%) of dermatological patients suffers from mental disorders (depressive and anxiety disorders being the most common). A person's attitude towards illness, its acceptance, and also the recognition of its limitations may be of a great importance in the process of the disease control. To evaluate of the relationship between the illness acceptance degree, and the presence and intensity of psychopathological symptoms in patients with psoriasis. The research was conducted on a group of 54 people (23 men and 31 women), who were treated for psoriasis in the Department of Dermatology and Venereology, Medical University of Lodz and in the Department of Dermatology, Pediatric Dermatology and Oncology, Medical University of Lodz. The following research methods were used: a questionnaire prepared for the purpose of the research, Acceptance of Illness Scale (AIS) and Symptom Checklist (SCL-90). It was found that there was a relationship between the skin illness acceptance degree and intensity of psychopathological symptoms in patients with psoriasis (negative correlations). The higher the degree of illness acceptance is, the better mental condition of patients with psoriasis is. The intensity of psychopathological symptoms is also affected by the duration of illness, other people's attitude to the skin disease, age and education level of the patients examined.

  20. Illness acceptance degree versus intensity of psychopathological symptoms in patients with psoriasis

    PubMed Central

    Tabała, Klaudia; Kocur, Józef

    2013-01-01

    Introduction Chronic inflammatory skin diseases such as psoriasis have undoubtedly a negative impact on the patients’ quality of life. Many of them may face various limitations in their psychosocial lives because of symptoms indicating the presence of psychopathological phenomena. Mental disorders in patients with skin diseases occur much more frequently than in the general population. Studies show that a considerable percentage (30-60%) of dermatological patients suffers from mental disorders (depressive and anxiety disorders being the most common). A person's attitude towards illness, its acceptance, and also the recognition of its limitations may be of a great importance in the process of the disease control. Aim To evaluate of the relationship between the illness acceptance degree, and the presence and intensity of psychopathological symptoms in patients with psoriasis. Material and methods The research was conducted on a group of 54 people (23 men and 31 women), who were treated for psoriasis in the Department of Dermatology and Venereology, Medical University of Lodz and in the Department of Dermatology, Pediatric Dermatology and Oncology, Medical University of Lodz. The following research methods were used: a questionnaire prepared for the purpose of the research, Acceptance of Illness Scale (AIS) and Symptom Checklist (SCL-90). Results It was found that there was a relationship between the skin illness acceptance degree and intensity of psychopathological symptoms in patients with psoriasis (negative correlations). Conclusions The higher the degree of illness acceptance is, the better mental condition of patients with psoriasis is. The intensity of psychopathological symptoms is also affected by the duration of illness, other people's attitude to the skin disease, age and education level of the patients examined. PMID:24278064

  1. Impact of illness and its treatment on workplace costs: regulatory and measurement issues.

    PubMed

    Greenberg, P E; Birnbaum, H G; Kessler, R C; Morgan, M; Stang, P

    2001-01-01

    In an attempt to document a broader spectrum of the benefits of their pharmaceutical products, drug companies increasingly seek to include productivity claims in their promotional campaigns. We describe the existing regulatory framework of the Food and Drug Administration (FDA) for considering productivity claims, distinguishing between the traditional "substantial evidence" standard and the "competent and reliable scientific evidence" standard. But the notion of competent and reliable scientific evidence may itself be problematic, even when it is the appropriate regulatory standard, because there exists no consistent measurement approach across diseases, workplaces, jobs, and worker capabilities that is widely accepted in this emerging area of health outcomes research. We examine the various measurement approaches that have been used to quantify the impact of illness and its treatment on workplace productivity, and we describe some of the shortcomings associated with each alternative. This discussion highlights the possible difficulties faced by the FDA in reviewing productivity-based promotional claims. Finally, we suggest possible strategies for furthering this field of investigation.

  2. 10 CFR 16.19 - Statute of limitations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REGULATORY COMMISSION SALARY OFFSET PROCEDURES FOR COLLECTING DEBTS OWED BY FEDERAL EMPLOYEES TO THE FEDERAL GOVERNMENT § 16.19 Statute of limitations. If a debt has been outstanding for more than 10 years after the agency's right to collect the debt first accrued, the agency may not collect by salary offset unless...

  3. The regulatory pyramid meets the food pyramid: can regulatory theory improve controls on television food advertising to Australian children?

    PubMed

    Reeve, Belinda

    2011-09-01

    This article examines whether responsive regulation has potential to improve the regulatory framework which controls free-to-air television advertising to children, so that the regulatory scheme can be used more effectively as a tool for obesity prevention. It presents two apparently conflicting arguments, the first being that responsive regulation, particularly monitoring and enforcement measures, can be used to refine the regulation of children's food advertising. The second argument is that there are limits to the improvements that responsive regulation can achieve, since it is trying to achieve the wrong goal, namely placing controls on misleading or deceptive advertising techniques rather than diminishing the sheer volume of advertisements to which children are exposed. These two positions reflect a conflict between public health experts and governments regarding the role of industry in chronic disease prevention, as well as a broader debate about how best to regulate industry.

  4. A New Look at the Science of Weight Control: How Acceptance and Commitment Strategies Can Address the Challenge of Self-Regulation

    PubMed Central

    Forman, Evan M.; Butryn, Meghan L.

    2014-01-01

    Despite decades of work, behavioral interventions for obesity are not yet able to facilitate long-term weight loss maintenance for most participants. The current manuscript proposes an acceptance-based, self-regulation framework for understanding the challenge of maintaining changes in weight-related behavior and describes how this framework can be integrated into the behavioral treatment of obesity. According to this framework, intrinsic drives to consume palatable, high-calorie food interact with a modern environment in which high calorie foods are easily accessible. This combination produces a chronic desire to eat unhealthy foods that exists in opposition to individuals’ weight control goals. Similarly, energy expenditure requirements in the modern environment are limited, and people’s innate preferences to conserve energy typically prevent the concerted effort that would be necessary to engage in lifestyle activity and structured activity. Both external (e.g., sight of food) and internal (e.g., an aversive emotion) cues motivate overeating and sedentary behavior. However, individuals vary in their responsivity to these cues. While standard behavior skills may enable those lower in responsivity to successfully achieve weight control, we suggest that those higher in responsivity need specialized self-regulatory skills to maintain healthy eating and exercise behaviors. These skills include an ability to tolerate uncomfortable internal reactions to triggers and a reduction of pleasure, behavioral commitment to clearly-defined values, and metacognitive awareness of decision-making processes. So-called “acceptance-based” interventions based on these skills have so far proven efficacious for weight control, especially for those who are the most susceptible to eating in response to internal and external cues (as predicted by the model). Despite the current empirical support for the postulated model and for the interventions which stem from it, much remains to

  5. Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

    PubMed Central

    Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F.; Mt-Isa, Shahrul; Luo, Sheng

    2018-01-01

    Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. PMID:29505866

  6. Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

    PubMed

    Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F; Mt-Isa, Shahrul; Luo, Sheng

    2018-04-01

    Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. Copyright © 2018 Elsevier Inc. All rights reserved.

  7. Factor structure and correlates of the acceptance of cosmetic surgery scale among South Korean university students.

    PubMed

    Swami, Viren; Hwang, Choon-Sup; Jung, Jaehee

    2012-02-01

    Research on the acceptance of cosmetic surgery has focused on relatively affluent Western samples, to the exclusion of non-Western samples and any potential cross-cultural differences. While rates of cosmetic surgery in South Korea have risen sharply in the past decade, mirroring rates in other East Asian nations, little is known about attitudes toward cosmetic surgery in the Korean population. To examine the factor structure and correlates of a Korean adaptation of the previously-published Acceptance of Cosmetic Surgery Scale (ACSS). South Korean university students (N = 267) completed the ACSS, as well as included Korean translations of measures for actual vs. ideal body weight discrepancy, body appreciation, sociocultural attitudes toward appearance, and demographics. The Korean ACSS reduced to a two-factor solution, mirroring results among other non-Western samples, although a one-factor solution was deemed more plausible. Compared to men, women had significantly higher total scores, suggesting that they were more accepting of cosmetic surgery. A multiple regression showed that, after controlling for the effects of participant sex, the only significant predictor of acceptance of cosmetic surgery was general body appreciation, suggesting that some may view cosmetic surgery as a means of enhancing their body image. The results reveal important global information for plastic surgeons-not only on the treatment of non-Western patients but on the South Korean market, in which the cosmetic surgery industry remains unregulated. Given the popularity and acceptance of cosmetic surgery in South Korea, there is an urgent need for regulatory intervention to ensure patient safety and satisfaction.

  8. Team structure and regulatory focus: the impact of regulatory fit on team dynamic.

    PubMed

    Dimotakis, Nikolaos; Davison, Robert B; Hollenbeck, John R

    2012-03-01

    We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus characteristics (prevention and promotion) in 2 organizational structures (functional and divisional), resulting in 84 observations. Results suggested that salient regulatory demands inherent in the task interacted with structure to determine objective and subjective team-level outcomes, such that functional structures were best suited to (i.e., had best fit with) tasks with a prevention regulatory focus and divisional structures were best suited to tasks with a promotion regulatory focus. This contingency finding integrates regulatory focus and structural contingency theories, and extends them to the team level with implications for models of performance, satisfaction, and team dynamics.

  9. Development of a prediction model on the acceptance of electronic laboratory notebooks in academic environments.

    PubMed

    Kloeckner, Frederik; Farkas, Robert; Franken, Tobias; Schmitz-Rode, Thomas

    2014-04-01

    Documentation of research data plays a key role in the biomedical engineering innovation processes. It makes an important contribution to the protection of intellectual property, the traceability of results and fulfilling the regulatory requirement. Because of the increasing digitalization in laboratories, an electronic alternative to the commonly-used paper-bound notebooks could contribute to the production of sophisticated documentation. However, compared to in an industrial environment, the use of electronic laboratory notebooks is not widespread in academic laboratories. Little is known about the acceptance of an electronic documentation system and the underlying reasons for this. Thus, this paper aims to establish a prediction model on the potential preference and acceptance of scientists either for paper-based or electronic documentation. The underlying data for the analysis originate from an online survey of 101 scientists in industrial, academic and clinical environments. Various parameters were analyzed to identify crucial factors for the system preference using binary logistic regression. The analysis showed significant dependency between the documentation system preference and the supposed workload associated with the documentation system (p<0.006; odds ratio=58.543) and an additional personal component. Because of the dependency of system choice on specific parameters it is possible to predict the acceptance of an electronic laboratory notebook before implementation.

  10. 75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

  11. 76 FR 25397 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change To Amend the By- Laws of FINRA Regulation, Inc. With Regard to District Committees April 28, 2011. I. Introduction On February 25, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the...

  12. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

  13. Chinese Nurses' Acceptance of PDA: A Cross-Sectional Survey Using a Technology Acceptance Model.

    PubMed

    Wang, Yanling; Xiao, Qian; Sun, Liu; Wu, Ying

    2016-01-01

    This study explores Chinese nurses' acceptance of PDA, using a questionnaire based on the framework of Technology Acceptance Model (TAM). 357 nurses were involved in the study. The results reveal the scores of the nurses' acceptance of PDA were means 3.18~3.36 in four dimensions. The younger of nurses, the higher nurses' title, the longer previous usage time, the more experienced using PDA, and the more acceptance of PDA. Therefore, the hospital administrators may change strategies to enhance nurses' acceptance of PDA, and promote the wide application of PDA.

  14. 10 CFR 51.35 - Requirement to publish finding of no significant impact; limitation on Commission action.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Requirement to publish finding of no significant impact; limitation on Commission action. 51.35 Section 51.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National...

  15. Self-Regulatory Imagery and Physical Activity in Middle-Aged and Older Adults: A Social-Cognitive Perspective.

    PubMed

    Kosteli, Maria-Christina; Cumming, Jennifer; Williams, Sarah E

    2018-01-01

    Limited research has investigated exercise imagery use in middle-aged and older adults and its relationship with affective and behavioral correlates. The study examined the association between self-regulatory imagery and physical activity (PA) through key social cognitive variables. Middle-aged and older adults (N = 299; M age = 59.73 years, SD = 7.73, range = 50 to 80) completed self-report measures assessing self-regulatory imagery use, self-efficacy, outcome expectations, perceived barriers, self-regulatory behavior, enjoyment, and PA levels. Path analysis supported a model (χ² [14] = 21.76, p = .08, CFI = .99, TLI = .97, SRMR = .03, RMSEA = .04) whereby self-regulatory imagery positively predicted self-efficacy, outcome expectations, and self-regulatory behaviors. Furthermore, self-regulatory imagery indirectly predicted barriers, outcome expectations, self-regulation, enjoyment, and PA. This research highlights self-regulatory imagery as an effective strategy in modifying exercise-related cognitions and behaviors. Incorporating social cognitive constructs into the design of imagery interventions may increase PA engagement.

  16. 75 FR 6422 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

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

  17. Perceived acceptability of female smoking in China.

    PubMed

    Sansone, Natalie; Yong, Hua-Hie; Li, Lin; Jiang, Yuan; Fong, Geoffrey T

    2015-11-01

    Female smoking prevalence in China is very low but may rise with increased tobacco marketing towards women and changing norms. However, little is known about current perceptions of women smoking in China. This study sought to examine smokers' and non-smokers' perceived acceptability of female smoking and how it changed over time in China. Data come from Waves 1 to 3 (2006-2009) of the International Tobacco Control China Survey, a face-to-face cohort survey of approximately 800 adult smokers and 200 non-smokers in each of seven cities in mainland China. At Wave 3 (2009), about 38% of smokers and 9% of non-smokers agreed that female smoking is acceptable with women being almost twice as likely to do so as men (67% vs 36% and 11% vs 6%, respectively). In addition to women, smokers who were younger and had more positive perceptions of smoking in general were more likely to say that female smoking is acceptable. This perception significantly increased from Wave 1 (2006) to Wave 3 (2009), as did the perception that smoking is a sign of sophistication, but other general perceptions of smoking did not significantly change between 2006 and 2009. Norms against female smoking appear to remain strong in China, but female smoking may be becoming more acceptable. It is important to monitor these perceptions to prevent a rise in female smoking prevalence along with an increase in tobacco-related death and disease among women in China. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  18. Relationships Between Personal Beliefs and Treatment Acceptability, and Preferences for Behavioral Treatments

    PubMed Central

    Sidani, Souraya; Miranda, Joyal; Epstein, Dana R.; Bootzin, Richard R.; Cousins, Jennifer; Moritz, Patricia

    2009-01-01

    Background The literature on preferences for behavioral interventions is limited in terms of understanding treatment-related factors that underlie treatment choice. The objectives of this study were to examine the direct relationships between personal beliefs about clinical condition, perception of treatment acceptability, and preferences for behavioral interventions for insomnia. Methods The data set used in this study was obtained from 431 persons with insomnia who participated in a partially randomized clinical trial and expressed preferences for treatment options. The data were collected at baseline. Logistic regression was used to examine the relationships between personal beliefs and treatment acceptability, and preferences. The relationships between personal beliefs and perception of treatment acceptability were explored with correlational analysis. Results Perception of treatment acceptability was associated with preferences. Persons viewing the option as convenient tended to choose that option for managing insomnia. Personal beliefs were not related to preferences. However, beliefs about sleep promoting behaviors were correlated with perceived treatment effectiveness. Conclusions Perception of treatment acceptability underlies expressed preferences for behavioral interventions. Personal beliefs about insomnia are not directly associated with preferences. Importance is highlighted for providing information about treatment options and exploring perception of each option’s acceptability during the process of treatment selection. PMID:19604500

  19. The Arabidopsis halophytic relative Thellungiella halophila tolerates nitrogen-limiting conditions by maintaining growth, nitrogen uptake, and assimilation.

    PubMed

    Kant, Surya; Bi, Yong-Mei; Weretilnyk, Elizabeth; Barak, Simon; Rothstein, Steven J

    2008-07-01

    A comprehensive knowledge of mechanisms regulating nitrogen (N) use efficiency is required to reduce excessive input of N fertilizers while maintaining acceptable crop yields under limited N supply. Studying plant species that are naturally adapted to low N conditions could facilitate the identification of novel regulatory genes conferring better N use efficiency. Here, we show that Thellungiella halophila, a halophytic relative of Arabidopsis (Arabidopsis thaliana), grows better than Arabidopsis under moderate (1 mm nitrate) and severe (0.4 mm nitrate) N-limiting conditions. Thellungiella exhibited a lower carbon to N ratio than Arabidopsis under N limitation, which was due to Thellungiella plants possessing higher N content, total amino acids, total soluble protein, and lower starch content compared with Arabidopsis. Furthermore, Thellungiella had higher amounts of several metabolites, such as soluble sugars and organic acids, under N-sufficient conditions (4 mm nitrate). Nitrate reductase activity and NR2 gene expression in Thellungiella displayed less of a reduction in response to N limitation than in Arabidopsis. Thellungiella shoot GS1 expression was more induced by low N than in Arabidopsis, while in roots, Thellungiella GS2 expression was maintained under N limitation but was decreased in Arabidopsis. Up-regulation of NRT2.1 and NRT3.1 expression was higher and repression of NRT1.1 was lower in Thellungiella roots under N-limiting conditions compared with Arabidopsis. Differential transporter gene expression was correlated with higher nitrate influx in Thellungiella at low (15)NO(3)(-) supply. Taken together, our results suggest that Thellungiella is tolerant to N-limited conditions and could act as a model system to unravel the mechanisms for low N tolerance.

  20. Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

    PubMed Central

    Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S

    2015-01-01

    While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of

  1. 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

  2. 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)

  3. 76 FR 71007 - Shetek Wind Inc., Jeffers South, LLC and Allco Renewable Energy Limited, Midwest Independent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL11-53-000] Shetek Wind Inc., Jeffers South, LLC and Allco Renewable Energy Limited, Midwest Independent Transmission System Operator... an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission...

  4. 78 FR 22357 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Order Approving, on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

    ... Basis, Proposed Rule Change Relating to Limit Up Limit Down Functionality April 9, 2013. I. Introduction... substance of the proposed rule change or raise any novel regulatory issues, Amendment No. 1 is not subject... defined in Exchange Rule 100 to include orders for the account of a person or entity that is a broker or...

  5. 75 FR 7532 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-19

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... is hereby given that on February 4, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA...) (SEC Approves Consolidated FINRA Rules Governing Financial Responsibility). FINRA announced in...

  6. 78 FR 73911 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-09

    ... 3120 To Extend the Pilot Program That Eliminated the Position Limits for Options on SPDR S&P 500 ETF... extend the pilot program that eliminated the position limits for options on SPDR S&P 500 ETF (``SPY...- regulatory organizations (``SROs'') have adopted similar rules eliminating position limits on SPY and market...

  7. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.

    PubMed

    Lesko, Lawrence J; Salerno, Ronald A; Spear, Brian B; Anderson, Donald C; Anderson, Timothy; Brazell, Celia; Collins, Jerry; Dorner, Andrew; Essayan, David; Gomez-Mancilla, Baltazar; Hackett, Joseph; Huang, Shiew-Mei; Ide, Susan; Killinger, Joanne; Leighton, John; Mansfield, Elizabeth; Meyer, Robert; Ryan, Stephen G; Schmith, Virginia; Shaw, Peter; Sistare, Frank; Watson, Mark; Worobec, Alexandra

    2003-04-01

    The use of pharmacogenetics and pharmacogenomics in the drug development process, and in the assessment of such data submitted to regulatory agencies by industry, has generated significant enthusiasm as well as important reservations within the scientific and medical communities. This situation has arisen because of the increasing number of exploratory and confirmatory investigations into variations in RNA expression patterns and DNA sequences being conducted in the preclinical and clinical phases of drug development, and the uncertainty surrounding the acceptance of these data by regulatory agencies. This report summarizes the outcome of a workshop cosponsored by the Food and Drug Administration (FDA), the Pharmacogenetics Working Group (PWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the PhRMA Preclinical Safety Committee (DruSafe). The specific aim of the workshop was to identify key issues associated with the application of pharmacogenetics and pharmacogenomics, including the feasibility of a regulatory "safe harbor" for exploratory genome-based data, and to provide a forum for industry-regulatory agency dialogue on these important issues.

  8. 75 FR 60157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

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

  9. 39 CFR 3010.25 - Limitation on unused rate adjustment authority rate adjustments.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Limitation on unused rate adjustment authority rate adjustments. 3010.25 Section 3010.25 Postal Service POSTAL REGULATORY COMMISSION PERSONNEL REGULATION OF RATES FOR MARKET DOMINANT PRODUCTS Rules for Applying the Price Cap § 3010.25 Limitation on...

  10. Development of food acceptance patterns in the first years of life.

    PubMed

    Birch, L L

    1998-11-01

    As young omnivores, children make the transition from the exclusive milk diet of infancy to consuming a variety of foods. They must learn to accept a set of the foods available in their environmental niche, and they 'come equipped' with a set of predispositions that facilitate the development of food acceptance patterns, constrained by predisposition and limited by what is offered to them. While children are predisposed to like sweet or salty foods and to avoid sour or bitter foods, their preferences for the majority of foods are shaped by repeated experience. The predispositions that shape food acceptance patterns also include neophobia and the predisposition to learn to prefer and accept new foods when they are offered repeatedly. In addition, the predisposition for associative conditioning affects children's developing food acceptance patterns, resulting in preferences for foods offered in positive contexts, while foods presented in negative contexts will become more disliked via the learning of associations with the social and environmental contexts. Children also learn to prefer energy-dense foods when consumption of those foods is followed by positive post-ingestive consequences, such as those produced when high-energy-density foods are eaten when hungry. Although children are predisposed to be responsive to the energy content of foods in controlling their intake, they are also responsive to parents' control attempts. We have seen that these parental control attempts can refocus the child away from responsiveness to internal cues of hunger and satiety and towards external factors such as the presence of palatable foods. This analysis suggests that taking a closer look at what children are learning about food and eating may provide clues regarding the formation of children's food acceptance patterns, and that this approach also suggests potential causative factors implicated in the aetiology of obesity and the emergence of weight concerns. Current data

  11. 76 FR 20759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

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

  12. Optimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine.

    PubMed

    Verbeken, Gilbert; Pirnay, Jean-Paul; De Vos, Daniel; Jennes, Serge; Zizi, Martin; Lavigne, Rob; Casteels, Minne; Huys, Isabelle

    2012-06-01

    For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe's current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment to antibiotic therapy, no bacteriophage-specific framework for documentation exists to date. Decades worth of historical clinical data on bacteriophage therapy (from Eastern Europe, particularly Poland, and the former Soviet republics, particularly Georgia and Russia, as well as from today's 27 EU member states and the US) have not been taken into account by European regulators because these data have not been validated under current Western regulatory standards. Consequently, applicants carrying out standard clinical trials on bacteriophages in Europe are obliged to initiate clinical work from scratch. This paper argues for a reduced documentation threshold for Phase 1 clinical trials of bacteriophages and maintains that bacteriophages should not be categorized as classical medicinal products for at least two reasons: (1) such a categorization is scientifically inappropriate for this specific therapy and (2) such a categorization limits the marketing authorization process to industry, the only stakeholder with sufficient financial resources to prepare a complete dossier for the competent authorities. This paper reflects on the current regulatory framework for medicines in Europe and assesses possible regulatory pathways for the (re-)introduction of bacteriophage therapy in a way that maintains its effectiveness and safety as well as its inherent characteristics of sustainability and in situ self-amplification and limitation.

  13. 77 FR 34379 - Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD06-6-000] Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold a joint meeting...

  14. End of FY10 report - used fuel disposition technical bases and lessons learned : legal and regulatory framework for high-level waste disposition in the United States.

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

    Weiner, Ruth F.; Blink, James A.; Rechard, Robert Paul

    This report examines the current policy, legal, and regulatory framework pertaining to used nuclear fuel and high level waste management in the United States. The goal is to identify potential changes that if made could add flexibility and possibly improve the chances of successfully implementing technical aspects of a nuclear waste policy. Experience suggests that the regulatory framework should be established prior to initiating future repository development. Concerning specifics of the regulatory framework, reasonable expectation as the standard of proof was successfully implemented and could be retained in the future; yet, the current classification system for radioactive waste, including hazardousmore » constituents, warrants reexamination. Whether or not consideration of multiple sites are considered simultaneously in the future, inclusion of mechanisms such as deliberate use of performance assessment to manage site characterization would be wise. Because of experience gained here and abroad, diversity of geologic media is not particularly necessary as a criterion in site selection guidelines for multiple sites. Stepwise development of the repository program that includes flexibility also warrants serious consideration. Furthermore, integration of the waste management system from storage, transportation, and disposition, should be examined and would be facilitated by integration of the legal and regulatory framework. Finally, in order to enhance acceptability of future repository development, the national policy should be cognizant of those policy and technical attributes that enhance initial acceptance, and those policy and technical attributes that maintain and broaden credibility.« less

  15. 75 FR 5834 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-04

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Certain Cross-References and Make Other Various Non-Substantive..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...

  16. 77 FR 36029 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Rule Cross-References and Make Non- Substantive Technical..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers...

  17. 76 FR 32246 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Rule Cross-References and Make Non- Substantive Technical..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  18. 76 FR 60106 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

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

  19. 78 FR 62017 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-11

    ...The Office of the Comptroller of the Currency (OCC) and Board of Governors of the Federal Reserve System (Board), are adopting a final rule that revises their risk-based and leverage capital requirements for banking organizations. The final rule consolidates three separate notices of proposed rulemaking that the OCC, Board, and FDIC published in the Federal Register on August 30, 2012, with selected changes. The final rule implements a revised definition of regulatory capital, a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for banking organizations subject to the advanced approaches risk-based capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator. The final rule incorporates these new requirements into the agencies' prompt corrective action (PCA) framework. In addition, the final rule establishes limits on a banking organization's capital distributions and certain discretionary bonus payments if the banking organization does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk-based capital requirements. Further, the final rule amends the methodologies for determining risk-weighted assets for all banking organizations, and introduces disclosure requirements that would apply to top-tier banking organizations domiciled in the United States with $50 billion or more in total assets. The final rule also adopts changes to the agencies' regulatory capital requirements that meet the requirements of section 171 and section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The final rule also codifies the agencies' regulatory capital rules, which have previously resided in various appendices to their respective regulations, into a harmonized integrated regulatory framework. In addition, the OCC is amending the market risk capital rule (market risk rule) to apply to

  20. 77 FR 39313 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-02

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...,\\2\\ notice is hereby given that on June 26, 2012, Financial Industry Regulatory Authority, Inc..., as FINRA shall designate, to file such additional financial or operational schedules or reports as...

  1. 77 FR 7218 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

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

  2. 76 FR 55441 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory... significant aspects of such statements. A. Self-Regulatory Organization's Statement of the Purpose of, and... professional responsibilities, including key regulatory and control themes, as well as the importance of...

  3. 10 CFR 20.1201 - Occupational dose limits for adults.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Occupational dose limits for adults. 20.1201 Section 20.1201 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose... surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational...

  4. 10 CFR 20.1201 - Occupational dose limits for adults.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Occupational dose limits for adults. 20.1201 Section 20.1201 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose... surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational...

  5. 10 CFR 20.1201 - Occupational dose limits for adults.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Occupational dose limits for adults. 20.1201 Section 20.1201 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose... surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational...

  6. 10 CFR 20.1201 - Occupational dose limits for adults.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Occupational dose limits for adults. 20.1201 Section 20.1201 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose... surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational...

  7. 10 CFR 20.1201 - Occupational dose limits for adults.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Occupational dose limits for adults. 20.1201 Section 20.1201 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose... surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational...

  8. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  9. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  10. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  11. 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

    ... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  12. 75 FR 11605 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Reporting Facility and OTC Reporting Facility Fees March 4, 2010. Pursuant to Section 19(b)(1) of the... March 1, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...

  13. 78 FR 60952 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... hereby given that, on September 24, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed... discussed any comments it received on the proposed rule change. The text of these statements may be examined...

  14. 40 CFR 227.27 - Limiting permissible con-cen-tra-tion (LPC).

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Limiting permissible con-cen-tra-tion... scientific literature or accepted by EPA as being reliable test organisms to determine the anticipated impact... for each type they represent, and that are documented in the scientific literature and accepted by EPA...

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

    NASA Technical Reports Server (NTRS)

    Duda, Kristen; Scroggins, Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross

  16. NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Duda, Kristen; Scroggins. Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross

  17. 78 FR 12405 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the... Approval of Change in Ownership, Control, or Business Operations) to provide for a refund of the...

  18. Evaluation of regulatory variation and theoretical health risk for pesticide maximum residue limits in food.

    PubMed

    Li, Zijian

    2018-08-01

    To evaluate whether pesticide maximum residue limits (MRLs) can protect public health, a deterministic dietary risk assessment of maximum pesticide legal exposure was conducted to convert global MRLs to theoretical maximum dose intake (TMDI) values by estimating the average food intake rate and human body weight for each country. A total of 114 nations (58% of the total nations in the world) and two international organizations, including the European Union (EU) and Codex (WHO) have regulated at least one of the most currently used pesticides in at least one of the most consumed agricultural commodities. In this study, 14 of the most commonly used pesticides and 12 of the most commonly consumed agricultural commodities were identified and selected for analysis. A health risk analysis indicated that nearly 30% of the computed pesticide TMDI values were greater than the acceptable daily intake (ADI) values; however, many nations lack common pesticide MRLs in many commonly consumed foods and other human exposure pathways, such as soil, water, and air were not considered. Normality tests of the TMDI values set indicated that all distributions had a right skewness due to large TMDI clusters at the low end of the distribution, which were caused by some strict pesticide MRLs regulated by the EU (normally a default MRL of 0.01 mg/kg when essential data are missing). The Box-Cox transformation and optimal lambda (λ) were applied to these TMDI distributions, and normality tests of the transformed data set indicated that the power transformed TMDI values of at least eight pesticides presented a normal distribution. It was concluded that unifying strict pesticide MRLs by nations worldwide could significantly skew the distribution of TMDI values to the right, lower the legal exposure to pesticide, and effectively control human health risks. Copyright © 2018 Elsevier Ltd. All rights reserved.

  19. A system-level model for the microbial regulatory genome.

    PubMed

    Brooks, Aaron N; Reiss, David J; Allard, Antoine; Wu, Wei-Ju; Salvanha, Diego M; Plaisier, Christopher L; Chandrasekaran, Sriram; Pan, Min; Kaur, Amardeep; Baliga, Nitin S

    2014-07-15

    Microbes can tailor transcriptional responses to diverse environmental challenges despite having streamlined genomes and a limited number of regulators. Here, we present data-driven models that capture the dynamic interplay of the environment and genome-encoded regulatory programs of two types of prokaryotes: Escherichia coli (a bacterium) and Halobacterium salinarum (an archaeon). The models reveal how the genome-wide distributions of cis-acting gene regulatory elements and the conditional influences of transcription factors at each of those elements encode programs for eliciting a wide array of environment-specific responses. We demonstrate how these programs partition transcriptional regulation of genes within regulons and operons to re-organize gene-gene functional associations in each environment. The models capture fitness-relevant co-regulation by different transcriptional control mechanisms acting across the entire genome, to define a generalized, system-level organizing principle for prokaryotic gene regulatory networks that goes well beyond existing paradigms of gene regulation. An online resource (http://egrin2.systemsbiology.net) has been developed to facilitate multiscale exploration of conditional gene regulation in the two prokaryotes. © 2014 The Authors. Published under the terms of the CC BY 4.0 license.

  20. CMIP: a software package capable of reconstructing genome-wide regulatory networks using gene expression data.

    PubMed

    Zheng, Guangyong; Xu, Yaochen; Zhang, Xiujun; Liu, Zhi-Ping; Wang, Zhuo; Chen, Luonan; Zhu, Xin-Guang

    2016-12-23

    A gene regulatory network (GRN) represents interactions of genes inside a cell or tissue, in which vertexes and edges stand for genes and their regulatory interactions respectively. Reconstruction of gene regulatory networks, in particular, genome-scale networks, is essential for comparative exploration of different species and mechanistic investigation of biological processes. Currently, most of network inference methods are computationally intensive, which are usually effective for small-scale tasks (e.g., networks with a few hundred genes), but are difficult to construct GRNs at genome-scale. Here, we present a software package for gene regulatory network reconstruction at a genomic level, in which gene interaction is measured by the conditional mutual information measurement using a parallel computing framework (so the package is named CMIP). The package is a greatly improved implementation of our previous PCA-CMI algorithm. In CMIP, we provide not only an automatic threshold determination method but also an effective parallel computing framework for network inference. Performance tests on benchmark datasets show that the accuracy of CMIP is comparable to most current network inference methods. Moreover, running tests on synthetic datasets demonstrate that CMIP can handle large datasets especially genome-wide datasets within an acceptable time period. In addition, successful application on a real genomic dataset confirms its practical applicability of the package. This new software package provides a powerful tool for genomic network reconstruction to biological community. The software can be accessed at http://www.picb.ac.cn/CMIP/ .

  1. 75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62476; File No. SR-FINRA-2010-012] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule Change To Amend FINRA Rule 8312 (FINRA BrokerCheck Disclosure) July 8, 2010. I. Introduction On March 30, 2010, the Financial Industry Regulatory...

  2. Increasing Regulatory Acceptance of Passive Samplers

    DTIC Science & Technology

    2010-12-01

    microextraction ( SPME ) • Accumulate freely-dissolved organic contaminants from surrounding water into a solid phase • Contaminant concentrations of the...based on SPME (pg/L) D i s s o l v e d C o n c e n t r a t i o n b a s e d o n M u s s e l s ( p g / L ) 4,4’-DDE 4,4’-DDD 4,4’-DDT 1:1 line

  3. Classification criteria and probability risk maps: limitations and perspectives.

    PubMed

    Saisana, Michaela; Dubois, Gregoire; Chaloulakou, Archontoula; Spyrellis, Nikolas

    2004-03-01

    Delineation of polluted zones with respect to regulatory standards, accounting at the same time for the uncertainty of the estimated concentrations, relies on classification criteria that can lead to significantly different pollution risk maps, which, in turn, can depend on the regulatory standard itself. This paper reviews four popular classification criteria related to the violation of a probability threshold or a physical threshold, using annual (1996-2000) nitrogen dioxide concentrations from 40 air monitoring stations in Milan. The relative advantages and practical limitations of each criterion are discussed, and it is shown that some of the criteria are more appropriate for the problem at hand and that the choice of the criterion can be supported by the statistical distribution of the data and/or the regulatory standard. Finally, the polluted area is estimated over the different years and concentration thresholds using the appropriate risk maps as an additional source of uncertainty.

  4. Assessment of the benefits and impacts in the U.S. Nuclear Power Industry of hypothesized lower occupational dose limits

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

    Andersen, R.L.; Schmitt, J.F.

    1995-03-01

    The International Commission on Radiological Protection and the National Council on Radiation Protection and Measurements have issued recommendations that would limit occupational exposure of individuals to doses lower than regulatory limits contained in the Nuclear Regulatory Commission`s 10 CFR Part 20, {open_quotes}Standards for Protection Against Radiation{close_quotes}. Because of this situation, there is interest in the potential benefits and impacts that would be associated with movement of the NRC regulatory limits toward the advisory bodies recommendations. The records of occupational worker doses in the U.S. commercial nuclear power industry show that the vast majority of these workers have doses that aremore » significantly below the regulatory limit of 50 mSv (5 rem) per year. Some workers doses do approach the limits, however. This is most common in the case of specially skilled workers, especially those with skills utilized in support of plant outage work. Any consideration of the potential benefits and impacts of hypothesized lower dose limits must address these workers as an important input to the overall assessment. There are also, of course, many other areas in which the benefits and impacts must be evaluated. To prepare to provide valid, constructive input on this matter, the U.S. nuclear power industry is undertaking an assessment, facilitated by the Nuclear Energy Institute (NEI), of the potential benefits and impacts at its facilities associated with hypothesized lower occupational dose limits. Some preliminary results available to date from this assessment are provided.« less

  5. Assessing efficacy and therapeutic claims in emerging indications for recombinant factor VIIa: regulatory perspectives.

    PubMed

    Farrugia, Albert

    2006-01-01

    When compared with the evidence-based, cost-effectiveness criteria underpinning most government reimbursement schemes in the social market economies, the three regulatory hurdles of safety, quality and efficacy are probably of modest impact in influencing increased usage of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk, Bagsvaerd, Denmark). Nevertheless, efficacy claims must be supported if regulatory approval is to be granted for the wider range of indications that have been proposed for rFVIIa. With the refinement of clinical trial designs over the past 40 years, the randomized controlled trial (RCT) has assumed the role of gold standard, providing the highest level of evidence for therapeutic efficacy. However, it is incorrect to assume that regulatory authorities give sole credence to RCTs in assessing claims. It is noteworthy that the indications already accepted for rFVIIa by international regulatory authorities--including the treatment of inhibitors to factor VIII and factor IX, substitution for FVII deficiency, and treatment of Glanzmann's thrombasthenia--were supported not by RCTs but by studies conventionally considered to provide modest evidence levels. Therefore, the use of studies other than RCTs for the more recently proposed indications for rFVIIa in a range of conditions requiring hemostatic correction is perfectly feasible. What regulators expect are well-conducted and well-described studies adhering to principles of good clinical practice, which can be scrutinized for evidence of clinical efficacy and which are based on the initially proven principle for the drug. This paper discusses the regulatory history of rFVIIa in the major regulatory authorities and assesses the route needed to support claims being made in the mainstream literature. Recent episodes where post-market events have forced regulators to be more than usually cautious will be used as examples to suggest possible pitfalls to the extension of approved claims for

  6. The Effect of State Regulatory Stringency on Nursing Home Quality

    PubMed Central

    Mukamel, Dana B; Weimer, David L; Harrington, Charlene; Spector, William D; Ladd, Heather; Li, Yue

    2012-01-01

    Objective To test the hypothesis that more stringent quality regulations contribute to better quality nursing home care and to assess their cost-effectiveness. Data Sources/Setting Primary and secondary data from all states and U.S. nursing homes between 2005 and 2006. Study Design We estimated seven models, regressing quality measures on the Harrington Regulation Stringency Index and control variables. To account for endogeneity between regulation and quality, we used instrumental variables techniques. Quality was measured by staffing hours by type per case-mix adjusted day, hotel expenditures, and risk-adjusted decline in activities of daily living, high-risk pressure sores, and urinary incontinence. Data Collection All states' licensing and certification offices were surveyed to obtain data about deficiencies. Secondary data included the Minimum Data Set, Medicare Cost Reports, and the Economic Freedom Index. Principal Findings Regulatory stringency was significantly associated with better quality for four of the seven measures studied. The cost-effectiveness for the activities-of-daily-living measure was estimated at about 72,000 in 2011/ Quality Adjusted Life Year. Conclusions Quality regulations lead to better quality in nursing homes along some dimensions, but not all. Our estimates of cost-effectiveness suggest that increased regulatory stringency is in the ballpark of other acceptable cost-effective practices. PMID:22946859

  7. Hydropower Licensing as a Bridge between Climate Science and Applications: Creating Actionable Science for Regulatory Decisionmaking

    NASA Astrophysics Data System (ADS)

    Ray, A. J.; Barsugli, J. J.; Walker, S. H.

    2016-12-01

    The Integrated Licensing Process (ILP) of the US Federal Energy Regulatory Commission (FERC) is an example of an existing regulatory process that has the capacity to bridge the gap between science and decision making by clearly delineating existing science, the climate-regulatory nexus, and additional scientific work needed to inform licensing or relicensing of non-federal hydropower projects. In a parallel, but interacting set of legal and regulatory processes, NOAA's National Marine Fisheries Service (NMFS) must conduct analyses based on the best available science in order to implement the requirements of the Endangered Species Act (ESA), the Magnuson-Stevens Act, and NEPA, and to develop terms and conditions to protect fisheries for the 30-50 year term of the license and the longer life of the project itself. Therefore, NMFS must understand the combined effects of hydropower projects and climate change to fulfill its own mandates to protect anadromous fish, protected species and habitat. Federal Executive Order (EO) #13693 on climate change sustainability require use of climate risks in planning, also recommended in NOAA's own guidance on implementing ESA, and the Council on Environmental Quality (CEQ) guidance on implementing NEPA; however, as an independent agency FERC is not subject to that EO. In the past, FERC has consistently rejected NMFS' climate study requests, stating, among other reasons, that climate science is `too uncertain,' and therefore not actionable. Thus, in order for NMFS to get the information needed for its own decision process, NOAA must first persuade FERC that the science is actionable. This presentation will describe our experiences in a multi-year effort by an interdisciplinary team of climate and fishery scientists to develop acceptable climate study requests that address FERC's concerns about uncertainty, for the Susitna-Watana project on Alaska's Susitna River, the LaGrange Project on the Tuolumne R. in California, and the Hiram

  8. Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

    PubMed

    Wang, Ting; McAuslane, Neil; Liberti, Lawrence; Leufkens, Hubert; Hövels, Anke

    2018-06-01

    To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  9. Using FAIRE (Formaldehyde-Assisted Isolation of Regulatory Elements) to isolate active regulatory DNA

    PubMed Central

    Simon, Jeremy M.; Giresi, Paul G.; Davis, Ian J.; Lieb, Jason D.

    2013-01-01

    Eviction or destabilization of nucleosomes from chromatin is a hallmark of functional regulatory elements of the eukaryotic genome. Historically identified by nuclease hypersensitivity, these regulatory elements are typically bound by transcription factors or other regulatory proteins. FAIRE (Formaldehyde-Assisted Isolation of Regulatory Elements) is an alternative approach to identify these genomic regions and has proven successful in a multitude of eukaryotic cell and tissue types. Cells or dissociated tissues are crosslinked briefly with formaldehyde, lysed, and sonicated. Sheared chromatin is subjected to phenol-chloroform extraction and the isolated DNA, typically encompassing 1–3% of the human genome, is purified. We provide guidelines for quantitative analysis by PCR, microarrays, or next-generation sequencing. Regulatory elements enriched by FAIRE display high concordance with those identified by nuclease hypersensitivity or ChIP, and the entire procedure can be completed in three days. FAIRE exhibits low technical variability, which allows its use in large-scale studies of chromatin from normal or diseased tissues. PMID:22262007

  10. 78 FR 68834 - Maryland Solar, LLC; Notice of Petition for Limited Waiver

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL14-10-000; QF11-171-003] Maryland Solar, LLC; Notice of Petition for Limited Waiver Take notice that on November 6, 2013, pursuant... Procedure, 18 CFR 292.207, Maryland Solar, LLC filed a petition for limited waiver of section 292.601(c)(1...

  11. The role of acceptable knowledge in transuranic waste disposal operations - 11117

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

    Chancellor, Christopher John; Nelson, Roger

    2010-11-08

    Achievable (ALARA) and budgetary savings. This substitution is referred to as an Acceptable Knowledge Sufficiency Determination. With a Sufficiency Determination Request, AK may supplant the need for one or all of the physical analysis methods. This powerful procedure may be used on a scale as small as a single container to that of a vast waste stream. Only under the most stringent requirements will an AK Sufficiency Determination be approved by the regulators and, to date, only six such Sufficiency Determinations have been approved. Although Acceptable Knowledge is legislated into the operational procedures of the WIPP facility there is more to it than compliance. AK is not merely one of a long list of requirements in the characterization and verification of transuranic (TRU) waste destined for the WIPP. Acceptable Knowledge goes beyond the regulatory threshold by offering a way to reduce risk, cost, time, and uncertainty on its own laurels. Therefore, AK alone can be argued superior to any other waste characterization technique.« less

  12. Effects of delay and noise in a negative feedback regulatory motif

    NASA Astrophysics Data System (ADS)

    Palassini, Matteo; Dies, Marta

    2009-03-01

    The small copy number of the molecules involved in gene regulation can induce nontrivial stochastic phenomena such as noise-induced oscillations. An often neglected aspect of regulation dynamics are the delays involved in transcription and translation. Delays introduce analytical and computational complications because the dynamics is non-Markovian. We study the interplay of noise and delays in a negative feedback model of the p53 core regulatory network. Recent experiments have found pronounced oscillations in the concentrations of proteins p53 and Mdm2 in individual cells subjected to DNA damage. Similar oscillations occur in the Hes-1 and NK-kB systems, and in circadian rhythms. Several mechanisms have been proposed to explain this oscillatory behaviour, such as deterministic limit cycles, with and without delay, or noise-induced excursions in excitable models. We consider a generic delayed Master Equation incorporating the activation of Mdm2 by p53 and the Mdm2-promoted degradation of p53. In the deterministic limit and for large delays, the model shows a Hopf bifurcation. Via exact stochastic simulations, we find strong noise-induced oscillations well outside the limit-cycle region. We propose that this may be a generic mechanism for oscillations in gene regulatory systems.

  13. Regulatory decision with EPA/NRC/DOE/State Session (Panel)

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

    O`Donnell, E.

    1995-12-31

    This panel will cover the Nuclear Regulatory Commission`s (NRC) proposed radiation limits in the Branch Technical Position on Low-Level Radioactive Waste Performance Assessment and the Environmental Protection Agency`s (EPA) draft regulation in Part 193. Representatives from NRC and EPA will discuss the inconsistencies in these two regulations. DOE and state representatives will discuss their perspective on how these regulations will affect low-level radioactive waste performance assessments.

  14. Impact of the flu mask regulation on health care personnel influenza vaccine acceptance rates.

    PubMed

    Edwards, Frances; Masick, Kevin D; Armellino, Donna

    2016-10-01

    Achieving high vaccination rates of health care personnel (HCP) is critical in preventing influenza transmission from HCP to patients and from patients to HCP; however, acceptance rates remain low. In 2013, New York State adopted the flu mask regulation, requiring unvaccinated HCP to wear a mask when in areas where patients are present. The purpose of this study assessed the impact of the flu mask regulation on the HCP influenza vaccination rate. A 13-question survey was distributed electronically and manually to the HCP to examine their knowledge of influenza transmission and the influenza vaccine and their personal vaccine acceptance history and perception about the use of the mask while working if not vaccinated. There were 1,905 respondents; 87% accepted the influenza vaccine, and 63% were first-time recipients who agreed the regulation influenced their vaccination decision. Of the respondents who declined the vaccine, 72% acknowledge HCP are at risk for transmitting influenza to patients, and 56% reported they did not receive enough information to make an educated decision. The flu mask protocol may have influenced HCP's choice to be vaccinated versus wearing a mask. The study findings supported that HCP may not have adequate knowledge on the morbidity and mortality associated with influenza. Regulatory agencies need to consider an alternative approach to increase HCP vaccination, such as mandating the influenza vaccine for HCP. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  15. 75 FR 52574 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Reinstitute Short Exempt Marking for Trade Reporting and OATS August 20, 2010. Pursuant to... is hereby given that on August 6, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA...

  16. 76 FR 60567 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Create an Exemption From Certain Reporting Obligations Under the Equity Trade Reporting Rules... September 16, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities...

  17. 75 FR 8169 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend the Codes of Arbitration Procedure To Provide for Attorney Representation of Non-Party... Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers...

  18. 41 CFR 102-38.290 - What types of payment may we accept?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... limited to, the following: (a) U.S. currency or any form of credit instrument made payable on demand in U.S. currency, e.g., cashier's check, money order. Promissory notes and postdated credit instruments are not acceptable. (b) Irrevocable commercial letters of credit issued by a United States bank...

  19. Gamete and Embryo Donation and Surrogacy in Australia: The Social Context and Regulatory Framework

    PubMed Central

    Hammarberg, Karin; Johnson, Louise; Petrillo, Tracey

    2011-01-01

    The social and legal acceptability of third-party reproduction varies around the world. In Australia, gamete and embryo donation and surrogacy are permitted within the regulatory framework set out by federal and state governments. The aim of this paper is to describe the social context and regulatory framework for third-party reproduction in Australia. This is a review of current laws and regulations related to third-party reproduction in Australia. Although subtle between-state differences exist, third-party reproduction is by and large a socially acceptable and legally permissible way to form a family throughout Australia. The overarching principles that govern the practice of third-party reproduction are altruism; the right of donorconceived people to be informed of their biological origins; and the provision of comprehensive counselling about the social, psychological, physical, ethical, financial and legal implications of third-party reproduction to those considering donating or receiving gametes or embryos and entering surrogacy arrangements. These principles ensure that donors are not motivated by financial gain, donor offspring can identify and meet with the person or persons who donated gametes or embryos, and prospective donors and recipients are aware of and have carefully considered the potential consequences of third-party reproduction. Australian state laws and federal guidelines prohibit commercial and anonymous third-party reproduction; mandate counselling of all parties involved in gamete and embryo donation and surrogacy arrangements; and require clinics to keep records with identifying and non- identifying information about the donor/s to allow donor-conceived offspring to trace their biological origins. PMID:24851179

  20. Gamete and embryo donation and surrogacy in australia: the social context and regulatory framework.

    PubMed

    Hammarberg, Karin; Johnson, Louise; Petrillo, Tracey

    2011-01-01

    The social and legal acceptability of third-party reproduction varies around the world. In Australia, gamete and embryo donation and surrogacy are permitted within the regulatory framework set out by federal and state governments. The aim of this paper is to describe the social context and regulatory framework for third-party reproduction in Australia. This is a review of current laws and regulations related to third-party reproduction in Australia. Although subtle between-state differences exist, third-party reproduction is by and large a socially acceptable and legally permissible way to form a family throughout Australia. The overarching principles that govern the practice of third-party reproduction are altruism; the right of donorconceived people to be informed of their biological origins; and the provision of comprehensive counselling about the social, psychological, physical, ethical, financial and legal implications of third-party reproduction to those considering donating or receiving gametes or embryos and entering surrogacy arrangements. These principles ensure that donors are not motivated by financial gain, donor offspring can identify and meet with the person or persons who donated gametes or embryos, and prospective donors and recipients are aware of and have carefully considered the potential consequences of third-party reproduction. Australian state laws and federal guidelines prohibit commercial and anonymous third-party reproduction; mandate counselling of all parties involved in gamete and embryo donation and surrogacy arrangements; and require clinics to keep records with identifying and non- identifying information about the donor/s to allow donor-conceived offspring to trace their biological origins.