75 FR 52996 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-30

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Draft Regulatory Guide, DG-8035, ``Administrative Practices in Radiation Surveys and Monitoring.'' FOR FURTHER...

Analysis of Regulatory Guidance for Health Monitoring

NASA Technical Reports Server (NTRS)

Munns, Thomas E.; Beard, Richard E.; Culp, Aubrey M.; Murphy, Dennis A.; Kent, Renee M.; Cooper, Eric G. (Technical Monitor)

2000-01-01

The purpose of this study was to assess the connection between current FAA regulations and the incorporation of Health Management (HM) systems into commercial aircraft. To address the overall objectives ARINC: (1) investigated FAA regulatory guidance, (2) investigated airline maintenance practices, (3) systematically identified regulations and practices that would be affected or could act as barriers to the introduction of HM technology, and (4) assessed regulatory and operational tradeoffs that should be considered for implementation. The assessment procedure was validated on a postulated structural HM capability for the B757 horizontal stabilizer.

Retrieval monitoring is influenced by information value: the interplay between importance and confidence on false memory.

PubMed

McDonough, Ian M; Bui, Dung C; Friedman, Michael C; Castel, Alan D

2015-10-01

The perceived value of information can influence one's motivation to successfully remember that information. This study investigated how information value can affect memory search and evaluation processes (i.e., retrieval monitoring). In Experiment 1, participants studied unrelated words associated with low, medium, or high values. Subsequent memory tests required participants to selectively monitor retrieval for different values. False memory effects were smaller when searching memory for high-value than low-value words, suggesting that people more effectively monitored more important information. In Experiment 2, participants studied semantically-related words, and the need for retrieval monitoring was reduced at test by using inclusion instructions (i.e., endorsement of any word related to the studied words) compared with standard instructions. Inclusion instructions led to increases in false recognition for low-value, but not for high-value words, suggesting that under standard-instruction conditions retrieval monitoring was less likely to occur for important information. Experiment 3 showed that words retrieved with lower confidence were associated with more effective retrieval monitoring, suggesting that the quality of the retrieved memory influenced the degree and effectiveness of monitoring processes. Ironically, unless encouraged to do so, people were less likely to carefully monitor important information, even though people want to remember important memories most accurately. Copyright © 2015 Elsevier B.V. All rights reserved.

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.

PubMed

Molzon, J A; Giaquinto, A; Lindstrom, L; Tominaga, T; Ward, M; Doerr, P; Hunt, L; Rago, L

2011-04-01

The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.

The Interplay between Value and Relatedness as Bases for Metacognitive Monitoring and Control: Evidence for Agenda-Based Monitoring

ERIC Educational Resources Information Center

Soderstrom, Nicholas C.; McCabe, David P.

2011-01-01

Two experiments are reported examining how value and relatedness interact to influence metacognitive monitoring and control processes. Participants studied unrelated and related word pairs, each accompanied by point values denoting how important the items were to remember. These values were presented either before or after each pair in a…

Regulatory environment and its impact on the market value of investor-owned electric utilities

NASA Astrophysics Data System (ADS)

Vishwanathan, Raman

While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of

76 FR 31382 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 8.2, Revision 1, ``Administrative Practices in Radiation Surveys and Monitoring.'' FOR FURTHER INFORMATION...

Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

PubMed

Shimazawa, Rumiko; Ikeda, Masayuki

2016-03-01

Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

Dual-test monitoring of hyperglycemia using daily glucose and weekly fructosamine values.

PubMed

Carter, A W; Borchardt, N; Cooney, M; Greene, D

2001-01-01

The purpose of this study was to assess the impact of using a dual-test blood glucose/fructosamine home monitoring system to assist individuals identified as having the potential for poor glycemic control to achieve values closer to normal. Forty-eight subjects found to have a fasting blood glucose value of > or = 126 mg/dL, casual blood glucose value of > or = 140 mg/dL, and/or blood fructosamine value of > or = 310 micromol/L, agreed to perform daily self testing for 90 days and were provided a dual-test blood glucose/fructosamine home monitoring system and testing supplies at no charge to them. Medication changes/compliance along with dietary and exercise habits were compared to testing results by the principle investigator at approximate 30-day intervals. The desired goal of this project was to achieve and/or maintain a fasting blood glucose value of < or = 110 mg/dL, a casual blood glucose value of < or = 140 mg/dL and a blood fructosamine value of < or = 310 micromol/L by encouraging each individual to realize the effect of dietary intake and exercise habits, and understand the importance of medication compliance, if appropriate, in achieving better overall glycemic control. Four subjects withdrew from the study prior to completion, 11 of the remaining 44 completed 60 days of testing and 33 of 44 completed 90 days of testing. Regular monitoring and counseling achieved an average reduction in blood glucose of 27.5% and a 16.6% reduction in average blood fructosamine when compared to original screening results of these 44 individuals. This study indicates that the addition of weekly fructosamine values to daily blood glucose values provides both the patient and clinician valuable information to evaluate the impact of dietary, exercise, and medication therapy changes on glycemic control by bridging the existing gap between daily blood glucose values and quarterly HbA1c confirmation of intervention results.

Integrative Genomic Analyses Yields Cell Cycle Regulatory Programs with Prognostic Value

PubMed Central

Cheng, Chao; Lou, Shaoke; Andrews, Erik H.; Ung, Matthew H.; Varn, Frederick S.

2016-01-01

Liposarcoma is the second most common form of sarcoma, which has been categorized into four molecular subtypes, which are associated with differential prognosis of patients. However, the transcriptional regulatory programs associated with distinct histological and molecular subtypes of liposarcoma have not been investigated. This study uses integrative analyses to systematically define the transcriptional regulatory programs associated with liposarcoma. Likewise, computational methods are used to identify regulatory programs associated with different liposarcoma subtypes as well as programs that are predictive of prognosis. Further analysis of curated gene sets was used to identify prognostic gene signatures. The integration of data from a variety sources including gene expression profiles, transcription factor (TF) binding data from ChIP-seq experiments, curated gene sets, and clinical information of patients indicated discrete regulatory programs (e.g., controlled by E2F1 and E2F4) with significantly different regulatory activity in one or multiple subtypes of liposarcoma with respect to normal adipose tissue. These programs were also shown to be prognostic, wherein liposarcoma patients with higher E2F4 or E2F1 activity associated with unfavorable prognosis. A total of 259 gene sets were significantly associated with patient survival in liposarcoma, among which >50% are involved in cell cycle and proliferation. PMID:26856934

Inferring Gene Regulatory Networks by Singular Value Decomposition and Gravitation Field Algorithm

PubMed Central

Zheng, Ming; Wu, Jia-nan; Huang, Yan-xin; Liu, Gui-xia; Zhou, You; Zhou, Chun-guang

2012-01-01

Reconstruction of gene regulatory networks (GRNs) is of utmost interest and has become a challenge computational problem in system biology. However, every existing inference algorithm from gene expression profiles has its own advantages and disadvantages. In particular, the effectiveness and efficiency of every previous algorithm is not high enough. In this work, we proposed a novel inference algorithm from gene expression data based on differential equation model. In this algorithm, two methods were included for inferring GRNs. Before reconstructing GRNs, singular value decomposition method was used to decompose gene expression data, determine the algorithm solution space, and get all candidate solutions of GRNs. In these generated family of candidate solutions, gravitation field algorithm was modified to infer GRNs, used to optimize the criteria of differential equation model, and search the best network structure result. The proposed algorithm is validated on both the simulated scale-free network and real benchmark gene regulatory network in networks database. Both the Bayesian method and the traditional differential equation model were also used to infer GRNs, and the results were used to compare with the proposed algorithm in our work. And genetic algorithm and simulated annealing were also used to evaluate gravitation field algorithm. The cross-validation results confirmed the effectiveness of our algorithm, which outperforms significantly other previous algorithms. PMID:23226565

7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 11 2014-01-01 2014-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 11 2013-01-01 2013-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

Designing the Monitoring of Water-Related Sustainable Development Goals Based on Value of Information

NASA Astrophysics Data System (ADS)

Chen, R. S.; Levy, M. A.; de Sherbinin, A. M.; Fischer, A.

2015-12-01

The proposed Sustainable Development Goals (SDGs) represent an unprecedented international commitment to collective action and targeted interventions at global, regional, and national scales. Existing monitoring and data infrastructures are inadequate for producing the variety of environmental and socioeconomic information needed to ensure efficient and effective outcomes across the range of interlinked SDGs and targets. The scientific community needs to take a lead in developing new tools and approaches that, at reasonable cost, provide monitoring data of sufficient quality and spatial and temporal coverage to support informed decision making by diverse stakeholders. The expanded SDGs related to water offer the opportunity to explore potential new monitoring approaches and data system architectures in a key sector, building on existing water monitoring capabilities and incorporating new technologies and methods. Since additional investments in monitoring will undoubtedly be limited, it is important to assess carefully the value of information produced by different options and their associated risks and tradeoffs. We review here the existing set of water monitoring systems, known gaps and limitations, stakeholder inputs on data needs, and the potential value of information in light of alternative water sector interventions. Of particular interest are opportunities to share investments in monitoring across sectors and stakeholders (e.g., public and private entities) and to identify where incremental improvements in water monitoring could have significant benefits for other SDGs (e.g., related to health, energy, agriculture, and climate change). Value of information is also driven by the numbers of people affected by decisions or able to take advantage of improved data, which implies the need not only to collect and archive data, but also to invest in making data accessible and usable to diverse and geographically dispersed users.

Missing Value Monitoring Enhances the Robustness in Proteomics Quantitation.

PubMed

Matafora, Vittoria; Corno, Andrea; Ciliberto, Andrea; Bachi, Angela

2017-04-07

In global proteomic analysis, it is estimated that proteins span from millions to less than 100 copies per cell. The challenge of protein quantitation by classic shotgun proteomic techniques relies on the presence of missing values in peptides belonging to low-abundance proteins that lowers intraruns reproducibility affecting postdata statistical analysis. Here, we present a new analytical workflow MvM (missing value monitoring) able to recover quantitation of missing values generated by shotgun analysis. In particular, we used confident data-dependent acquisition (DDA) quantitation only for proteins measured in all the runs, while we filled the missing values with data-independent acquisition analysis using the library previously generated in DDA. We analyzed cell cycle regulated proteins, as they are low abundance proteins with highly dynamic expression levels. Indeed, we found that cell cycle related proteins are the major components of the missing values-rich proteome. Using the MvM workflow, we doubled the number of robustly quantified cell cycle related proteins, and we reduced the number of missing values achieving robust quantitation for proteins over ∼50 molecules per cell. MvM allows lower quantification variance among replicates for low abundance proteins with respect to DDA analysis, which demonstrates the potential of this novel workflow to measure low abundance, dynamically regulated proteins.

Reconciling Estimates of the Value to Firms of Reduced Regulatory Delay in the Marketing of Their New Drugs.

PubMed

Wilmoth, Daniel R

2015-12-01

The prescription drug user fee program provides additional resources to the U.S. Food and Drug Administration at the expense of regulated firms. Those resources accelerate the review of new drugs. Faster approvals allow firms to realize profits sooner, and the program is supported politically by industry. However, published estimates of the value to firms of reduced regulatory delay vary dramatically. It is shown here that this variation is driven largely by differences in methods that correspond to differences in implicit assumptions about the effects of reduced delay. Theoretical modeling is used to derive an equation describing the relationship between estimates generated using different methods. The method likely to yield the most accurate results is identified. A reconciliation of published estimates yields a value to a firm for a one-year reduction in regulatory delay at the time of approval of about $60 million for a typical drug. Published 2015. This article is a U.S. Government work and is in the public domain in the U.S.A. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

[Regulatory T cells].

PubMed

Marinić, Igor; Gagro, Alenka; Rabatić, Sabina

2006-12-01

involve autoimmune endocrine disorders (type 1 diabetes, thyroiditis), respiratory and nutritive allergy, eczema and severe infections. In different types of allergy (pollen allergy, dust mite, nutritive allergens, contact hypersensitivity, etc.) and autoimmune diseases (such as rheumatoid arthritis, multiple sclerosis and type 1 diabetes) a lower number or decreased functional capability of regulatory T cells have been described. In inflammatory conditions and infections, this cell population has an important task in restricting immune response and protecting the host from excessive damage. This ability of regulatory T cells can be used by some pathogens (Epstein Barr virus, Mycobacterium tuberculosis, Leishmania major, etc.) and tumor cells to avoid host response and therefore contribute to the development of some pathological conditions. The knowledge gained on the phenotype and function of regulatory T cells could be useful in many medical conditions. In allergy, autoimmune diseases and in transplant procedures in medicine it would be desirable to increase their function, thus to partially suppress the immune system activity. On the other hand, in some infections and tumors, it would be preferable to decrease the activity of regulatory T cells and boost the function of effector T cells. Regulatory T cells comprise a very active field of immunology, therefore monitoring and modulating of their activity is of great potential significance in a broad spectrum of clinical conditions. By developing and standardizing methods for their monitoring, it would be possible to follow additional parameters of certain clinical conditions and possibly utilize them in therapy.

Helping Undergraduates Discover the Value of a Dollar through Self-Monitoring

ERIC Educational Resources Information Center

Palmer, Lance; Bliss, Donna L.; Goetz, Joseph W.; Moorman, Diann

2010-01-01

Many college undergraduates lack basic financial management knowledge and skills while bearing ever increasing debt burdens upon graduation. In order to encourage students to become aware of their spending patterns and weigh those patterns against personal values, a self-monitoring project was implemented as a class activity. The resulting effect…

Setting monitoring objectives for landscape-size areas

Treesearch

Craig M. Olson; Dean Angelides

2000-01-01

The setting of objectives for monitoring schemes for landscape-size areas should be a complex task in today's regulatory and sociopolitical atmosphere. The technology available today, the regulatory environment, and the sociopolitical considerations require multiresource inventory and monitoring schemes, whether tile ownership is industrial or for preservation....

Passive in-home health and wellness monitoring: overview, value and examples.

PubMed

Alwan, Majd

2009-01-01

Modern sensor and communication technology, coupled with advances in data analysis and artificial intelligence techniques, is causing a paradigm shift in remote management and monitoring of chronic disease. In-home monitoring technology brings the added benefit of measuring individualized health status and reporting it to the care provider and caregivers alike, allowing timely and targeted preventive interventions, even in home and community based settings. This paper presents a paradigm for geriatric care based on monitoring older adults passively in their own living settings through placing sensors in their living environments or the objects they use. Activity and physiological data can be analyzed, archived and mined to detect indicators of early disease onset or changes in health conditions at various levels. Examples of monitoring systems are discussed and results from field evaluation pilot studies are summarized. The approach has shown great promise for a significant value proposition to all the stakeholders involved in caring for older adults. The paradigm would allow care providers to extend their services into the communities they serve.

Groundwater monitoring of hydraulic fracturing in California: Recommendations for permit-required monitoring

NASA Astrophysics Data System (ADS)

Esser, B. K.; Beller, H. R.; Carroll, S.; Cherry, J. A.; Jackson, R. B.; Jordan, P. D.; Madrid, V.; Morris, J.; Parker, B. L.; Stringfellow, W. T.; Varadharajan, C.; Vengosh, A.

2015-12-01

California recently passed legislation mandating dedicated groundwater quality monitoring for new well stimulation operations. The authors provided the State with expert advice on the design of such monitoring networks. Factors that must be considered in designing a new and unique groundwater monitoring program include: Program design: The design of a monitoring program is contingent on its purpose, which can range from detection of individual well leakage to demonstration of regional impact. The regulatory goals for permit-required monitoring conducted by operators on a well-by-well basis will differ from the scientific goals of a regional monitoring program conducted by the State. Vulnerability assessment: Identifying factors that increase the probability of transport of fluids from the hydrocarbon target zone to a protected groundwater zone enables the intensity of permit-required monitoring to be tiered by risk and also enables prioritization of regional monitoring of groundwater basins based on vulnerability. Risk factors include well integrity; proximity to existing wellbores and geologic features; wastewater disposal; vertical separation between the hydrocarbon and groundwater zones; and site-specific hydrogeology. Analyte choice: The choice of chemical analytes in a regulatory monitoring program is guided by the goals of detecting impact, assuring public safety, preventing resource degradation, and minimizing cost. Balancing these goals may be best served by tiered approach in which targeted analysis of specific chemical additives is triggered by significant changes in relevant but more easily analyzed constituents. Such an approach requires characterization of baseline conditions, especially in areas with long histories of oil and gas development. Monitoring technology: Monitoring a deep subsurface process or a long wellbore is more challenging than monitoring a surface industrial source. The requirement for monitoring multiple groundwater aquifers across

Predictive value of early near-infrared spectroscopy monitoring of patients with traumatic brain injury.

PubMed

Vilkė, Alina; Bilskienė, Diana; Šaferis, Viktoras; Gedminas, Martynas; Bieliauskaitė, Dalia; Tamašauskas, Arimantas; Macas, Andrius

2014-01-01

Traumatic brain injury (TBI) is the leading cause of death and disability in young adults. Study aimed to define the predictive value of early near-infrared spectroscopy (NIRS) monitoring of TBI patients in a Lithuanian clinical setting. Data of 61 patients was analyzed. Predictive value of early NIRS monitoring, computed tomography data and regular intensive care unit (ICU) parameters was investigated. Twenty-six patients expressed clinically severe TBI; 14 patients deceased. Patients who survived expressed higher NIRS values at the periods of admission to operative room (75.4%±9.8% vs. 71.0%±20.5%; P=0.013) and 1h after admission to ICU (74.7%±1.5% vs. 61.9%±19.4%; P=0.029). The NIRS values discriminated hospital mortality groups more accurately than admission GCS score, blood sugar or hemoglobin levels. Admission INR value and NIRS value at 1h after admission to ICU were selected by discriminant analysis into the optimal set of features when classifying hospital mortality groups. Average efficiency of classification using this method was 88.9%. When rsO2 values at 1h after admission to ICU did not exceed 68.0% in the left hemisphere and 68.3% in the right hemisphere, the hazard ratio for death increased by 17.7 times (P<0.01) and 5.1 times (P<0.05), respectively. NIRS plays an important role in the clinical care of TBI patients. Regional brain saturation monitoring provides accurate predictive data, which can improve the allocation of scarce medical resources, set the treatment goals and alleviate the early communication with patients' relatives. Copyright © 2014 Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Effective standards and regulatory tools for respiratory gas monitors and pulse oximeters: the role of the engineer and clinician.

PubMed

Weininger, Sandy

2007-12-01

Developing safe and effective medical devices involves understanding the hazardous situations that can arise in clinical practice and implementing appropriate risk control measures. The hazardous situations may have their roots in the design or in the use of the device. Risk control measures may be engineering or clinically based. A multidisciplinary team of engineers and clinicians is needed to fully identify and assess the risks and implement and evaluate the effectiveness of the control measures. In this paper, I use three issues, calibration/accuracy, response time, and protective measures/alarms, to highlight the contributions of these groups. This important information is captured in standards and regulatory tools to control risk for respiratory gas monitors and pulse oximeters. This paper begins with a discussion of the framework of safety, explaining how voluntary standards and regulatory tools work. The discussion is followed by an examination of how engineering and clinical knowledge are used to support the assurance of safety.

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

Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies.

PubMed

Grignolo, Alberto; Mingping, Zhang

2018-01-01

Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infrastructure that both reflect and help drive international regulatory convergence and accelerate delivery of needed, innovative products to patients. In this rapidly evolving regulatory and commercial environment, drug developers can benefit from reforms and proliferating accelerated pathway (AP) frameworks, but only with regulatory and evidence-generation strategies tailored to the region. Otherwise, they will confront significant pricing and reimbursement headwinds. Although APAC economies are at different stages of development, they share a common imperative: to balance pharmaceutical innovation with affordability. Despite the complexity of meeting these sometimes conflicting demands, companies that focus on demonstrating and delivering value for money, and that price new treatments reasonably and sustainably, can succeed both for their shareholders and the region's patient population.

A decision tree model to estimate the value of information provided by a groundwater quality monitoring network

NASA Astrophysics Data System (ADS)

Khader, A.; Rosenberg, D.; McKee, M.

2012-12-01

Nitrate pollution poses a health risk for infants whose freshwater drinking source is groundwater. This risk creates a need to design an effective groundwater monitoring network, acquire information on groundwater conditions, and use acquired information to inform management. These actions require time, money, and effort. This paper presents a method to estimate the value of information (VOI) provided by a groundwater quality monitoring network located in an aquifer whose water poses a spatially heterogeneous and uncertain health risk. A decision tree model describes the structure of the decision alternatives facing the decision maker and the expected outcomes from these alternatives. The alternatives include: (i) ignore the health risk of nitrate contaminated water, (ii) switch to alternative water sources such as bottled water, or (iii) implement a previously designed groundwater quality monitoring network that takes into account uncertainties in aquifer properties, pollution transport processes, and climate (Khader and McKee, 2012). The VOI is estimated as the difference between the expected costs of implementing the monitoring network and the lowest-cost uninformed alternative. We illustrate the method for the Eocene Aquifer, West Bank, Palestine where methemoglobinemia is the main health problem associated with the principal pollutant nitrate. The expected cost of each alternative is estimated as the weighted sum of the costs and probabilities (likelihoods) associated with the uncertain outcomes resulting from the alternative. Uncertain outcomes include actual nitrate concentrations in the aquifer, concentrations reported by the monitoring system, whether people abide by manager recommendations to use/not-use aquifer water, and whether people get sick from drinking contaminated water. Outcome costs include healthcare for methemoglobinemia, purchase of bottled water, and installation and maintenance of the groundwater monitoring system. At current

Groundwater contamination from waste management sites: The interaction between risk-based engineering design and regulatory policy: 2. Results

NASA Astrophysics Data System (ADS)

Massmann, Joel; Freeze, R. Allan

1987-02-01

The risk-cost-benefit analysis developed in the companion paper (J. Massmann and R. A. Freeze, this issue) is here applied to (1) an assessment of the relative worth of containment-construction activities, site-exploration activities, and monitoring activities as components of a design strategy for the owner/operator of a waste management facility; (2) an assessment of alternative policy options available to a regulatory agency; and (3) a case history. Sensitivity analyses designed to address the first issue show that the allocation of resources by the owner/operator is sensitive to the stochastic parameters used to describe the hydraulic conductivity field at a site. For the cases analyzed, the installation of a dense monitoring network is of less value to the owner/operator than a more conservative containment design. Sensitivity analyses designed to address the second issue suggest that from a regulatory perspective, design standards should be more effective than performance standards in reducing risk, and design specifications on the containment structure should be more effective than those on the monitoring network. Performance bonds posted before construction have a greater potential to influence design than prospective penalties to be imposed at the time of failure. Siting on low-conductivity deposits is a more effective method of risk reduction than any form of regulatory influence. Results of the case history indicate that the methodology can be successfully applied at field sites.

Monitoring the Social Environment for Forestry: The case of National Forest Benefits and Values

Treesearch

David N. Bengston; David P. Fan; Doris N. Celarier

1997-01-01

This paper describes a new approach for monitoring the social environment for forestry. Computer methods were used to analyze almost 30,000 online news media stories about the national forests for expressions of four main categories of benefits and values. Recreation benefits and values were expressed more often than other categories, both at the national and regional...

Value of information analysis for groundwater quality monitoring network design Case study: Eocene Aquifer, Palestine

NASA Astrophysics Data System (ADS)

Khader, A.; McKee, M.

2010-12-01

Value of information (VOI) analysis evaluates the benefit of collecting additional information to reduce or eliminate uncertainty in a specific decision-making context. It makes explicit any expected potential losses from errors in decision making due to uncertainty and identifies the “best” information collection strategy as one that leads to the greatest expected net benefit to the decision-maker. This study investigates the willingness to pay for groundwater quality monitoring in the Eocene Aquifer, Palestine, which is an unconfined aquifer located in the northern part of the West Bank. The aquifer is being used by 128,000 Palestinians to fulfill domestic and agricultural demands. The study takes into account the consequences of pollution and the options the decision maker might face. Since nitrate is the major pollutant in the aquifer, the consequences of nitrate pollution were analyzed, which mainly consists of the possibility of methemoglobinemia (blue baby syndrome). In this case, the value of monitoring was compared to the costs of treating for methemoglobinemia or the costs of other options like water treatment, using bottled water or importing water from outside the aquifer. And finally, an optimal monitoring network that takes into account the uncertainties in recharge (climate), aquifer properties (hydraulic conductivity), pollutant chemical reaction (decay factor), and the value of monitoring is designed by utilizing a sparse Bayesian modeling algorithm called a relevance vector machine.

Reference values for anxiety questionnaires: the Leiden Routine Outcome Monitoring Study.

PubMed

Schulte-van Maaren, Yvonne W M; Giltay, Erik J; van Hemert, Albert M; Zitman, Frans G; de Waal, Margot W M; Carlier, Ingrid V E

2013-09-25

The monitoring of patients with an anxiety disorder can benefit from Routine Outcome Monitoring (ROM). As anxiety disorders differ in phenomenology, several anxiety questionnaires are included in ROM: Brief Scale for Anxiety (BSA), PADUA Inventory Revised (PI-R), Panic Appraisal Inventory (PAI), Penn State Worry Questionnaire (PSWQ), Worry Domains Questionnaire (WDQ), Social Interaction, Anxiety Scale (SIAS), Social Phobia Scale (SPS), and the Impact of Event Scale-Revised (IES-R). We aimed to generate reference values for both 'healthy' and 'clinically anxious' populations for these anxiety questionnaires. We included 1295 subjects from the general population (ROM reference-group) and 5066 psychiatric outpatients diagnosed with a specific anxiety disorder (ROM patient-group). The MINI was used as diagnostic device in both the ROM reference group and the ROM patient group. To define limits for one-sided reference intervals (95th percentile; P95) the outermost 5% of observations were used. Receiver Operating Characteristics (ROC) analyses were used to yield alternative cut-off values for the anxiety questionnaires. For the ROM reference-group the mean age was 40.3 years (SD=12.6), and for the ROM patient-group it was 36.5 years (SD=11.9). Females constituted 62.8% of the reference-group and 64.4% of the patient-group. P95 ROM reference group cut-off values for reference versus clinically anxious populations were 11 for the BSA, 43 for the PI-R, 37 for the PAI Anticipated Panic, 47 for the PAI Perceived Consequences, 65 for the PAI Perceived Self-efficacy, 66 for the PSWQ, 74 for the WDQ, 32 for the SIAS, 19 for the SPS, and 36 for IES-R. ROC analyses yielded slightly lower reference values. The discriminative power of all eight anxiety questionnaires was very high. Substantial non-response and limited generalizability. For eight anxiety questionnaires a comprehensive set of reference values was provided. Reference values were generally higher in women than in men

A decision tree model to estimate the value of information provided by a groundwater quality monitoring network

NASA Astrophysics Data System (ADS)

Khader, A. I.; Rosenberg, D. E.; McKee, M.

2013-05-01

Groundwater contaminated with nitrate poses a serious health risk to infants when this contaminated water is used for culinary purposes. To avoid this health risk, people need to know whether their culinary water is contaminated or not. Therefore, there is a need to design an effective groundwater monitoring network, acquire information on groundwater conditions, and use acquired information to inform management options. These actions require time, money, and effort. This paper presents a method to estimate the value of information (VOI) provided by a groundwater quality monitoring network located in an aquifer whose water poses a spatially heterogeneous and uncertain health risk. A decision tree model describes the structure of the decision alternatives facing the decision-maker and the expected outcomes from these alternatives. The alternatives include (i) ignore the health risk of nitrate-contaminated water, (ii) switch to alternative water sources such as bottled water, or (iii) implement a previously designed groundwater quality monitoring network that takes into account uncertainties in aquifer properties, contaminant transport processes, and climate (Khader, 2012). The VOI is estimated as the difference between the expected costs of implementing the monitoring network and the lowest-cost uninformed alternative. We illustrate the method for the Eocene Aquifer, West Bank, Palestine, where methemoglobinemia (blue baby syndrome) is the main health problem associated with the principal contaminant nitrate. The expected cost of each alternative is estimated as the weighted sum of the costs and probabilities (likelihoods) associated with the uncertain outcomes resulting from the alternative. Uncertain outcomes include actual nitrate concentrations in the aquifer, concentrations reported by the monitoring system, whether people abide by manager recommendations to use/not use aquifer water, and whether people get sick from drinking contaminated water. Outcome costs

76 FR 65753 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at...) re-issued Draft Regulatory Guide, DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear... Revision 4A to Nuclear Management and Resources Council (NUMARC) 93-01, ``Industry Guideline for Monitoring...

Building the case for independent monitoring of food advertising on Australian television.

PubMed

King, Lesley; Hebden, Lana; Grunseit, Anne; Kelly, Bridget; Chapman, Kathy

2013-12-01

To provide an independent monitoring report examining the ongoing impact of Australian self-regulatory pledges on food and drink advertising to children on commercial television. Analysis of food advertisements across comparable sample time periods in April/May 2006, 2007, 2009, 2010 and 2011. The main outcome measure comprised change in the mean rate of non-core food advertisements from 2006 to 2011. Sydney free-to-air television channels. Televised food advertisements. In 2011 the rate of non-core food advertisements was not significantly different from that in 2006 or 2010 (3·2/h v. 4·1/h and 3·1/h), although there were variations across the intervening years. The rate of fast-food advertising in 2010 was significantly higher than in 2006 (1·8/h v. 1·1/h, P < 0·001), but the same as that in 2011 (1·5/h). The frequency of non-core food advertising on Sydney television has remained essentially unchanged between 2006 and 2011, despite the implementation of two industry self-regulatory pledges. The current study illustrates the value of independent monitoring as a basic requirement of any responsive regulatory approach.

Environmental monitoring plan

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

Holland, R.C.

This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 52 refs., 10 figs., 12 tabs.

Social Values, Regulatory Tensions and Professional Practices with Underprivileged Populations: The Case of Quebec's Oral Healthcare System

PubMed Central

Bedos, Christophe

2011-01-01

Objective: Dentists may experience frustration in their practice with people living on welfare, often perceiving them in a negative light. The difficulties encountered are detrimental to the patient—professional relationship and contribute to compromising access to care for this underprivileged population. In order to fully understand patient—professional interactions, we must consider the macroscopic contexts in which they occur. This paper examines the systemic influences of these interpersonal relationships to deepen our understanding of an important access-to-care determinant for people living on welfare. Methods: Two frameworks are applied to the analysis of Quebec's oral healthcare system: the social values framework and the regulatory logics framework. Results: Our assessment leads us to posit two phenomena: (1) certain negative stereotypes regarding patients living on welfare allow dentists to manage the inevitable regulatory conflicts (i.e., economic vs. professional) involved in their practice and (2) the behaviours of people living on welfare are frequently judged according to the social values embodied in the organization of Quebec's oral healthcare system, delivery and financing. Conclusion: Quebec's oral healthcare system fails to provide effective access to care for individuals living in poverty, and the government must significantly augment its involvement in this healthcare sector. Dentists should also understand the impact that systemic influences have on their rapport with people living on welfare. We argue that new orientations for the field of dental professional education should be considered. This paper was originally published in French, in the journal Pratiques et Organisation des Soins 2011 42(3). PMID:22851989

Assessing the value of information for long-term structural health monitoring

NASA Astrophysics Data System (ADS)

Pozzi, Matteo; Der Kiureghian, Armen

2011-04-01

In the field of Structural Health Monitoring, tests and sensing systems are intended as tools providing diagnoses, which allow the operator of the facility to develop an efficient maintenance plan or to require extraordinary measures on a structure. The effectiveness of these systems depends directly on their capability to guide towards the most optimal decision for the prevailing circumstances, avoiding mistakes and wastes of resources. Though this is well known, most studies only address the accuracy of the information gained from sensors without discussing economic criteria. Other studies evaluate these criteria separately, with only marginal or heuristic connection with the outcomes of the monitoring system. The concept of "Value of Information" (VoI) provides a rational basis to rank measuring systems according to a utility-based metric, which fully includes the decision-making process affected by the monitoring campaign. This framework allows, for example, an explicit assessment of the economical justifiability of adopting a sensor depending on its precision. In this paper we outline the framework for assessing the VoI, as applicable to the ranking of competitive measuring systems. We present the basic concepts involved, highlight issues related to monitoring of civil structures, address the problem of non-linearity of the cost-to-utility mapping, and introduce an approximate Monte Carlo approach suitable for the implementation of time-consuming predictive models.

Daily Laboratory Monitoring is of Poor Health Care Value in Adolescents Acutely Hospitalized for Eating Disorders.

PubMed

Ridout, Kathryn K; Kole, Jonathan; Fitzgerald, Kelly L; Ridout, Samuel J; Donaldson, Abigail A; Alverson, Brian

2016-07-01

This study investigates how the clinical practice guideline-recommended laboratory monitoring for refeeding syndrome impacts management and outcomes of adolescents with eating disorders hospitalized for acute medical stabilization and examines the value of laboratory monitoring (defined as the patient health outcomes achieved per dollar spent). A retrospective chart review of medical admissions in a children's hospital between October 2010 and February 2014 was performed. Encounters were identified using International Classification of Diseases, Ninth Revision codes of eating disorders as primary or secondary diagnoses. Exclusion criteria included systemic diseases associated with significant electrolyte abnormalities. Chart abstraction was performed using a predetermined form. Costs were estimated by converting hospital-fixed Medicaid charges using a statewide cost-to-charge ratio. Of the 196 patient encounters, there were no cases of refeeding syndrome. A total of 3,960 key recommended laboratories were obtained; 1.9% were below normal range and .05% were critical values. Of these, .28% resulted in supplementation; none were associated with a change in inpatient management. Total laboratory costs were $269,250.85; the calculated health care value of this monitoring is 1.04 × 10(-8) differential outcomes per dollar spent. This study provides evidence to suggest that daily laboratory monitoring for refeeding syndrome is a poor health care value in the management of adolescents hospitalized for acute medical stabilization with eating disorders. This initial analysis suggests that starting at a relatively low caloric level and advancing nutrition slowly may negate the need for daily laboratory assessment, which may have important implications for current guidelines. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

76 FR 15012 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... such registration. Members would be responsible for tracking and monitoring their associated persons to... from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization... supervising the securities or investment banking business of a member firm be qualified and registered persons...

14 CFR 313.4 - Major regulatory actions.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) PROCEDURAL REGULATIONS IMPLEMENTATION OF THE ENERGY POLICY AND CONSERVATION ACT § 313.4 Major regulatory... major regulatory action requiring an energy statement, if it: (1) May cause a near-term net annual... its precedential value, substantial controversy with respect to energy conservation and efficiency, or...

14 CFR 313.4 - Major regulatory actions.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) PROCEDURAL REGULATIONS IMPLEMENTATION OF THE ENERGY POLICY AND CONSERVATION ACT § 313.4 Major regulatory... major regulatory action requiring an energy statement, if it: (1) May cause a near-term net annual... its precedential value, substantial controversy with respect to energy conservation and efficiency, or...

Advancing Sensor Technology to Monitor Wildfires

EPA Pesticide Factsheets

EPA and partners are looking at ways to use miniature sensors to monitor air quality near wildfires. Data from these small sensors can complement measurements obtained from more complex regulatory-grade monitors that are stationary.

Medical research misconduct need regulatory reforms.

PubMed

Bedi, Neeraj

2014-10-01

The medical research misconduct has become a global problem. Except from countries like the USA, China, and Germany the exact figures of misconduct are not available. The research misconduct include fabricating the data, falsifying data, and plagiarism. The irresponsible research practices are publishing research data more than once, conflicts of interest is not declared, selective reporting of data and including an author who has not contributed at all and many more. About 2% of scientists have been found to admit the fabricating the data and 33% researchers were involved in irresponsible research practices. There is no formal regulatory programs available to monitor the research projects. Few developed countries like the USA, Germany, and China tried to develop programs which can monitor the medical research misconduct. There is a need to develop a regulatory system at national and institutional level to regulate the research activity to ensure that good ethical and scientific standards are practiced by medical researchers.

10 CFR 26.406 - Fitness monitoring.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Fitness monitoring. 26.406 Section 26.406 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.406 Fitness monitoring. (a...) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and...

10 CFR 26.406 - Fitness monitoring.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Fitness monitoring. 26.406 Section 26.406 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.406 Fitness monitoring. (a...) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and...

10 CFR 26.406 - Fitness monitoring.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Fitness monitoring. 26.406 Section 26.406 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.406 Fitness monitoring. (a...) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and...

10 CFR 26.406 - Fitness monitoring.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Fitness monitoring. 26.406 Section 26.406 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.406 Fitness monitoring. (a...) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and...

10 CFR 26.406 - Fitness monitoring.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Fitness monitoring. 26.406 Section 26.406 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.406 Fitness monitoring. (a...) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and...

Lessons from the polybrominated diphenyl ethers (PBDEs): precautionary principle, primary prevention, and the value of community-based body-burden monitoring using breast milk.

PubMed

Hooper, Kim; She, Jianwen

2003-01-01

Levels of chemicals in humans (body burdens) are useful indicators of environmental quality and of community health. Chemical body burdens are easily monitored using breast milk samples collected from first-time mothers (primiparae) with infants 2-8 weeks of age. Currently, there is no body-burden monitoring program using breast milk in the United States, although ad hoc systems operate successfully in several European countries. In this article we describe the value of such monitoring and important considerations of how it might be accomplished, drawing from our experiences with pilot monitoring projects. Breast milk has several advantages as a sampling matrix: It is simple and noninvasive, with samples collected by the mother. It monitors body burdens in reproductive-age women and it estimates in utero and nursing-infant exposures, all important to community health. Time-trend data from breast milk monitoring serve as a warning system that identifies chemicals whose body burdens and human exposures are increasing. Time trends also serve as a report card on how well past regulatory actions have reduced environmental chemical exposures. Body-burden monitoring using breast milk should include educational programs that encourage breast-feeding. Finally, and most important, clean breast milk matters to people and leads to primary prevention--the limiting of chemical exposures. We illustrate these advantages with polybrominated diphenyl ethers (PBDEs), a formerly obscure group of brominated flame retardants that rose to prominence and were regulated in Sweden when residue levels were found to be rapidly increasing in breast milk. A community-based body-burden monitoring program using breast milk could be set up in the United States in collaboration with the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC has a large number of lactating first-time mothers: It has 6,000 clinics nationwide and serves almost half (47%) the infants born in

Monitored plutonium aerosols at a soil cleanup site on Johnston Atoll

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

Shinn, J.H.; Fry, C.O.; Johnson, J.S.

1996-01-23

Suspended plutonium in air was monitored for four periods near the operation of a stationary sorting system used to {open_quotes}mine{close_quotes} contaminated soil on Johnston Atoll. The monitoring periods were 14 October-14 November 1992, 20 October-15 November 1993, 16 August-3 November 1994, and 17 February-27 February 1995. Pairs of high volume air samplers were located at each of four locations of the process stream: the {open_quotes}spoils pile{close_quotes} that was the feedstock, the {open_quotes}plant area{close_quotes} near the hot soil gate of the sorter, the {open_quotes}clean pile{close_quotes} conveyer area where sorted clean soil was moved, and the {open_quotes}oversize soil{close_quotes} crushing area. These locationsmore » were monitored only during the working hours, while air monitoring was also done at an upwind, {open_quotes}background{close_quotes} area 24-hours per day. The median concentrations of Pu in {open_quotes}workplace{close_quotes} air (combined spoils pile, plant area, and clean pile sites) in 1992 was 397 aCi/m{sup 3} (15 {mu}Bq/m{sup 3}), but increased to median values of 23000 aCi/m{sup 3} (852 {mu}Bq/m{sup 3}) in August-November 1994 and 29800 aCi/m{sup 3} (1100 {mu}Bq/m{sup 3}) in February 1995. The highest median value at the worksites (29800 aCi/m{sup 3}) was more than 200 times lower than the regulatory level. The highest observed value was 84200 aCi/m{sup 3} at the spoils pile site, and this was more than 70 times lower than the regulatory level. The conclusion was that, in spite of the dusty environment, and the increased level of specific activity, we did not find that the soil processing posed any significant risk to workers during the observation periods 1992-1995.« less

A context-intensive approach to imputation of missing values in data sets from networks of environmental monitors.

PubMed

Larsen, Lawrence C; Shah, Mena

2016-01-01

Although networks of environmental monitors are constantly improving through advances in technology and management, instances of missing data still occur. Many methods of imputing values for missing data are available, but they are often difficult to use or produce unsatisfactory results. I-Bot (short for "Imputation Robot") is a context-intensive approach to the imputation of missing data in data sets from networks of environmental monitors. I-Bot is easy to use and routinely produces imputed values that are highly reliable. I-Bot is described and demonstrated using more than 10 years of California data for daily maximum 8-hr ozone, 24-hr PM2.5 (particulate matter with an aerodynamic diameter <2.5 μm), mid-day average surface temperature, and mid-day average wind speed. I-Bot performance is evaluated by imputing values for observed data as if they were missing, and then comparing the imputed values with the observed values. In many cases, I-Bot is able to impute values for long periods with missing data, such as a week, a month, a year, or even longer. Qualitative visual methods and standard quantitative metrics demonstrate the effectiveness of the I-Bot methodology. Many resources are expended every year to analyze and interpret data sets from networks of environmental monitors. A large fraction of those resources is used to cope with difficulties due to the presence of missing data. The I-Bot method of imputing values for such missing data may help convert incomplete data sets into virtually complete data sets that facilitate the analysis and reliable interpretation of vital environmental data.

78 FR 64030 - Monitoring Criteria and Methods To Calculate Occupational Radiation Doses

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0234] Monitoring Criteria and Methods To Calculate... regulatory guide (DG), DG-8031, ``Monitoring Criteria and Methods to Calculate Occupational Radiation Doses.'' This guide describes methods that the NRC staff considers acceptable for licensees to use to determine...

76 FR 55137 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-06

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at... comment draft regulatory guide (DG) DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' This guide endorses Revision 4A to Nuclear Management and Resources Council (NUMARC) 93...

Fluorescence Spectroscopy Applied to Monitoring Biodiesel Degradation: Correlation with Acid Value and UV Absorption Analyses.

PubMed

Vasconcelos, Maydla Dos Santos; Passos, Wilson Espíndola; Lescanos, Caroline Honaiser; Pires de Oliveira, Ivan; Trindade, Magno Aparecido Gonçalves; Caires, Anderson Rodrigues Lima; Muzzi, Rozanna Marques

2018-01-01

The techniques used to monitor the quality of the biodiesel are intensely discussed in the literature, partly because of the different oil sources and their intrinsic physicochemical characteristics. This study aimed to monitor the thermal degradation of the fatty acid methyl esters of Sesamum indicum L. and Raphanus sativus L. biodiesels (SILB and RSLB, resp.). The results showed that both biodiesels present a high content of unsaturated fatty acids, ∼84% (SILB) and ∼90% (RSLB). The SILB had a high content of polyunsaturated linoleic fatty acid (18  :  2), about 49%, and the oleic monounsaturated (18  :  1), ∼34%. On the other hand, RSLB presented a considerable content of linolenic fatty acid (18  :  3), ∼11%. The biodiesel samples were thermal degraded at 110°C for 48 hours, and acid value, UV absorption, and fluorescence spectroscopy analysis were carried out. The results revealed that both absorption and fluorescence presented a correlation with acid value as a function of degradation time by monitoring absorptions at 232 and 270 nm as well as the emission at 424 nm. Although the obtained correlation is not completely linear, a direct correlation was observed in both cases, revealing that both properties can be potentially used for monitoring the biodiesel degradation.

Efficacy of T Regulatory Cells, Th17 Cells and the Associated Markers in Monitoring Tuberculosis Treatment Response

PubMed Central

Agrawal, Sonali; Parkash, Om; Palaniappan, Alangudi Natarajan; Bhatia, Ashok Kumar; Kumar, Santosh; Chauhan, Devendra Singh; Madhan Kumar, M.

2018-01-01

Treatment monitoring is an essential aspect for tuberculosis (TB) disease management. Sputum smear microscopy is the only available tool for monitoring, but it suffers from demerits. Therefore, we sought to evaluate markers and cellular subsets of T regulatory (Treg) cells and T helper (Th) 17 cells in pulmonary TB patients (PTB) for TB treatment monitoring. Peripheral blood mononuclear cells (PBMCs) were stimulated in vitro (with purified protein derivative (PPD)) overnight which was followed by a polychromatic flow cytometry approach to study Treg and Th17 markers and cellular subsets in PTB (n = 12) undergoing antituberculous treatment (ATT). The baseline levels of these markers and cellular subsets were evaluated in normal healthy subjects (NHS). We observed a significant decrease in the expression of CD25 (p<0.01) marker and percentage of T-cell subsets like CD4+CD25+ (p<0.001) and CD4+CD25+CD39+ (p<0.05) at the end of intensive phase (IP) as well as in the continuation phase (CP) of ATT. A decrease in CD25 marker expression and percentage of CD4+CD25+ T cell subset showed a positive correlation to sputum conversion both in high and low sputum positive PTB. In eight PTB with cavitary lesions, only CD4+CD25+FoxP3 Treg subset manifested a significant decrease at the end of CP. Thus, results of this study show that CD25 marker and CD4+CD25+ T cells can serve as better markers for monitoring TB treatment efficacy. The Treg subset CD4+CD25+FoxP3 may be useful for prediction of favorable response in PTB with extensive lung lesions. However, these findings have to be evaluated in a larger patient cohort. PMID:29472922

Compliance Groundwater Monitoring of Nonpoint Sources - Emerging Approaches

NASA Astrophysics Data System (ADS)

Harter, T.

2008-12-01

Groundwater monitoring networks are typically designed for regulatory compliance of discharges from industrial sites. There, the quality of first encountered (shallow-most) groundwater is of key importance. Network design criteria have been developed for purposes of determining whether an actual or potential, permitted or incidental waste discharge has had or will have a degrading effect on groundwater quality. The fundamental underlying paradigm is that such discharge (if it occurs) will form a distinct contamination plume. Networks that guide (post-contamination) mitigation efforts are designed to capture the shape and dynamics of existing, finite-scale plumes. In general, these networks extend over areas less than one to ten hectare. In recent years, regulatory programs such as the EU Nitrate Directive and the U.S. Clean Water Act have forced regulatory agencies to also control groundwater contamination from non-incidental, recharging, non-point sources, particularly agricultural sources (fertilizer, pesticides, animal waste application, biosolids application). Sources and contamination from these sources can stretch over several tens, hundreds, or even thousands of square kilometers with no distinct plumes. A key question in implementing monitoring programs at the local, regional, and national level is, whether groundwater monitoring can be effectively used as a landowner compliance tool, as is currently done at point-source sites. We compare the efficiency of such traditional site-specific compliance networks in nonpoint source regulation with various designs of regional nonpoint source monitoring networks that could be used for compliance monitoring. We discuss advantages and disadvantages of the site vs. regional monitoring approaches with respect to effectively protecting groundwater resources impacted by nonpoint sources: Site-networks provide a tool to enforce compliance by an individual landowner. But the nonpoint source character of the contamination

Monitoring in landfills

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

Nuckols, T.E.

Environmental monitoring is a very important activity performed on landfills. The data obtained is vital to ensuring that the landfill is in compliance with the regulatory standards. More importantly monitoring data can be used as historical documentation should enforcement or legal action be taken against the landfill. It is very difficult, if not impossible, to defend against alleged mismanagement or misconduct when there is no record to prove otherwise.

Monitoring quality of care at dialysis facilities: a case for regulatory parsimony--and beyond.

PubMed

Stivelman, John C

2012-10-01

With the issuance of the new Conditions for Coverage in 2008 and the implementation of the Prospective Payment System in 2011, the Centers for Medicare & Medicaid Services has fundamentally altered the regulatory landscape of quality in the ESRD program. Although these changes-largely through use of tools comparing individual facility performance to regional and national quality expectations-have increased facility accountability for the quality of patient care in many quarters, they have also complicated both substance and process of facility adherence to quality rules in that component of the program. This editorial critically assesses the main quality tools now in use for dialysis facilities and reviews the issues arising from their conjoint use. A scheme for improving the effectiveness of each quality tool is proposed, and an assessment of their future value and effectiveness in quality improvement is offered.

10 CFR 36.29 - Radiation monitors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Radiation monitors. 36.29 Section 36.29 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance Requirements for Irradiators § 36.29 Radiation monitors. (a) Irradiators with automatic product conveyor...

10 CFR 36.29 - Radiation monitors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Radiation monitors. 36.29 Section 36.29 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance Requirements for Irradiators § 36.29 Radiation monitors. (a) Irradiators with automatic product conveyor...

10 CFR 36.29 - Radiation monitors.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Radiation monitors. 36.29 Section 36.29 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance Requirements for Irradiators § 36.29 Radiation monitors. (a) Irradiators with automatic product conveyor...

10 CFR 36.29 - Radiation monitors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Radiation monitors. 36.29 Section 36.29 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance Requirements for Irradiators § 36.29 Radiation monitors. (a) Irradiators with automatic product conveyor...

10 CFR 36.29 - Radiation monitors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Radiation monitors. 36.29 Section 36.29 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance Requirements for Irradiators § 36.29 Radiation monitors. (a) Irradiators with automatic product conveyor...

Overview of Sensors and Needs for Environmental Monitoring

PubMed Central

Ho, Clifford K.; Robinson, Alex; Miller, David R.; Davis, Mary J.

2005-01-01

This paper surveys the needs associated with environmental monitoring and long-term environmental stewardship. Emerging sensor technologies are reviewed to identify compatible technologies for various environmental monitoring applications. The contaminants that are considered in this report are grouped into the following categories: (1) metals, (2) radioisotopes, (3) volatile organic compounds, and (4) biological contaminants. United States regulatory drivers are evaluated for different applications (e.g., drinking water, storm water, pretreatment, and air emissions), and sensor requirements are derived from these regulatory metrics. Sensor capabilities are then summarized according to contaminant type, and the applicability of the different sensors to various environmental monitoring applications is discussed.

10 CFR 34.47 - Personnel monitoring.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...

10 CFR 34.47 - Personnel monitoring.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...

10 CFR 34.47 - Personnel monitoring.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...

10 CFR 34.47 - Personnel monitoring.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...

10 CFR 34.47 - Personnel monitoring.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...

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

Academic performance and self-regulatory skills in elite youth soccer players.

PubMed

Jonker, Laura; Elferink-Gemser, Marije T; Toering, Tynke T; Lyons, James; Visscher, Chris

2010-12-01

Although elite athletes have been reported to be high academic achievers, many elite soccer players struggle with a stereotype of being low academic achievers. The purpose of this study was to compare the academic level (pre-university or pre-vocational) and self-regulatory skills (planning, self-monitoring, evaluation, reflection, effort, and self-efficacy) of elite youth soccer players aged 12-16 years (n = 128) with those of 164 age-matched controls (typical students). The results demonstrate that the elite youth soccer players are more often enrolled in the pre-university academic system, which means that they are high academic achievers, compared with the typical student. The elite players also report an increased use of self-regulatory skills, in particular self-monitoring, evaluation, reflection, and effort. In addition, control students in the pre-university system had more highly developed self-regulatory skills than those in the pre-vocational system, whereas no difference was observed within the soccer population. This suggests that the relatively stronger self-regulatory skills reported by the elite youth soccer players may be essential for performance at the highest levels of sport competition and in academia.

10 CFR 74.53 - Process monitoring.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Process monitoring. 74.53 Section 74.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.53 Process monitoring. (a) Licensees subject to § 74.51...

10 CFR 74.53 - Process monitoring.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Process monitoring. 74.53 Section 74.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.53 Process monitoring. (a) Licensees subject to § 74.51...

10 CFR 74.53 - Process monitoring.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Process monitoring. 74.53 Section 74.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.53 Process monitoring. (a) Licensees subject to § 74.51...

10 CFR 74.53 - Process monitoring.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Process monitoring. 74.53 Section 74.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.53 Process monitoring. (a) Licensees subject to § 74.51...

10 CFR 74.55 - Item monitoring.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Item monitoring. 74.55 Section 74.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.55 Item monitoring. (a) Licensees subject to § 74.51...

10 CFR 74.55 - Item monitoring.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Item monitoring. 74.55 Section 74.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.55 Item monitoring. (a) Licensees subject to § 74.51...

10 CFR 74.55 - Item monitoring.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Item monitoring. 74.55 Section 74.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.55 Item monitoring. (a) Licensees subject to § 74.51...

10 CFR 74.55 - Item monitoring.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Item monitoring. 74.55 Section 74.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.55 Item monitoring. (a) Licensees subject to § 74.51...

24-hour esophageal pH-monitoring in children suspected of gastroesophageal reflux disease: analysis of intraesophageal pH monitoring values recorded in distal and proximal channel at diagnosis.

PubMed

Semeniuk, Janusz; Kaczmarski, Maciej

2007-10-14

To assess values of 24-h esophageal pH-monitoring parameters with dual-channel probe (distal and proximal channel) in children suspected of gastroesophageal reflux disease (GERD). 264 children suspected of gastroesophageal reflux (GER) were enrolled in a study (mean age c=20.78+/-17.23 mo). The outcomes of this study, immunoallerrgological tests and positive result of oral food challenge test with a potentially noxious nutrient, enabled to qualify children into particular study groups. 32 (12.1%) infants (group 1) had physiological GER diagnosed. Pathological acid GER was confirmed in 138 (52.3%) children. Primary GER was diagnosed in 76 (28.8%) children (group 2) and GER secondary to allergy to cow milk protein and/or other food (CMA/FA) in 62 (23.5%) children (group 3). 32 (12.1%) of them had CMA/FA (group 4-reference group), and in remaining 62 (23.5%) children neither GER nor CMA/FA was confirmed (group 5). Mean values of pH monitoring parameters measured in distal and proximal channel were analyzed in individual groups. This analysis showed statistically significant differentiation of mean values in the case of: number of episodes of acid GER, episodes of acid GER lasting >5 min, duration of the longest episode of acid GER in both channels, acid GER index total and supine in proximal channel. Statistically significant differences of mean values among examined groups, especially between group 2 and 3 in the case of total acid GER index (only distal channel) were confirmed. 24-h esophageal pH monitoring confirmed pathological acid GER in 52.3% of children with typical and atypical symptoms of GERD. The similar pH-monitoring values obtained in group 2 and 3 confirm the necessity of implementation of differential diagnosis for primary vs secondary cause of GER.

Comparison of Erosion Rates Estimated by Sediment Budget Techniques and Suspended Sediment Monitoring and Regulatory Implications

NASA Astrophysics Data System (ADS)

O'Connor, M.; Eads, R.

2007-12-01

Watersheds in the northern California Coast Range have been designated as "impaired" with respect to water quality because of excessive sediment loads and/or high water temperature. Sediment budget techniques have typically been used by regulatory authorities to estimate current erosion rates and to develop targets for future desired erosion rates. This study examines erosion rates estimated by various methods for portions of the Gualala River watershed, designated as having water quality impaired by sediment under provisions of the Clean Water Act Section 303(d), located in northwest Sonoma County (~90 miles north of San Francisco). The watershed is underlain by Jurassic age sedimentary and meta-sedimentary rocks of the Franciscan formation. The San Andreas Fault passes through the western edge of watershed, and other active faults are present. A substantial portion of the watershed is mantled by rock slides and earth flows, many of which are considered dormant. The Coast Range is geologically young, and rapid rates of uplift are believed to have contributed to high erosion rates. This study compares quantitative erosion rate estimates developed at different spatial and temporal scales. It is motivated by a proposed vineyard development project in the watershed, and the need to document conditions in the project area, assess project environmental impacts and meet regulatory requirements pertaining to water quality. Erosion rate estimates were previously developed using sediment budget techniques for relatively large drainage areas (~100 to 1,000 km2) by the North Coast Regional Water Quality Control Board and US EPA and by the California Geological Survey. In this study, similar sediment budget techniques were used for smaller watersheds (~3 to 8 km2), and were supplemented by a suspended sediment monitoring program utilizing Turbidity Threshold Sampling techniques (as described in a companion study in this session). The duration of the monitoring program to date

The utility of Bayesian predictive probabilities for interim monitoring of clinical trials

PubMed Central

Connor, Jason T.; Ayers, Gregory D; Alvarez, JoAnn

2014-01-01

Background Bayesian predictive probabilities can be used for interim monitoring of clinical trials to estimate the probability of observing a statistically significant treatment effect if the trial were to continue to its predefined maximum sample size. Purpose We explore settings in which Bayesian predictive probabilities are advantageous for interim monitoring compared to Bayesian posterior probabilities, p-values, conditional power, or group sequential methods. Results For interim analyses that address prediction hypotheses, such as futility monitoring and efficacy monitoring with lagged outcomes, only predictive probabilities properly account for the amount of data remaining to be observed in a clinical trial and have the flexibility to incorporate additional information via auxiliary variables. Limitations Computational burdens limit the feasibility of predictive probabilities in many clinical trial settings. The specification of prior distributions brings additional challenges for regulatory approval. Conclusions The use of Bayesian predictive probabilities enables the choice of logical interim stopping rules that closely align with the clinical decision making process. PMID:24872363

10 CFR 39.65 - Personnel monitoring.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...

10 CFR 39.65 - Personnel monitoring.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...

10 CFR 39.65 - Personnel monitoring.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...

10 CFR 39.65 - Personnel monitoring.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...

10 CFR 39.65 - Personnel monitoring.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...

Effect-based trigger values for in vitro bioassays: Reading across from existing water quality guideline values.

PubMed

Escher, Beate I; Neale, Peta A; Leusch, Frederic D L

2015-09-15

Cell-based bioassays are becoming increasingly popular in water quality assessment. The new generations of reporter-gene assays are very sensitive and effects are often detected in very clean water types such as drinking water and recycled water. For monitoring applications it is therefore imperative to derive trigger values that differentiate between acceptable and unacceptable effect levels. In this proof-of-concept paper, we propose a statistical method to read directly across from chemical guideline values to trigger values without the need to perform in vitro to in vivo extrapolations. The derivation is based on matching effect concentrations with existing chemical guideline values and filtering out appropriate chemicals that are responsive in the given bioassays at concentrations in the range of the guideline values. To account for the mixture effects of many chemicals acting together in a complex water sample, we propose bioanalytical equivalents that integrate the effects of groups of chemicals with the same mode of action that act in a concentration-additive manner. Statistical distribution methods are proposed to derive a specific effect-based trigger bioanalytical equivalent concentration (EBT-BEQ) for each bioassay of environmental interest that targets receptor-mediated toxicity. Even bioassays that are indicative of the same mode of action have slightly different numeric trigger values due to differences in their inherent sensitivity. The algorithm was applied to 18 cell-based bioassays and 11 provisional effect-based trigger bioanalytical equivalents were derived as an illustrative example using the 349 chemical guideline values protective for human health of the Australian Guidelines for Water Recycling. We illustrate the applicability using the example of a diverse set of water samples including recycled water. Most recycled water samples were compliant with the proposed triggers while wastewater effluent would not have been compliant with a few

Enhancing Self-Regulatory Skills through an Intervention Embedded in a Middle School Mathematics Curriculum

ERIC Educational Resources Information Center

Digiacomo, Gregory; Chen, Peggy P.

2016-01-01

We investigated the effects of a self-regulatory intervention strategy designed to improve middle-school students' calibration accuracy, self-regulatory skills, and math achievement. Focusing on self-monitoring and self-reflection as the two key processes of this intervention in relation to improving students' math achievement and overall…

Biological Monitoring Density Values

DOE Data Explorer

Horne, John

2017-04-11

Density values from active acoustic measurements at South Energy Test Site. This data correspond to a bottom mounted upward-looking WBAT, deployed from April 19th to September 30th. Samples (175 pings) were collected hourly at 1Hz.

76 FR 35922 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-20

... CONTACT: Harriet Karagiannis, Regulatory Guide Development Branch, Division of Engineering, Office of... direct the use of individual monitoring devices. In addition, 10 CFR part 34, ``Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations,'' includes a specific...

Regulatory approaches for addressing dissolved oxygen concerns at hydropower facilities

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

Peterson, Mark J.; Cada, Glenn F.; Sale, Michael J.

Low dissolved oxygen (DO) concentrations are a common water quality problem downstream of hydropower facilities. At some facilities, structural improvements (e.g. installation of weir dams or aerating turbines) or operational changes (e.g., spilling water over the dam) can be made to improve DO levels. In other cases, structural and operational approaches are too costly for the project to implement or are likely to be of limited effectiveness. Despite improvements in overall water quality below dams in recent years, many hydropower projects are unable to meet state water quality standards for DO. Regulatory agencies in the U.S. are considering or implementingmore » dramatic changes in their approach to protecting the quality of the Nation’s waters. New policies and initiatives have emphasized flexibility, increased collaboration and shared responsibility among all parties, and market-based, economic incentives. The use of new regulatory approaches may now be a viable option for addressing the DO problem at some hydropower facilities. This report summarizes some of the regulatory-related options available to hydropower projects, including negotiation of site-specific water quality criteria, use of biological monitoring, watershed-based strategies for the management of water quality, and watershed-based trading. Key decision points center on the health of the local biological communities and whether there are contributing impacts (i.e., other sources of low DO effluents) in the watershed. If the biological communities downstream of the hydropower project are healthy, negotiation for site-specific water quality standards or biocriteria (discharge performance criteria based on characteristics of the aquatic biota) might be pursued. If there are other effluent dischargers in the watershed that contribute to low DO problems, watershed-scale strategies and effluent trading may be effective. This report examines the value of regulatory approaches by reviewing their use

A Novel Software Platform Extending Advances in Monitoring Technologies to On-demand Decision Support

NASA Astrophysics Data System (ADS)

Ormerod, R.; Scholl, M.

2017-12-01

Rapid evolution is occurring in the monitoring and assessment of air emissions and their impacts. The development of next generation lower cost sensor technologies creates the potential for much more intensive and far-reaching monitoring networks that provide spatially rich data. While much attention at present is being directed at the types and performance characteristics of sensor technologies, it is important also that the full potential of rich data sources be realized. Parallel to sensor developments, software platforms to display and manage data in real time are increasingly common adjuncts to sensor networks. However, the full value of data can be realized by extending platform capabilities to include complex scientific functions that are integrated into an action-oriented management framework. Depending on the purpose and nature of a monitoring network, there will be a variety of potential uses of the data or its derivatives, for example: statistical analysis for policy development, event analysis, real-time issue management including emergency response and complaints, and predictive management. Moving these functions into an on-demand, optionally mobile, environment greatly increases the value and accessibility of the data. Increased interplay between monitoring data and decision-making in an operational environment is optimised by a system that is designed with equal weight on technical robustness and user experience. A system now being used by several regulatory agencies and a larger number of industries in the US, Latin America, Europe, Australia and Asia has been developed to provide a wide range of on-demand decision-support in addition to the basic data collection, display and management that most platforms offer. With stable multi-year operation, the platform, known as Envirosuite, is assisting organisations to both reduce operating costs and improve environmental performance. Some current examples of its application across a range of applications

Prediction of regulatory gene pairs using dynamic time warping and gene ontology.

PubMed

Yang, Andy C; Hsu, Hui-Huang; Lu, Ming-Da; Tseng, Vincent S; Shih, Timothy K

2014-01-01

Selecting informative genes is the most important task for data analysis on microarray gene expression data. In this work, we aim at identifying regulatory gene pairs from microarray gene expression data. However, microarray data often contain multiple missing expression values. Missing value imputation is thus needed before further processing for regulatory gene pairs becomes possible. We develop a novel approach to first impute missing values in microarray time series data by combining k-Nearest Neighbour (KNN), Dynamic Time Warping (DTW) and Gene Ontology (GO). After missing values are imputed, we then perform gene regulation prediction based on our proposed DTW-GO distance measurement of gene pairs. Experimental results show that our approach is more accurate when compared with existing missing value imputation methods on real microarray data sets. Furthermore, our approach can also discover more regulatory gene pairs that are known in the literature than other methods.

Student Metacognitive Monitoring: Predicting Test Achievement from Judgment Accuracy

ERIC Educational Resources Information Center

Valdez, Alfred

2013-01-01

Metacognitive monitoring processes have been shown to be critical determinants of human learning. Metacognitive monitoring consist of various knowledge estimates that enable learners to engage in self-regulatory processes important for both the acquisition of knowledge and the monitoring of one's knowledge when engaged in assessment. This study…

10 CFR 51.20 - Criteria for and identification of licensing and regulatory actions requiring environmental...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Criteria for and identification of licensing and regulatory actions requiring environmental impact statements. 51.20 Section 51.20 Energy NUCLEAR REGULATORY... radioactive waste in a monitored retrievable storage installation (MRS). (10) Issuance of a license for a...

Cost-effective water quality assessment through the integration of monitoring data and modeling results

NASA Astrophysics Data System (ADS)

Lobuglio, Joseph N.; Characklis, Gregory W.; Serre, Marc L.

2007-03-01

Sparse monitoring data and error inherent in water quality models make the identification of waters not meeting regulatory standards uncertain. Additional monitoring can be implemented to reduce this uncertainty, but it is often expensive. These costs are currently a major concern, since developing total maximum daily loads, as mandated by the Clean Water Act, will require assessing tens of thousands of water bodies across the United States. This work uses the Bayesian maximum entropy (BME) method of modern geostatistics to integrate water quality monitoring data together with model predictions to provide improved estimates of water quality in a cost-effective manner. This information includes estimates of uncertainty and can be used to aid probabilistic-based decisions concerning the status of a water (i.e., impaired or not impaired) and the level of monitoring needed to characterize the water for regulatory purposes. This approach is applied to the Catawba River reservoir system in western North Carolina as a means of estimating seasonal chlorophyll a concentration. Mean concentration and confidence intervals for chlorophyll a are estimated for 66 reservoir segments over an 11-year period (726 values) based on 219 measured seasonal averages and 54 model predictions. Although the model predictions had a high degree of uncertainty, integration of modeling results via BME methods reduced the uncertainty associated with chlorophyll estimates compared with estimates made solely with information from monitoring efforts. Probabilistic predictions of future chlorophyll levels on one reservoir are used to illustrate the cost savings that can be achieved by less extensive and rigorous monitoring methods within the BME framework. While BME methods have been applied in several environmental contexts, employing these methods as a means of integrating monitoring and modeling results, as well as application of this approach to the assessment of surface water monitoring networks

A framework for quantifying and optimizing the value of seismic monitoring of infrastructure

NASA Astrophysics Data System (ADS)

Omenzetter, Piotr

2017-04-01

This paper outlines a framework for quantifying and optimizing the value of information from structural health monitoring (SHM) technology deployed on large infrastructure, which may sustain damage in a series of earthquakes (the main and the aftershocks). The evolution of the damage state of the infrastructure without or with SHM is presented as a time-dependent, stochastic, discrete-state, observable and controllable nonlinear dynamical system. The pre-posterior Bayesian analysis and the decision tree are used for quantifying and optimizing the value of SHM information. An optimality problem is then formulated how to decide on the adoption of SHM and how to manage optimally the usage and operations of the possibly damaged infrastructure and its repair schedule using the information from SHM. The objective function to minimize is the expected total cost or risk.

Analytical Chemistry in the Regulatory Science of Medical Devices.

PubMed

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

Diagnostic value of different adherence measures using electronic monitoring and virologic failure as reference standards.

PubMed

Deschamps, Ann E; De Geest, Sabina; Vandamme, Anne-Mieke; Bobbaers, Herman; Peetermans, Willy E; Van Wijngaerden, Eric

2008-09-01

Nonadherence to antiretroviral therapy is a substantial problem in HIV and jeopardizes the success of treatment. Accurate measurement of nonadherence is therefore imperative for good clinical management but no gold standard has been agreed on yet. In a single-center prospective study nonadherence was assessed by electronic monitoring: percentage of doses missed and drug holidays and by three self reports: (1) a visual analogue scale (VAS): percentage of overall doses taken; (2) the Swiss HIV Cohort Study Adherence Questionnaire (SHCS-AQ): percentage of overall doses missed and drug holidays and (3) the European HIV Treatment Questionnaire (EHTQ): percentage of doses missed and drug holidays for each antiretroviral drug separately. Virologic failure prospectively assessed during 1 year, and electronic monitoring were used as reference standards. Using virologic failure as reference standard, the best results were for (1) the SHCS-AQ after electronic monitoring (sensitivity, 87.5%; specificity, 78.6%); (2) electronic monitoring (sensitivity, 75%; specificity, 85.6%), and (3) the VAS combined with the SHCS-AQ before electronic monitoring (sensitivity, 87.5%; specificity, 58.6%). The sensitivity of the complex EHTQ was less than 50%. Asking simple questions about doses taken or missed is more sensitive than complex questioning about each drug separately. Combining the VAS with the SHCS-AQ seems a feasible nonadherence measure for daily clinical practice. Self-reports perform better after electronic monitoring: their diagnostic value could be lower when given independently.

Comparison of remote sensing and fixed-site monitoring approaches for examining air pollution and health in a national study population

NASA Astrophysics Data System (ADS)

Prud'homme, Genevieve; Dobbin, Nina A.; Sun, Liu; Burnett, Richard T.; Martin, Randall V.; Davidson, Andrew; Cakmak, Sabit; Villeneuve, Paul J.; Lamsal, Lok N.; van Donkelaar, Aaron; Peters, Paul A.; Johnson, Markey

2013-12-01

Satellite remote sensing (RS) has emerged as a cutting edge approach for estimating ground level ambient air pollution. Previous studies have reported a high correlation between ground level PM2.5 and NO2 estimated by RS and measurements collected at regulatory monitoring sites. The current study examined associations between air pollution and adverse respiratory and allergic health outcomes using multi-year averages of NO2 and PM2.5 from RS and from regulatory monitoring. RS estimates were derived using satellite measurements from OMI, MODIS, and MISR instruments. Regulatory monitoring data were obtained from Canada's National Air Pollution Surveillance Network. Self-reported prevalence of doctor-diagnosed asthma, current asthma, allergies, and chronic bronchitis were obtained from the Canadian Community Health Survey (a national sample of individuals 12 years of age and older). Multi-year ambient pollutant averages were assigned to each study participant based on their six digit postal code at the time of health survey, and were used as a marker for long-term exposure to air pollution. RS derived estimates of NO2 and PM2.5 were associated with 6-10% increases in respiratory and allergic health outcomes per interquartile range (3.97 μg m-3 for PM2.5 and 1.03 ppb for NO2) among adults (aged 20-64) in the national study population. Risk estimates for air pollution and respiratory/allergic health outcomes based on RS were similar to risk estimates based on regulatory monitoring for areas where regulatory monitoring data were available (within 40 km of a regulatory monitoring station). RS derived estimates of air pollution were also associated with adverse health outcomes among participants residing outside the catchment area of the regulatory monitoring network (p < 0.05). The consistency between risk estimates based on RS and regulatory monitoring as well as the associations between air pollution and health among participants living outside the catchment area for

75 FR 62436 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-08

... Power Plants,'' includes in its scope safety- related structures, systems, and components (SSCs) that... monitor the effectiveness of maintenance for protective coatings within its scope (as discrete systems or... and Management System (ADAMS) under Accession No. ML102230359. Electronic copies of Regulatory Guide 1...

The Predictive Prognostic Values of Serum TNF-α in Comparison to SOFA Score Monitoring in Critically Ill Patients

PubMed Central

Yousef, Ayman Abd Al-Maksoud; Suliman, Ghada Abdulmomen

2013-01-01

Background. The use of inflammatory markers to follow up critically ill patients is controversial. The short time frame, the need for frequent and serial measurement of biomarkers, the presence of soluble receptor and their relatively high cost are the major drawbacks. Our study's objective is to compare the prognostic values of serum TNF-α and SOFA score monitoring in critically ill patients. Patients and Methods. A total of ninety patients were included in the study. Forty-five patients developed septic complication (sepsis group). Forty-five patients were critically ill without evidence of infectious organism (SIRS group). Patients' data include clinical status, central venous pressure, and laboratory analysis were measured. A serum level of TNF-α and SOFA score were monitored. Results. Monitoring of TNF-α revealed significant elevation of TNF-α at 3rd and 5th days of ICU admission in both groups. Monitoring of SOFA score revealed significant elevation of SOFA scores in both groups throughout their ICU stay, particularly in nonsurvivors. Positive predictive ability of SOFA score was demonstrated in critically ill patients. Conclusion. Transient significant increase in serum levels of TNF-α were detected in septic patients. Persistent elevation of SOFA score was detected in nonsurvivor septic patients. SOFA score is an independent prognostic value in critically ill patients. PMID:24175285

Adaptive responses of the cardiovascular system to prolonged spaceflight conditions: assessment with Holter monitoring

NASA Technical Reports Server (NTRS)

Baevsky, R. M.; Bennett, B. S.; Bungo, M. W.; Charles, J. B.; Goldberger, A. L.; Nikulina, G. A.

1997-01-01

This article presents selected findings obtained with Holter monitoring from two crew members of the expedition, performed during a 175-day space mission on board orbital space station "MIR." Using mathematical processing of daily cardiointervals files, 5-minute sections of records were analyzed consecutively. Then, the average daily values of indices, the average-per-every-eight-hours values (morning, evening, night) and mean values per hour were computed. The results of analysis showed that prolonged exposure of man to microgravity conditions leads to important functional alteration in human neuroautonomic regulatory mechanisms. Both crew members had significant increase of heart rate, the rise of stress index, the decrease in power of the spectrum in the range of respiratory sinus arrhythmia. These marked signs of activation of the sympathetic section of the vegetative nervous system showed individual variations. The analysis of the daily collection of cardiointervals with Holter monitoring allows us to understand and forecast the functional feasibilities of the human organism under a variety of stress conditions associated with acute and chronic microgravity exposure.

76 FR 52715 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

... review Draft Final Regulatory Guide (RG) 1.93, ``Availability of Electric Power Sources,'' Revision 1 and new Draft Final RG 1.218, ``Condition Monitoring Techniques for Electric Cables Used in Nuclear Power... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS...

Value of Available Global Soil Moisture Products for Agricultural Monitoring

NASA Astrophysics Data System (ADS)

Mladenova, Iliana; Bolten, John; Crow, Wade; de Jeu, Richard

2016-04-01

The first operationally derived and publicly distributed global soil moil moisture product was initiated with the launch of the Advanced Scanning Microwave Mission on the NASA's Earth Observing System Aqua satellite (AMSR-E). AMSR-E failed in late 2011, but its legacy is continued by AMSR2, launched in 2012 on the JAXA Global Change Observation Mission-Water (GCOM-W) mission. AMSR is a multi-frequency dual-polarization instrument, where the lowest two frequencies (C- and X-band) were used for soil moisture retrieval. Theoretical research and small-/field-scale airborne campaigns, however, have demonstrated that soil moisture would be best monitored using L-band-based observations. This consequently led to the development and launch of the first L-band-based mission-the ESA's Soil Moisture Ocean Salinity (SMOS) mission (2009). In early 2015 NASA launched the second L-band-based mission, the Soil Moisture Active Passive (SMAP). These satellite-based soil moisture products have been demonstrated to be invaluable sources of information for mapping water stress areas, crop monitoring and yield forecasting. Thus, a number of agricultural agencies routinely utilize and rely on global soil moisture products for improving their decision making activities, determining global crop production and crop prices, identifying food restricted areas, etc. The basic premise of applying soil moisture observations for vegetation monitoring is that the change in soil moisture conditions will precede the change in vegetation status, suggesting that soil moisture can be used as an early indicator of expected crop condition change. Here this relationship was evaluated across multiple microwave frequencies by examining the lag rank cross-correlation coefficient between the soil moisture observations and the Normalized Difference Vegetation Index (NDVI). A main goal of our analysis is to evaluate and inter-compare the value of the different soil moisture products derived using L-band (SMOS

Data monitoring committees: Promoting best practices to address emerging challenges.

PubMed

Fleming, Thomas R; DeMets, David L; Roe, Matthew T; Wittes, Janet; Calis, Karim A; Vora, Amit N; Meisel, Alan; Bain, Raymond P; Konstam, Marvin A; Pencina, Michael J; Gordon, David J; Mahaffey, Kenneth W; Hennekens, Charles H; Neaton, James D; Pearson, Gail D; Andersson, Tomas Lg; Pfeffer, Marc A; Ellenberg, Susan S

2017-04-01

Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees. Prospective data monitoring committee members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. Data monitoring committee members should be protected against legal liability arising from their service. While avoiding breaches in confidentiality of interim data remains a high priority, data monitoring committees should have access to unblinded efficacy and safety data throughout the trial to enable informed judgments about risks and benefits. Because overly rigid procedures can compromise their independence, data monitoring committees should have the flexibility necessary to best fulfill their responsibilities. Data monitoring committee charters should articulate principles that guide the data monitoring committee process rather than list a rigid set of requirements. Data monitoring committees should develop their recommendations by consensus rather than through voting processes. The format for the meetings of the data monitoring committee should maintain the committee's independence and clearly establish the leadership of the data monitoring committee chair. The independent statistical group at the Statistical Data Analysis Center should have sufficient depth of knowledge about the study at hand and

A cis-regulatory logic simulator.

PubMed

Zeigler, Robert D; Gertz, Jason; Cohen, Barak A

2007-07-27

A major goal of computational studies of gene regulation is to accurately predict the expression of genes based on the cis-regulatory content of their promoters. The development of computational methods to decode the interactions among cis-regulatory elements has been slow, in part, because it is difficult to know, without extensive experimental validation, whether a particular method identifies the correct cis-regulatory interactions that underlie a given set of expression data. There is an urgent need for test expression data in which the interactions among cis-regulatory sites that produce the data are known. The ability to rapidly generate such data sets would facilitate the development and comparison of computational methods that predict gene expression patterns from promoter sequence. We developed a gene expression simulator which generates expression data using user-defined interactions between cis-regulatory sites. The simulator can incorporate additive, cooperative, competitive, and synergistic interactions between regulatory elements. Constraints on the spacing, distance, and orientation of regulatory elements and their interactions may also be defined and Gaussian noise can be added to the expression values. The simulator allows for a data transformation that simulates the sigmoid shape of expression levels from real promoters. We found good agreement between sets of simulated promoters and predicted regulatory modules from real expression data. We present several data sets that may be useful for testing new methodologies for predicting gene expression from promoter sequence. We developed a flexible gene expression simulator that rapidly generates large numbers of simulated promoters and their corresponding transcriptional output based on specified interactions between cis-regulatory sites. When appropriate rule sets are used, the data generated by our simulator faithfully reproduces experimentally derived data sets. We anticipate that using simulated

EXPOSURE MONITORING COMPONENT FOR DETROIT CHILDREN'S HEALTH STUDY ( DCHS )

EPA Science Inventory

Conventional, regulatory-based air monitoring is expensive and, thus, conducted at one or few locations in a city. This provides limited info on intra-urban variability and spatial distribution of air pollution. Research-oriented urban network monitoring has progressed with inc...

Groundwater contamination from waste management sites: The interaction between risk-based engineering design and regulatory policy: 1. Methodology

NASA Astrophysics Data System (ADS)

Massmann, Joel; Freeze, R. Allan

1987-02-01

This paper puts in place a risk-cost-benefit analysis for waste management facilities that explicitly recognizes the adversarial relationship that exists in a regulated market economy between the owner/operator of a waste management facility and the government regulatory agency under whose terms the facility must be licensed. The risk-cost-benefit analysis is set up from the perspective of the owner/operator. It can be used directly by the owner/operator to assess alternative design strategies. It can also be used by the regulatory agency to assess alternative regulatory policy, but only in an indirect manner, by examining the response of an owner/operator to the stimuli of various policies. The objective function is couched in terms of a discounted stream of benefits, costs, and risks over an engineering time horizon. Benefits are in the form of revenues for services provided; costs are those of construction and operation of the facility. Risk is defined as the cost associated with the probability of failure, with failure defined as the occurrence of a groundwater contamination event that violates the licensing requirements established for the facility. Failure requires a breach of the containment structure and contaminant migration through the hydrogeological environment to a compliance surface. The probability of failure can be estimated on the basis of reliability theory for the breach of containment and with a Monte-Carlo finite-element simulation for the advective contaminant transport. In the hydrogeological environment the hydraulic conductivity values are defined stochastically. The probability of failure is reduced by the presence of a monitoring network operated by the owner/operator and located between the source and the regulatory compliance surface. The level of reduction in the probability of failure depends on the probability of detection of the monitoring network, which can be calculated from the stochastic contaminant transport simulations. While

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

PubMed

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

2012-11-01

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

Value of Free-Run Electromyographic Monitoring of Extraocular Cranial Nerves during Expanded Endonasal Surgery (EES) of the Skull Base.

PubMed

Thirumala, Parthasarathy D; Mohanraj, Santhosh Kumar; Habeych, Miguel; Wichman, Kelley; Chang, Yue-Fang; Gardner, Paul; Snyderman, Carl; Crammond, Donald J; Balzer, Jeffrey

2013-06-01

Objective To evaluate the value of free-run electromyography (f-EMG) monitoring of extraocular cranial nerves (EOCN) III, IV, and VI during expanded endonasal surgery (EES) of the skull base in reducing iatrogenic cranial nerve (CN) deficits. Design We retrospectively identified 200 patients out of 990 who had at least one EOCN monitored during EES. We further separated patients into groups according to the specific CN monitored. In each CN group, we classified patients who had significant (SG) f-EMG activity as Group I and those who did not as Group II. Results A total of 696 EOCNs were monitored. The number of muscles supplied by EOCNs that had SG f-EMG activity was 88, including CN III = 46, CN IV = 21, and CN VI = 21. There were two deficits involving CN VI in patients who had SG f-EMG activity during surgery. There were 14 deficits observed, including CN III = 3, CN IV = 2, and CN VI = 9 in patients who did not have SG f-EMG activity during surgery. Conclusions f-EMG monitoring of EOCN during EES can be useful in identifying the location of the nerve. It seems to have limited value in predicting postoperative neurological deficits. Future studies to evaluate the EMG of EOCN during EES need to be done with both f-EMG and triggered EMG.

Value of Free-Run Electromyographic Monitoring of Extraocular Cranial Nerves during Expanded Endonasal Surgery (EES) of the Skull Base

PubMed Central

Thirumala, Parthasarathy D.; Mohanraj, Santhosh Kumar; Habeych, Miguel; Wichman, Kelley; Chang, Yue-fang; Gardner, Paul; Snyderman, Carl; Crammond, Donald J.; Balzer, Jeffrey

2013-01-01

Objective To evaluate the value of free-run electromyography (f-EMG) monitoring of extraocular cranial nerves (EOCN) III, IV, and VI during expanded endonasal surgery (EES) of the skull base in reducing iatrogenic cranial nerve (CN) deficits. Design We retrospectively identified 200 patients out of 990 who had at least one EOCN monitored during EES. We further separated patients into groups according to the specific CN monitored. In each CN group, we classified patients who had significant (SG) f-EMG activity as Group I and those who did not as Group II. Results A total of 696 EOCNs were monitored. The number of muscles supplied by EOCNs that had SG f-EMG activity was 88, including CN III = 46, CN IV = 21, and CN VI = 21. There were two deficits involving CN VI in patients who had SG f-EMG activity during surgery. There were 14 deficits observed, including CN III = 3, CN IV = 2, and CN VI = 9 in patients who did not have SG f-EMG activity during surgery. Conclusions f-EMG monitoring of EOCN during EES can be useful in identifying the location of the nerve. It seems to have limited value in predicting postoperative neurological deficits. Future studies to evaluate the EMG of EOCN during EES need to be done with both f-EMG and triggered EMG. PMID:23943720

REGULATORY APPLICATIONS OF POREWATER TOXICITY TESTING

EPA Science Inventory

The purpose of this chapter is to evaluate the use of porewater toxicity tests in regulatory applications, including their potential use in the development of sediment quality guideline (SQG) values. Specifically, the following discussion focuses on the appropriateness and readin...

Mapping and monitoring High Nature Value farmlands: challenges in European landscapes.

PubMed

Lomba, Angela; Guerra, Carlos; Alonso, Joaquim; Honrado, João Pradinho; Jongman, Rob; McCracken, David

2014-10-01

The importance of low intensity farming for the conservation of biodiversity throughout Europe was acknowledged early in the 1990s when the concept of 'High Nature Value farmlands' (HNVf) was devised. HNVf has subsequently been given high priority within the EU Rural Development Programme. This puts a requirement on each EU Member State not only to identify the extent and condition of HNVf within their borders but also to track trends in HNVf over time. However, the diversity of rural landscapes across the EU, the scarcity of (adequate) datasets on biodiversity, land cover and land use, and the lack of a common methodology for HNVf mapping currently represent obstacles to the implementation of the HNVf concept across Europe. This manuscript provides an overview of the characteristics of HNVf across Europe together with a description of the development of the HNVf concept. Current methodological approaches for the identification and mapping of HNVf across EU-27 and Switzerland are then reviewed, the main limitations of these approaches highlighted and recommendations made as to how the identification, mapping and reporting of HNVf state and trends across Europe can potentially be improved and harmonised. In particular, we propose a new framework that is built on the need for strategic HNVf monitoring based on a hierarchical, bottom-up structure of assessment units, coincident with the EU levels of political decision and devised indicators, and which is linked strongly to a collaborative European network that can provide the integration and exchange of data from different sources and scales under common standards. Such an approach is essential if the scale of the issues facing HNVf landscapes are to be identified and monitored properly at the European level. This would then allow relevant agri-environmental measures to be developed, implemented and evaluated at the scale(s) required to maintain the habitats and species of high nature conservation value that are

Emergent self-regulatory activity among young children during scientific inquiry: An analysis of six kindergarten children

NASA Astrophysics Data System (ADS)

Lomangino, Adrienne Gelpi

2000-10-01

This qualitative investigation extends the study of self-regulation to examine young children's developing self-regulated learning competencies. The framework for this research draws upon social cognitive, developmental, and sociocultural perspectives on self-regulation and research on children's scientific thinking. Taking a multiple case study approach, this study examines six kindergarten children's emerging self-regulatory competencies during inquiry-based science instruction. Data were collected during two inquiry-based science programs of study, one pertaining to light and shadow and a second pertaining to motion on inclined planes. Data sources included: videotaped records of the instruction, transcriptions of the videotapes, interviews with the children and teacher, student work, and field notes. Taking an inductive approach to analysis, patterns in the children's activity were identified through a recursive process of defining and refining categories that characterized the children's verbal and behavioral activity. Each case study examines a child's behavior within each phase of the inquiry for evidence of emerging self-regulatory competence. Analysis revealed nascent forms of goal-setting and planning, monitoring, resource management, seeking social assistance, and evaluating. Monitoring activity occurred more frequently than planning or evaluating. For several children, animating materials served to promote motivation. Children's efforts to support peers' activity and monitor the meaning of ongoing discourse contrast with common assumptions about children's attention to others' thinking. Variations in self-regulatory activity were found across phases of instruction. The children exhibited interpersonal self-regulatory efforts, in which monitoring and control of the self was entwined with the activity of others. Joint participation also played a critical role in supporting the metacognitive demands of self-regulation and prompting metacognitive awareness

Serial Monitoring of Immune Markers Being Represented Regulatory T Cell/T Helper 17 Cell Ratio: Indicating Tolerance for Tapering Immunosuppression after Liver Transplantation

PubMed Central

Jhun, JooYeon; Lee, Seung Hoon; Lee, Soon Kyu; Kim, Hee Yeon; Jung, Eun Sun; Kim, Dong Goo; Choi, JeongWon; Bae, Si Hyun; Yoon, Seung Kew; Chung, Byung Ha; Yang, Chul Woo; Cho, Mi-La; Choi, Jong Young

2018-01-01

Recipients of liver transplantation (LT) require long-term immunosuppressive drug treatment, but lifelong immunosuppressive treatment has severe side effects. It is known that some LT recipients develop immune tolerance, and although the development of such operational tolerance should allow a decrease in the burden of immunosuppressive drug treatment, the factors that indicate operational tolerance are not clear. This study aimed to monitor immunological markers over time in LT recipients to identify those markers indicating the development of operational tolerance. We performed a prospective pilot study measuring immune markers, including the ratio of regulatory T (Treg) and T helper (Th) 17 cells in peripheral blood in the 14 most immunologically stable patients among 70 clinically stable LT recipients. The doses of immunosuppressive drugs given to these 14 LT recipients were tapered over time and they were monitored for immunological markers related to the development of immune tolerance. As the doses of immunosuppressive drugs were reduced, the Treg/Th17, Th1/Th17, and CD8/Th17 ratio in tolerant recipients was significantly increased compared with that of nontolerant recipients. These results suggest that monitoring of changes in the immune makers, including Treg/Th17 ratio during tapering of immunosuppression may allow prediction of the development of tolerance. PMID:29545795

Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis.

PubMed

Rathore, Anurag S; Pathak, Mili; Jain, Renu; Jadaun, Gaurav Pratap Singh

2016-07-01

Monitoring the quality of pharmaceutical products is a global challenge, heightened by the implications of letting subquality drugs come to the market on public safety. Regulatory agencies do their due diligence at the time of approval as per their prescribed regulations. However, product quality needs to be monitored post-approval as well to ensure patient safety throughout the product life cycle. This is particularly complicated for biotechnology-based therapeutics where seemingly minor changes in process and/or raw material attributes have been shown to have a significant effect on clinical safety and efficacy of the product. This article provides a perspective on the topic of monitoring the quality of biotech therapeutics. In the backdrop of challenges faced by the regulatory agencies, the potential use of multivariate data analysis as a tool for effective monitoring has been proposed. Case studies using data from several insulin biosimilars have been used to illustrate the key concepts.

[Computer simulation of thyroid regulatory mechanisms in health and malignancy].

PubMed

Abduvaliev, A A; Gil'dieva, M S; Khidirov, B N; Saĭdalieva, M; Saatov, T S

2010-07-01

The paper describes a computer model for regulation of the number of thyroid follicular cells in health and malignancy. The authors'computer program for mathematical simulation of the regulatory mechanisms of a thyroid follicular cellular community cannot be now referred to as good commercial products. For commercialization of this product, it is necessary to draw up a direct relation of the introduced corrected values from the actually existing normal values, such as the peripheral blood concentrations of thyroid hormones or the mean values of endocrine tissue mitotic activity. However, the described computer program has been also used in researches by our scientific group in the study of thyroid cancer. The available biological experimental data and theoretical provisions on thyroid structural and functional organization at the cellular level allow one to construct mathematical models for quantitative analysis of the regulation of the size of a cellular community of a thyroid follicle in health and abnormalities, by using the method for simulation of the regulatory mechanisms of living systems and the equations of cellular community regulatory communities.

Comparison of Remote Sensing and Fixed-Site Monitoring Approaches for Examining Air Pollution and Health in a National Study Population

NASA Technical Reports Server (NTRS)

Prud'homme, Genevieve; Dobbin, Nina A.; Sun, Liu; Burnet, Richard T.; Martin, Randall V.; Davidson, Andrew; Cakmak, Sabit; Villeneuve, Paul J.; Lamsal, Lok N.; vanDonkelaar, Aaron;

Wilderness monitoring and data management

USGS Publications Warehouse

Riebau, A. R.

1994-01-01

In the last decade, increased public interest in natural areas has resulted in increased monitoring activity by federal wilderness managers to assess the status of wilderness values. Wilderness values are those large-scale entities of wilderness which comprise, in sum, wilderness character. Data collected through wilderness monitoring must support the maintenance of wilderness values. Wilderness monitoring must include the development of clear data management strategies and provisions for hypothesis testing. Unfortunately, some monitoring programs do not support the status assessment of wilderness values. Often wilderness monitoring programs have neglected even the most rudimentary principles of data management. This paper presents a model for wilderness monitoring, guidelines for data management, and an overview of a PC-compatible wilderness monitoring data base, the Monitoring Information Data Analysis System (MIDAS).

78 FR 62814 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Assume... Authority and Supervision September 30, 2013. On July 31, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or...) Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

Value of self-monitoring blood glucose pattern analysis in improving diabetes outcomes.

PubMed

Parkin, Christopher G; Davidson, Jaime A

2009-05-01

Self-monitoring of blood glucose (SMBG) is an important adjunct to hemoglobin A1c (HbA1c) testing. This action can distinguish between fasting, preprandial, and postprandial hyperglycemia; detect glycemic excursions; identify and monitor resolution of hypoglycemia; and provide immediate feedback to patients about the effect of food choices, activity, and medication on glycemic control. Pattern analysis is a systematic approach to identifying glycemic patterns within SMBG data and then taking appropriate action based upon those results. The use of pattern analysis involves: (1) establishing pre- and postprandial glucose targets; (2) obtaining data on glucose levels, carbohydrate intake, medication administration (type, dosages, timing), activity levels and physical/emotional stress; (3) analyzing data to identify patterns of glycemic excursions, assessing any influential factors, and implementing appropriate action(s); and (4) performing ongoing SMBG to assess the impact of any therapeutic changes made. Computer-based and paper-based data collection and management tools can be developed to perform pattern analysis for identifying patterns in SMBG data. This approach to interpreting SMBG data facilitates rational therapeutic adjustments in response to this information. Pattern analysis of SMBG data can be of equal or greater value than measurement of HbA1c levels. 2009 Diabetes Technology Society.

Analysis of the performance of the CONTOUR® TS Blood Glucose Monitoring System: when regulatory performance criteria are met, should we have confidence to use a medical device with all patients?

PubMed

Lyon, Martha E; Lyon, Andrew W

2011-01-01

The article entitled, Performance of the CONTOUR® TS Blood Glucose Monitoring System, by Frank and colleagues in this issue of Journal of Diabetes Science and Technology, demonstrates that the CONTOUR® TS glucose meter exceeds current regulatory expectations for glucose meter performance. However, the appropriateness of current regulatory expectations, such as International Organization for Standardization (ISO) 15197:2003, is being reevaluated because of increasing concern regarding the reliability of glucose meters in ambulatory and hospitalized environments. Between 2004 and 2008, 12,673 serious adverse events with glucose meters that met the ISO 15197 expectations were reported in the Food and Drug Administration-Manufacturer and User Facility Device Experience surveillance database. Should different glucose meter performance criteria be applied to ambulatory versus critical care patients? © 2010 Diabetes Technology Society.

Health-Based Cyanotoxin Guideline Values Allow for Cyanotoxin-Based Monitoring and Efficient Public Health Response to Cyanobacterial Blooms

PubMed Central

Farrer, David; Counter, Marina; Hillwig, Rebecca; Cude, Curtis

2015-01-01

Human health risks from cyanobacterial blooms are primarily related to cyanotoxins that some cyanobacteria produce. Not all species of cyanobacteria can produce toxins. Those that do often do not produce toxins at levels harmful to human health. Monitoring programs that use identification of cyanobacteria genus and species and enumeration of cyanobacterial cells as a surrogate for cyanotoxin presence can overestimate risk and lead to unnecessary health advisories. In the absence of federal criteria for cyanotoxins in recreational water, the Oregon Health Authority (OHA) developed guideline values for the four most common cyanotoxins in Oregon’s fresh waters (anatoxin-a, cylindrospermopsin, microcystins, and saxitoxins). OHA developed three guideline values for each of the cyanotoxins found in Oregon. Each of the guideline values is for a specific use of cyanobacteria-affected water: drinking water, human recreational exposure and dog recreational exposure. Having cyanotoxin guidelines allows OHA to promote toxin-based monitoring (TBM) programs, which reduce the number of health advisories and focus advisories on times and places where actual, rather than potential, risks to health exist. TBM allows OHA to more efficiently protect public health while reducing burdens on local economies that depend on water recreation-related tourism. PMID:25664510

An Overview of Process Monitoring Related to the Production of Uranium Ore Concentrate

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

McGinnis, Brent

2014-04-01

Uranium ore concentrate (UOC) in various chemical forms, is a high-value commodity in the commercial nuclear market, is a potential target for illicit acquisition, by both State and non-State actors. With the global expansion of uranium production capacity, control of UOC is emerging as a potentially weak link in the nuclear supply chain. Its protection, control and management thus pose a key challenge for the international community, including States, regulatory authorities and industry. This report evaluates current process monitoring practice and makes recommendations for utilization of existing or new techniques for managing the inventory and tracking this material.

The effect of temperature correction of blood gas values on the accuracy of end-tidal carbon dioxide monitoring in children after cardiac surgery.

PubMed

Suominen, Pertti K; Stayer, Stephen; Wang, Wei; Chang, Anthony C

2007-01-01

We evaluated accuracy of end-tidal carbon dioxide tension (PETco2) monitoring and measured the effect of temperature correction of blood gas values in children after cardiac surgery. Data from 49 consecutive mechanically ventilated children after cardiac surgery in the cardiac intensive care unit were prospectively collected. One patient was excluded from the study. Four arterial-end-tidal CO2 pairs in each patient were obtained. Both the arterial carbon dioxide tension (Paco2) values determined at a temperature of 37 degrees C and values corrected to body temperature (Patcco2) were compared with the PETco2 values. After the surgical correction 28 patients had biventricular, acyanotic (mean age 2.7 +/- 4.8 years) and 20 patients had a cyanotic lesion (mean age 1.0 +/- 1.7 years). The body temperature ranged from 35.2 degrees C to 38.9 degrees C. The Pa-PETco2 discrepancy was affected both by the type of cardiac lesion and by the temperature correction of Paco2 values. Correlation slopes of the Pa-PETco2 and Patc-PETco2 discrepancies were significantly different (p = 0.040) when the body temperature was higher or lower than 37 degrees C. In children, after cardiac surgery, end-tidal CO2 monitoring provided a clinically acceptable estimate of arterial CO2 value, which remained stabile in repeated measurements. End-tidal CO2 monitoring more accurately reflects temperature-corrected blood gas values.

20 years of long-term atrazine monitoring in a shallow aquifer in western Germany.

PubMed

Vonberg, David; Vanderborght, Jan; Cremer, Nils; Pütz, Thomas; Herbst, Michael; Vereecken, Harry

2014-03-01

Atrazine was banned in Germany in 1991 due to findings of atrazine concentrations in ground- and drinking waters exceeding threshold values. Monitoring of atrazine concentrations in the groundwater since then provides information about the resilience of the groundwater quality to changing agricultural practices. In this study, we present results of a monitoring campaign of atrazine concentrations in the Zwischenscholle aquifer. This phreatic aquifer is exposed to intensive agricultural land use and susceptible to contaminants due to a shallow water table. In total 60 observation wells (OWs) have been monitored since 1991, of which 15 are sampled monthly today. Descriptive statistics of monitoring data were derived using the "regression on order statistics" (ROS) data censoring approach, estimating values for nondetects. The monitoring data shows that even 20 years after the ban of atrazine, the groundwater concentrations of sampled OWs remain on a level close to the threshold value of 0.1 μg l(-1) without any considerable decrease. The spatial distribution of atrazine concentrations is highly heterogeneous with OWs exhibiting permanently concentrations above the regulatory threshold on the one hand and OWs were concentrations are mostly below the limit of quantification (LOQ) on the other hand. A deethylatrazine-to-atrazine ratio (DAR) was used to distinguish between diffuse - and point-source contamination, with a global mean value of 0.84 indicating mainly diffuse contamination. Principle Component Analysis (PCA) of the monitoring dataset demonstrated relationships between the metabolite desisopropylatrazine, which was found to be exclusively associated with the parent compound simazine but not with atrazine, and between deethylatrazine, atrazine, nitrate, and the specific electrical conductivity. These parameters indicate agricultural impacts on groundwater quality. The findings presented in this study point at the difficulty to estimate mean concentrations

Interaction initiatives between regulatory, health technology assessment and coverage bodies, and industry.

PubMed

Frønsdal, Katrine; Pichler, Franz; Mardhani-Bayne, Logan; Henshall, Chris; Røttingen, John-Arne; Mørland, Berit; Klemp, Marianne

2012-10-01

There has been an increased focus on the relationship between health technology assessment (HTA) and regulatory assessments and how regulatory, HTA and coverage bodies, and industry can work better together to improve efficiency and alignment of processes. There is increasingly agreement across sectors that improved communication and coordination could contribute to facilitating timely patient access to effective, affordable treatments that offer value to the health system. Discussions on aspects of this relationship are being held in different forums and various forms of coordination and collaboration are being developed or piloted within several jurisdictions. It is therefore both timely and of value to stakeholders to describe and reflect on current initiatives intended to improve interactions between regulatory, HTA and coverage bodies, and industry. Drawing on 2011 meetings of the HTAi Policy Forum and the Center for Innovation in Regulatory Science (CIRS), this study aims to describe and compare initiatives, and point to success factors and challenges that are likely to inform future work and collaboration.

Steering healthcare service delivery: a regulatory perspective.

PubMed

Prakash, Gyan

2015-01-01

The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.

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

PubMed Central

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

2012-01-01

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

10 CFR 74.55 - Item monitoring.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Item monitoring. 74.55 Section 74.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula... quantitatively measured, the validity of that measurement independently confirmed, and that additionally have...

Demonstrating the viability and value of community-based monitoring schemes in catchment science

NASA Astrophysics Data System (ADS)

Starkey, Eleanor; Parkin, Geoff; Quinn, Paul; Large, Andy

2016-04-01

for the purpose of assessing the quality of citizen science observations. It has been found that citizen science observations are essential for capturing localised convective storms. Citizen scientists want their observations to be used to gain meaningful information and tackle local issues. Data has therefore been utilised to build, calibrate and validate hydrological models and support a range of catchment management applications. This has further demonstrated the value of citizen science, along with the social benefits it has to offer. Other communities are also beginning to source funding and implement their own monitoring schemes, indicating that they are both capable and self-motivated. Citizen science makes use of evolving and more readily available technology, providing catchment stakeholders with vital information. Although these types of observations present various challenges, it is argued that a citizen science approach is not intending to replace traditional techniques, rather they can be used to complement them, fill the gaps and/or provide an indication of catchment behaviour across space and through time.

GARP: a surface molecule of regulatory T cells that is involved in the regulatory function and TGF-β releasing.

PubMed

Sun, Liping; Jin, Hao; Li, Hui

2016-07-05

There are many molecules that define regulatory T cells (Tregs) phenotypically and functionally. Glycoprotein A repetitions predominant (GARP) is a transmembrane protein containing leucine rich repeats. Recently, GARP is found to express highly on the surface of activated Tregs. The combination of GARP and other surface molecules isolates Tregs with higher purity. Besides, GARP is a cell surface molecule of Tregs that maintains their regulatory function and homeosatsis. GARP has also been proved to promote the activation and secretion of transforming growth factor β (TGF-β). Moreover, its potential value in cancer immunotherapy is also discussed in this work.

What drives the value of a medical practice?

PubMed

Carden, Carol

2008-01-01

In a complex healthcare environment, it is important to understand what drives the value of a medical practice, how to balance regulatory and business goals, and how physicians can positively impact the value of their practice.

10 CFR 20.1502 - Conditions requiring individual monitoring of external and internal occupational dose.

Code of Federal Regulations, 2014 CFR

2014-01-01

... internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Surveys and Monitoring § 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. Each licensee shall monitor exposures to radiation and radioactive...

10 CFR 20.1502 - Conditions requiring individual monitoring of external and internal occupational dose.

Code of Federal Regulations, 2012 CFR

2012-01-01

... internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Surveys and Monitoring § 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. Each licensee shall monitor exposures to radiation and radioactive...

10 CFR 20.1502 - Conditions requiring individual monitoring of external and internal occupational dose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Surveys and Monitoring § 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. Each licensee shall monitor exposures to radiation and radioactive...

10 CFR 20.1502 - Conditions requiring individual monitoring of external and internal occupational dose.

Code of Federal Regulations, 2013 CFR

2013-01-01

... internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Surveys and Monitoring § 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. Each licensee shall monitor exposures to radiation and radioactive...

10 CFR 20.1502 - Conditions requiring individual monitoring of external and internal occupational dose.

Code of Federal Regulations, 2010 CFR

2010-01-01

... internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Surveys and Monitoring § 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. Each licensee shall monitor exposures to radiation and radioactive...

Value of free-run electromyographic monitoring of lower cranial nerves in endoscopic endonasal approach to skull base surgeries.

PubMed

Thirumala, Parthasarathy D; Mohanraj, Santhosh Kumar; Habeych, Miguel; Wichman, Kelley; Chang, Yue-Fang; Gardner, Paul; Snyderman, Carl; Crammond, Donald J; Balzer, Jeffrey

2012-08-01

Objective The main objective of this study was to evaluate the value of free-run electromyography (f-EMG) monitoring of cranial nerves (CNs) VII, IX, X, XI, and XII in skull base surgeries performed using endoscopic endonasal approach (EEA) to reduce iatrogenic CN deficits. Design We retrospectively identified 73 patients out of 990 patients who had EEA in our institution who had at least one CN monitored. In each CN group, we classified patients who had significant (SG) f-EMG activity as group I and those who did not as group II. Results We monitored a total of 342 CNs. A total of 62 nerves had SG f-EMG activity including CN VII = 18, CN IX = 16, CN X = 13, CN XI = 5, and CN XII = 10. No nerve deficit was found in the nerves that had significant activity during procedure. A total of five nerve deficits including (CN IX = 1, CN X = 2, CN XII = 2) were observed in the group that did not display SG f-EMG activity during surgery. Conclusions f-EMG seems highly sensitive to surgical manipulations and in locating CNs. It seems to have limited value in predicting postoperative neurological deficits. Future studies to evaluate the EMG of lower CNs during EEA procedures need to be done with both f-EMG and triggered EMG.

Value of Free-Run Electromyographic Monitoring of Lower Cranial Nerves in Endoscopic Endonasal Approach to Skull Base Surgeries

PubMed Central

Thirumala, Parthasarathy D.; Mohanraj, Santhosh Kumar; Habeych, Miguel; Wichman, Kelley; Chang, Yue-Fang; Gardner, Paul; Snyderman, Carl; Crammond, Donald J.; Balzer, Jeffrey

2012-01-01

Objective The main objective of this study was to evaluate the value of free-run electromyography (f-EMG) monitoring of cranial nerves (CNs) VII, IX, X, XI, and XII in skull base surgeries performed using endoscopic endonasal approach (EEA) to reduce iatrogenic CN deficits. Design We retrospectively identified 73 patients out of 990 patients who had EEA in our institution who had at least one CN monitored. In each CN group, we classified patients who had significant (SG) f-EMG activity as group I and those who did not as group II. Results We monitored a total of 342 CNs. A total of 62 nerves had SG f-EMG activity including CN VII = 18, CN IX = 16, CN X = 13, CN XI = 5, and CN XII = 10. No nerve deficit was found in the nerves that had significant activity during procedure. A total of five nerve deficits including (CN IX = 1, CN X = 2, CN XII = 2) were observed in the group that did not display SG f-EMG activity during surgery. Conclusions f-EMG seems highly sensitive to surgical manipulations and in locating CNs. It seems to have limited value in predicting postoperative neurological deficits. Future studies to evaluate the EMG of lower CNs during EEA procedures need to be done with both f-EMG and triggered EMG. PMID:23904999

Kalman Filtering for Genetic Regulatory Networks with Missing Values

PubMed Central

Liu, Qiuhua; Lai, Tianyue; Wang, Wu

2017-01-01

The filter problem with missing value for genetic regulation networks (GRNs) is addressed, in which the noises exist in both the state dynamics and measurement equations; furthermore, the correlation between process noise and measurement noise is also taken into consideration. In order to deal with the filter problem, a class of discrete-time GRNs with missing value, noise correlation, and time delays is established. Then a new observation model is proposed to decrease the adverse effect caused by the missing value and to decouple the correlation between process noise and measurement noise in theory. Finally, a Kalman filtering is used to estimate the states of GRNs. Meanwhile, a typical example is provided to verify the effectiveness of the proposed method, and it turns out to be the case that the concentrations of mRNA and protein could be estimated accurately. PMID:28814967

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

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

Using Inequality Measures to Incorporate Environmental Justice into Regulatory Analyses

PubMed Central

Harper, Sam; Ruder, Eric; Roman, Henry A.; Geggel, Amelia; Nweke, Onyemaechi; Payne-Sturges, Devon; Levy, Jonathan I.

2013-01-01

Formally evaluating how specific policy measures influence environmental justice is challenging, especially in the context of regulatory analyses in which quantitative comparisons are the norm. However, there is a large literature on developing and applying quantitative measures of health inequality in other settings, and these measures may be applicable to environmental regulatory analyses. In this paper, we provide information to assist policy decision makers in determining the viability of using measures of health inequality in the context of environmental regulatory analyses. We conclude that quantification of the distribution of inequalities in health outcomes across social groups of concern, considering both within-group and between-group comparisons, would be consistent with both the structure of regulatory analysis and the core definition of environmental justice. Appropriate application of inequality indicators requires thorough characterization of the baseline distribution of exposures and risks, leveraging data generally available within regulatory analyses. Multiple inequality indicators may be applicable to regulatory analyses, and the choice among indicators should be based on explicit value judgments regarding the dimensions of environmental justice of greatest interest. PMID:23999551

10 CFR 61.53 - Environmental monitoring.

Code of Federal Regulations, 2010 CFR

2010-01-01

... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

10 CFR 61.53 - Environmental monitoring.

Code of Federal Regulations, 2012 CFR

2012-01-01

... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

10 CFR 61.53 - Environmental monitoring.

Code of Federal Regulations, 2013 CFR

2013-01-01

... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

10 CFR 61.53 - Environmental monitoring.

Code of Federal Regulations, 2014 CFR

2014-01-01

... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

10 CFR 61.53 - Environmental monitoring.

Code of Federal Regulations, 2011 CFR

2011-01-01

... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

78 FR 50123 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-16

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule Change to Assume... NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed with the Securities and Exchange...: Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives.

PubMed

Hampel, Harald; Frank, Richard; Broich, Karl; Teipel, Stefan J; Katz, Russell G; Hardy, John; Herholz, Karl; Bokde, Arun L W; Jessen, Frank; Hoessler, Yvonne C; Sanhai, Wendy R; Zetterberg, Henrik; Woodcock, Janet; Blennow, Kaj

2010-07-01

Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in onset and progression of the condition would significantly reduce the global burden of the disease. To effectively test compounds for Alzheimer's disease and bring therapy to individuals as early as possible there is an urgent need for collaboration between academic institutions, industry and regulatory organizations for the establishment of standards and networks for the identification and qualification of biological marker candidates. Biomarkers are needed to monitor drug safety, to identify individuals who are most likely to respond to specific treatments, to stratify presymptomatic patients and to quantify the benefits of treatments. Biomarkers that achieve these characteristics should enable objective business decisions in portfolio management and facilitate regulatory approval of new therapies.

Optimal spatio-temporal design of water quality monitoring networks for reservoirs: Application of the concept of value of information

NASA Astrophysics Data System (ADS)

Maymandi, Nahal; Kerachian, Reza; Nikoo, Mohammad Reza

2018-03-01

This paper presents a new methodology for optimizing Water Quality Monitoring (WQM) networks of reservoirs and lakes using the concept of the value of information (VOI) and utilizing results of a calibrated numerical water quality simulation model. With reference to the value of information theory, water quality of every checkpoint with a specific prior probability differs in time. After analyzing water quality samples taken from potential monitoring points, the posterior probabilities are updated using the Baye's theorem, and VOI of the samples is calculated. In the next step, the stations with maximum VOI is selected as optimal stations. This process is repeated for each sampling interval to obtain optimal monitoring network locations for each interval. The results of the proposed VOI-based methodology is compared with those obtained using an entropy theoretic approach. As the results of the two methodologies would be partially different, in the next step, the results are combined using a weighting method. Finally, the optimal sampling interval and location of WQM stations are chosen using the Evidential Reasoning (ER) decision making method. The efficiency and applicability of the methodology are evaluated using available water quantity and quality data of the Karkheh Reservoir in the southwestern part of Iran.

[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

PubMed

Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

2016-05-01

Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

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.

77 FR 30030 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at... (RG) 1.160, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' This guide endorses Revision 4A to Nuclear Management and Resources Council (NUMARC) 93-01, ``Industry Guideline for...

Mutual information and the fidelity of response of gene regulatory models

NASA Astrophysics Data System (ADS)

Tabbaa, Omar P.; Jayaprakash, C.

2014-08-01

We investigate cellular response to extracellular signals by using information theory techniques motivated by recent experiments. We present results for the steady state of the following gene regulatory models found in both prokaryotic and eukaryotic cells: a linear transcription-translation model and a positive or negative auto-regulatory model. We calculate both the information capacity and the mutual information exactly for simple models and approximately for the full model. We find that (1) small changes in mutual information can lead to potentially important changes in cellular response and (2) there are diminishing returns in the fidelity of response as the mutual information increases. We calculate the information capacity using Gillespie simulations of a model for the TNF-α-NF-κ B network and find good agreement with the measured value for an experimental realization of this network. Our results provide a quantitative understanding of the differences in cellular response when comparing experimentally measured mutual information values of different gene regulatory models. Our calculations demonstrate that Gillespie simulations can be used to compute the mutual information of more complex gene regulatory models, providing a potentially useful tool in synthetic biology.

18 CFR 12.41 - Monitoring instruments.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Monitoring instruments. 12.41 Section 12.41 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS AND PROJECT WORKS...

18 CFR 12.41 - Monitoring instruments.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Monitoring instruments. 12.41 Section 12.41 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS AND PROJECT WORKS...

Functional analysis of a large set of BRCA2 exon 7 variants highlights the predictive value of hexamer scores in detecting alterations of exonic splicing regulatory elements.

PubMed

Di Giacomo, Daniela; Gaildrat, Pascaline; Abuli, Anna; Abdat, Julie; Frébourg, Thierry; Tosi, Mario; Martins, Alexandra

2013-11-01

Exonic variants can alter pre-mRNA splicing either by changing splice sites or by modifying splicing regulatory elements. Often these effects are difficult to predict and are only detected by performing RNA analyses. Here, we analyzed, in a minigene assay, 26 variants identified in the exon 7 of BRCA2, a cancer predisposition gene. Our results revealed eight new exon skipping mutations in this exon: one directly altering the 5' splice site and seven affecting potential regulatory elements. This brings the number of splicing regulatory mutations detected in BRCA2 exon 7 to a total of 11, a remarkably high number considering the total number of variants reported in this exon (n = 36), all tested in our minigene assay. We then exploited this large set of splicing data to test the predictive value of splicing regulator hexamers' scores recently established by Ke et al. (). Comparisons of hexamer-based predictions with our experimental data revealed high sensitivity in detecting variants that increased exon skipping, an important feature for prescreening variants before RNA analysis. In conclusion, hexamer scores represent a promising tool for predicting the biological consequences of exonic variants and may have important applications for the interpretation of variants detected by high-throughput sequencing. © 2013 WILEY PERIODICALS, INC.

Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

PubMed

Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

2017-03-15

Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

Use of new scientific developments in regulatory risk assessments: challenges and opportunities.

PubMed

Tarazona, Jose V

2013-07-01

Since the 1990s, science based ecological risk assessments constitute an essential tool for supporting decision making in the regulatory context. Using the European REACH Regulation as example, this article presents the challenges and opportunities for new scientific developments within the area of chemical control and environmental protection. These challenges can be sorted out in 3 main related topics (sets). In the short term, the challenges are directly associated with the regulatory requirements, required for facilitating a scientifically sound implementation of the different obligations for industry and authorities. It is important to mention that although the actual tools are different due to the regulatory requirements, the basic needs are still the same as those addressed in the early 1990s: understanding the ecological relevance of the predicted effects, including the uncertainty, and facilitating the link with the socio-economic assessment. The second set of challenges covers the opportunities for getting an added value from the regulatory efforts. The information compiled through REACH registration and notification processes is analyzed as source for new integrative developments for assessing the combined chemical risk at the regional level. Finally, the article discusses the challenge of inverting the process and developing risk assessment methods focusing on the receptor, the individual or ecosystem, instead of on the stressor or source. These approaches were limited in the past due to the lack of information, but the identification and dissemination of standard information, including uses, manufacturing sites, physical-chemical, environmental, ecotoxicological, and toxicological properties as well as operational conditions and risk management measures for thousands of chemicals, combined by the knowledge gathered through large scale monitoring programs and spatial information systems is generating new opportunities. The challenge is liking

Finding Value in Human Relations

DTIC Science & Technology

2011-04-01

equality is complimented by the ideal objective of social justice. Equality cannot be achieved without Finding Value in Human, 3 social justice and... social justice cannot be achieved without equality , but equality is pursued differently than social justice. The third value is regulatory fit as the...the ideal objectives of nondiscrimination, equality , and social justice. For example, diversity information is more likely to “feel right” to EOA

Field evaluations of newly available "interference-free" monitors for nitrogen dioxide and ozone at near-road and conventional National Ambient Air Quality Standards compliance sites.

PubMed

Leston, Alan R; Ollison, Will M

2017-11-01

Long-standing measurement techniques for determining ground-level ozone (O 3 ) and nitrogen dioxide (NO 2 ) are known to be biased by interfering compounds that result in overestimates of high O 3 and NO 2 ambient concentrations under conducive conditions. An increasing near-ground O 3 gradient (NGOG) with increasing height above ground level is also known to exist. Both the interference bias and NGOG were investigated by comparing data from a conventional Federal Equivalent Method (FEM) O 3 photometer and an identical monitor upgraded with an "interference-free" nitric oxide O 3 scrubber that alternatively sampled at 2 m and 6.2 m inlet heights above ground level (AGL). Intercomparison was also made between a conventional nitrogen oxide (NO x ) chemiluminescence Federal Reference Method (FRM) monitor and a new "direct-measure" NO 2 NO x 405 nm photometer at a near-road air quality measurement site. Results indicate that the O 3 monitor with the upgraded scrubber recorded lower regulatory-oriented concentrations than the deployed conventional metal oxide-scrubbed monitor and that O 3 concentrations 6.2 m AGL were higher than concentrations 2.0 m AGL, the nominal nose height of outdoor populations. Also, a new direct-measure NO 2 photometer recorded generally lower NO 2 regulatory-oriented concentrations than the conventional FRM chemiluminescence monitor, reporting lower daily maximum hourly average concentrations than the conventional monitor about 3 of every 5 days. Employing bias-prone instruments for measurement of ambient ozone or nitrogen dioxide from inlets at inappropriate heights above ground level may result in collection of positively biased data. This paper discusses tests of new regulatory instruments, recent developments in bias-free ozone and nitrogen dioxide measurement technology, and the presence/extent of a near-ground O 3 gradient (NGOG). Collection of unbiased monitor inlet height-appropriate data is crucial for determining accurate design

Genetically engineered microbial biosensors for in situ monitoring of environmental pollution.

PubMed

Shin, Hae Ja

2011-02-01

Microbial biosensors are compact, portable, cost effective, and simple to use, making them seem eminently suitable for the in situ monitoring of environmental pollution. One promising approach for such applications is the fusion of reporter genes with regulatory genes that are dose-dependently responsive to the target chemicals or physiological signals. Their biosensor capabilities, such as target range and sensitivity, could be improved by modification of regulatory genes. Recent uses of such genetically engineered microbial biosensors include the development of portable biosensor kits and high-throughput cell arrays on chips, optic fibers, or other platforms for on-site and on-line monitoring of environmental pollution. This mini-review discusses recent advances in microbial biosensors and their future prospects, with a focus on the development and application of genetically modified microbial biosensors for in situ environmental monitoring.

75 FR 62534 - Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference October 1, 2010. The Federal...-referenced proceeding to explore issues associated with reliability monitoring, enforcement and compliance...

77 FR 24228 - Condition Monitoring Techniques for Electric Cables Used in Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-23

... Used in Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance... guide, (RG) 1.218, ``Condition Monitoring Techniques for Electric Cables Used in Nuclear Power Plants... of electric cables for nuclear power plants. RG 1.218 is not intended to be prescriptive, instead it...

Developing self-regulation for dietary temptations: intervention effects on physical, self-regulatory and psychological outcomes.

PubMed

McKee, Heather C; Ntoumanis, Nikos

2014-12-01

We aimed to investigate whether a self-regulatory skills intervention can improve weight loss-related outcomes. Fifty-five participants (M BMI = 32.60 ± 4.86) were randomized into self-regulation training and advice groups and received two training workshops and weekly practice tasks. The self-regulation training group was trained to use six self-regulatory skills: Delayed gratification, thought control, goal setting, self-monitoring, mindfulness, and coping. The advice group received dietary and physical activity advice for weight loss. Physical, self-regulatory, and psychological measures were taken at baseline, end of intervention (week 8) and at follow-up (week 12). Using intention-to-treat analysis, weight, waist circumference, body fat and body mass index (BMI) were significantly reduced at follow-up for both groups. There were significant increases in all six self-regulatory skills and the psychological measures of self-efficacy, self-regulatory success, and physical self-worth for both groups. Results indicate that self-regulatory skills training might be as effective as dietary and physical activity advice in terms of weight loss and related outcomes.

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

PubMed Central

Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

2016-01-01

Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

The need for transparency and reproducibility in documenting values for regulatory decision making and evaluating causality: The example of formaldehyde.

PubMed

Van Landingham, Cynthia; Mundt, Kenneth A; Allen, Bruce C; Gentry, P Robinan

2016-11-01

Reproducibility and transparency in scientific reporting is paramount to advancing science and providing the foundation required for sound regulation. Recent examples demonstrate that pivotal scientific findings cannot be replicated, due to poor documentation or methodological bias, sparking debate across scientific and regulatory communities. However, there is general agreement that improvements in communicating and documenting research and risk assessment methods are needed. In the case of formaldehyde, the peer-review conducted by a National Academy of Sciences (NAS) Committee questioned the approaches used by the Integrated Risk Information System (IRIS) in developing draft unit risk values. Using the original data from the key study (Beane Freeman et al., 2009) and documentation provided in the draft IRIS profile, we attempted to duplicate the reported inhalation unit risk values and address the NAS Committee's questions regarding application of the appropriate dose-response model. Overall, documentation of the methods lacked sufficient detail to allow for replication of the unit risk estimates, specifically for Hodgkin lymphoma and leukemias, the key systemic endpoints selected by IRIS. The lack of apparent exposure-response relationships for selected endpoints raises the question whether quantitative analyses are appropriate for these endpoints, and if so, how results are to be interpreted. Copyright © 2016. Published by Elsevier Inc.

Monitoring changes in acid value, total polar material, and antioxidant capacity of oils used for frying chicken.

PubMed

Song, JuHee; Kim, Mi-Ja; Kim, Young-Jun; Lee, JaeHwan

2017-04-01

Oxidation products and tocol homologues were monitored in oils during chicken frying to determine the discarding point of highly used frying oils. Oils were heated without chicken for 170h while chicken frying was performed 130 cycles at 180°C. As heating time and frying cycles increased, all oxidation parameters including acid value, total polar materials (TPM), conjugated dienoic acid (CDA), and p-anisidine values (p-AV) increased significantly (p<0.05). γ-Tocopherol and γ-tocotrienol had the lowest stability in oils during heating or frying processes compared to other tocol homologues. TPM values over 24% were obtained after about 109h for heated oil and 100 cycles for oils used to fry chicken. A decrease of 2,2-diphenyl-1-picrylhydrazyl (DPPH) in isooctane and methanol was highly correlated with the formation of TPM in oils during the frying process. Both DPPH loss and TPM values could be applied to determine the discarding points of highly used frying oils. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of a metrics dashboard for monitoring involvement in the 340B Drug Pricing Program.

PubMed

Karralli, Rusol; Tipton, Joyce; Dumitru, Doina; Scholz, Lisa; Masilamani, Santhi

2015-09-01

An electronic tool to support hospital organizations in monitoring and addressing financial and compliance challenges related to participation in the 340B Drug Pricing Program is described. In recent years there has been heightened congressional and regulatory scrutiny of the federal 340B program, which provides discounted drug prices on Medicaid-covered drugs to safety net hospitals and other 340B-eligible healthcare organizations, or "covered entities." Historically, the 340B program has lacked a metrics-driven reporting framework to help covered entities capture the value of 340B program involvement, community benefits provided to underserved populations, and costs associated with compliance with 340B eligibility requirements. As part of an initiative by a large health system to optimize its 340B program utilization and regulatory compliance efforts, a team of pharmacists led the development of an electronic dashboard tool to help monitor 340B program activities at the system's 340B-eligible facilities. After soliciting input from an array of internal and external 340B program stakeholders, the team designed the dashboard and associated data-entry tools to facilitate the capture and analysis of 340B program-related data in four domains: cost savings and revenue, program maintenance costs, community benefits, and compliance. A large health system enhanced its ability to evaluate and monitor 340B program-related activities through the use of a dashboard tool capturing key metrics on cost savings achieved, maintenance costs, and other aspects of program involvement. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

What Is the Value of Value-Based Purchasing?

PubMed

Tanenbaum, Sandra J

2016-10-01

Value-based purchasing (VBP) is a widely favored strategy for improving the US health care system. The meaning of value that predominates in VBP schemes is (1) conformance to selected process and/or outcome metrics, and sometimes (2) such conformance at the lowest possible cost. In other words, VBP schemes choose some number of "quality indicators" and financially incent providers to meet them (and not others). Process measures are usually based on clinical science that cannot determine the effects of a process on individual patients or patients with comorbidities, and do not necessarily measure effects that patients value; additionally, there is no provision for different patients valuing different things. Proximate outcome measures may or may not predict distal ones, and the more distal the outcome, the less reliably it can be attributed to health care. Outcome measures may be quite rudimentary, such as mortality rates, or highly contestable: survival or function after prostate surgery? When cost is an element of value-based purchasing, it is the cost to the value-based payer and not to other payers or patients' families. The greatest value of value-based purchasing may not be to patients or even payers, but to policy makers seeking a morally justifiable alternative to politically contested regulatory policies. Copyright © 2016 by Duke University Press.

75 FR 68780 - Reliability Monitoring, Enforcement and Compliance Issues; Agenda for the Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-09

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Agenda for the Technical Conference November 2, 2010. The... associated with reliability monitoring, enforcement and compliance. The Commission announced the conference...

Sampling and monitoring for closure

USGS Publications Warehouse

McLemore, Virginia T.; Smith, Kathleen S.; Russell, Carol C.

2007-01-01

An important aspect of planning a new mine or mine expansion within the modern regulatory framework is to design for ultimate closure. Sampling and monitoring for closure is a form of environmental risk management. By implementing a sampling and monitoring program early in the life of the mining operation, major costs can be avoided or minimized. The costs for treating mine drainage in perpetuity are staggering, especially if they are unanticipated. The Metal Mining Sector of the Acid Drainage Technology Initiative (ADTI-MMS), a cooperative government-industry-academia organization, was established to address drainage-quality technologies of metal mining and metallurgical operations. ADTI-MMS recommends that sampling and monitoring programs consider the entire mine-life cycle and that data needed for closure of an operation be collected from exploration through postclosure.

Essays on remote monitoring as an emerging tool for centralized management of decentralized wastewater systems

NASA Astrophysics Data System (ADS)

Solomon, Clement

According to the United States Environmental Protections Agency (USEPA), nearly one in four households in the United States depends on an individual septic system (commonly referred as an onsite system or a decentralized wastewater system) to treat and disperse wastewater. More than half of these systems are over 30 years old, and surveys indicate at least 10 to 20% might not be functioning properly. The USEPA concluded in its 1997 report to Congress that adequately managed decentralized wastewater systems (DWS) are a cost-effective and long-term option for meeting public health and water quality goals, particularly in less densely populated areas. The major challenge however is the absence of a guiding national regulatory framework based on consistent performance-based standards and lack of proper management of DWS. These inconsistencies pose a significant threat to our water resources, local economies, and public health. This dissertation addresses key policy and regulatory strategies needed in response to the new realities confronting decentralized wastewater management. The two core objectives of this research are to demonstrate the centralized management of DWS paradigm and to present a scientific methodology to develop performance-based standards (a regulatory shift from prescriptive methods) using remote monitoring. The underlying remote monitoring architecture for centralized DWS management and the value of science-based policy making are presented. Traditionally, prescriptive standards using conventional grab sampling data are the norm by which most standards are set. Three case studies that support the potential of remote monitoring as a tool for standards development and system management are presented. The results revealed a vital role for remote monitoring in the development of standardized protocols, policies and procedures that are greatly lacking in this field. This centralized management and remote monitoring paradigm fits well and complements

The interplay between societal concerns and the regulatory frame on GM crops in the European Union.

PubMed

Devos, Yann; Reheul, Dirk; De Waele, Danny; Van Speybroeck, Linda

2006-01-01

Recapitulating how genetic modification technology and its agro-food products aroused strong societal opposition in the European Union, this paper demonstrates how this opposition contributed to shape the European regulatory frame on GM crops. More specifically, it describes how this opposition contributed to a de facto moratorium on the commercialization of new GM crop events in the end of the nineties. From this period onwards, the regulatory frame has been continuously revised in order to slow down further erosion of public and market confidence. Various scientific and technical reforms were made to meet societal concerns relating to the safety of GM crops. In this context, the precautionary principle, environmental post-market monitoring and traceability were adopted as ways to cope with scientific uncertainties. Labeling, traceability, co-existence and public information were installed in an attempt to meet the general public request for more information about GM agro-food products, and the specific demand to respect the consumers' and farmers' freedom of choice. Despite these efforts, today, the explicit role of public participation and/or ethical consultation during authorization procedures is at best minimal. Moreover, no legal room was created to progress to an integral sustainability evaluation during market procedures. It remains to be seen whether the recent policy shift towards greater transparency about value judgments, plural viewpoints and scientific uncertainties will be one step forward in integrating ethical concerns more explicitly in risk analysis. As such, the regulatory frame stands open for further interpretation, reflecting in various degrees a continued interplay with societal concerns relating to GM agro-food products. In this regard, both societal concerns and diversely interpreted regulatory criteria can be inferred as signaling a request - and even a quest - to render more explicit the broader-than-scientific dimension of the actual

Biomedical applications of tissue engineering technology: regulatory issues.

PubMed

Hellman, K B

1995-01-01

for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.

Choices in recreational water quality monitoring: new opportunities and health risk trade-offs.

PubMed

Nevers, Meredith B; Byappanahalli, Muruleedhara N; Whitman, Richard L

2013-04-02

With the recent release of new recreational water quality monitoring criteria, there are more options for regulatory agencies seeking to protect beachgoers from waterborne pathogens. Included are methods that can reduce analytical time, providing timelier estimates of water quality, but the application of these methods has not been examined at most beaches for expectation of health risk and management decisions. In this analysis, we explore health and monitoring outcomes expected at Lake Michigan beaches using protocols for indicator bacteria including culturable Escherichia coli (E. coli; EC), culturable enterococci (ENT), and enterococci as analyzed by qPCR (QENT). Correlations between method results were generally high, except at beaches with historically high concentrations of EC. The "beach action value" was exceeded most often when using EC or ENT as the target indicator; QENT exceeded the limit far less frequently. Measured water quality between years was varied. Although methods with equivalent health expectation have been established, the lack of relationship among method outcomes and annual changes in mean indicator bacteria concentrations complicates the decision-making process. The monitoring approach selected by beach managers may be a combination of available tools that maximizes timely health protection, cost efficiency, and collaboration among beach jurisdictions.

Optimizing disinfection by-product monitoring points in a distribution system using cluster analysis.

PubMed

Delpla, Ianis; Florea, Mihai; Pelletier, Geneviève; Rodriguez, Manuel J

2018-06-04

Trihalomethanes (THMs) and Haloacetic Acids (HAAs) are the main groups detected in drinking water and are consequently strictly regulated. However, the increasing quantity of data for disinfection byproducts (DBPs) produced from research projects and regulatory programs remains largely unexploited, despite a great potential for its use in optimizing drinking water quality monitoring to meet specific objectives. In this work, we developed a procedure to optimize locations and periods for DBPs monitoring based on a set of monitoring scenarios using the cluster analysis technique. The optimization procedure used a robust set of spatio-temporal monitoring results on DBPs (THMs and HAAs) generated from intensive sampling campaigns conducted in a residential sector of a water distribution system. Results shows that cluster analysis allows for the classification of water quality in different groups of THMs and HAAs according to their similarities, and the identification of locations presenting water quality concerns. By using cluster analysis with different monitoring objectives, this work provides a set of monitoring solutions and a comparison between various monitoring scenarios for decision-making purposes. Finally, it was demonstrated that the data from intensive monitoring of free chlorine residual and water temperature as DBP proxy parameters, when processed using cluster analysis, could also help identify the optimal sampling points and periods for regulatory THMs and HAAs monitoring. Copyright © 2018 Elsevier Ltd. All rights reserved.

Incidence and localizing value of vertigo and dizziness in patients with epilepsy: Video-EEG monitoring study.

PubMed

Kim, Dong Wook; Sunwoo, Jun-Sang; Lee, Sang Kun

2016-10-01

Vertigo and dizziness are common neurological complaints that have long been associated with epilepsy. However, studies of patients with epileptic vertigo or dizziness with concurrent EEG monitoring are scarce. We performed the present study to investigate the incidence and localizing value of vertigo and dizziness in patients with epilepsy who had confirmation of EEG changes via video-EEG monitoring. Data of aura and clinical seizure episodes of 831 consecutive patients who underwent video-EEG monitoring were analyzed retrospectively. Out of 831 patients, 40 patients (4.8%) experienced vertigo or dizziness as aura (mean age, 32.8±11.8years), all of whom had partial seizures. Eight had mesial temporal, 20 had lateral temporal, four had frontal, one had parietal, and seven had occipital lobe onset seizures. An intracranial EEG with cortical stimulation study was performed in seven patients, and the area of stimulation-induced vertigo or dizziness coincided with the ictal onset area in only one patient. Our study showed that vertigo or dizziness is a common aura in patients with epilepsy, and that the temporal lobe is the most frequent ictal onset area in these patients. However, it can be suggested that the symptomatogenic area in patients with epileptic vertigo and dizziness may not coincide with the ictal onset area. Copyright © 2016 Elsevier B.V. All rights reserved.

Monitored natural attenuation forum: MNA of metals and radionuclides

EPA Science Inventory

While the natural attenuation of many organic compounds is established and accepted by the regulated and regulatory communities, there is some debate whether monitored natural attenuation (MNA) of metals and radionuclides is a reasonable remedial alternative to consider. Do you...

HANDBOOK: CONTINUOUS EMISSION MONITORING SYSTEMS FOR NON-CRITERIA POLLUTANTS

EPA Science Inventory

This Handbook provides a description of the methods used to continuously monitor non-criteria pollutants emitted from stationary sources. The Handbook contains a review of current regulatory programs, the state-of-the-art sampling system design, analytical techniques, and the use...

Multiple species inventory and monitoring technical guide

Treesearch

P.N. Manley; B. Van Horne; J.K. Roth; W.J. Zielinski; M.M. McKenzie; T.J. Weller; F.W. Weckerly; C. Vojta

2006-01-01

The National Forest Management Act (1976) recognizes the importance of maintaining species and community diversity on National Forest System (NFS) lands as a critical component of our ecological and cultural heritage. Monitoring is required of land management to assess the success of management activities in meeting legal, regulatory, and policy objectives, including...

40 CFR 63.751 - Monitoring requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) National Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.751 Monitoring... specific monitoring procedures; (ii) Set the operating parameter value, or range of values, that... monitoring data. (1) The data may be recorded in reduced or nonreduced form (e.g., parts per million (ppm...

40 CFR 63.751 - Monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) National Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.751 Monitoring... specific monitoring procedures; (ii) Set the operating parameter value, or range of values, that... monitoring data. (1) The data may be recorded in reduced or nonreduced form (e.g., parts per million (ppm...

40 CFR 63.751 - Monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) National Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.751 Monitoring... specific monitoring procedures; (ii) Set the operating parameter value, or range of values, that... monitoring data. (1) The data may be recorded in reduced or nonreduced form (e.g., parts per million (ppm...

40 CFR 63.751 - Monitoring requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) National Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.751 Monitoring... specific monitoring procedures; (ii) Set the operating parameter value, or range of values, that... monitoring data. (1) The data may be recorded in reduced or nonreduced form (e.g., parts per million (ppm...

40 CFR 63.751 - Monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) National Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.751 Monitoring... specific monitoring procedures; (ii) Set the operating parameter value, or range of values, that... monitoring data. (1) The data may be recorded in reduced or nonreduced form (e.g., parts per million (ppm...

10 CFR 40.65 - Effluent monitoring reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Effluent monitoring reporting requirements. 40.65 Section 40.65 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL Records, Reports... possess and use source material in uranium milling, in production of uranium hexafluoride, or in a uranium...

Value of molecular monitoring during the treatment of chronic myeloid leukemia: a Cancer and Leukemia Group B study.

PubMed

Stock, W; Westbrook, C A; Peterson, B; Arthur, D C; Szatrowski, T P; Silver, R T; Sher, D A; Wu, D; Le Beau, M M; Schiffer, C A; Bloomfield, C D

1997-01-01

Disappearance of the Philadelphia chromosome during treatment for chronic myeloid leukemia (CML) has become an important therapeutic end point. To determine the additional value of molecular monitoring during treatment for CML, we performed a prospective, sequential analysis using quantitative Southern blot monitoring of BCR gene rearrangements of blood and marrow samples from Cancer and Leukemia Group B (CALGB) study 8761. Sixty-four previously untreated adults with chronic-phase CML who were enrolled onto CALGB 8761, a molecular-monitoring companion study to a treatment study for adults with chronic-phase CML (CALGB 9013). Treatment consisted of repetitive cycles of interferon alfa and low-dose subcutaneous cytarabine. Blood and marrow Southern blot quantitation of BCR gene rearrangements was compared with marrow cytogenetic analysis before the initiation of treatment and of specified points during therapy. Reverse-transcriptase polymerase chain reaction (RT-PCR) analysis was performed to detect residual disease in patients who achieved a complete response by Southern blot or cytogenetic analysis. Quantitative molecular monitoring by Southern blot analysis of blood samples was found to be equivalent to marrow monitoring at all time points. Twelve of 62 (19%) follow-up samples studied by Southern blot analysis had a complete loss of BCR gene rearrangement in matched marrow and blood specimens. Southern blot monitoring of blood samples was also found to be highly correlated to marrow cytogenetic evaluation at all points, although there were four discordant cases in which Southern blot analysis of blood showed no BCR gene rearrangement, yet demonstrated from 12% to 20% Philadelphia chromosome-positive metaphase cells in the marrow. RT-PCR analysis detected residual disease in five of six patients in whom no malignant cells were detected using Southern blot or cytogenetic analyses. Quantitative Southern blot analysis of blood samples may be substituted for bone

The value of point-of-care CD4+ and laboratory viral load in tailoring antiretroviral therapy monitoring strategies to resource limitations.

PubMed

Hyle, Emily P; Jani, Ilesh V; Rosettie, Katherine L; Wood, Robin; Osher, Benjamin; Resch, Stephen; Pei, Pamela P; Maggiore, Paolo; Freedberg, Kenneth A; Peter, Trevor; Parker, Robert A; Walensky, Rochelle P

2017-09-24

To examine the clinical and economic value of point-of-care CD4 (POC-CD4) or viral load monitoring compared with current practices in Mozambique, a country representative of the diverse resource limitations encountered by HIV treatment programs in sub-Saharan Africa. We use the Cost-Effectiveness of Preventing AIDS Complications-International model to examine the clinical impact, cost (2014 US$), and incremental cost-effectiveness ratio [$/year of life saved (YLS)] of ART monitoring strategies in Mozambique. We compare: monitoring for clinical disease progression [clinical ART monitoring strategy (CLIN)] vs. annual POC-CD4 in rural settings without laboratory services and biannual laboratory CD4 (LAB-CD4), biannual POC-CD4, and annual viral load in urban settings with laboratory services. We examine the impact of a range of values in sensitivity analyses, using Mozambique's 2014 per capita gross domestic product ($620) as a benchmark cost-effectiveness threshold. In rural settings, annual POC-CD4 compared to CLIN improves life expectancy by 2.8 years, reduces time on failed ART by 0.6 years, and yields an incremental cost-effectiveness ratio of $480/YLS. In urban settings, biannual POC-CD4 is more expensive and less effective than viral load. Compared to biannual LAB-CD4, viral load improves life expectancy by 0.6 years, reduces time on failed ART by 1.0 year, and is cost-effective ($440/YLS). In rural settings, annual POC-CD4 improves clinical outcomes and is cost-effective compared to CLIN. In urban settings, viral load has the greatest clinical benefit and is cost-effective compared to biannual POC-CD4 or LAB-CD4. Tailoring ART monitoring strategies to specific settings with different available resources can improve clinical outcomes while remaining economically efficient.

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.

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

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

Science, policy, and the transparency of values.

PubMed

Elliott, Kevin C; Resnik, David B

2014-07-01

Opposing groups of scientists have recently engaged in a heated dispute over a preliminary European Commission (EC) report on its regulatory policy for endocrine-disrupting chemicals. In addition to the scientific issues at stake, a central question has been how scientists can maintain their objectivity when informing policy makers. Drawing from current ethical, conceptual, and empirical studies of objectivity and conflicts of interest in scientific research, we propose guiding principles for communicating scientific findings in a manner that promotes objectivity, public trust, and policy relevance. Both conceptual and empirical studies of scientific reasoning have shown that it is unrealistic to prevent policy-relevant scientific research from being influenced by value judgments. Conceptually, the current dispute over the EC report illustrates how scientists are forced to make value judgments about appropriate standards of evidence when informing public policy. Empirical studies provide further evidence that scientists are unavoidably influenced by a variety of potentially subconscious financial, social, political, and personal interests and values. When scientific evidence is inconclusive and major regulatory decisions are at stake, it is unrealistic to think that values can be excluded from scientific reasoning. Thus, efforts to suppress or hide interests or values may actually damage scientific objectivity and public trust, whereas a willingness to bring implicit interests and values into the open may be the best path to promoting good science and policy.

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

Regulatory constraints as seen from the pharmaceutical industry.

PubMed

Galligani, G; David-Andersen, I; Fossum, B

2005-01-01

In Chile, Canada, Europe, Japan, and the USA, which are the main geographical areas for fish farming of high value fish such as salmonids, sea bass, sea bream, yellowtail and catfish, vaccination has been established as an important method for the prevention of infectious diseases. To make new vaccines available to the fish farming industry, pharmaceutical companies must comply with the regulatory framework for licensing of fish vaccines, which in recent years has become more regulated. Considerable scientific and regulatory skills are thus required to develop, document and license vaccines in accordance with the requirements in the different geographical areas. International co-operation to harmonise requirements for the licensing documentation is ongoing. Even though there are obvious benefits to the pharmaceutical industry from the harmonisation process, it may sometimes impose unreasonable requirements. The regulatory framework for fish vaccines clearly has an impact on the time for bringing a new fish vaccine to the market. Several hurdles need to be passed to complete the regulatory process, i.e. obtain a licence. Fulfilment of the rather detailed and extensive requirements for documentation of the production and controls, as well as safety and efficacy of the vaccine, represent a challenge to the pharmaceutical industry, as do the different national and regional licensing procedures. This paper describes regulatory constraints related to the documentation, the licensing process, the site of production and the continuing international harmonisation work, with emphasis on inactivated conventional fish vaccines.

Survey Guidelines and its Reading Criteria for Monitoring and Transmitting Cultural Heritage Values

NASA Astrophysics Data System (ADS)

De Masi, A.

2015-08-01

The paper describes reading criteria for an analysis and interpretation of material systems in relation to a built space, survey guidelines and its reading criteria for Cultural Heritage (CH) values'monitoring and transmission. In addition, integrated systems of digital technologies and 2D/3D digitization of CH are introduced for an effective and accurate reading of Venice and Milan's monuments. Specifically, the guidelines for an architectural survey allow to organize and document historic monuments information, and to identify the significant cultural/physical elements of our past in order for them to be preserved and protected for future generations. In addition, in this paper the studied projects introduce a combination of virtual technologies and historical reality with experimenting innovative solutions for CH. From the methodological point of view, this study has made use of the identification of levels of study (LS) differentiated, each of which is capable of identifying categories.

Fuel processor temperature monitoring and control

DOEpatents

Keskula, Donald H.; Doan, Tien M.; Clingerman, Bruce J.

2002-01-01

In one embodiment, the method of the invention monitors one or more of the following conditions: a relatively low temperature value of the gas stream; a relatively high temperature value of the gas stream; and a rate-of-change of monitored temperature. In a preferred embodiment, the rate of temperature change is monitored to prevent the occurrence of an unacceptably high or low temperature condition. Here, at least two temperatures of the recirculating gas stream are monitored over a period of time. The rate-of-change of temperature versus time is determined. Then the monitored rate-of-change of temperature is compared to a preselected rate-of-change of value. The monitoring of rate-of-change of temperature provides proactive means for preventing occurrence of an unacceptably high temperature in the catalytic reactor.

Monitoring of Hazardous Air Pollutant Surrogates Using Resonance Enhanced Multiphoton Ionization/Time of Flight Mass Spectrometry

EPA Science Inventory

EPA’s preferred approach for regulatory emissions compliance is based upon real-time monitoring of individual hazardous air pollutants (HAPs). Real-time, continuous monitoring not only provides the most comprehensive assurance of emissions compliance, but also can serve as...

Regulatory Impact Analysis (RIA) for the Proposed Revisions to the Sulfur Dioxide National Ambient Air Quality Standards (NAAQS)

EPA Pesticide Factsheets

This Regulatory Impact Analysis (RIA) provides estimates of the incremental costs and monetized human health benefits of attaining a revised short‐term Sulfur Dioxide (SO2) NAAQS within the current monitoring network.

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...

Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies

PubMed Central

Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

2013-01-01

The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254) of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies’ ability to oversee their growing use and application in society. PMID:24244662

Network Monitoring Traffic Compression Using Singular Value Decomposition

DTIC Science & Technology

2014-03-27

Shootouts." Workshop on Intrusion Detection and Network Monitoring. 1999. [12] Goodall , John R. "Visualization is better! a comparative evaluation...34 Visualization for Cyber Security, 2009. VizSec 2009. 6th International Workshop on IEEE, 2009. [13] Goodall , John R., and Mark Sowul. "VIAssist...Viruses and Log Visualization.” In Australian Digital Forensics Conference. Paper 54, 2008. [30] Tesone, Daniel R., and John R. Goodall . "Balancing

10 CFR 34.83 - Records of personnel monitoring procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...

10 CFR 34.83 - Records of personnel monitoring procedures.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...

10 CFR 34.83 - Records of personnel monitoring procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...

10 CFR 34.83 - Records of personnel monitoring procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...

10 CFR 34.83 - Records of personnel monitoring procedures.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...

Micro Electrochemical pH Sensor Applicable for Real-Time Ratiometric Monitoring of pH Values in Rat Brains.

PubMed

Zhou, Jie; Zhang, Limin; Tian, Yang

2016-02-16

To develop in vivo monitoring meter for pH measurements is still the bottleneck for understanding the role of pH plays in the brain diseases. In this work, a selective and sensitive electrochemical pH meter was developed for real-time ratiometric monitoring of pH in different regions of rat brains upon ischemia. First, 1,2-naphthoquinone (1,2-NQ) was employed and optimized as a selective pH recognition element to establish a 2H(+)/2e(-) approach over a wide range of pH from 5.8 to 8.0. The pH meter demonstrated remarkable selectivity toward pH detection against metal ions, amino acids, reactive oxygen species, and other biological species in the brain. Meanwhile, an inner reference, 6-(ferrocenyl)hexanethiol (FcHT), was selected as a built-in correction to avoid the environmental effect through coimmobilization with 1,2-NQ. In addition, three-dimensional gold nanoleaves were electrodeposited onto the electrode surface to amplify the signal by ∼4.0-fold and the measurement was achieved down to 0.07 pH. Finally, combined with the microelectrode technique, the microelectrochemical pH meter was directly implanted into brain regions including the striatum, hippocampus, and cortex and successfully applied in real-time monitoring of pH values in these regions of brain followed by global cerebral ischemia. The results demonstrated that pH values were estimated to 7.21 ± 0.05, 7.13 ± 0.09, and 7.27 ± 0.06 in the striatum, hippocampus, and cortex in the rat brains, respectively, in normal conditions. However, pH decreased to 6.75 ± 0.07 and 6.52 ± 0.03 in the striatum and hippocampus, upon global cerebral ischemia, while a negligible pH change was obtained in the cortex.

Determinants of Pregnant Women’s Online Self-Regulatory Activities for Appropriate Gestational Weight Gain

PubMed Central

Kim, Hye Kyung; Niederdeppe, Jeff; Guillory, Jamie; Graham, Meredith; Olson, Christine; Gay, Geri

2015-01-01

This study examined psychosocial and socio-demographic factors associated with pregnant women’s use of web-based tools to set and monitor personal goals for healthy diet and physical activity. These tools were made available to women participating in a randomized trial testing a web-based intervention to promote appropriate gestational weight gain. We used data from a baseline survey of pregnant women assigned to the intervention group and log data on women’s use of various intervention features (N = 873). Women who believed that appropriate gestational weight gain would lead to healthy outcomes for their child were more likely to engage in online goal-setting and self-monitoring. Less positive outcome expectancy beliefs about the relationship between their own weight and baby’s health partially explains why some at risk subpopulations (e.g., African-American women) were less likely to utilize online self-regulatory tools. This study specifies key psychosocial and motivational factors that guide the construction and monitoring of goals among pregnant women. These findings offer guidance for the design of interventions to promote self-regulatory techniques by identifying groups for whom those features are most likely to be useful, as well as psychological determinants of their use. PMID:25205417

78 FR 39420 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-01

... state that ``[t]he Member's supervisory procedures must be reasonably designed to assure that the orders... by the Exchange, and (ii) monitor whether its broker-dealer customer's Retail Order flow continues to... the retail order flow submitted to the Exchange, the Financial Industry Regulatory Authority (``FINRA...

Integrating environmental monitoring with cumulative effects management and decision making.

PubMed

Cronmiller, Joshua G; Noble, Bram F

2018-05-01

Cumulative effects (CE) monitoring is foundational to emerging regional and watershed CE management frameworks, yet monitoring is often poorly integrated with CE management and decision-making processes. The challenges are largely institutional and organizational, more so than scientific or technical. Calls for improved integration of monitoring with CE management and decision making are not new, but there has been limited research on how best to integrate environmental monitoring programs to ensure credible CE science and to deliver results that respond to the more immediate questions and needs of regulatory decision makers. This paper examines options for the integration of environmental monitoring with CE frameworks. Based on semistructured interviews with practitioners, regulators, and other experts in the Lower Athabasca, Alberta, Canada, 3 approaches to monitoring system design are presented. First, a distributed monitoring system, reflecting the current approach in the Lower Athabasca, where monitoring is delegated to different external programs and organizations; second, a 1-window system in which monitoring is undertaken by a single, in-house agency for the purpose of informing management and regulatory decision making; third, an independent system driven primarily by CE science and understanding causal relationships, with knowledge adopted for decision support where relevant to specific management questions. The strengths and limitations of each approach are presented. A hybrid approach may be optimal-an independent, nongovernment, 1-window model for CE science, monitoring, and information delivery-capitalizing on the strengths of distributed, 1-window, and independent monitoring systems while mitigating their weaknesses. If governments are committed to solving CE problems, they must invest in the long-term science needed to do so; at the same time, if science-based monitoring programs are to be sustainable over the long term, they must be responsive to

Better by design: business preferences for environmental regulatory reform.

PubMed

Taylor, Christopher M; Pollard, Simon J T; Rocks, Sophie A; Angus, Andrew J

2015-04-15

We present the preferences for environmental regulatory reform expressed by 30 UK businesses and industry bodies from 5 sectors. While five strongly preferred voluntary regulation, seven expressed doubts about its effectiveness, and 18 expressed no general preference between instrument types. Voluntary approaches were valued for flexibility and lower burdens, but direct regulation offered stability and a level playing field. Respondents sought regulatory frameworks that: are coherent; balance clarity, prescription and flexibility; are enabled by positive regulatory relationships; administratively efficient; targeted according to risk magnitude and character; evidence-based and that deliver long-term market stability for regulatees. Anticipated differences in performance between types of instrument can be undermined by poor implementation. Results underline the need for policy makers and regulators to tailor an effective mix of instruments for a given sector, and to overcome analytical, institutional and political barriers to greater coherence, to better coordinate existing instruments and tackle new environmental challenges as they emerge. Copyright © 2015 Elsevier B.V. All rights reserved.

Monitoring substrate enables real-time regulation of a protein localization pathway.

PubMed

Ito, Koreaki; Mori, Hiroyuki; Chiba, Shinobu

2018-06-01

Protein localization machinery supports cell survival and physiology, suggesting the potential importance of its expression regulation. Here, we summarize a remarkable scheme of regulation, which allows real-time feedback regulation of the machinery expression. A class of regulatory nascent polypeptides, called monitoring substrates, undergoes force-sensitive translation arrest. The resulting ribosome stalling on the mRNA then affects mRNA folding to expose the ribosome-binding site of the downstream target gene and upregulate its translation. The target gene encodes a component of the localization machinery, whose physical action against the monitoring substrate leads to arrest cancellation. Thus, this scheme of feedback loop allows the cell to adjust the amount of the machinery to correlate inversely with the effectiveness of the process at a given moment. The system appears to have emerged late in evolution, in which a narrow range of organisms selected a distinct monitoring substrate-machinery combination. Currently, regulatory systems of SecM-SecA, VemP-SecDF2 and MifM-YidC2 are known to occur in different bacterial species.

Engine monitoring display study

NASA Technical Reports Server (NTRS)

Hornsby, Mary E.

1992-01-01

The current study is part of a larger NASA effort to develop displays for an engine-monitoring system to enable the crew to monitor engine parameter trends more effectively. The objective was to evaluate the operational utility of adding three types of information to the basic Boeing Engine Indicating and Crew Alerting System (EICAS) display formats: alphanumeric alerting messages for engine parameters whose values exceed caution or warning limits; alphanumeric messages to monitor engine parameters that deviate from expected values; and a graphic depiction of the range of expected values for current conditions. Ten training and line pilots each flew 15 simulated flight scenarios with five variants of the basic EICAS format; these variants included different combinations of the added information. The pilots detected engine problems more quickly when engine alerting messages were included in the display; adding a graphic depiction of the range of expected values did not affect detection speed. The pilots rated both types of alphanumeric messages (alert and monitor parameter) as more useful and easier to interpret than the graphic depiction. Integrating engine parameter messages into the EICAS alerting system appears to be both useful and preferred.

French Regulatory practice and experience feedback on steam generator tube integrity

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

Sandon, G.

1997-02-01

This paper summarizes the way the French Safety Authority applies regulatory rules and practices to the problem of steam generator tube cracking in French PWR reactors. There are 54 reactors providing 80% of French electrical consumption. The Safety Authority closely monitors the performance of tubes in steam generators, and requires application of a program which deals with problems prior to the actual development of leakage. The actual rules regarding such performance are flexible, responding to the overall performance of operating steam generators. In addition there is an inservice inspection service to examine tubes during shutdown, and to monitor steam generatorsmore » for leakage during operation, with guidelines for when generators must be pulled off line.« less

Monitoring and management of tritium from the nuclear power plant effluent

NASA Astrophysics Data System (ADS)

Zhang, Qiaoe; Liu, Ting; Yang, Lili; Meng, De; Song, Dahu

2018-01-01

It is important to regulate tritium nuclides from the nuclear power plant effluent, the paper briefly analyzes the main source of tritium, and the regulatory requirements associated with tritium in our country and the United States. The monitoring methods of tritium from the nuclear power plant effluent are described, and the purpose to give some advice to our national nuclear power plant about the effluent of tritium monitoring and management.

Digital High-Current Monitor

NASA Technical Reports Server (NTRS)

Cash, B.

1985-01-01

Simple technique developed for monitoring direct currents up to several hundred amperes and digitally displaying values directly in current units. Used to monitor current magnitudes beyond range of standard laboratory ammeters, which typically measure 10 to 20 amperes maximum. Technique applicable to any current-monitoring situation.

40 CFR 52.480 - Photochemical Assessment Monitoring Stations (PAMS) Program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of Columbia's Department of Consumer and Regulatory Affairs submitted a plan for the establishment... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Photochemical Assessment Monitoring Stations (PAMS) Program. 52.480 Section 52.480 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

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...

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.

10 CFR 20.2106 - Records of individual monitoring results.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Records of individual monitoring results. 20.2106 Section 20.2106 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20... includes records required under the standards for protection against radiation in effect prior to January 1...

10 CFR 20.2106 - Records of individual monitoring results.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Records of individual monitoring results. 20.2106 Section 20.2106 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20... includes records required under the standards for protection against radiation in effect prior to January 1...

10 CFR 20.2106 - Records of individual monitoring results.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Records of individual monitoring results. 20.2106 Section 20.2106 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20... includes records required under the standards for protection against radiation in effect prior to January 1...

10 CFR 20.2106 - Records of individual monitoring results.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Records of individual monitoring results. 20.2106 Section 20.2106 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20... includes records required under the standards for protection against radiation in effect prior to January 1...

10 CFR 20.2106 - Records of individual monitoring results.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Records of individual monitoring results. 20.2106 Section 20.2106 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20... includes records required under the standards for protection against radiation in effect prior to January 1...

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)...

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.

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...

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.

Regular monitoring of cytomegalovirus (CMV)-specific cell-mediated immunity in intermediate-risk kidney transplant recipients: predictive value of the immediate post-transplant assessment.

PubMed

Fernández-Ruiz, Mario; Giménez, Estela; Vinuesa, Víctor; Ruiz-Merlo, Tamara; Parra, Patricia; Amat, Paula; Montejo, Miguel; Paez-Vega, Aurora; Cantisán, Sara; Torre-Cisneros, Julián; Fortún, Jesús; Andrés, Amado; San Juan, Rafael; López-Medrano, Francisco; Navarro, David; María Aguado, José

2018-05-24

Previous studies on monitoring of post-transplant cytomegalovirus (CMV)-specific cell-mediated immunity (CMI) are limited by single-center designs and disparate risk categories. We aimed to assess the clinical value of a regular monitoring strategy in a large multicenter cohort of intermediate-risk kidney transplant (KT) recipients. We recruited 124 CMV-seropositive KT recipients with no T-cell-depleting induction preemptively managed at four Spanish institutions. CMV-specific interferon-γ-producing CD4 + and CD8 + T-cells were enumerated through the first post-transplant year by intracellular cytokine staining after stimulation with pp65 and IE-1 peptides (mean of 6 measurements per patient). The primary outcome was the occurrence of any CMV event (asymptomatic infection and/or disease). Optimal cut-off values for CMV-specific T-cells were calculated at baseline and day 15. Twelve-month cumulative incidence of CMV infection and/or disease was 47.6%. Patients with pre-transplant CMV-specific CD8 + T-cell count <1.0 cells/μL had higher risk of CMV events (adjusted hazard ratio [aHR]: 2.84; P-value = 0.054). When the CMI assessment was performed at the immediate post-transplant period (day 15), the presence of <2.0 CD8 + T-cells/μL (aHR: 2.18; P-value = 0.034) or <1.0 CD4 + T-cells/μL (aHR: 2.43; P-value = 0.016) also predicted the subsequent development of CMV event. In addition, lower counts of CMV-specific CD4 + (but not CD8 + ) T-cells at days 60 and 180 were associated with a higher incidence of late-onset events. Monitoring for CMV-specific CMI in intermediate-risk KT recipients must be regular to reflect dynamic changes in overall immunosuppression and individual susceptibility. The early assessment at post-transplant day 15 remains particularly informative. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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...

Alarms based on real-time sensor glucose values alert patients to hypo- and hyperglycemia: the guardian continuous monitoring system.

PubMed

Bode, Bruce; Gross, Kenneth; Rikalo, Nancy; Schwartz, Sherwyn; Wahl, Timothy; Page, Casey; Gross, Todd; Mastrototaro, John

2004-04-01

The purposes of this study were to demonstrate the accuracy and effectiveness of the Guardian Continuous Monitoring System (Medtronic MiniMed, Northridge, California) and to demonstrate that the application of real-time alarms to continuous monitoring alerts users to hypo and hyperglycemia and reduces excursions in people with diabetes. A total of 71 subjects with type 1 diabetes, mean hemoglobin A1c of 7.6 +/- 1.1%, age 44.0 +/- 11.4 years, and duration of diabetes 23.6 +/- 10.6 years were enrolled in this two-period, randomized, multicenter study. Subjects were randomized into either an Alert group or a Control group. The accuracy of the Guardian was evaluated by treating the study data as a single-sample correlational design. Effectiveness of the Guardian alerts was evaluated by comparing the Alert group with the Control group. The mean (median) absolute relative error between home blood glucose meter readings and sensor values was 21.3% (17.3%), and the Guardian, on average, read 12.8 mg/dL below the concurrent home blood glucose meter readings. The hypoglycemia alert was able to distinguished glucose values < or =70 mg/dL with 67% sensitivity, 90% specificity, and 47% false alerts. The hyperglycemia alert showed a similar ability to detect sensor values > or =250 mg/dL with 63% sensitivity, 97% specificity, and 19% false alerts. The Alert group demonstrated a median decrease in the duration of hypoglycemic excursions (-27.8 min) that was significantly greater than the median decrease in the duration of hypoglycemic excursions in the Control group (-4.5 min) (P = 0.03). A marginally significant increase in the frequency of hyperglycemic excursions (P = 0.07) between Period 1 and Period 2 was accompanied by a decrease of 9.6 min in the duration of hyperglycemic excursions in the Alert group. Glucose measurements differ between blood samples taken from the finger and interstitial fluid, especially when levels are changing rapidly; however, these results

Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents

PubMed Central

Leong Wai Yeen, James; Salek, Sam; Walker, Stuart

2014-01-01

The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template. PMID:25538620

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.

Regulatory Supervision of Radiological Protection in the Russian Federation as Applied to Facility Decommissioning and Site Remediation

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

Sneve, M.K.; Shandala, N.K.

2007-07-01

The Russian Federation is carrying out major work to manage the legacy of exploitation of nuclear power and use of radioactive materials. This paper describes work on-going to provide enhanced regulatory supervision of these activities as regards radiological protection. The scope includes worker and public protection in routine operation; emergency preparedness and response; radioactive waste management, including treatment, interim storage and transport as well as final disposal; and long term site restoration. Examples examined include waste from facilities in NW Russia, including remediation of previous shore technical bases (STBs) for submarines, spent fuel and radioactive waste management from ice-breakers, andmore » decommissioning of Radio-Thermal-Generators (RTGs) used in navigational devices. Consideration is given to the identification of regulatory responsibilities among different regulators; development of necessary regulatory instruments; and development of regulatory procedures for safety case reviews and compliance monitoring and international cooperation between different regulators. (authors)« less

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...

Occupational noise exposure and regulatory adherence in music venues in the United Kingdom.

PubMed

Barlow, Christopher; Castilla-Sanchez, Francisco

2012-01-01

Noise in most working environments is an unwanted by-product of the process. In most countries, noise exposure for workers has been controlled by legislation for many years. In the music industry the "noise" is actually the "desired" product, and for a long time the UK entertainment industry was exempt from these regulations. From April 2008, however, it became regulated under the Noise at Work Regulations 2005, meaning that employers from orchestras to nightclubs are legally required to adhere to the same requirements (based on ISO 9612:2009) for controlling noise exposure for their staff that have been applied to other industries for many years. A key question is to what degree, 2 years after implementation, these employers are complying with their legal responsibilities to protect the staff from noise? This study assessed four public music venues where live and/or recorded music is regularly played. Thirty staff members in different roles in the venues were monitored using noise dosimetry to determine noise exposure. Questionnaires were used to determine work patterns, attitudes to noise and hearing loss, and levels of training about noise risk. Results showed that the majority of staff (70%) in all venues exceeded the daily noise exposure limit value in their working shift. Use of hearing protection was rare (<30%) and not enforced by most venues. The understanding of the hazard posed by noise was low, and implementation of the noise regulations was haphazard, with staff regularly exceeding regulatory limits. The implication is that the industry is failing to meet regulatory requirements.

The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).

PubMed

Yokotsuka, M; Aoyama, M; Kubota, K

2000-07-01

The Medical Dictionary for Regulatory Activities Terminology (MedDRA) version 2.1 (V2.1) was released in March 1999 accompanied by the MedDRA/J V2.1J specifically for Japanese users. In prescription-event monitoring in Japan (J-PEM), we have employed the MedDRA/J for data entry, signal generation and event listing. In J-PEM, the lowest level terms (LLTs) in the MedDRA/J are used in data entry because the richness of LLTs is judged to be advantageous. A signal is generated normally at the preferred term (PT) level, but it has been found that various reporters describe the same event using descriptions that are potentially encoded by LLTs under different PTs. In addition, some PTs are considered too specific to generate the proper signal. In the system used in J-PEM, when an LLT is selected as a candidate to encode an event, another LLT under a different PT, if any, is displayed on the computer screen so that it may be coded instead of, or in addition to, the candidate LLT. The five-level structure of the MedDRA is used when listing events but some modification is required to generate a functional event list.

Who owns Australia's water--elements of an effective regulatory model.

PubMed

McKay, J

2003-01-01

This paper identifies and describes a number of global trends in regulatory theory and legal scholarship. It points out the huge level of complexity demanded by globalisation and the unfortunate complication of this is that there is legal indeterminacy. The legal indeterminacy springs from the desire to amend and alter existing models. That has been the thrust of the Council of Australian Governments changes to adapt and add huge amounts of complexity to a flawed system. This paper argues that an effective water regulatory model requires a fundamental re-examination of the concept of water ownership and a capturing by the State of the right to allocate rainfall. This foundation is effective and the way forward to deal with the key issues in this transition phase. The second key element to an effective regulatory model is the concept of performance-based assessment. This requires information and schemes to be set up to work out ways to monitor and evaluate the performance of the utility on selected criteria. For Australia at present there is a dire lack of agreed criteria on these key issues and these have the potential to pull apart the whole process. The key issues are indigenous rights, governance issues, public participation, alteration of pre-existing rights and incorporation of environmental requirements.

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.

A methodology for post-EIS (environmental impact statement) monitoring

USGS Publications Warehouse

Marcus, Linda Graves

1979-01-01

A methodology for monitoring the impacts predicted in environmental impact statements (EIS's) was developed using the EIS on phosphate development in southeastern Idaho as a case study. A monitoring system based on this methodology: (1) coordinates a comprehensive, intergovernmental monitoring effort; (2) documents the major impacts that result, thereby improving the accuracy of impact predictions in future EIS's; (3) helps agencies control impacts by warning them when critical impact levels are reached and by providing feedback on the success of mitigating measures; and (4) limits monitoring data to the essential information that agencies need to carry out their regulatory and environmental protection responsibilities. The methodology is presented as flow charts accompanied by tables that describe the objectives, tasks, and products for each work element in the flow chart.

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...

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...

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...

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...

Education for worksite monitors of impaired nurses.

PubMed

Young, Linda J

2008-01-01

Boards of nursing sponsor programs, including those for alternatives to discipline, for recovering nurses. These programs rely on worksite monitors who are oftentimes other nurses or supervisors of nurses, to work with recovering nurses when they return to practice. The skills of these monitors vary with respect to understanding the monitor role and recognizing traits in chemical dependency and relapse. To determine the degree of content value and the best teaching method for monitors to learn program content, 17 currently active worksite monitors participated in a study to evaluate content value to 2 groups, new and experienced monitors, and to select the best method to teach 4 content topics. Results showed that current content was valued without necessary additions and that group instruction in urban areas was preferred over one-to-one instruction. Implementation of study outcomes yielded that issues of confidentiality made group instruction unsatisfactory.

Benefit-Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project.

PubMed

Bollaerts, Kaatje; De Smedt, Tom; Donegan, Katherine; Titievsky, Lina; Bauchau, Vincent

2018-03-26

New vaccines are launched based on their benefit-risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness and impact. With this work, we aim to assess the feasibility and added value of using an interactive dashboard as a potential methodology for near real-time monitoring of vaccine coverage and pre-specified health benefits and risks of vaccines. We developed a web application with an interactive dashboard for B/R monitoring. The dashboard is demonstrated using simulated electronic healthcare record data mimicking the introduction of rotavirus vaccination in the UK. The interactive dashboard allows end users to select certain parameters, including expected vaccine effectiveness, age groups, and time periods and allows calculation of the incremental net health benefit (INHB) as well as the incremental benefit-risk ratio (IBRR) for different sets of preference weights. We assessed the potential added value of the dashboard by user testing amongst a range of stakeholders experienced in the post-marketing monitoring of vaccines. The dashboard was successfully implemented and demonstrated. The feedback from the potential end users was generally positive, although reluctance to using composite B/R measures was expressed. The use of interactive dashboards for B/R monitoring is promising and received support from various stakeholders. In future research, the use of such an interactive dashboard will be further tested with real-life data as opposed to simulated data.

Managing "Academic Value": The 360-Degree Perspective

ERIC Educational Resources Information Center

Wilson, Margaret R.; Corr, Philip J.

2018-01-01

The "raison d'etre" of all universities is to create and deliver "academic value", which we define as the sum total of the contributions from the 360-degree "angles" of the academic community, including all categories of staff, as well as external stakeholders (e.g. regulatory, commercial, professional and community…

Identification of regulatory network hubs that control lipid metabolism in Chlamydomonas reinhardtii

DOE PAGES

Gargouri, Mahmoud; Park, Jeong -Jin; Holguin, F. Omar; ...

2015-05-28

Microalgae-based biofuels are promising sources of alternative energy, but improvements throughout the production process are required to establish them as economically feasible. One of the most influential improvements would be a significant increase in lipid yields, which could be achieved by altering the regulation of lipid biosynthesis and accumulation. Chlamydomonas reinhardtii accumulates oil (triacylglycerols, TAG) in response to nitrogen (N) deprivation. Although a few important regulatory genes have been identified that are involved in controlling this process, a global understanding of the larger regulatory network has not been developed. In order to uncover this network in this species, a combinedmore » omics (transcriptomic, proteomic and metabolomic) analysis was applied to cells grown in a time course experiment after a shift from N-replete to N-depleted conditions. Changes in transcript and protein levels of 414 predicted transcription factors (TFs) and transcriptional regulators (TRs) were monitored relative to other genes. The TF and TR genes were thus classified by two separate measures: up-regulated versus down-regulated and early response versus late response relative to two phases of polar lipid synthesis (before and after TAG biosynthesis initiation). Lipidomic and primary metabolite profiling generated compound accumulation levels that were integrated with the transcript dataset and TF profiling to produce a transcriptional regulatory network. In conclusion, evaluation of this proposed regulatory network led to the identification of several regulatory hubs that control many aspects of cellular metabolism, from N assimilation and metabolism, to central metabolism, photosynthesis and lipid metabolism.« less

Dynamic extreme values modeling and monitoring by means of sea shores water quality biomarkers and valvometry.

PubMed

Durrieu, Gilles; Pham, Quang-Khoai; Foltête, Anne-Sophie; Maxime, Valérie; Grama, Ion; Tilly, Véronique Le; Duval, Hélène; Tricot, Jean-Marie; Naceur, Chiraz Ben; Sire, Olivier

2016-07-01

Water quality can be evaluated using biomarkers such as tissular enzymatic activities of endemic species. Measurement of molluscs bivalves activity at high frequency (e.g., valvometry) during a long time period is another way to record the animal behavior and to evaluate perturbations of the water quality in real time. As the pollution affects the activity of oysters, we consider the valves opening and closing velocities to monitor the water quality assessment. We propose to model the huge volume of velocity data collected in the framework of valvometry using a new nonparametric extreme values statistical model. The objective is to estimate the tail probabilities and the extreme quantiles of the distribution of valve closing velocity. The tail of the distribution function of valve closing velocity is modeled by a Pareto distribution with parameter t,τ , beyond a threshold τ according to the time t of the experiment. Our modeling approach reveals the dependence between the specific activity of two enzymatic biomarkers (Glutathione-S-transferase and acetylcholinesterase) and the continuous recording of oyster valve velocity, proving the suitability of this tool for water quality assessment. Thus, valvometry allows in real-time in situ analysis of the bivalves behavior and appears as an effective early warning tool in ecological risk assessment and marine environment monitoring.

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...

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.

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...

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...

Reconstructing gene regulatory networks from knock-out data using Gaussian Noise Model and Pearson Correlation Coefficient.

PubMed

Mohamed Salleh, Faridah Hani; Arif, Shereena Mohd; Zainudin, Suhaila; Firdaus-Raih, Mohd

2015-12-01

A gene regulatory network (GRN) is a large and complex network consisting of interacting elements that, over time, affect each other's state. The dynamics of complex gene regulatory processes are difficult to understand using intuitive approaches alone. To overcome this problem, we propose an algorithm for inferring the regulatory interactions from knock-out data using a Gaussian model combines with Pearson Correlation Coefficient (PCC). There are several problems relating to GRN construction that have been outlined in this paper. We demonstrated the ability of our proposed method to (1) predict the presence of regulatory interactions between genes, (2) their directionality and (3) their states (activation or suppression). The algorithm was applied to network sizes of 10 and 50 genes from DREAM3 datasets and network sizes of 10 from DREAM4 datasets. The predicted networks were evaluated based on AUROC and AUPR. We discovered that high false positive values were generated by our GRN prediction methods because the indirect regulations have been wrongly predicted as true relationships. We achieved satisfactory results as the majority of sub-networks achieved AUROC values above 0.5. Copyright © 2015 Elsevier Ltd. All rights reserved.

The National Ambient Air Monitoring Stategy: Rethinking the Role of National Networks

EPA Science Inventory

A current re-engineering of the United States routine ambient monitoring networks intended to improve the balance in addressing both regulatory and scientific objectives is addressed in this paper. Key attributes of these network modifications include the addition of collocated ...

Emerging air monitoring technologies and thoughts on role of Department of State

EPA Science Inventory

The slides will support topics ranging from federal reference/equivalent level monitoring that is already underway at a number of embassies and consulates worldwide, as well as discuss non-regulatory research methods that could be considered to answer specific questions. Finally...

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...

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...

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...

Pesticide Residue Monitoring on South African Fresh Produce Exported over a 6-Year Period.

PubMed

Mutengwe, M T; Chidamba, L; Korsten, L

2016-10-01

Six years of pesticide residue data from fresh produce destined for the export market were analyzed for the period 2009 to 2014. A total of 37,838 fruit (99.27%) and vegetable (0.73%) data sets analyzed for the presence of 73 pesticides were compared. Pesticides were detected on 56.46% of samples, of which 0.78% had multiple residues. Noncompliances detected were because of the use of unregistered pesticides (0.73%), values that exceeded established maximum residue levels (MRLs) (0.32%), or the combination of values that exceeded MRLs and the use of unregistered pesticide residues (0.003%). The most commonly detected pesticides that exceeded established MRLs were imazalil (37.71%), prochloraz (28.69%), and iprodione (5.74%). The unregistered pesticide most often found on grapes and avocados was also imazalil (62.23%) and, on nectarines and avocados, diphenylamine (11.15%). Exceedances of MRL values were mostly associated with oranges (43.44%), avocados (27.87%), grapefruits (7.38%), and lemons (6.56%). Residual pesticide monitoring on fruits and vegetables is a key tool to ensure conformity with regulatory requirements and compliance with good agricultural practices and the trade requirements set by the importing country.

78 FR 57668 - U.S. Nuclear Regulatory Commission Planned for Monitoring Activities for the Saltstone Disposal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-19

... Monitoring Activities for the Saltstone Disposal Facility at the Savannah River Site, Revision 1 AGENCY... responsibilities for monitoring DOE's waste disposal activities at the Saltstone Disposal Facility (SDF) at the... Monitoring Disposal Actions Taken by the U.S. Department of Energy at the Savannah River Site Saltstone...

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...

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...

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...

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...

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...

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...

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...

A simple protocol using underwater epoxy to install annual temperature monitoring sites in rivers and streams

Treesearch

Daniel J. Isaak; Dona L. Horan; Sherry P. Wollrab

2013-01-01

Thermal regimes in rivers and streams are fundamental determinants of biological processes and are often monitored for regulatory compliance. Here, we describe a simple technique for establishing annual monitoring sites that uses underwater epoxy to attach miniature sensors to large rocks and cement bridge supports, which then serve as protective anchors. More than 500...

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

PubMed

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

2017-11-01

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

Colorado Water Watch: real-time groundwater monitoring for possible contamination from oil and gas activities.

PubMed

Son, Ji-Hee; Hanif, Asma; Dhanasekar, Ashwin; Carlson, Kenneth H

2018-02-13

Currently, only a few states in the USA (e.g., Colorado and Ohio) require mandatory baseline groundwater sampling from nearby groundwater wells prior to drilling a new oil or gas well. Colorado is the first state to regulate groundwater testing before and after drilling, which requires one pre-drilling sample and two additional post-drilling samples within 6-12 months and 5-6 years of drilling. However, the monitoring method is limited to the state's regulatory agency and to ex situ sampling, which offers only a snapshot in time. To overcome the limitations and increase monitoring performance, a new groundwater monitoring system, Colorado Water Watch (CWW), was introduced as a decision-making tool to support the state's regulatory agency and also to provide real-time groundwater quality data to both the industry and the public. The CWW uses simple in situ water quality sensors based on the surrogate sensing technology that employs an event detection system to screen the incoming data in near real-time.

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

Economic Implications of Potential Changes to Regulatory and Reimbursement Policies for Medical Devices

PubMed Central

Reed, Shelby D.; Shea, Alisa M.

2007-01-01

Objective To evaluate the impact of regulatory scenarios on the financial viability of medical device companies. Design We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be “reasonable and necessary” if the patients participate in clinical studies or registries. Measurements and Main results When applying assumptions consistent with the implantable cardioverter-defibrillator market, the net present value at the start of development was an estimated $553 million in the current regulatory environment, $322 million in the pharmaceutical scenario, and $403 million in the CSP scenario. Sensitivity analyses showed that the device industry would likely be profitable in all 3 scenarios over a range of assumptions. Conclusions The environment in which the medical device industry operates is financially attractive. Furthermore, when compared with the alternative of applying the same evidence standards for pharmaceuticals to medical devices, the CSP policy offers improved financial incentives for medical device companies. PMID:18095045

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...

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...

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...

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...

Regulatory elements of the floral homeotic gene AGAMOUS identified by phylogenetic footprinting and shadowing.

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

Hong, R. L., Hamaguchi, L., Busch, M. A., and Weigel, D.

2003-06-01

OAK-B135 In Arabidopsis thaliana, cis-regulatory sequences of the floral homeotic gene AGAMOUS (AG) are located in the second intron. This 3 kb intron contains binding sites for two direct activators of AG, LEAFY (LFY) and WUSCHEL (WUS), along with other putative regulatory elements. We have used phylogenetic footprinting and the related technique of phylogenetic shadowing to identify putative cis-regulatory elements in this intron. Among 29 Brassicaceae, several other motifs, but not the LFY and WUS binding sites previously identified, are largely invariant. Using reporter gene analyses, we tested six of these motifs and found that they are all functionally importantmore » for activity of AG regulatory sequences in A. thaliana. Although there is little obvious sequence similarity outside the Brassicaceae, the intron from cucumber AG has at least partial activity in A. thaliana. Our studies underscore the value of the comparative approach as a tool that complements gene-by-gene promoter dissection, but also highlight that sequence-based studies alone are insufficient for a complete identification of cis-regulatory sites.« less

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...

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...

Design of a perfluorocarbon tracer based monitoring network to support monitoring verification and accounting of sequestered CO2

NASA Astrophysics Data System (ADS)

Watson, T.; Sullivan, T.

2013-05-01

The levels of CO2 in the atmosphere have been growing since the beginning of the industrial revolution. The current level is 391 ppm. If there are no efforts to mitigate CO2 emissions, the levels will rise to 750 ppm by 2100. Geologic carbon sequestration is one strategy that may be used to begin to reduce emissions. Sequestration will not be effective unless reservoir leak rates are significantly less than 1%. There must be rigorous monitoring protocols in place to ensure sequestration projects meet regulatory and environmental goals. Monitoring for CO2 leakage directly is difficult because of the large background levels and variability of CO2 in the atmosphere. Using tracers to tag the sequestered CO2 can mitigate some of the difficulties of direct measurement but a tracer monitoring network and the levels of tagging need to be carefully designed. Simple diffusion and dispersion models are used to predict the surface and atmospheric concentrations that would be seen by a network monitoring a sequestration site. Levels of tracer necessary to detect leaks from 0.01 to 1% are presented and suggestions for effective monitoring and protection of global tracer utility are presented.

1996 LMITCO environmental monitoring program report for the Idaho National Engineering and Environmental Laboratory

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

NONE

1997-09-01

This report describes the calendar year 1996 environmental surveillance and compliance monitoring activities of the Lockheed Martin Idaho Technologies Company Environmental Monitoring Program performed at the Idaho National Engineering and Environmental Laboratory (INEEL). Results of sampling performed by the Radiological Environmental Surveillance, Site Environmental Surveillance, Drinking Water, Effluent Monitoring, Storm Water Monitoring, Groundwater Monitoring, and Special Request Monitoring Programs are included in this report. The primary purposes of the surveillance and monitoring activities are to evaluate environmental conditions, to provide and interpret data, to verify compliance with applicable regulations or standards, and to ensure protection of human health and themore » environment. This report compares 1996 data with program-specific regulatory guidelines and past data to evaluate trends.« less

Science advancements key to increasing management value of life stage monitoring networks for endangered Sacramento River winter-run Chinook salmon in California

USGS Publications Warehouse

Johnson, Rachel C.; Windell, Sean; Brandes, Patricia L.; Conrad, J. Louise; Ferguson, John; Goertler, Pascale A. L.; Harvey, Brett N.; Heublein, Joseph; Isreal, Joshua A.; Kratville, Daniel W.; Kirsch, Joseph E.; Perry, Russell W.; Pisciotto, Joseph; Poytress, William R.; Reece, Kevin; Swart, Brycen G.

2017-01-01

A robust monitoring network that provides quantitative information about the status of imperiled species at key life stages and geographic locations over time is fundamental for sustainable management of fisheries resources. For anadromous species, management actions in one geographic domain can substantially affect abundance of subsequent life stages that span broad geographic regions. Quantitative metrics (e.g., abundance, movement, survival, life history diversity, and condition) at multiple life stages are needed to inform how management actions (e.g., hatcheries, harvest, hydrology, and habitat restoration) influence salmon population dynamics. The existing monitoring network for endangered Sacramento River winterrun Chinook Salmon (SRWRC, Oncorhynchus tshawytscha) in California’s Central Valley was compared to conceptual models developed for each life stage and geographic region of the life cycle to identify relevant SRWRC metrics. We concluded that the current monitoring network was insufficient to diagnose when (life stage) and where (geographic domain) chronic or episodic reductions in SRWRC cohorts occur, precluding within- and among-year comparisons. The strongest quantitative data exist in the Upper Sacramento River, where abundance estimates are generated for adult spawners and emigrating juveniles. However, once SRWRC leave the upper river, our knowledge of their identity, abundance, and condition diminishes, despite the juvenile monitoring enterprise. We identified six system-wide recommended actions to strengthen the value of data generated from the existing monitoring network to assess resource management actions: (1) incorporate genetic run identification; (2) develop juvenile abundance estimates; (3) collect data for life history diversity metrics at multiple life stages; (4) expand and enhance real-time fish survival and movement monitoring; (5) collect fish condition data; and (6) provide timely public access to monitoring data in open data

76 FR 72991 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65800; File No. SR-C2-2011-035] Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to a Temporary Quote Risk Monitor Mechanism Rule November 21, 2011. Pursuant to Section 19(b)(1) of the Securities...

The clinical value of pharyngeal pH monitoring using a double-probe, triple-sensor catheter in patients with laryngopharyngeal reflux.

PubMed

Muderris, Togay; Gokcan, M Kursat; Yorulmaz, Irfan

2009-02-01

To determine the clinical value of pharyngeal pH monitoring for the diagnosis of laryngopharyngeal reflux (LPR) by using a double-probe, triple-sensor catheter in patients with symptoms of LPR. Prospective review of pH values recorded at the pharyngeal sensor, with the sensor placed in the proximal esophagus in patients with suspected LPR. Tertiary care university hospital. Thirty-three consecutive patients with symptoms of LPR. A pH test result was considered abnormal if a single reflux episode was detected in the hypopharynx and if, in the proximal esophagus, the total percentage of time the pH value was below 4 was 1.0% or higher. Data obtained from sensors were compared to determine the validity of pharyngeal sensor. Correlation between patients' reflux finding scores, reflux finding indexes, and reflux episodes were analyzed. Of 33 patients, 17 had more than 1 reflux episode detected by the pharyngeal sensor and 19 had pathological reflux detected by the proximal esophageal sensor. Four patients who had pharyngeal reflux had a normal esophageal acid exposure time, and 6 patients who had pathological reflux detected by the proximal esophageal sensor did not experienced any pharyngeal reflux episode. Four patients would have had a false-negative test result and 6 subjects would have had a false-positive test result if a hypopharyngeal pH sensor was not implemented. The adjustable, bifurcated, triple-sensor pH probe allows identifying true hypopharyngeal reflux episodes. If single-probe, double-sensor pH monitoring is to be performed, the proximal probe should be placed in the pharynx, not in the upper esophagus.

Regulatory Organizations and Their Requirements. MAS-113. Waste Isolation Division (WID). Management and Supervisor Training (MAST) Program.

ERIC Educational Resources Information Center

Westinghouse Electric Corp., Carlsbad, NM.

This learning module, which is part of a management and supervisor training program for managers and supervisors employed at the Department of Energy's Waste Isolation Division, is designed to enable trainees to identify regulatory organizations and oversight groups and monitor and provide guidance in the implementation of the requirements of…

Improved cost monitoring and control through the Earned Value Management System

NASA Astrophysics Data System (ADS)

Hunter, Howard; Fitzgerald, Richard; Barlow, Dewey

2014-01-01

As economic pressure and competition for budget among federal agencies has increased, there has been an increasing need for more granular data and robust management information systems. This is especially true for the execution of major civilian space programs. This need has resulted in new program management requirements being implemented in an attempt to limit cost and schedule growth. In particular, NASA Procedural Requirements (NPR) 7120.5D requires the implementation of an Earned Value Management System (EVMS) compliant with the requirements of American National Standards Institute (ANSI)/Electronic Industries Alliance Standard 748-B. The Radiation Belt Storm Probes (RBSP) program management team at The Johns Hopkins University Applied Physics Laboratory (JHU/APL) made a decision to implement an EVMS on RBSP during Phase B—a year earlier than specified in the contractual Phase C reporting requirement as defined in the NPR. This decision was made so that the project would have the benefit of 12 months of training and hands-on implementation during Phase B. Although there were a number of technical and process hurdles encountered during Phase B and into Phase C, the system was working well when the Integrated Baseline Review (IBR) was held in August 2009. The IBR was a success because it met the review requirements. It was also clear to all IBR participants that the EVMS was providing value to the project management team. Although the IBR pointed out some areas of concern regarding process and ANSI compliance, the system had markedly improved the project's ability to monitor cost and schedule. This, in turn, allowed the project team to foresee problems in advance, formulate corrective actions, and implement course corrections without causing significant adverse impact to the project. Opponents of EVMS systems often communicate the unfavorable opinion that EVMS systems create unnecessary cost and administration. Although it is undeniable that EVMS

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...

The Value of Continuous ST-Segment Monitoring in the Emergency Department.

PubMed

Bovino, Leonie Rose; Funk, Marjorie; Pelter, Michele M; Desai, Mayur M; Jefferson, Vanessa; Andrews, Laura Kierol; Forte, Kenneth

2015-01-01

Practice standards for electrocardiographic monitoring recommend continuous ST-segment monitoring (C-STM) in patients presenting to the emergency department (ED) with signs and/or symptoms of acute coronary syndrome (ACS), but few studies have evaluated its use in the ED. We compared time to diagnosis and 30-day adverse events before and after implementation of C-STM. We also evaluated the diagnostic accuracy of C-STM in detecting ischemia and infarction. We prospectively studied 163 adults (preintervention: n = 78; intervention: n = 85) in a single ED and stratified them into low (n = 51), intermediate (n = 100), or high (n = 12) risk using History, ECG, Age, Risk factors, and Troponin (HEART) scores. The principal investigator monitored participants, activating C-STM on bedside monitors in the intervention phase. We used likelihood ratios (LRs) as the measure of diagnostic accuracy. Overall, 9% of participants were diagnosed with ACS. Median time to diagnosis did not differ before and after implementation of C-STM (5.55 vs. 5.98 hr; p = 0.43). In risk-stratified analyses, no significant pre-/postdifference in time to diagnosis was found in low-, intermediate-, or high-risk participants. There was no difference in the rate of 30-day adverse events before versus after C-STM implementation (11.5% vs. 10.6%; p = 0.85). The +LR and -LR of C-STM for ischemia were 24.0 (95% confidence interval [CI]: 1.4, 412.0) and 0.3 (95% CI: 0.02, 2.9), respectively, and for infarction were 13.7 (95% CI: 1.7, 112.3) and 0.7 (95% CI: 0.3, 1.5), respectively. Use of C-STM did not provide added diagnostic benefit for patients with signs and/or symptoms of myocardial ischemia in the ED.

Conducting remote bioanalytical data monitoring and review based on scientific quality objectives.

PubMed

He, Ling

2011-07-01

For bioanalytical laboratories that follow GLP regulations and generate data for new drug filing, ensuring quality standards set by regulatory guidance is a fundamental expectation. Numerous guidelines and White Papers have been published by regulatory agencies, professional working groups and field experts in the past two decades, and have significantly improved the standards of good practices for bioanalysis. From a sponsor's perspective, continuous quality monitoring of the data generated by CRO laboratories, identifying adverse trends and taking corrective and preventative actions against issues encountered, are critical aspects of effective bioanalytical outsourcing management. This is especially important for clinical bioanalysis, where one validated assay is applied for analyzing a large number of samples of diverse demographics and disease states. This perspective article presents thoughts toward remote data monitoring and its merits for scientific quality oversight, and introduces a novel Bioanalytical Data Review software that was custom-developed and platform-neural, to conduct remote data monitoring on raw or processed LC-MS/MS data from CROs. Flexible, adaptive and user-customizable queries are applied for conducting project-, batch- and sample-level data review based on scientific quality performance factors commonly assessed for good bioanalytical practice.

FutureGen 2.0 Monitoring Program: An Overview of the Monitoring Approach and Technologies Selected for Implementation

DOE PAGES

Vermeul, Vince R.; Strickland, Chris E.; Thorne, Paul D.; ...

2014-12-31

The FutureGen 2.0 Project will design and build a first-of-its-kind, near-zero emissions coal-fueled power plant with carbon capture and storage (CCS). To assess storage site performance and meet the regulatory requirements of the Class VI Underground Injection Control (UIC) Program for CO2 Geologic Sequestration, the FutureGen 2.0 project will implement a suite of monitoring technologies designed to 1) evaluate CO2 mass balance and 2) detect any unforeseen loss in CO2 containment. The monitoring program will include direct monitoring of the injection stream and reservoir, and early-leak-detection monitoring directly above the primary confining zone. It will also implement an adaptive monitoringmore » strategy whereby monitoring results are continually evaluated and the monitoring network is modified as required, including the option to drill additional wells in out-years. Wells will be monitored for changes in CO2 concentration and formation pressure, and other geochemical/isotopic signatures that provide indication of CO2 or brine leakage. Indirect geophysical monitoring technologies that were selected for implementation include passive seismic, integrated surface deformation, time-lapse gravity, and pulsed neutron capture logging. Near-surface monitoring approaches that have been initiated include surficial aquifer and surface- water monitoring, soil-gas monitoring, atmospheric monitoring, and hyperspectral data acquisition for assessment of vegetation conditions. Initially, only the collection of baseline data sets is planned; the need for additional near- surface monitoring will be continually evaluated throughout the design and operational phases of the project, and selected approaches may be reinstituted if conditions warrant. Given the current conceptual understanding of the subsurface environment, early and appreciable impacts to near-surface environments are not expected.« less

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...

Humans as Sensors: Assessing the Information Value of Qualitative Farmer's Crop Condition Surveys for Crop Yield Monitoring and Forecasting

NASA Astrophysics Data System (ADS)

Beguería, S.

2017-12-01

While large efforts are devoted to developing crop status monitoring and yield forecasting systems trough the use of Earth observation data (mostly remotely sensed satellite imagery) and observational and modeled weather data, here we focus on the information value of qualitative data on crop status from direct observations made by humans. This kind of data has a high value as it reflects the expert opinion of individuals directly involved in the development of the crop. However, they have issues that prevent their direct use in crop monitoring and yield forecasting systems, such as their non-spatially explicit nature, or most importantly their qualitative nature. Indeed, while the human brain is good at categorizing the status of physical systems in terms of qualitative scales (`very good', `good', `fair', etcetera), it has difficulties in quantifying it in physical units. This has prevented the incorporation of this kind of data into systems that make extensive use of numerical information. Here we show an example of using qualitative crop condition data to estimate yields of the most important crops in the US early in the season. We use USDA weekly crop condition reports, which are based on a sample of thousands of reporters including mostly farmers and people in direct contact with them. These reporters provide subjective evaluations of crop conditions, in a scale including five levels ranging from `very poor' to `excellent'. The USDA report indicates, for each state, the proportion of reporters fort each condition level. We show how is it possible to model the underlying non-observed quantitative variable that reflects the crop status on each state, and how this model is consistent across states and years. Furthermore, we show how this information can be used to monitor the status of the crops and to produce yield forecasts early in the season. Finally, we discuss approaches for blending this information source with other, more classical earth data sources

Cultural Differences in Values as Self-Guides.

PubMed

Cheung, Wing-Yee; Maio, Gregory R; Rees, Kerry J; Kamble, Shanmukh; Mane, Sangeetha

2016-06-01

Three studies tested whether individualism-collectivism moderates the extent to which values are endorsed as ideal self-guides and ought self-guides, and the consequences for regulatory focus and emotion. Across Studies 1 and 2, individualists endorsed values that are relatively central to the self as stronger ideals than oughts, whereas collectivists endorsed them as ideals and oughts to a similar degree. Study 2 found that individualists justified central values using reasons that were more promotion focused than prevention focused, whereas collectivists used similar amount of prevention-focused and promotion-focused reasons. In Study 3, individualists felt more dejected after violating a central (vs. peripheral) value and more agitated after violating a peripheral (vs. central) value. Collectivists felt a similar amount of dejection regardless of values centrality and more agitation after violating central (vs. peripheral) values. Overall, culture has important implications for how we regulate values that are central or peripheral to our self-concept. © 2016 by the Society for Personality and Social Psychology, Inc.

RSAT: regulatory sequence analysis tools.

PubMed

Thomas-Chollier, Morgane; Sand, Olivier; Turatsinze, Jean-Valéry; Janky, Rekin's; Defrance, Matthieu; Vervisch, Eric; Brohée, Sylvain; van Helden, Jacques

2008-07-01

The regulatory sequence analysis tools (RSAT, http://rsat.ulb.ac.be/rsat/) is a software suite that integrates a wide collection of modular tools for the detection of cis-regulatory elements in genome sequences. The suite includes programs for sequence retrieval, pattern discovery, phylogenetic footprint detection, pattern matching, genome scanning and feature map drawing. Random controls can be performed with random gene selections or by generating random sequences according to a variety of background models (Bernoulli, Markov). Beyond the original word-based pattern-discovery tools (oligo-analysis and dyad-analysis), we recently added a battery of tools for matrix-based detection of cis-acting elements, with some original features (adaptive background models, Markov-chain estimation of P-values) that do not exist in other matrix-based scanning tools. The web server offers an intuitive interface, where each program can be accessed either separately or connected to the other tools. In addition, the tools are now available as web services, enabling their integration in programmatic workflows. Genomes are regularly updated from various genome repositories (NCBI and EnsEMBL) and 682 organisms are currently supported. Since 1998, the tools have been used by several hundreds of researchers from all over the world. Several predictions made with RSAT were validated experimentally and published.

76 FR 9620 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63906; File No. SR-NASDAQ-2011-024] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Establish and Adopt Fees for the New Short Sale Monitor Service and Nasdaq Data Add-On February 14, 2011. Pursuant to Section...

76 FR 72011 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65744; File No. SR-C2-2011-034] Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Related to the Quote Risk Monitor Mechanism November 14, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 193...

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

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...

Independent data monitoring committees: Preparing a path for the future

PubMed Central

Hess, Connie N.; Roe, Matthew T.; Gibson, C. Michael; Temple, Robert J.; Pencina, Michael J.; Zarin, Deborah A.; Anstrom, Kevin J.; Alexander, John H.; Sherman, Rachel E.; Fiedorek, Fred T.; Mahaffey, Kenneth W.; Lee, Kerry L.; Chow, Shein-Chung; Armstrong, Paul W.; Califf, Robert M.

2014-01-01

Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs. PMID:25066551

Integrated photovoltaic (PV) monitoring system

NASA Astrophysics Data System (ADS)

Mahinder Singh, Balbir Singh; Husain, NurSyahidah; Mohamed, Norani Muti

2012-09-01

The main aim of this research work is to design an accurate and reliable monitoring system to be integrated with solar electricity generating system. The performance monitoring system is required to ensure that the PVEGS is operating at an optimum level. The PV monitoring system is able to measure all the important parameters that determine an optimum performance. The measured values are recorded continuously, as the data acquisition system is connected to a computer, and data is stored at fixed intervals. The data can be locally used and can also be transmitted via internet. The data that appears directly on the local monitoring system is displayed via graphical user interface that was created by using Visual basic and Apache software was used for data transmission The accuracy and reliability of the developed monitoring system was tested against the data that captured simultaneously by using a standard power quality analyzer device. The high correlation which is 97% values indicates the level of accuracy of the monitoring system. The aim of leveraging on a system for continuous monitoring system is achieved, both locally, and can be viewed simultaneously at a remote system.

Residential surface soil guidance values applied worldwide to the original 2001 Stockholm Convention POP pesticides.

PubMed

Jennings, Aaron A; Li, Zijian

2015-09-01

Surface soil contamination is a worldwide problem. Many regulatory jurisdictions attempt to control human exposures with regulatory guidance values (RGVs) that specify a soil's maximum allowable concentration. Pesticides are important soil contaminants because of their intentional toxicity and widespread surface soil application. Worldwide, at least 174 regulatory jurisdictions from 54 United Nations member states have published more than 19,400 pesticide RGVs for at least 739 chemically unique pesticides. This manuscript examines the variability of the guidance values that are applied worldwide to the original 2001 Stockholm Convention persistent organic pollutants (POP) pesticides (Aldrin, Chlordane, DDT, Dieldrin, Endrin, Heptachlor, Mirex, and Toxaphene) for which at least 1667 RGVs have been promulgated. Results indicate that the spans of the RGVs applied to each of these pesticides vary from 6.1 orders of magnitude for Toxaphene to 10.0 orders of magnitude for Mirex. The distribution of values across these value spans resembles the distribution of lognormal random variables, but also contain non-random value clusters. Approximately 40% of all the POP RGVs fall within uncertainty bounds computed from the U.S. Environmental Protection Agency (USEPA) RGV cancer risk model. Another 22% of the values fall within uncertainty bounds computed from the USEPA's non-cancer risk model, but the cancer risk calculations yield the binding (lowest) value for all POP pesticides except Endrin. The results presented emphasize the continued need to rationalize the RGVs applied worldwide to important soil contaminants. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed

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

2006-11-01

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

Monitoring Active Volcanoes

NASA Astrophysics Data System (ADS)

Swanson, Don

Monitoring volcanoes is a surprisingly controversial enterprise. Some volcanologists argue that monitoring promises too much and delivers too little for risk mitigation. They trust only strict land-use measures (and accompanying high insurance premiums in risky zones) and urge that funds be used for public education and awareness rather than for instrumental monitoring. Others claim that monitoring is more akin to Brownian motion than to science: lots of action but little net progress. Still other volcanologists acknowledge the potential value of monitoring for prediction and warning but despair at the difficulty of it all. And, finally, some shy from surveillance, fearing the legal consequences of a failed monitoring effort during these litigious times. They wonder, “Will I be sued if an eruption is not foreseen or if an instrument fails at a critical time?”

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...

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...

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...

The Effects of Rising Interest Rates on Electric Utility Stock Prices: Regulatory Considerations and Approaches

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

Kihm, Steve; Satchwell, Andrew; Cappers, Peter

This technical brief identifies conditions under which utility regulators should consider implementing policy approaches that seek to mitigate negative outcomes due to an increase in interest rates. Interest rates are a key factor in determining a utility’s cost of equity and investors find value when returns exceed the cost of equity. Through historical observations of periods of rising and falling interest rates and application of a pro forma financial tool, we identify the key drivers of utility stock valuations and estimate the degree to which those valuations might be affected by increasing interest rates.3 We also analyze the efficacy ofmore » responses by utility regulators to mitigate potential negative financial impacts. We find that regulators have several possible approaches to mitigate a decline in value in an environment of increasing interest rates, though regulators must weigh the tradeoffs of improving investor value with potential increases in customer costs. Furthermore, the range of approaches reflects today’s many different electric utility regulatory models and regulatory responses to a decline in investor value will fit within state-specific models.« less

Subnuclear organization and trafficking of regulatory proteins: implications for biological control and cancer.

PubMed

Stein, G S; van Wijnen, A J; Stein, J L; Lian, J B; Montecino, M; Zaidi, K; Javed, A

2000-01-01

The regulated and regulatory components that interrelate nuclear structure and function must be experimentally established. A formidable challenge is to define further the control of transcription factor targeting to acceptor sites associated with the nuclear matrix. It will be important to determine whether acceptor proteins are associated with a pre-existing core-filament structural lattice or whether a compositely organized scaffold of regulatory factors is dynamically assembled. An inclusive model for all steps in the targeting of proteins to subnuclear sites cannot yet be proposed. However, this model must account for the apparent diversity of intranuclear targeting signals. It is also important to assess the extent to which regulatory discrimination is mediated by subnuclear domain-specific trafficking signals. Furthermore, the checkpoints that monitor subnuclear distribution of regulatory factors and the sorting steps that ensure both structural and functional fidelity of nuclear domains in which replication and expression of genes occur must be biochemically and mechanistically defined. There is emerging recognition that placement of regulatory components of gene expression must be temporally and spatially coordinated to facilitate biological control. The consequences of breaches in nuclear structure-function relationships are observed in an expanding series of diseases that include cancer [Weis et al., 1994; Rogaia et al., 1997; Yano et al., 1997; Rowley, 1998; Zeng et al., 1998; McNeil et al., 1999; Tao and Levine, 1999a] and neurological disorders [Skinner et al., 1997]. As the repertoire of architecture-associated regulatory factors and cofactors expands, workers in the field are becoming increasingly confident that nuclear organization contributes significantly to control of transcription. To gain increased appreciation for the complexities of subnuclear organization and gene regulation, we must continue to characterize mechanisms that direct

Default values for assessment of potential dermal exposure of the hands to industrial chemicals in the scope of regulatory risk assessments.

PubMed

Marquart, Hans; Warren, Nicholas D; Laitinen, Juha; van Hemmen, Joop J

2006-07-01

Dermal exposure needs to be addressed in regulatory risk assessment of chemicals. The models used so far are based on very limited data. The EU project RISKOFDERM has gathered a large number of new measurements on dermal exposure to industrial chemicals in various work situations, together with information on possible determinants of exposure. These data and information, together with some non-RISKOFDERM data were used to derive default values for potential dermal exposure of the hands for so-called 'TGD exposure scenarios'. TGD exposure scenarios have similar values for some very important determinant(s) of dermal exposure, such as amount of substance used. They form narrower bands within the so-called 'RISKOFDERM scenarios', which cluster exposure situations according to the same purpose of use of the products. The RISKOFDERM scenarios in turn are narrower bands within the so-called Dermal Exposure Operation units (DEO units) that were defined in the RISKOFDERM project to cluster situations with similar exposure processes and exposure routes. Default values for both reasonable worst case situations and typical situations were derived, both for single datasets and, where possible, for combined datasets that fit the same TGD exposure scenario. The following reasonable worst case potential hand exposures were derived from combined datasets: (i) loading and filling of large containers (or mixers) with large amounts (many litres) of liquids: 11,500 mg per scenario (14 mg cm(-2) per scenario with surface of the hands assumed to be 820 cm(2)); (ii) careful mixing of small quantities (tens of grams in <1l): 4.1 mg per scenario (0.005 mg cm(-2) per scenario); (iii) spreading of (viscous) liquids with a comb on a large surface area: 130 mg per scenario (0.16 mg cm(-2) per scenario); (iv) brushing and rolling of (relatively viscous) liquid products on surfaces: 6500 mg per scenario (8 mg cm(-2) per scenario) and (v) spraying large amounts of liquids (paints, cleaning

Department of Defense Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries include only: (1) Rules that are in the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely to have a significant...

76 FR 62128 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change to Amend Certain Trade Reporting and Compliance Rules September 30, 2011. Pursuant to Section 19(b... hereby given that on September 22, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...

Value added medicines: what value repurposed medicines might bring to society?

PubMed

Toumi, Mondher; Rémuzat, Cécile

2017-01-01

Background & objectives : Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods : A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing ( healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results : Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as 'medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers'. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine access

Value added medicines: what value repurposed medicines might bring to society?

PubMed Central

Toumi, Mondher; Rémuzat, Cécile

2017-01-01

ABSTRACT Background & objectives: Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods: A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing (healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results: Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as ‘medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers’. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine

Zero drift of intraventricular and subdural intracranial pressure monitoring systems.

PubMed

Chen, Li; Du, Hang-gen; Yin, Li-chun; He, Min; Zhang, Guo-jun; Tian, Yong; Wang, Cheng; Hao, Bi-lie; Li, Hong-yu

2013-01-01

To assess zero drift of intraventricular and subdural intracranial pressure (ICP) monitoring systems. A prospective study was conducted in patients who received Codman ICP monitoring in the neurosurgical department from January 2010 to December 2011. According to the location of sensors, the patients were categorized into two groups: intraventricular group and subdural group. Zero drift between the two groups and its association with the duration of ICP monitor were analyzed. Totally, 22 patients undergoing intraventricular ICP monitoring and 27 receiving subdural ICP monitoring were enrolled. There was no significant difference in duration of ICP monitoring, zero drift value and its absolute value between intraventricular and subdural groups (5.38 d+/-2.58 d vs 4.58 d+/-2.24 d, 0.77 mm Hg+/-2.18 mm Hg vs 1.03 mm Hg+/-2.06 mm Hg, 1.68 mm Hg+/-1.55 mm Hg vs 1.70 mm Hg+/-1.53 mm Hg, respectively; all P larger than 0.05). Absolute value of zero drift in both groups significantly rose with the increased duration of ICP monitoring (P less than 0.05) while zero drift value did not. Moreover, daily absolute value in the intraventricular group was significantly smaller than that in the subdural group (0.27 mm Hg+/-0.32 mm Hg vs 0.29 mm Hg+/-0.18 mm Hg, P less than 0.05). This study demonstrates that absolute value of zero drift significantly correlates with duration of both intraventricular and subdural ICP monitoring. Due to the smaller daily absolute value, ICP values recorded from intraventricular system may be more reliable than those from subdural system.

KWOC (Key-Word-Out-of-Context) Index of US Nuclear Regulatory Commission Regulatory Guide Series

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

Jennings, S.D.

1990-04-01

To meet the objectives of the program funded by the Department of Energy (DOE)-Nuclear Energy (NE) Technology Support Programs, the Performance Assurance Project Office (PAPO) administers a Performance Assurance Information Program that collects, compiles, and distributes program-related information, reports, and publications for the benefit of the DOE-NE program participants. THE KWOC Index of US Nuclear Regulatory Commission Regulatory Guide Series'' is prepared as an aid in searching for specific topics in the US Nuclear Regulatory Commission, Regulatory Guide Series.

76 FR 70523 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change to Adopt FINRA Rule 4524 (Supplemental FOCUS Information) and Proposed Supplementary Schedule to...). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the...

Professional and Regulatory Search

EPA Pesticide Factsheets

Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

Regulatory assessment of chemical mixtures: Requirements, current approaches and future perspectives.

PubMed

Kienzler, Aude; Bopp, Stephanie K; van der Linden, Sander; Berggren, Elisabet; Worth, Andrew

2016-10-01

This paper reviews regulatory requirements and recent case studies to illustrate how the risk assessment (RA) of chemical mixtures is conducted, considering both the effects on human health and on the environment. A broad range of chemicals, regulations and RA methodologies are covered, in order to identify mixtures of concern, gaps in the regulatory framework, data needs, and further work to be carried out. Also the current and potential future use of novel tools (Adverse Outcome Pathways, in silico tools, toxicokinetic modelling, etc.) in the RA of combined effects were reviewed. The assumptions made in the RA, predictive model specifications and the choice of toxic reference values can greatly influence the assessment outcome, and should therefore be specifically justified. Novel tools could support mixture RA mainly by providing a better understanding of the underlying mechanisms of combined effects. Nevertheless, their use is currently limited because of a lack of guidance, data, and expertise. More guidance is needed to facilitate their application. As far as the authors are aware, no prospective RA concerning chemicals related to various regulatory sectors has been performed to date, even though numerous chemicals are registered under several regulatory frameworks. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

EVALUATION OF REAL-TIME INNOVATIVE BIOLOGICAL AND CHEMICAL MONITORING SYSTEMS TO PROTECT SOURCE WATERS

EPA Science Inventory

Evaluation of Real-Time Innovative Biological and Chemical Monitoring Systems
To Protect Source Waters

Drinking water supplies have in recent years come under increasing pressure from regulatory concerns regarding TMDL designations and restoration strategies as well ...

The future of yogurt: scientific and regulatory needs.

PubMed

German, J Bruce

2014-05-01

Lactation biology, microbial selection, and human diversity are central themes that could guide investment in scientific research, industrial innovation, and regulatory policy oversight to propel yogurt into the central role for health-promoting food products. The ability of yogurt to provide the nourishing properties of milk together with the live microorganisms from fermentation provides a unique combination of food assets. Academic research must now define the various targets on which these biological assets act to improve health and develop the metrics that can quantitatively document their benefits. The food industry must reconcile that yogurt and its microorganisms cannot be expected to provide measurable benefits for all consumers, at all doses, and at all times. A supportive regulatory oversight must demand safety and yet encourage innovations that support a value proposition for yogurt in health. Health valuation in the marketplace will be driven by parallel innovations, including accurate assessment technologies, validated microbial ingredients, and health-aware consumers.

[Influence of geomagnetic storms on the balance of autonomic regulatory mechanisms].

PubMed

Chichinadze, G; Tvildiani, L; Kvachadze, I; Tarkhan-Mouravi, I

2005-09-01

The investigation aimed to evaluate autonomic regulatory mechanisms in practically healthy persons during the geomagnetically quiet periods and during geomagnetic storms. The examinations were conducted among the volunteer young men (n=64) 18-22 years of age. The autonomic function was studied on the basis of the heart rate variability. The geomagnetically quiet periods were considered when the value of the K-index was no more then 2 and a geomagnetic storm was considered when the value of the index was 5 and more. It is ascertained that in the both cases the basic statistical indices of the heart rate were identical. The analysis of R-R intervals spectral power gave the possibility to sort the persons examined into the three different groups. The data obtained allowed to suggest that geomagnetic storms influence human organisms through the vagus centers by means of their excitation. This phenomenon may be considered as a self-regulatory physiologic mechanism of the adaptive character. The analysis of the spectral power of R-R intervals may be considered as a sensitive method for the detection of the magnitolabile persons.

The next generation of low-cost personal air quality sensors for quantitative exposure monitoring

NASA Astrophysics Data System (ADS)

Piedrahita, R.; Xiang, Y.; Masson, N.; Ortega, J.; Collier, A.; Jiang, Y.; Li, K.; Dick, R. P.; Lv, Q.; Hannigan, M.; Shang, L.

2014-10-01

Advances in embedded systems and low-cost gas sensors are enabling a new wave of low-cost air quality monitoring tools. Our team has been engaged in the development of low-cost, wearable, air quality monitors (M-Pods) using the Arduino platform. These M-Pods house two types of sensors - commercially available metal oxide semiconductor (MOx) sensors used to measure CO, O3, NO2, and total VOCs, and NDIR sensors used to measure CO2. The MOx sensors are low in cost and show high sensitivity near ambient levels; however they display non-linear output signals and have cross-sensitivity effects. Thus, a quantification system was developed to convert the MOx sensor signals into concentrations. We conducted two types of validation studies - first, deployments at a regulatory monitoring station in Denver, Colorado, and second, a user study. In the two deployments (at the regulatory monitoring station), M-Pod concentrations were determined using collocation calibrations and laboratory calibration techniques. M-Pods were placed near regulatory monitors to derive calibration function coefficients using the regulatory monitors as the standard. The form of the calibration function was derived based on laboratory experiments. We discuss various techniques used to estimate measurement uncertainties. The deployments revealed that collocation calibrations provide more accurate concentration estimates than laboratory calibrations. During collocation calibrations, median standard errors ranged between 4.0-6.1 ppb for O3, 6.4-8.4 ppb for NO2, 0.28-0.44 ppm for CO, and 16.8 ppm for CO2. Median signal to noise (S / N) ratios for the M-Pod sensors were higher than the regulatory instruments: for NO2, 3.6 compared to 23.4; for O3, 1.4 compared to 1.6; for CO, 1.1 compared to 10.0; and for CO2, 42.2 compared to 300-500. By contrast, lab calibrations added bias and made it difficult to cover the necessary range of environmental conditions to obtain a good calibration. A separate user study

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

Predictive regulatory models in Drosophila melanogaster by integrative inference of transcriptional networks

PubMed Central

Marbach, Daniel; Roy, Sushmita; Ay, Ferhat; Meyer, Patrick E.; Candeias, Rogerio; Kahveci, Tamer; Bristow, Christopher A.; Kellis, Manolis

2012-01-01

Gaining insights on gene regulation from large-scale functional data sets is a grand challenge in systems biology. In this article, we develop and apply methods for transcriptional regulatory network inference from diverse functional genomics data sets and demonstrate their value for gene function and gene expression prediction. We formulate the network inference problem in a machine-learning framework and use both supervised and unsupervised methods to predict regulatory edges by integrating transcription factor (TF) binding, evolutionarily conserved sequence motifs, gene expression, and chromatin modification data sets as input features. Applying these methods to Drosophila melanogaster, we predict ∼300,000 regulatory edges in a network of ∼600 TFs and 12,000 target genes. We validate our predictions using known regulatory interactions, gene functional annotations, tissue-specific expression, protein–protein interactions, and three-dimensional maps of chromosome conformation. We use the inferred network to identify putative functions for hundreds of previously uncharacterized genes, including many in nervous system development, which are independently confirmed based on their tissue-specific expression patterns. Last, we use the regulatory network to predict target gene expression levels as a function of TF expression, and find significantly higher predictive power for integrative networks than for motif or ChIP-based networks. Our work reveals the complementarity between physical evidence of regulatory interactions (TF binding, motif conservation) and functional evidence (coordinated expression or chromatin patterns) and demonstrates the power of data integration for network inference and studies of gene regulation at the systems level. PMID:22456606

Monitoring the injured brain: registered, patient specific atlas models to improve accuracy of recovered brain saturation values

NASA Astrophysics Data System (ADS)

Clancy, Michael; Belli, Antonio; Davies, David; Lucas, Samuel J. E.; Su, Zhangjie; Dehghani, Hamid

2015-07-01

The subject of superficial contamination and signal origins remains a widely debated topic in the field of Near Infrared Spectroscopy (NIRS), yet the concept of using the technology to monitor an injured brain, in a clinical setting, poses additional challenges concerning the quantitative accuracy of recovered parameters. Using high density diffuse optical tomography probes, quantitatively accurate parameters from different layers (skin, bone and brain) can be recovered from subject specific reconstruction models. This study assesses the use of registered atlas models for situations where subject specific models are not available. Data simulated from subject specific models were reconstructed using the 8 registered atlas models implementing a regional (layered) parameter recovery in NIRFAST. A 3-region recovery based on the atlas model yielded recovered brain saturation values which were accurate to within 4.6% (percentage error) of the simulated values, validating the technique. The recovered saturations in the superficial regions were not quantitatively accurate. These findings highlight differences in superficial (skin and bone) layer thickness between the subject and atlas models. This layer thickness mismatch was propagated through the reconstruction process decreasing the parameter accuracy.

The next generation of low-cost personal air quality sensors for quantitative exposure monitoring

NASA Astrophysics Data System (ADS)

Piedrahita, R.; Xiang, Y.; Masson, N.; Ortega, J.; Collier, A.; Jiang, Y.; Li, K.; Dick, R.; Lv, Q.; Hannigan, M.; Shang, L.

2014-03-01

Advances in embedded systems and low-cost gas sensors are enabling a new wave of low cost air quality monitoring tools. Our team has been engaged in the development of low-cost wearable air quality monitors (M-Pods) using the Arduino platform. The M-Pods use commercially available metal oxide semiconductor (MOx) sensors to measure CO, O3, NO2, and total VOCs, and NDIR sensors to measure CO2. MOx sensors are low in cost and show high sensitivity near ambient levels; however they display non-linear output signals and have cross sensitivity effects. Thus, a quantification system was developed to convert the MOx sensor signals into concentrations. Two deployments were conducted at a regulatory monitoring station in Denver, Colorado. M-Pod concentrations were determined using laboratory calibration techniques and co-location calibrations, in which we place the M-Pods near regulatory monitors to then derive calibration function coefficients using the regulatory monitors as the standard. The form of the calibration function was derived based on laboratory experiments. We discuss various techniques used to estimate measurement uncertainties. A separate user study was also conducted to assess personal exposure and M-Pod reliability. In this study, 10 M-Pods were calibrated via co-location multiple times over 4 weeks and sensor drift was analyzed with the result being a calibration function that included drift. We found that co-location calibrations perform better than laboratory calibrations. Lab calibrations suffer from bias and difficulty in covering the necessary parameter space. During co-location calibrations, median standard errors ranged between 4.0-6.1 ppb for O3, 6.4-8.4 ppb for NO2, 0.28-0.44 ppm for CO, and 16.8 ppm for CO2. Median signal to noise (S/N) ratios for the M-Pod sensors were higher for M-Pods than the regulatory instruments: for NO2, 3.6 compared to 23.4; for O3, 1.4 compared to 1.6; for CO, 1.1 compared to 10.0; and for CO2, 42.2 compared to 300

78 FR 17975 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Relating to FINRA Rule 8313 (Release of Disciplinary Complaints, Decisions and Other Information... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's...

76 FR 9840 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-22

.... 78s(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..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...

The Value of Ultrasound Monitoring of Adnexal Masses for Early Detection of Ovarian Cancer

PubMed Central

Suh-Burgmann, Elizabeth; Kinney, Walter

2016-01-01

Although ultrasound has so far been found to be ineffective as a screening tool for ovarian cancer, it is commonly used as a means of evaluating or following ovarian or adnexal masses once they are detected. We review the use of serial ultrasound for the management of adnexal masses and propose an approach to monitoring based on an understanding of the overall risk of cancer among the population in question and an assessment of how the potential benefit of monitoring compares with potential risk. In our approach, masses that are symptomatic, large (>10 cm), associated with an elevated CA 125 level or overt signs of malignancy, or that are determined to have a worrisome appearance by stringent ultrasound criteria should be evaluated surgically. Women with masses that have none of these characteristics should be offered monitoring. Short-term initial ultrasound monitoring carries significant potential benefit in terms of aiding detection of early malignancy and avoidance of unnecessary surgery. However, if a mass remains stable but persistent, the potential benefit of ongoing monitoring wanes with time, whereas the potential harms, in terms of patient anxiety, cost, and the risk of incidental findings and unnecessary surgery increase. Therefore, monitoring of stable lesions should be limited in duration in order to limit potential harms from overtreatment and overdiagnosis. PMID:26904503

76 FR 9618 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63905; File No. SR-Phlx-2011-17] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Establish and Adopt Fees for the New Short Sale Monitor Service and PSX Data Add-On February 14, 2011. Pursuant to Section 19(b)(1) of th...

Legal and Regulatory Barriers to Reverse Innovation.

PubMed

Rowthorn, Virginia; Plum, Alexander J; Zervos, John

Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers. The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States. Semistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each. Purely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market. Conflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of

Department of Transportation Agency Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of Transportation Agency Semiannual Regulatory Agenda ] Part XIII Department of Transportation Semiannual Regulatory Agenda [[Page 79812

76 FR 9623 - Self-Regulatory Organizations; NASDAQ OMX BX; Notice of Filing and Immediate Effectiveness of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63907; File No. SR-BX-2011-008] Self-Regulatory Organizations; NASDAQ OMX BX; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Establish and Adopt Fees for the New Short Sale Monitor Service and BX Data Add-On February 14, 2011. Pursuant to Section 19(b)(1) of the...

Department of the Interior Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of the Interior Semiannual Regulatory Agenda] Part X Department of the Interior Semiannual Regulatory Agenda [[Page 79796

76 FR 9838 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-22

.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance..., and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... in sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory...

Value of Information References

DOE Data Explorer

Morency, Christina

2014-12-12

This file contains a list of relevant references on value of information (VOI) in RIS format. VOI provides a quantitative analysis to evaluate the outcome of the combined technologies (seismology, hydrology, geodesy) used to monitor Brady's Geothermal Field.

The Bright Elusive Butterfly of Value in Health Technology Development Comment on "Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies".

PubMed

Greenhalgh, Trisha; Fahy, Nick; Shaw, Sara

2017-05-29

The current system of health technology development is characterised by multiple misalignments. The "supply" side (innovation policy-makers, entrepreneurs, investors) and the "demand" side (health policy-makers, regulators, health technology assessment, purchasers) operate under different - and conflicting - logics. The system is less a "pathway" than an unstable ecosystem of multiple interacting sub-systems. "Value" means different things to each of the numerous actors involved. Supply-side dynamics are built on fictions; regulatory checks and balances are designed to assure quality, safety and efficacy, not to ensure that technologies entering the market are either desirable or cost-effective. Assessment of comparative and cost-effectiveness usually comes too late in the process to shape an innovation's development. We offer no simple solutions to these problems, but in the spirit of commencing a much-needed public debate, we suggest some tentative ways forward. First, universities and public research funders should play a more proactive role in shaping the system. Second, the role of industry in forging long-term strategic partnerships for public benefit should be acknowledged (though not uncritically). Third, models of "responsible innovation" and public input to research priority-setting should be explored. Finally, the evidence base on how best to govern inter-sectoral health research partnerships should be developed and applied. © 2018 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

OVERSEER: An Expert System Monitor for the Psychiatric Hospital

PubMed Central

Bronzino, Joseph D.; Morelli, Ralph A.; Goethe, John W.

1988-01-01

In order to improve patient care, comply with regulatory guidelines and decrease potential liability, psychiatric hospitals and clinics have been searching for computer systems to monitor the management and treatment of patients. This paper describes OVERSEER: a knowledge based system that monitors the treatment of psychiatric patients in real time. Based on procedures and protocols developed in the psychiatric setting, OVERSEER monitors the clinical database and issues alerts when standard clinical practices are not followed or when laboratory results or other clinical indicators are abnormal. Written in PROLOG, OVERSEER is designed to interface directly with the hospital's database, and, thereby utilizes all available pharmacy and laboratory data. Moreover, unlike the interactive expert systems developed for the psychiatric clinic, OVERSEER does not require extensive data entry by the clinician. Consequently, the chief benefit of OVERSEER's monitoring approach is the unobtrusive manner in which it evaluates treatment and patient responses and provides information regarding patient management.

Valuing Assessment in Teacher Education - Multiple-Choice Competency Testing

ERIC Educational Resources Information Center

Martin, Dona L.; Itter, Diane

2014-01-01

When our focus is on assessment educators should work to value the nature of assessment. This paper presents a new approach to multiple-choice competency testing in mathematics education. The instrument discussed here reflects student competence, encourages self-regulatory learning behaviours and links content with current curriculum documents and…

Perspectives on the relevance of the circadian time structure to workplace threshold limit values and employee biological monitoring.

PubMed

Smolensky, Michael H; Reinberg, Alain E; Sackett-Lundeen, Linda

2017-01-01

The circadian time structure (CTS) and its disruption by rotating and nightshift schedules relative to work performance, accident risk, and health/wellbeing have long been areas of occupational medicine research. Yet, there has been little exploration of the relevance of the CTS to setting short-term, time-weighted, and ceiling threshold limit values (TLVs); conducting employee biological monitoring (BM); and establishing normative reference biological exposure indices (BEIs). Numerous publications during the past six decades document the CTS substantially affects the disposition - absorption, distribution, metabolism, and elimination - and effects of medications. Additionally, laboratory animal and human studies verify the tolerance to chemical, biological (contagious), and physical agents can differ extensively according to the circadian time of exposure. Because of slow and usually incomplete CTS adjustment by rotating and permanent nightshift workers, occupational chemical and other contaminant encounters occur during a different circadian stage than for dayshift workers. Thus, the intended protection of some TLVs when working the nightshift compared to dayshift might be insufficient, especially in high-risk settings. The CTS is germane to employee BM in that large-amplitude predictable-in-time 24h variation can occur in the concentration of urine, blood, and saliva of monitored chemical contaminants and their metabolites plus biomarkers indicative of adverse xenobiotic exposure. The concept of biological time-qualified (for rhythms) reference values, currently of interest to clinical laboratory pathology practice, is seemingly applicable to industrial medicine as circadian time and workshift-specific BEIs to improve surveillance of night workers, in particular. Furthermore, BM as serial assessments performed frequently both during and off work, exemplified by employee self-measurement of lung function using a small portable peak expiratory flow meter, can

Regulatory focus and adherence to self-care behaviors among adults with type 2 diabetes.

PubMed

Avraham, Rinat; Van Dijk, Dina; Simon-Tuval, Tzahit

2016-09-01

The aims of this study were, first, to test the association between regulatory focus of adults with type 2 diabetes and their adherence to two types of self-care behaviors - lifestyle change (e.g. physical activity and diet) and medical care regimens (blood-glucose monitoring, foot care and medication usage). Second, to explore whether a fit between the message framing and patients' regulatory focus would improve their intentions to adhere specifically when the type of behavior fits the patients' regulatory focus as well. A cross-sectional study was conducted among 130 adults with type 2 diabetes who were hospitalized in an academic medical center. The patients completed a set of questionnaires that included their diabetes self-care activities, regulatory focus, self-esteem and demographic, socioeconomic and clinical data. In addition, participants were exposed to either a gain-framed or a loss-framed message, and were then asked to indicate their intention to improve adherence to self-care behaviors. A multivariable linear regression model revealed that promoters reported higher adherence to lifestyle change behaviors than preventers did (B = .60, p = .028). However, no effect of regulatory focus on adherence to medical care regimens was found (B = .46, p = .114). In addition, preventers reported higher intentions to adhere to medical care behaviors when the message framing was congruent with prevention focus (B = 1.16, p = .023). However, promoters did not report higher intentions to adhere to lifestyle behaviors when the message framing was congruent with promotion focus (B = -.16, p = .765). These findings justify the need to develop tailor-made interventions that are adjusted to both patients' regulatory focus and type of health behavior.

Monitoring Welding-Gas Quality

NASA Technical Reports Server (NTRS)

Huddleston, Kevin L.

1988-01-01

System monitors welding gas to ensure characteristics within predetermined values. Responds to changes that might go unnoticed by human operator and acts quickly to prevent weld defects. Electronic pressure controller employs various amounts of gain, equalization, and compensation to respond to changes in gas-supply pressure. Works in conjuction with pressure/oxygen/moisture monitor.

Regulatory sequence analysis tools.

PubMed

van Helden, Jacques

2003-07-01

The web resource Regulatory Sequence Analysis Tools (RSAT) (http://rsat.ulb.ac.be/rsat) offers a collection of software tools dedicated to the prediction of regulatory sites in non-coding DNA sequences. These tools include sequence retrieval, pattern discovery, pattern matching, genome-scale pattern matching, feature-map drawing, random sequence generation and other utilities. Alternative formats are supported for the representation of regulatory motifs (strings or position-specific scoring matrices) and several algorithms are proposed for pattern discovery. RSAT currently holds >100 fully sequenced genomes and these data are regularly updated from GenBank.

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

PubMed Central

2018-01-01

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

Embryonic Explant Culture: Studying Effects of Regulatory Molecules on Gene Expression in Craniofacial Tissues.

PubMed

Närhi, Katja

2017-01-01

The ex vivo culture of embryonic tissue explants permits the continuous monitoring of growth and morphogenesis at specific embryonic stages. The functions of soluble regulatory molecules can be analyzed by introducing them into culture medium or locally with beads to the tissue. Gene expression in the manipulated tissue explants can be analyzed using in situ hybridization, quantitative PCR, and reporter constructs combined to organ culture to examine the functions of the signaling molecules.

Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

PubMed

Layton, Deborah; Shakir, Saad A W

2015-02-01

The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications.

Regulatory Approaches for Adding Capacity to Existing Hydropower Facilities

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

Levine, Aaron L.; Curtis, Taylor L.; Kazerooni, Borna

In 2015, hydroelectric generation accounted for more than 6 percent of total net electricity generation in the United States and 46 percent of electricity generation from all renewables. The United States has considerable hydroelectric potential beyond what is already being developed. Nearly 7 GW of this potential is found by adding capacity to existing hydropower facilities. To optimize the value of hydroelectric generation, the U.S. Department of Energy's Hydropower Vision Study highlights the importance of adding capacity to existing facilities. This report provides strategic approaches and considerations for Federal Energy Regulatory Commission licensed and exempt hydropower facilities seeking to increasemore » generation capacity, which may include increases from efficiency upgrades. The regulatory approaches reviewed for this report include capacity and non-capacity amendments, adding capacity during relicensing, and adding capacity when converting a license to a 10-MW exemption.« less

Global Summit on Regulatory Science 2013.

PubMed

Howard, Paul C; Tong, Weida; Weichold, Frank; Healy, Marion; Slikker, William

2014-12-01

Regulatory science has been defined as the science that is used to develop regulatory decisions by government bodies. Regulatory science encompasses many scientific disciplines that oversee many studies producing a wide array of data. These may include fundamental research into the cellular interaction or response to a particular chemical or substance, hazard-assessment and dose-response studies in animal species, neurophysiological or neurobehavioral studies, best practices for the generation and analysis of genomics data, bioinformatics approaches, and mathematical modeling of risk. The Global Summit on Regulatory Science is an international conference with a mission to explore emerging and innovative technologies, and provide a platform to enhance translation of basic science into regulatory applications. The Third Global Summit on Regulatory Science which focused on nanotechnology is discussed. Published by Elsevier Inc.

Effects of Four Different Regulatory Mechanisms on the Dynamics of Gene Regulatory Cascades

NASA Astrophysics Data System (ADS)

Hansen, Sabine; Krishna, Sandeep; Semsey, Szabolcs; Lo Svenningsen, Sine

2015-07-01

Gene regulatory cascades (GRCs) are common motifs in cellular molecular networks. A given logical function in these cascades, such as the repression of the activity of a transcription factor, can be implemented by a number of different regulatory mechanisms. The potential consequences for the dynamic performance of the GRC of choosing one mechanism over another have not been analysed systematically. Here, we report the construction of a synthetic GRC in Escherichia coli, which allows us for the first time to directly compare and contrast the dynamics of four different regulatory mechanisms, affecting the transcription, translation, stability, or activity of a transcriptional repressor. We developed a biologically motivated mathematical model which is sufficient to reproduce the response dynamics determined by experimental measurements. Using the model, we explored the potential response dynamics that the constructed GRC can perform. We conclude that dynamic differences between regulatory mechanisms at an individual step in a GRC are often concealed in the overall performance of the GRC, and suggest that the presence of a given regulatory mechanism in a certain network environment does not necessarily mean that it represents a single optimal evolutionary solution.

Transcriptional Regulatory Network Analysis of MYB Transcription Factor Family Genes in Rice.

PubMed

Smita, Shuchi; Katiyar, Amit; Chinnusamy, Viswanathan; Pandey, Dev M; Bansal, Kailash C

2015-01-01

MYB transcription factor (TF) is one of the largest TF families and regulates defense responses to various stresses, hormone signaling as well as many metabolic and developmental processes in plants. Understanding these regulatory hierarchies of gene expression networks in response to developmental and environmental cues is a major challenge due to the complex interactions between the genetic elements. Correlation analyses are useful to unravel co-regulated gene pairs governing biological process as well as identification of new candidate hub genes in response to these complex processes. High throughput expression profiling data are highly useful for construction of co-expression networks. In the present study, we utilized transcriptome data for comprehensive regulatory network studies of MYB TFs by "top-down" and "guide-gene" approaches. More than 50% of OsMYBs were strongly correlated under 50 experimental conditions with 51 hub genes via "top-down" approach. Further, clusters were identified using Markov Clustering (MCL). To maximize the clustering performance, parameter evaluation of the MCL inflation score (I) was performed in terms of enriched GO categories by measuring F-score. Comparison of co-expressed cluster and clads analyzed from phylogenetic analysis signifies their evolutionarily conserved co-regulatory role. We utilized compendium of known interaction and biological role with Gene Ontology enrichment analysis to hypothesize function of coexpressed OsMYBs. In the other part, the transcriptional regulatory network analysis by "guide-gene" approach revealed 40 putative targets of 26 OsMYB TF hubs with high correlation value utilizing 815 microarray data. The putative targets with MYB-binding cis-elements enrichment in their promoter region, functional co-occurrence as well as nuclear localization supports our finding. Specially, enrichment of MYB binding regions involved in drought-inducibility implying their regulatory role in drought response in rice

Cost efficiency and reimbursement of remote monitoring: a US perspective.

PubMed

Slotwiner, David; Wilkoff, Bruce

2013-06-01

Demographic and technological changes are driving increased utilization of cardiac implantable electronic devices (CIEDs) remote monitoring. In the USA, fee-for-service model of healthcare delivery, services rendered are valued based upon time, intensity, and technical or practice expense costs. As a consequence of this perspective, and to contain spending, Medicare has grouped physician services into families. Spending within each family of services must, by law, remain budget neutral. Cardiac implantable electronic devices monitoring services, remote and in-person, are grouped into one family. As the volume of services within this family increases, the individual encounters are destined to be discounted into ever decreasing portions. However, if the value of remote monitoring is demonstrated to extend beyond the previous boundaries of in-person interrogations, a rational request can be made to reconsider the relative value of remote monitoring. Outcome data supporting the value-added benefits of remote monitoring are rapidly accumulating, including (i) patient convenience, with reduced use of office services, (ii) equal safety compared with in-person evaluation, (iii) shorter detection time to actionable events (arrhythmias, cardiovascular disease progression, and device malfunction), (iv) reduced length of stay for hospitalizations, (v) reduced inappropriate shocks, (vi) increased battery longevity, and (vii) a relative reduction in the risk of death. Fully automatic wireless technology, only recently widely implemented, will add considerable clinical efficiencies and further increase the value of remote monitoring. The U.S. challenge will be to appropriately define the relative value of CIEDs remote monitoring now that outcome data have demonstrated its value extends beyond in-person interrogation.

Current methods of monitoring radiation exposure from CT.

PubMed

Talati, Ronak K; Dunkin, Jared; Parikh, Shrujal; Moore, William H

2013-09-01

Increased public and regulatory scrutiny of imaging-related radiation exposure requires familiarity with current dose-monitoring techniques and best practices. CT-related ionizing radiation exposure has been cited as the largest and fastest growing source of population-wide iatrogenic ionizing radiation exposure. Upcoming federal regulations require imaging centers to familiarize themselves with available dose-monitoring techniques and implement comprehensive strategies to track patient dose, with particular emphasis on CT. Because of institution-specific and vendor-specific technologies, there are significant barriers to adoption and implementation. In this article, the authors outline the core components of a universal dose-monitoring strategy and detail a few of the many available commercial platforms. In addition, the authors introduce a cloud-based hybrid model dose-tracking system with the goal of rapid implementation, multicenter scalability, real-time dose feedback for technologists, cumulative dose monitoring, and optional dose communication to patients and into the record; doing so results in improved patient loyalty, referring physician satisfaction, and opportunity for repeat business. Copyright © 2013 American College of Radiology. All rights reserved.

Value of Underground Storage in Today's Natural Gas Industry, The

EIA Publications

1995-01-01

This report explores the significant and changing role of storage in the industry by examining the value of natural gas storage; short-term relationships between prices, storage levels, and weather; and some longer term impacts of the Federal Energy Regulatory Commission's (FERC) Order 636.

The Role of Value-Based Care in Patients with Cirrhosis.

PubMed

Volk, Michael L

2017-02-01

Value-based care means delivering high-quality care while keeping costs at a reasonable level. Many physicians have long viewed quality care and the responsible utilization of resources to be an integral part of their professional responsibilities. As the health care system changes, however, physicians are increasingly being asked to objectively demonstrate value. In this review article, the author describes the reimbursement and regulatory shift toward value-based care, and provides specific strategies for meeting this care. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Remote Real-Time Monitoring of Subsurface Landfill Gas Migration

PubMed Central

Fay, Cormac; Doherty, Aiden R.; Beirne, Stephen; Collins, Fiachra; Foley, Colum; Healy, John; Kiernan, Breda M.; Lee, Hyowon; Maher, Damien; Orpen, Dylan; Phelan, Thomas; Qiu, Zhengwei; Zhang, Kirk; Gurrin, Cathal; Corcoran, Brian; O’Connor, Noel E.; Smeaton, Alan F.; Diamond, Dermot

2011-01-01

The cost of monitoring greenhouse gas emissions from landfill sites is of major concern for regulatory authorities. The current monitoring procedure is recognised as labour intensive, requiring agency inspectors to physically travel to perimeter borehole wells in rough terrain and manually measure gas concentration levels with expensive hand-held instrumentation. In this article we present a cost-effective and efficient system for remotely monitoring landfill subsurface migration of methane and carbon dioxide concentration levels. Based purely on an autonomous sensing architecture, the proposed sensing platform was capable of performing complex analytical measurements in situ and successfully communicating the data remotely to a cloud database. A web tool was developed to present the sensed data to relevant stakeholders. We report our experiences in deploying such an approach in the field over a period of approximately 16 months. PMID:22163975

Remote real-time monitoring of subsurface landfill gas migration.

PubMed

Fay, Cormac; Doherty, Aiden R; Beirne, Stephen; Collins, Fiachra; Foley, Colum; Healy, John; Kiernan, Breda M; Lee, Hyowon; Maher, Damien; Orpen, Dylan; Phelan, Thomas; Qiu, Zhengwei; Zhang, Kirk; Gurrin, Cathal; Corcoran, Brian; O'Connor, Noel E; Smeaton, Alan F; Diamond, Dermot

2011-01-01

The cost of monitoring greenhouse gas emissions from landfill sites is of major concern for regulatory authorities. The current monitoring procedure is recognised as labour intensive, requiring agency inspectors to physically travel to perimeter borehole wells in rough terrain and manually measure gas concentration levels with expensive hand-held instrumentation. In this article we present a cost-effective and efficient system for remotely monitoring landfill subsurface migration of methane and carbon dioxide concentration levels. Based purely on an autonomous sensing architecture, the proposed sensing platform was capable of performing complex analytical measurements in situ and successfully communicating the data remotely to a cloud database. A web tool was developed to present the sensed data to relevant stakeholders. We report our experiences in deploying such an approach in the field over a period of approximately 16 months.

[Diagnostic value of dynamic monitoring of C-reactive protein in drain drainage to predict early anastomotic leakage after colorectal cancer surgery].

PubMed

Lu, Jia; Zheng, Lei; Li, Runtian; Hao, Chunmin; Gao, Wenbin; Feng, Ziwei; Yin, Guangya; Wang, Yue

2017-09-25

To evaluate the diagnostic value of dynamic monitoring of C-reactive protein (CRP) in drainage fluid in predicting early anastomotic leakage after colorectal surgery. This study enrolled 172 patients, who were diagnosed as colorectal cancer before operation and underwent radical surgery, without residual tumor tissues by postoperative pathology and perioperative infection, at the Tianjin Medical University Cancer Hospital between July 2015 and January 2016. The C-reactive(CRP) protein level in drainage fluid was continuously monitored from postoperative days (POD) 1 to 5. CRP level was compared between anastomotic leakage (AL) group and non-anastomotic leakage (NAL) group. Receiver operating characteristics (ROC) curve was used to estimate the value of monitoring CRP in drainage fluid to predict anastomotic leakage after colorectal surgery. Among 172 patients, 101 cases were male and 71 cases were female, with age of (59.9±10.3) years. Anastomotic leakage occurred after colorectal surgery in 24 cases(14.0%, AL group ) and other 148 cases were defined as NAL group. Other than body mass index (BMI), differences in baseline data were not statistically significant between two groups. The CRP lever in AL group and NAL group showed rising trend from POD1 to POD4 [Day 1: (6.7±8.4) g/L vs. (8.0±10.6) g/L; Day 2: (24.8±14.6) g/L vs. (28.3±21.1) g/L, Day 3: (54.8±26.5) g/L vs. (53.8±27.6)g/L, Day 4: (62.0±32.2) g/L vs. (58.4±30.7) g/L], while the differences were not significant (all P>0.05). At POD 5, the CRP lever of AL group increased continuously, while that of NAL group decreased with significant difference [(65.3±38.9) g/L vs. (44.7±39.5) g/L, t=-2.85, P=0.005]. Further stratification analysis on AL group revealed CRP level in early AL (AL occurrence POD 10) showed rising trend from POD 1 to 4, then decreased slightly at POD 5, but whose differences were not significant

Estimating the social value of geologic map information: A regulatory application

USGS Publications Warehouse

Bernknopf, R.L.; Brookshire, D.S.; McKee, M.; Soller, D.R.

1997-01-01

People frequently regard the landscape as part of a static system. The mountains and rivers that cross the landscape, and the bedrock that supports the surface, change little during the course of a lifetime. Society can alter the geologic history of an area and, in so doing, affect the occurrence and impact of environmental hazards. For example, changes in land use can induce changes in erosion, sedimentation, and ground-water supply. As the environmental system is changed by both natural processes and human activities, the system's capacity to respond to additional stresses also changes. Information such as geologic maps describes the physical world and is critical for identifying solutions to land use and environmental issues. In this paper, a method is developed for estimating the economic value of applying geologic map information to siting a waste disposal facility. An improvement in geologic map information is shown to have a net positive value to society. Such maps enable planners to make superior land management decisions.

Extreme dissolved oxygen variability in urbanised tropical wetlands: The need for detailed monitoring to protect nursery ground values

NASA Astrophysics Data System (ADS)

Dubuc, Alexia; Waltham, Nathan; Malerba, Martino; Sheaves, Marcus

2017-11-01

Little is known about levels of dissolved oxygen fish are exposed to daily in typical urbanised tropical wetlands found along the Great Barrier Reef coastline. This study investigates diel dissolved oxygen (DO) dynamics in one of these typical urbanised wetlands, in tropical North Queensland, Australia. High frequency data loggers (DO, temperature, depth) were deployed for several days over the summer months in different tidal pools and channels that fish use as temporal or permanent refuges. DO was extremely variable over a 24 h cycle, and across the small-scale wetland. The high spatial and temporal DO variability measured was affected by time of day and tidal factors, namely water depth, tidal range and tidal direction (flood vs ebb). For the duration of the logging time, DO was mainly above the adopted threshold for hypoxia (50% saturation), however, for around 11% of the time, and on almost every logging day, DO values fell below the threshold, including a severe hypoxic event (<5% saturation) that continued for several hours. Fish still use this wetland intensively, so must be able to cope with low DO periods. Despite the ability of fish to tolerate extreme conditions, continuing urban expansion is likely to lead to further water quality degradation and so potential loss of nursery ground value. There is a substantial discontinuity between the recommended DO values in the Australian and New Zealand Guidelines for Fresh and Marine Water Quality and the values observed in this wetland, highlighting the limited value of these guidelines for management purposes. Local and regional high frequency data monitoring programs, in conjunction with local exposure risk studies are needed to underpin the development of the management that will ensure the sustainability of coastal wetlands.

Sampling and monitoring for closure

USGS Publications Warehouse

McLemore, V.T.; Russell, C.C.; Smith, K.S.

2004-01-01

The Metals Mining Sector of the Acid Drainage Technology Initiative (ADTI-MMS) addresses technical drainage-quality issues related to metal mining and related metallurgical operations, for future and active mines, as well as, for historical mines and mining districts. One of the first projects of ADTI-MMS is to develop a handbook describing the best sampling, monitoring, predicting, mitigating, and modeling of drainage from metal mines, pit lakes and related metallurgical facilities based upon current scientific and engineering practices. One of the important aspects of planning a new mine in today's regulatory environment is the philosophy of designing a new or existing mine or expansion of operations for ultimate closure. The holistic philosophy taken in the ADTI-MMS handbook maintains that sampling and monitoring programs should be designed to take into account all aspects of the mine-life cycle. Data required for the closure of the operation are obtained throughout the mine-life cycle, from exploration through post-closure.

Establishment of a reference value for chromium in the blood for biological monitoring among occupational chromium workers.

PubMed

Li, Ping; Li, Yang; Zhang, Ji; Yu, Shan-Fa; Wang, Zhi-Liang; Jia, Guang

2016-10-01

The concentration of chromium in the blood (CrB) has been confirmed as a biomarker for occupational chromium exposure, but its biological exposure indices (BEIs) are still unclear, so we collected data from the years 2006 and 2008 (Shandong Province, China) to analyze the relationship between the concentration of chromium in the air (CrA) of the workplaces and CrB to establish a reference value of CrB for biological monitoring of occupational workers. The levels of the indicators for nasal injury, kidney (β2 microglobulin (β2-MG)), and genetic damages (8-hydroxy-deoxyguanosine (8-OHdG) and micronucleus (MN)) were measured in all subjects of the year 2011 (Henan Province, China) to verify the protective effect in this reference value of CrB. Compared with the control groups, the concentrations of CrA and CrB in chromium exposed groups were significantly higher (P < 0.05). Positive correlations were found between CrA and CrB in chromium exposed groups (r 2006 = 0.60, r 2008 = 0.35) in the years 2006 and 2008. According to the occupational exposure limitation of CrA (50 μg/m(3), China), the reference value of CrB was recommended to 20 μg/L. The levels of nasal injury, β2-MG, 8-OhdG, and MN were not significantly different between the low chromium exposed group (CrB ≤ 20 μg/L) and the control group, while the levels of β2-MG, 8-OHdG, and MN were statistically different in the high chromium exposed group than that in the control group. This research proved that only in occupational workers, CrB could be used as a biomarker to show chromium exposure in the environment. The recommended reference value of CrB was 20 μg/L. © The Author(s) 2015.

Deciphering the transcriptional cis-regulatory code.

PubMed

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

2013-01-01

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

Flood effects on an Alaskan stream restoration project: the value of long-term monitoring

USGS Publications Warehouse

Densmore, Roseann V.; Karle, Kenneth F.

2009-01-01

On a nationwide basis, few stream restoration projects have long-term programs in place to monitor the effects of floods on channel and floodplain configuration and floodplain vegetation, but long-term and event-based monitoring is required to measure the effects of these stochastic events and to use the knowledge for adaptive management and the design of future projects. This paper describes a long-term monitoring effort (15 years) on a stream restoration project in Glen Creek in Denali National Park and Preserve in Alaska. The stream channel and floodplain of Glen Creek had been severely degraded over a period of 80 years by placer mining for gold, which left many reaches with unstable and incised streambeds without functioning vegetated floodplains. The objectives of the original project, initiated in 1991, were to develop and test methods for the hydraulic design of channel and floodplain morphology and for floodplain stabilization and riparian habitat recovery, and to conduct research and monitoring to provide information for future projects in similar degraded watersheds. Monitoring methods included surveyed stream cross-sections, vegetation plots, and aerial, ground, and satellite photos. In this paper we address the immediate and outlying effects of a 25-year flood on the stream and floodplain geometry and riparian vegetation. The long-term monitoring revealed that significant channel widening occurred following the flood, likely caused by excessive upstream sediment loading and the fairly slow development of floodplain vegetation in this climate. Our results illustrated design flaws, particularly in regard to identification and analysis of sediment sources and the dominant processes of channel adjustment.

Passive Sampling in Regulatory Chemical Monitoring of Nonpolar Organic Compounds in the Aquatic Environment.

PubMed

Booij, Kees; Robinson, Craig D; Burgess, Robert M; Mayer, Philipp; Roberts, Cindy A; Ahrens, Lutz; Allan, Ian J; Brant, Jan; Jones, Lisa; Kraus, Uta R; Larsen, Martin M; Lepom, Peter; Petersen, Jördis; Pröfrock, Daniel; Roose, Patrick; Schäfer, Sabine; Smedes, Foppe; Tixier, Céline; Vorkamp, Katrin; Whitehouse, Paul

2016-01-05

We reviewed compliance monitoring requirements in the European Union, the United States, and the Oslo-Paris Convention for the protection of the marine environment of the North-East Atlantic, and evaluated if these are met by passive sampling methods for nonpolar compounds. The strengths and shortcomings of passive sampling are assessed for water, sediments, and biota. Passive water sampling is a suitable technique for measuring concentrations of freely dissolved compounds. This method yields results that are incompatible with the EU's quality standard definition in terms of total concentrations in water, but this definition has little scientific basis. Insufficient quality control is a present weakness of passive sampling in water. Laboratory performance studies and the development of standardized methods are needed to improve data quality and to encourage the use of passive sampling by commercial laboratories and monitoring agencies. Successful prediction of bioaccumulation based on passive sampling is well documented for organisms at the lower trophic levels, but requires more research for higher levels. Despite the existence of several knowledge gaps, passive sampling presently is the best available technology for chemical monitoring of nonpolar organic compounds. Key issues to be addressed by scientists and environmental managers are outlined.

Developing A National Groundwater-Monitoring Network In Korea

NASA Astrophysics Data System (ADS)

Kim, N. J.; Cho, M. J.; Woo, N. C.

1995-04-01

Since the 1960's, the groundwater resources of Korea have been developed without a proper regulatory system for monitoring and preservation, resulting in significant source depletion, land subsidence, water contamination, and sea-water intrusion. With the activation of the "Groundwater Law" in June 1994, the government initiated a project to develop a groundwater-monitoring network to describe general groundwater quality, to define its long-term changes, and to identify major factors affecting changes in groundwater quality and yield. In selecting monitoring locations nationwide, criteria considered are 1) spatial distribution, 2) aquifer characteristics of hydrogeologic units, 3) local groundwater flow regime, 4) linkage with surface hydrology observations, 5) site accessibility, and 6) financial situations. A total of 310 sites in 78 small hydrologic basins were selected to compose the monitoring network. Installation of monitoring wells is scheduled to start in 1995 for 15 sites; the remainder are scheduled to be completed by 2001. At each site, a nest of monitoring wells was designed; shallow and deep groundwater will be monitored for water temperature, pH, EC, DO and TDS every month. Water-level fluctuations will also be measured by automatic recorders equipped with pressure transducers. As a next step, the government plans to develop a groundwater-database management system, which could be linked with surface hydrologic data.

77 FR 32703 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass...

Predicting gene regulatory networks of soybean nodulation from RNA-Seq transcriptome data.

PubMed

Zhu, Mingzhu; Dahmen, Jeremy L; Stacey, Gary; Cheng, Jianlin

2013-09-22

High-throughput RNA sequencing (RNA-Seq) is a revolutionary technique to study the transcriptome of a cell under various conditions at a systems level. Despite the wide application of RNA-Seq techniques to generate experimental data in the last few years, few computational methods are available to analyze this huge amount of transcription data. The computational methods for constructing gene regulatory networks from RNA-Seq expression data of hundreds or even thousands of genes are particularly lacking and urgently needed. We developed an automated bioinformatics method to predict gene regulatory networks from the quantitative expression values of differentially expressed genes based on RNA-Seq transcriptome data of a cell in different stages and conditions, integrating transcriptional, genomic and gene function data. We applied the method to the RNA-Seq transcriptome data generated for soybean root hair cells in three different development stages of nodulation after rhizobium infection. The method predicted a soybean nodulation-related gene regulatory network consisting of 10 regulatory modules common for all three stages, and 24, 49 and 70 modules separately for the first, second and third stage, each containing both a group of co-expressed genes and several transcription factors collaboratively controlling their expression under different conditions. 8 of 10 common regulatory modules were validated by at least two kinds of validations, such as independent DNA binding motif analysis, gene function enrichment test, and previous experimental data in the literature. We developed a computational method to reliably reconstruct gene regulatory networks from RNA-Seq transcriptome data. The method can generate valuable hypotheses for interpreting biological data and designing biological experiments such as ChIP-Seq, RNA interference, and yeast two hybrid experiments.

Validation of the digital opacity compliance system under regulatory enforcement conditions.

PubMed

McFarland, Michael J; Rasmussen, Steve L; Stone, Daniel A; Palmer, Glenn R; Wander, Joseph D

2006-09-01

U.S. Environmental Protection Agency (EPA) Emission Measurement Center in conjunction with EPA Regions VI and VIII, the state of Utah, and the U.S. Department of Defense have conducted a series of long-term pilot and field tests to determine the accuracy and reliability of a visible opacity monitoring system consisting of a conventional digital camera and a separate computer software application for plume opacity determination. This technology, known as the Digital Opacity Compliance System (DOCS), has been successfully demonstrated at EPA-sponsored Method-9 "smoke schools", as well as at a number of government and commercially operated industrial facilities. Results from the current DOCS regulatory pilot study demonstrated that, under regulatory enforcement conditions, the average difference in opacity measurement between the DOCS technology and EPA Reference Method 9 (Method 9) was 1.12%. This opacity difference, which was computed from the evaluation of 241 regulated air sources, was found to be statistically significant at the 99% confidence level. In evaluating only those sources for which a nonzero visible opacity level was recorded, the

WATERBORNE DISEASES AND MICROBIAL QUALITY MONITORING FOR RECREATIONAL WATER BODIES USING REGULATORY METHODS

EPA Science Inventory

This chapter will provide the reader with a historical perspective of microbial water quality and monitoring of recreational waters, with special attention to marine environments. It will review the regulations that are currently in effect in the United States and discuss critic...

Clinical value of natriuretic peptides in chronic kidney disease.

PubMed

Santos-Araújo, Carla; Leite-Moreira, Adelino; Pestana, Manuel

2015-01-01

According to several lines of evidence, natriuretic peptides (NP) are the main components of a cardiac-renal axis that operate in clinical conditions of decreased cardiac hemodynamic tolerance to regulate sodium homeostasis, blood pressure and vascular function. Even though it is reasonable to assume that NP may exert a relevant role in the adaptive response to renal mass ablation, evidence gathered so far suggest that this contribution is probably complex and dependent on the type and degree of the functional mass loss. In the last years NP have been increasingly used to diagnose, monitor treatment and define the prognosis of several cardiovascular (CV) diseases. However, in many clinical settings, like chronic kidney disease (CKD), the predictive value of these biomarkers has been questioned. In fact, it is now well established that renal function significantly affects the plasmatic levels of NP and that renal failure is the clinical condition associated with the highest plasmatic levels of these peptides. The complexity of the relation between NP plasmatic levels and CV and renal functions has obvious consequences, as it may limit the predictive value of NP in CV assessment of CKD patients and be a demanding exercise for clinicians involved in the daily management of these patients. This review describes the role of NP in the regulatory response to renal function loss and addresses the main factors involved in the clinical valorization of the peptides in the context of significant renal failure. Copyright © 2015 The Authors. Published by Elsevier España, S.L.U. All rights reserved.

Do you know the fair market value of quality?

PubMed

Johnson, Jen

2009-10-01

To develop a physician compensation package that includes fair-market-value incentive payments for their efforts to improve healthcare quality, a hospital first needs to: Evaluate current market data on quality incentive payments. Be familiar with the existing regulatory guidelines related to paying for quality. Understand the requirements for complying with the regulations.

76 FR 40150 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Commission publishes its semiannual regulatory flexibility agenda. In addition, this document includes an...) requires each agency to publish twice each year a regulatory flexibility agenda containing a brief... 12866 requires each agency to publish twice each year a regulatory agenda of regulations under...

77 FR 55519 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

...\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to adopt existing NASD Interpretive Material... Policy The proposed rule change would replace several existing provisions in the Front Running Policy...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change...

78 FR 58580 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-24

... proposed rule change, FINRA would no longer require a customer to elect one of the two existing panel...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change...,\\2\\ a proposed rule change amending the Code of Arbitration Procedure for Customer Disputes...

Airborne particle monitoring in clean room environments for stem cell cultures.

PubMed

Cobo, Fernando; Grela, David; Concha, Angel

2008-01-01

Modern high-technology industrial practices like pharmaceutical and stem cell line production demand high-quality environmental conditions to avoid particle contamination in the final product. Particles are important because their presence can affect both the output and the productivity and because they can have repercussion on human health. In this kind of production practice it is necessary to implement optimal methods for particle management and to introduce an environmental monitoring program. This should also address the regional regulatory requirements and will depend on local conditions in each processing center. Each center must evaluate its specific needs and establish appropriate monitoring procedures.

A global regulatory science agenda for vaccines.

PubMed

Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

2013-04-18

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable

Evaluating the value of ENVISAT ASAR Data for the mapping and monitoring of peatland water table depths

NASA Astrophysics Data System (ADS)

Bechtold, Michel; Schlaffer, Stefan

2015-04-01

The Advanced Synthetic Aperture Radar (ASAR) onboard ENVISAT collected C-Band microwave backscatter data from 2005 to 2012. Backscatter in the C-Band depends to a large degree on the roughness and the moisture status of vegetation and soil surface with a penetration depth of ca. 3 cm. In wetlands with stable high water levels, the annual soil surface moisture dynamics are very distinct compared to the surrounding areas, which allows the monitoring of such environments with ASAR data (Reschke et al. 2012). Also in drained peatlands, moisture status of vegetation and soil surface strongly depends on water table depth due to high hydraulic conductivities of many peat soils in the low suction range (Dettmann et al. 2014). We hypothesize that this allows the characterization of water table depths with ASAR data. Here we analyze whether ASAR data can be used for the spatial and temporal estimation of water table depths in different peatlands (natural, near-natural, agriculturally-used and rewetted). Mapping and monitoring of water table depths is of crucial importance, e.g. for upscaling greenhouse gas emissions and evaluating the success of peatland rewetting projects. Here, ASAR data is analyzed with a new map of water table depths for the organic soils in Germany (Bechtold et al. 2014) as well as with a comprehensive data set of monitored peatland water levels from 1100 dip wells and 54 peatlands. ASAR time series from the years 2005-2012 with irregular temporal sampling intervals of 3-14 days were processed. Areas covered by snow were masked. Primary results about the accuracy of spatial estimates show significant correlations between long-term backscatter statistics and spatially-averaged water table depths extracted from the map at the resolution of the ASAR data. Backscatter also correlates with long-term averages of point-scale water table depth data of the monitoring wells. For the latter, correlation is highest between the dry reference backscatter values and

75 FR 3760 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-22

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0018] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory...) is issuing for public comment a draft guide in the agency's ``Regulatory Guide'' series. This series...

75 FR 20645 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-20

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0158] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make...

76 FR 189 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-03

.../reading-rm/doc-collections/ . In addition, regulatory guides are available for inspection at the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 3...

3 CFR - Regulatory Compliance

Code of Federal Regulations, 2012 CFR

2012-01-01

... 3 The President 1 2012-01-01 2012-01-01 false Regulatory Compliance Presidential Documents Other Presidential Documents Memorandum of January 18, 2011 Regulatory Compliance Memorandum for the Heads of Executive Departments and Agencies My Administration is committed to enhancing effectiveness and efficiency in Government. Pursuant to the...

Emerging principles of regulatory evolution.

PubMed

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

2007-05-15

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

47 CFR 101.1309 - Regulatory status.

Code of Federal Regulations, 2010 CFR

2010-10-01

... party may challenge the regulatory status granted an MAS licensee. System License Requirements ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status. 101.1309 Section 101.1309... SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission will...

I: Biomarker quantification in fish exposed to crude oil as input to species sensitivity distributions and threshold values for environmental monitoring.

PubMed

Sanni, Steinar; Björkblom, Carina; Jonsson, Henrik; Godal, Brit F; Liewenborg, Birgitta; Lyng, Emily; Pampanin, Daniela M

2017-04-01

The aim of this study was to determine a suitable set of biomarker based methods for environmental monitoring in sub-arctic and temperate offshore areas using scientific knowledge on the sensitivity of fish species to dispersed crude oil. Threshold values for environmental monitoring and risk assessment were obtained based on a quantitative comparison of biomarker responses. Turbot, halibut, salmon and sprat were exposed for up to 8 weeks to five different sub-lethal concentrations of dispersed crude oil. Biomarkers assessing PAH metabolites, oxidative stress, detoxification system I activity, genotoxicity, immunotoxicity, endocrine disruption, general cellular stress and histological changes were measured. Results showed that PAH metabolites, CYP1A/EROD, DNA adducts and histopathology rendered the most robust results across the different fish species, both in terms of sensitivity and dose-responsiveness. The reported results contributed to forming links between biomonitoring and risk assessment procedures by using biomarker species sensitivity distributions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Interpretation of Biochemical Tests Using the Reference Change Value in Monitoring Adverse Effects of Oral Isotretinoin in 102 Ethnic Turkish Patients.

PubMed

Bugdayci, Guler; Polat, Mualla; Oguzman, Hamdi; Cinpolat, Havva Yasemin

2016-08-01

The aim of this study was to model the use of reference change values (RCVs) for the follow-up of 4 parameters of patients using oral isotretinoin which is gaining widespread popularity for monitoring the side effects of the treatment. 102 patients received 30 mg/day oral isotretinoin for 24 weeks for the diagnosis of acne vulgaris. Repetitive measurements of the patients were interpreted with RCVs, after comparing the first and second doses based on RCVs: TC, TG, AST and ALT results increased in 12%, 20%, 14% and 12% of the patients respectively. When the first dose was compared with the last dose, the increases were 20%, 29%, 22% and 18% respectively interpreted as significant changes based on laboratory medicine. A more sensitive follow-up is possible in the monitorization of adverse effects by using RCVs method. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Nanomedicines: addressing the scientific and regulatory gap.

PubMed

Tinkle, Sally; McNeil, Scott E; Mühlebach, Stefan; Bawa, Raj; Borchard, Gerrit; Barenholz, Yechezkel Chezy; Tamarkin, Lawrence; Desai, Neil

2014-04-01

Nanomedicine is the application of nanotechnology to the discipline of medicine: the use of nanoscale materials for the diagnosis, monitoring, control, prevention, and treatment of disease. Nanomedicine holds tremendous promise to revolutionize medicine across disciplines and specialties, but this promise has yet to be fully realized. Beyond the typical complications associated with drug development, the fundamentally different and novel physical and chemical properties of some nanomaterials compared to materials on a larger scale (i.e., their bulk counterparts) can create a unique set of opportunities as well as safety concerns, which have only begun to be explored. As the research community continues to investigate nanomedicines, their efficacy, and the associated safety issues, it is critical to work to close the scientific and regulatory gaps to assure that nanomedicine drives the next generation of biomedical innovation. © 2014 New York Academy of Sciences.

Regulatory affairs and biotechnology in Europe. I. Introduction into good regulatory practice.

PubMed

Tryzelaar, B

1988-01-01

The high cost and risks associated with the research and development of new drugs demand an alert as well as realistic legislative policy at both national and international levels. Registration of a new drug required before a marketing license is granted, is important for all branches of the pharmaceutical industry but is crucial for success in the innovative biotechnological sector. Innovation as such is no guarantee to be profitable. Increasing government demands have introduced uncertainty on whether new products will secure registration and have led to a disproportionate increase in the economical risks for innovative industry. Preparation and submission of an application for registration should be undertaken seriously and professionally since it has significantly more consequences than simply obtaining a marketing licence. It will influence marketing strategies and results. It is proposed--since dealing with regulatory affairs can be considered as an essential specialism--to apply a Quality Assurance approach. Activities in this context should comply with the same performance standards as developed for GMP, GLP and GCP leading to Good Regulatory Practice (GRP). By acknowledging regulatory affairs as a quality assurance means one can define a set of standard procedures within an organization to ensure that decisions are made on current and future regulations. In such a setup regulatory affairs becomes a marketing tool. This paper illustrates the complex problems found in registration activities. It underlines the necessity of introducing a GRP-approach of performance resulting in substantive evidence of regulatory efficacy.

A Golden Ticket to Future Occupational and Environmental Health Monitoring

DTIC Science & Technology

2015-10-01

by the BE career field, an assessment of the regulatory monitoring requirements and current detection capabilities was critical . The next step in...research criteria due to the inability to predict the cost of production for these detection systems. Until a standardization of mass scale production...the health risk assessment process and is critical to keeping the base population safe from occupational and environmental exposures. The predominant

78 FR 21449 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... ``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to amend FINRA's Customer and Industry... arbitrator'' in the Codes. Specifically, the proposed rule change would (a) exclude persons associated with a...

78 FR 62784 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Relating to Wash Sale Transactions and FINRA Rule...-4 thereunder,\\2\\ a proposed rule change to amend FINRA Rule 5210. The proposed rule change was...

77 FR 3019 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-20

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass... 19b-4 thereunder,\\2\\ a proposed rule change related to post-trade transparency for agency pass-through...

75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

The future of yogurt: scientific and regulatory needs1234

PubMed Central

German, J Bruce

2014-01-01

Lactation biology, microbial selection, and human diversity are central themes that could guide investment in scientific research, industrial innovation, and regulatory policy oversight to propel yogurt into the central role for health-promoting food products. The ability of yogurt to provide the nourishing properties of milk together with the live microorganisms from fermentation provides a unique combination of food assets. Academic research must now define the various targets on which these biological assets act to improve health and develop the metrics that can quantitatively document their benefits. The food industry must reconcile that yogurt and its microorganisms cannot be expected to provide measurable benefits for all consumers, at all doses, and at all times. A supportive regulatory oversight must demand safety and yet encourage innovations that support a value proposition for yogurt in health. Health valuation in the marketplace will be driven by parallel innovations, including accurate assessment technologies, validated microbial ingredients, and health-aware consumers. PMID:24695899

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

PubMed

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

2016-05-01

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

General Services Administration Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... regulatory plan. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch, at... Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat Branch, Office of...: 202 501-4755 Fax: 202 501-4067 Email: hada.flowers@gsa.gov RIN: 3090-AI32 276. GSAR CASE 2008-G517...

76 FR 6085 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

...-2011-0014] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice Availability of Draft Regulatory Guide. SUMMARY: The U.S. Nuclear Regulatory Commission (Commission or NRC) is issuing for public comment Draft Regulatory Guide, DG-5019, ``Reporting and...

Comparison of Consumer and Research Monitors under Semistructured Settings.

PubMed

Bai, Yang; Welk, Gregory J; Nam, Yoon Ho; Lee, Joey A; Lee, Jung-Min; Kim, Youngwon; Meier, Nathan F; Dixon, Philip M

2016-01-01

This study evaluated the relative validity of different consumer and research activity monitors during semistructured periods of sedentary activity, aerobic exercise, and resistance exercise. Fifty-two (28 male and 24 female) participants age 18-65 yr performed 20 min of self-selected sedentary activity, 25 min of aerobic exercise, and 25 min of resistance exercise, with 5 min of rest between each activity. Each participant wore five wrist-worn consumer monitors [Fitbit Flex, Jawbone Up24, Misfit Shine (MS), Nike+ Fuelband SE (NFS), and Polar Loop] and two research monitors [ActiGraph GT3X+ on the waist and BodyMedia Core (BMC) on the arm] while being concurrently monitored with Oxycon Mobile (OM), a portable metabolic measuring system. Energy expenditure (EE) on different activity sessions was measured by OM and estimated by all monitors. Mean absolute percent error (MAPE) values for the full 80-min protocol ranged from 15.3% (BMC) to 30.4% (MS). EE estimates from ActiGraph GT3X+ were found to be equivalent to those from OM (± 10% equivalence zone, 285.1-348.5). Correlations between OM and the various monitors were generally high (ranged between 0.71 and 0.90). Three monitors had MAPE values lower than 20% for sedentary activity: BMC (15.7%), MS (18.2%), and NFS (20.0%). Two monitors had MAPE values lower than 20% for aerobic exercise: BMC (17.2%) and NFS (18.5%). None of the monitors had MAPE values lower than 25% for resistance exercise. Overall, the research monitors and Fitbit Flex, Jawbone Up24, and NFS provided reasonably accurate total EE estimates at the individual level. However, larger error was evident for individual activities, especially resistance exercise. Further research is needed to examine these monitors across various activities and intensities as well as under real-world conditions.

Leveraging cell type specific regulatory regions to detect SNPs associated with tissue factor pathway inhibitor plasma levels.

PubMed

Dennis, Jessica; Medina-Rivera, Alejandra; Truong, Vinh; Antounians, Lina; Zwingerman, Nora; Carrasco, Giovana; Strug, Lisa; Wells, Phil; Trégouët, David-Alexandre; Morange, Pierre-Emmanuel; Wilson, Michael D; Gagnon, France

2017-07-01

Tissue factor pathway inhibitor (TFPI) regulates the formation of intravascular blood clots, which manifest clinically as ischemic heart disease, ischemic stroke, and venous thromboembolism (VTE). TFPI plasma levels are heritable, but the genetics underlying TFPI plasma level variability are poorly understood. Herein we report the first genome-wide association scan (GWAS) of TFPI plasma levels, conducted in 251 individuals from five extended French-Canadian Families ascertained on VTE. To improve discovery, we also applied a hypothesis-driven (HD) GWAS approach that prioritized single nucleotide polymorphisms (SNPs) in (1) hemostasis pathway genes, and (2) vascular endothelial cell (EC) regulatory regions, which are among the highest expressers of TFPI. Our GWAS identified 131 SNPs with suggestive evidence of association (P-value < 5 × 10 -8 ), but no SNPs reached the genome-wide threshold for statistical significance. Hemostasis pathway genes were not enriched for TFPI plasma level associated SNPs (global hypothesis test P-value = 0.147), but EC regulatory regions contained more TFPI plasma level associated SNPs than expected by chance (global hypothesis test P-value = 0.046). We therefore stratified our genome-wide SNPs, prioritizing those in EC regulatory regions via stratified false discovery rate (sFDR) control, and reranked the SNPs by q-value. The minimum q-value was 0.27, and the top-ranked SNPs did not show association evidence in the MARTHA replication sample of 1,033 unrelated VTE cases. Although this study did not result in new loci for TFPI, our work lays out a strategy to utilize epigenomic data in prioritization schemes for future GWAS studies. © 2017 WILEY PERIODICALS, INC.

Analyzing the value of monitoring duodenal mucosal perfusion using photoplethysmography.

PubMed

Fink, Mitchell P

2014-10-13

Photoplethysmography (PPG) is a technique that permits noninvasive measurement of changes in the volume of tissues. A novel device uses PPG to assess changes in duodenal mucosal perfusion. When tested in septic piglets, data obtained using this device correlate with the blood lactate concentration and duodenal serosal microvascular blood flow as measured with a laser Doppler flowmeter. This new PPG-based approach for continuously monitoring gut mucosal perfusion warrants further development, leading to prospective clinical trials in patients.

78 FR 17969 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Require Members To Report OTC Equity Transactions... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to amend FINRA trade reporting rules...

Spurious symptom reduction in fault monitoring

NASA Technical Reports Server (NTRS)

Shontz, William D.; Records, Roger M.; Choi, Jai J.

1993-01-01

Previous work accomplished on NASA's Faultfinder concept suggested that the concept was jeopardized by spurious symptoms generated in the monitoring phase. The purpose of the present research was to investigate methods of reducing the generation of spurious symptoms during in-flight engine monitoring. Two approaches for reducing spurious symptoms were investigated. A knowledge base of rules was constructed to filter known spurious symptoms and a neural net was developed to improve the expectation values used in the monitoring process. Both approaches were effective in reducing spurious symptoms individually. However, the best results were obtained using a hybrid system combining the neural net capability to improve expectation values with the rule-based logic filter.

The value of Sentinel 1 and 2 for agricultural monitoring: lessons learned from a few case studies.

NASA Astrophysics Data System (ADS)

Azzari, G.; Lobell, D. B.

2016-12-01

The exponential growth in the number of earth-observing satellites during the last few years, along with the advent of novel and powerful computational platforms and algorithms, has enabled significant progress toward agricultural monitoring from space. Among recently-deployed sensors from both the public and private sector, ESA's Sentinel 1 (radar) and 2 (optical) offer great promise for several agricultural applications, used both individually or in combination. We will present results from case studies in Africa and the United States where Sentinel 1 and 2 are used to estimate several agricultural variables including crop yield, crop type, and management practices (e.g. no-till) in different landscapes. Emphasis will be placed on comparisons with ground data collected at the field level, and on comparing the relative value of radar and optical data for assessing different outcomes.

Prognostic value of cell cycle regulatory proteins in muscle-infiltrating bladder cancer.

PubMed

Galmozzi, Fabia; Rubagotti, Alessandra; Romagnoli, Andrea; Carmignani, Giorgio; Perdelli, Luisa; Gatteschi, Beatrice; Boccardo, Francesco

2006-12-01

The aims of this study were to investigate the expression levels of proteins involved in cell cycle regulation in specimens of bladder cancer and to correlate them with the clinicopathological characteristics, proliferative activity and survival. Eighty-two specimens obtained from patients affected by muscle-invasive bladder cancer were evaluated immunohistochemically for p53, p21 and cyclin D1 expression, as well as for the tumour proliferation index, Ki-67. The statistical analysis included Kaplan-Meier curves with log-rank test and Cox proportional hazards models. In univariate analyses, low Ki-67 proliferation index (P = 0.045) and negative p21 immunoreactivity (P = 0.04) were associated to patient's overall survival (OS), but in multivariate models p21 did not reach statistical significance. When the combinations of the variables were assessed in two separate multivariate models that included tumour stage, grading, lymph node status, vascular invasion and perineural invasion, the combined variables p21/Ki-67 or p21/cyclin D1 expression were independent predictors for OS; in particular, patients with positive p21/high Ki-67 (P = 0.015) or positive p21/negative cyclin D1 (P = 0.04) showed the worst survival outcome. Important alterations in the cell cycle regulatory pathways occur in muscle-invasive bladder cancer and the combined use of cell cycle regulators appears to provide significant prognostic information that could be used to select the patients most suitable for multimodal therapeutic approaches.

Frequencies of decision making and monitoring in adaptive resource management

PubMed Central

Johnson, Fred A.

2017-01-01

Adaptive management involves learning-oriented decision making in the presence of uncertainty about the responses of a resource system to management. It is implemented through an iterative sequence of decision making, monitoring and assessment of system responses, and incorporating what is learned into future decision making. Decision making at each point is informed by a value or objective function, for example total harvest anticipated over some time frame. The value function expresses the value associated with decisions, and it is influenced by system status as updated through monitoring. Often, decision making follows shortly after a monitoring event. However, it is certainly possible for the cadence of decision making to differ from that of monitoring. In this paper we consider different combinations of annual and biennial decision making, along with annual and biennial monitoring. With biennial decision making decisions are changed only every other year; with biennial monitoring field data are collected only every other year. Different cadences of decision making combine with annual and biennial monitoring to define 4 scenarios. Under each scenario we describe optimal valuations for active and passive adaptive decision making. We highlight patterns in valuation among scenarios, depending on the occurrence of monitoring and decision making events. Differences between years are tied to the fact that every other year a new decision can be made no matter what the scenario, and state information is available to inform that decision. In the subsequent year, however, in 3 of the 4 scenarios either a decision is repeated or monitoring does not occur (or both). There are substantive differences in optimal values among the scenarios, as well as the optimal policies producing those values. Especially noteworthy is the influence of monitoring cadence on valuation in some years. We highlight patterns in policy and valuation among the scenarios, and discuss management

Frequencies of decision making and monitoring in adaptive resource management

USGS Publications Warehouse

Williams, Byron K.; Johnson, Fred A.

2017-01-01

Adaptive management involves learning-oriented decision making in the presence of uncertainty about the responses of a resource system to management. It is implemented through an iterative sequence of decision making, monitoring and assessment of system responses, and incorporating what is learned into future decision making. Decision making at each point is informed by a value or objective function, for example total harvest anticipated over some time frame. The value function expresses the value associated with decisions, and it is influenced by system status as updated through monitoring. Often, decision making follows shortly after a monitoring event. However, it is certainly possible for the cadence of decision making to differ from that of monitoring. In this paper we consider different combinations of annual and biennial decision making, along with annual and biennial monitoring. With biennial decision making decisions are changed only every other year; with biennial monitoring field data are collected only every other year. Different cadences of decision making combine with annual and biennial monitoring to define 4 scenarios. Under each scenario we describe optimal valuations for active and passive adaptive decision making. We highlight patterns in valuation among scenarios, depending on the occurrence of monitoring and decision making events. Differences between years are tied to the fact that every other year a new decision can be made no matter what the scenario, and state information is available to inform that decision. In the subsequent year, however, in 3 of the 4 scenarios either a decision is repeated or monitoring does not occur (or both). There are substantive differences in optimal values among the scenarios, as well as the optimal policies producing those values. Especially noteworthy is the influence of monitoring cadence on valuation in some years. We highlight patterns in policy and valuation among the scenarios, and discuss management

The trade in human organs in Tamil Nadu: the anatomy of regulatory failure.

PubMed

Muraleedharan, Vangal R; Jan, Stephen; Ram Prasad, S

2006-01-01

There has been much recent interest in the trade in human organs in India. This paper examines both the extent to which regulatory controls through the Transplantation of Human Organs Act (1994) are effective in curbing commercialization and the nature of the constraints on the effective implementation of this Act. The study, a politico-economic analysis of health sector regulation, is based on a stakeholder analysis drawing on the views of key decision makers, service providers, organ donors and recipients. The findings indicate widespread acknowledgement of an organs trade and highlight four major constraints on the effective implementation of the Act: the commercial interests of middlemen and service providers, the ambiguities and loopholes in the Act; the low monitoring capacity of the regulatory authorities, and the pressures and responsibilities exerted upon the Authorizing Committees. A feature of the Act is that its implementation is subject to a major incentive compatibility constraint - it is seemingly not in the interests of any of the key players, including the regulatory authorities, to restrict the organ trade. To some extent, this institutional problem is created by the specific nature of the regulatory intervention, and, as a consequence, measures involving straightforward redrafting of the regulation might go some way to addressing this incentive problem. Another solution may entail a 'harm-reduction' strategy involving a controlled trade where procurement and organ matching is carried out by a government agency (this would require, however, the prior resolution of the broader ethical question concerning the legitimacy of such trade).

Hybrid hard- and soft-modeling of spectrophotometric data for monitoring of ciprofloxacin and its main photodegradation products at different pH values

NASA Astrophysics Data System (ADS)

Razuc, Mariela; Garrido, Mariano; Caro, Yamile S.; Teglia, Carla M.; Goicoechea, Héctor C.; Fernández Band, Beatriz S.

2013-04-01

A simple and fast on line spectrophotometric method combined with a hybrid hard-soft modeling multivariate curve resolution (HS-MCR) was proposed for the monitoring of photodegradation reaction of ciprofloxacin under UV radiation. The studied conditions attempt to emulate the effect of sunlight on these antibiotics that could be eventually present in the environment. The continuous flow system made it possible to study the ciprofloxacin degradation at different pH values almost at real time, avoiding errors that could arise from typical batch monitoring of the reaction. On the base of a concentration profiles obtained by previous pure soft-modeling approach, reaction pathways have been proposed for the parent compound and its photoproducts at different pH values. These kinetic models were used as a constraint in the HS-MCR analysis. The kinetic profiles and the corresponding pure response profile (UV-Vis spectra) of ciprofloxacin and its main degradation products were recovered after the application of HS-MCR analysis to the spectra recorded throughout the reaction. The observed behavior showed a good agreement with the photodegradation studies reported in the bibliography. Accordingly, the photodegradation reaction was studied by high performance liquid chromatography coupled with UV-Vis diode array detector (HPLC-DAD). The spectra recorded during the chromatographic analysis present a good correlation with the ones recovered by UV-Vis/HS-MCR method.

Team Structure and Regulatory Focus: The Impact of Regulatory Fit on Team Dynamic

ERIC Educational Resources Information Center

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

2012-01-01

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…

40 CFR 92.6 - Regulatory structure.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...

40 CFR 94.6 - Regulatory structure.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this Part 94 are intended to control...

Novice Interpretations of Progress Monitoring Graphs: Extreme Values and Graphical Aids

ERIC Educational Resources Information Center

Newell, Kirsten W.; Christ, Theodore J.

2017-01-01

Curriculum-Based Measurement of Reading (CBM-R) is frequently used to monitor instructional effects and evaluate response to instruction. Educators often view the data graphically on a time-series graph that might include a variety of statistical and visual aids, which are intended to facilitate the interpretation. This study evaluated the effects…

A Systems' Biology Approach to Study MicroRNA-Mediated Gene Regulatory Networks

PubMed Central

Kunz, Manfred; Vera, Julio; Wolkenhauer, Olaf

2013-01-01

MicroRNAs (miRNAs) are potent effectors in gene regulatory networks where aberrant miRNA expression can contribute to human diseases such as cancer. For a better understanding of the regulatory role of miRNAs in coordinating gene expression, we here present a systems biology approach combining data-driven modeling and model-driven experiments. Such an approach is characterized by an iterative process, including biological data acquisition and integration, network construction, mathematical modeling and experimental validation. To demonstrate the application of this approach, we adopt it to investigate mechanisms of collective repression on p21 by multiple miRNAs. We first construct a p21 regulatory network based on data from the literature and further expand it using algorithms that predict molecular interactions. Based on the network structure, a detailed mechanistic model is established and its parameter values are determined using data. Finally, the calibrated model is used to study the effect of different miRNA expression profiles and cooperative target regulation on p21 expression levels in different biological contexts. PMID:24350286

Values of Deploying a Compact Polarimetric Radar to Monitor Extreme Precipitation in a Mountainous Area: Mineral County, Colorado

NASA Astrophysics Data System (ADS)

Cheong, B. L.; Kirstetter, P. E.; Yu, T. Y.; Busto, J.; Speeze, T.; Dennis, J.

2015-12-01

Precipitation in mountainous regions can trigger flash floods and landslides especially in areas affected by wildfire. Because of the small space-time scales required for observation, they remain poorly observed. A light-weighted X-band polarimetric radar can rapidly respond to the situation and provide continuous rainfall information with high resolution for flood forecast and emergency management. A preliminary assessment of added values to the operational practice in Mineral county, Colorado was performed in Fall 2014 and Summer 2015 with a transportable polarimetric radar deployed at the Lobo Overlook. This region is one of the numerous areas in the Rocky Mountains where the WSR-88D network does not provide sufficient weather coverage due to blockages, and the limitations have impeded forecasters and local emergency managers from making accurate predictions and issuing weather warnings. High resolution observations were collected to document the precipitation characteristics and demonstrate the added values of deploying a small weather radar in such context. The analysis of the detailed vertical structure of precipitation explain the decreased signal sampled by the operational radars. The specific microphysics analyzed though polarimetry suggest that the operational Z-R relationships may not be appropriate to monitor severe weather over this wildfire affected region. Collaboration with the local emergency managers and the National Weather Service shows the critical value of deploying mobile, polarimetric and unmanned radars in complex terrain. Several selected cases are provided in this paper for illustration.

EXTRAPOLATING ACUTE MORTALITY OF AMPELISCA ABDITA TO POPULATION RISK USING A POPULATION MODEL AND MONITORING DATA

EPA Science Inventory

Ten-day acute mortality of the benthic amphipod, Ampelisca abdita, is used in a number of regulatory, research, and monitoring programs to evaluate chemical contamination of marine sediments. Although this endpoint has proven to be valuable for characterizing the relative toxicit...

75 FR 18245 - Public Federal Regulatory Enforcement Fairness Hearing Region IX Regulatory Fairness Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... the meeting is for Business Organizations, Trade Associations, Chambers of Commerce and related... SMALL BUSINESS ADMINISTRATION Public Federal Regulatory Enforcement Fairness Hearing Region IX... hereby given that the U.S. Small Business Administration (SBA) Region IX Regulatory Fairness Board and...

The added predictive value of biphasic events in ST analysis of the fetal electrocardiogram for intrapartum fetal monitoring.

PubMed

Becker, Jeroen H; Krikhaar, Anniek; Schuit, Ewoud; Mårtendal, Annika; Maršál, Karel; Kwee, Anneke; Visser, Gerard H A; Amer-Wåhlin, Isis

2015-02-01

To study the predictive value of biphasic ST-events for interventions for suspected fetal distress and adverse neonatal outcome, when using ST-analysis of the fetal electrocardiogram (FECG) for intrapartum fetal monitoring. Prospective cohort study. Three academic hospitals in Sweden. Women in labor with a high-risk singleton fetus in cephalic position beyond 36 weeks of gestation. In women in labor who were monitored with conventional cardiotocography, ST-waveform analysis was recorded and concealed. Traces with biphasic ST-events of the FECG (index) were compared with traces without biphasic events of the FECG. The ability of biphasic events to predict interventions for suspected fetal distress and adverse outcome was assessed using univariable and multivariable logistic regression analyses. Interventions for suspected fetal distress and adverse outcome (defined as presence of metabolic acidosis (i.e. umbilical cord pH <7.05 and base deficit in extracellular fluid >12 mmol), umbilical cord pH <7.00, 5-min Apgar score <7, admittance to neonatal intensive care unit or perinatal death). Although the presence of biphasic events of the FECG was associated with more interventions for fetal distress and an increased risk of adverse outcome compared with cases with no biphasic events, the presence of significant (i.e. intervention advised according to cardiotocography interpretation) biphasic events showed no independent association with interventions for fetal distress [odds ratio (OR) 1.71, 95% confidence interval (CI) 0.65-4.50] or adverse outcome (OR 1.96, 95% CI 0.74-5.24). The presence of significant biphasic events did not discriminate in the prediction of interventions for fetal distress or adverse outcome. Therefore, biphasic events in relation to ST-analysis monitoring during birth should be omitted if future studies confirm our findings. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Sequential monitoring and stability of ex vivo-expanded autologous and non-autologous regulatory T cells following infusion in non-human primates

PubMed Central

Zhang, H.; Guo, H.; Lu, L.; Zahorchak, A. F.; Wiseman, R. W.; Raimondi, G.; Cooper, D. K. C.; Ezzelarab, M. B.; Thomson, A. W.

2016-01-01

Ex vivo-expanded cynomolgus monkey CD4+CD25+CD127− regulatory T cells (Treg) maintained Foxp3 demethylation status at the Treg-Specific Demethylation Region (TSDR), and potently suppressed T cell proliferation through 3 rounds of expansion. When CFSE- or VPD450-labeled autologous (auto) and non-autologous (non-auto) expanded Treg were infused into monkeys, the number of labeled auto-Treg in peripheral blood declined rapidly during the first week, but persisted at low levels in both normal and anti-thymocyte globulin plus rapamycin-treated (immunosuppressed; IS) animals for at least 3 weeks. By contrast, MHC-mismatched non-auto-Treg could not be detected in normal monkey blood or in blood of two out of the three IS monkeys by day 6 post-infusion. They were also more difficult to detect than auto-Treg in peripheral lymphoid tissue. Both auto- and non-auto-Treg maintained Ki67 expression early after infusion. Sequential monitoring revealed that adoptively-transferred auto-Treg maintained similarly high levels of Foxp3 and CD25 and low CD127 compared with endogenous Treg, although Foxp3 staining diminished over time in these non-transplanted recipients. Thus, infused ex vivo-expanded auto-Treg persist longer than MHC-mismatched non-auto-Treg in blood of non-human primates and can be detected in secondary lymphoid tissue. Host lymphodepletion and rapamycin administration did not consistently prolong the persistence of non-auto-Treg in these sites. PMID:25783759

The Austrian radiation monitoring network ARAD - best practice and added value

NASA Astrophysics Data System (ADS)

Olefs, Marc; Baumgartner, Dietmar; Obleitner, Friedrich; Bichler, Christoph; Foelsche, Ulrich; Pietsch, Helga; Rieder, Harald; Weihs, Philipp; Geyer, Florian; Haiden, Thomas; Schöner, Wolfgang

2016-04-01

The Austrian RADiation monitoring network (ARAD) has been established to advance the national climate monitoring and to support satellite retrieval, atmospheric modelling and solar energy techniques development. Measurements cover the downwelling solar and thermal infrared radiation using instruments according to Baseline Surface Radiation Network (BSRN) standards. A unique feature of ARAD is its vertical dimension of five stations, covering an air column between about 200 m a.s.l. (Vienna) and 3100 m a.s.l. (BSRN site Sonnblick). The contribution outlines the aims and scopes of ARAD, its measurement and calibration standards, methods, strategies and station locations. ARAD network operation uses innovative data processing for quality assurance and quality control, applying manual and automated control algorithms. A combined uncertainty estimate for the broadband shortwave radiation fluxes at all five ARAD stations indicates that accuracies range from 1.5 to 23 %. If a directional response error of the pyranometers and the temperature response of the instruments and the data acquisition system (DAQ) is corrected, this expanded uncertainty reduces to 1.4 to 5.2 %. Thus, for large signals (global: 1000 W m-2, diffuse: 500 W m-2) BSRN target accuracies are met or closely met for 70 % of valid measurements at the ARAD stations after this correction. For small signals (50 W m-2), the targets are not achieved as a result of uncertainties associated with the DAQ or the instrument sensitivities. Additional accuracy gains can be achieved in future by additional measurements and corrections. However, for the measurement of direct solar radiation improved instrument accuracy is needed. ARAD could serve as a powerful example for establishing state-of-the-art radiation monitoring at the national level with a multiple-purpose approach. Instrumentation, guidelines and tools (such as the data quality control) developed within ARAD are best practices which could be adopted in other

The Austrian radiation monitoring network ARAD - best practice and added value

NASA Astrophysics Data System (ADS)

Olefs, M.; Baumgartner, D. J.; Obleitner, F.; Bichler, C.; Foelsche, U.; Pietsch, H.; Rieder, H. E.; Weihs, P.; Geyer, F.; Haiden, T.; Schöner, W.

2015-10-01

The Austrian RADiation monitoring network (ARAD) has been established to advance the national climate monitoring and to support satellite retrieval, atmospheric modelling and solar energy techniques development. Measurements cover the downwelling solar and thermal infrared radiation using instruments according to Baseline Surface Radiation Network (BSRN) standards. A unique feature of ARAD is its vertical dimension of five stations, covering an air column between about 200 m a.s.l. (Vienna) and 3100 m a.s.l. (BSRN site Sonnblick). The paper outlines the aims and scopes of ARAD, its measurement and calibration standards, methods, strategies and station locations. ARAD network operation uses innovative data processing for quality assurance and quality control, applying manual and automated control algorithms. A combined uncertainty estimate for the broadband shortwave radiation fluxes at all five ARAD stations indicates that accuracies range from 1.5 to 23 %. If a directional response error of the pyranometers and the temperature response of the instruments and the data acquisition system (DAQ) is corrected, this expanded uncertainty reduces to 1.4 to 5.2 %. Thus, for large signals (global: 1000 W m-2, diffuse: 500 W m-2) BSRN target accuracies are met or closely met for 70 % of valid measurements at the ARAD stations after this correction. For small signals (50 W m-2), the targets are not achieved as a result of uncertainties associated with the DAQ or the instrument sensitivities. Additional accuracy gains can be achieved in future by additional measurements and corrections. However, for the measurement of direct solar radiation improved instrument accuracy is needed. ARAD could serve as a powerful example for establishing state-of-the-art radiation monitoring at the national level with a multiple-purpose approach. Instrumentation, guidelines and tools (such as the data quality control) developed within ARAD are best practices which could be adopted in other

Individual differences in regulatory focus predict neural response to reward.

PubMed

Scult, Matthew A; Knodt, Annchen R; Hanson, Jamie L; Ryoo, Minyoung; Adcock, R Alison; Hariri, Ahmad R; Strauman, Timothy J

2017-08-01

Although goal pursuit is related to both functioning of the brain's reward circuits and psychological factors, the literatures surrounding these concepts have often been separate. Here, we use the psychological construct of regulatory focus to investigate individual differences in neural response to reward. Regulatory focus theory proposes two motivational orientations for personal goal pursuit: (1) promotion, associated with sensitivity to potential gain, and (2) prevention, associated with sensitivity to potential loss. The monetary incentive delay task was used to manipulate reward circuit function, along with instructional framing corresponding to promotion and prevention in a within-subject design. We observed that the more promotion oriented an individual was, the lower their ventral striatum response to gain cues. Follow-up analyses revealed that greater promotion orientation was associated with decreased ventral striatum response even to no-value cues, suggesting that promotion orientation may be associated with relatively hypoactive reward system function. The findings are also likely to represent an interaction between the cognitive and motivational characteristics of the promotion system with the task demands. Prevention orientation did not correlate with ventral striatum response to gain cues, supporting the discriminant validity of regulatory focus theory. The results highlight a dynamic association between individual differences in self-regulation and reward system function.

How to select a continuous emission monitoring system

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

Radigan, M.J.

1994-02-01

Selecting a continuous emission monitoring system (CEMS) involves more than picking an analyzer. Successful CEMS interface sampling and data-management systems to produce accurate, reliable reports required by regulatory agencies. Following objective guidelines removes some of the misery from CEMS shopping. However, prospective CEMS buyers should do their homework and develop well-thought-out, detailed specification for the processes' sampling criteria. Fine tuning the analyzer/data management system can eliminate maintenance costs and keep the facility operating within its permit restrictions.

75 FR 4596 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 20, 2010, Financial Industry... deletions are in brackets: * * * * * 4000. FINANCIAL AND OPERATIONAL RULES * * * * * 4500. BOOKS, RECORDS...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

77 FR 7972 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... Prison Rape (Reg Plan Seq No. 85). References in boldface appear in The Regulatory Plan in part II of... 396. National Standards to Prevent, Detect, and Respond to Prison Rape Regulatory Plan: This entry is...

Aircraft signal definition for flight safety system monitoring system

NASA Technical Reports Server (NTRS)

Gibbs, Michael (Inventor); Omen, Debi Van (Inventor)

2003-01-01

A system and method compares combinations of vehicle variable values against known combinations of potentially dangerous vehicle input signal values. Alarms and error messages are selectively generated based on such comparisons. An aircraft signal definition is provided to enable definition and monitoring of sets of aircraft input signals to customize such signals for different aircraft. The input signals are compared against known combinations of potentially dangerous values by operational software and hardware of a monitoring function. The aircraft signal definition is created using a text editor or custom application. A compiler receives the aircraft signal definition to generate a binary file that comprises the definition of all the input signals used by the monitoring function. The binary file also contains logic that specifies how the inputs are to be interpreted. The file is then loaded into the monitor function, where it is validated and used to continuously monitor the condition of the aircraft.

Diagnostic monitor for carbon fiber processing

DOEpatents

Paulauskas, Felix L.; Bigelow, Timothy S.; Meek, Thomas T.

2002-01-01

A method for monitoring characteristics of materials includes placing a material in an application zone, measuring a change in at least one property value of the application zone caused by placing the material in the application zone and relating changes in the property value of the application zone caused by the material to at least one characteristic of the material An apparatus for monitoring characteristics of a material includes a measuring device for measuring a property value resulting from applying a frequency signal to the application zone after placing a material in the application zone and a processor for relating changes in the property value caused by placement of the material in the application zone to at least one desired characteristic of the material. The application zone is preferably a resonant cavity.

Heliospheric Modulation Strength During The Neutron Monitor Era

NASA Astrophysics Data System (ADS)

Usoskin, I. G.; Alanko, K.; Mursula, K.; Kovaltsov, G. A.

Using a stochastic simulation of a one-dimensional heliosphere we calculate galactic cosmic ray spectra at the Earth's orbit for different values of the heliospheric mod- ulation strength. Convoluting these spectra with the specific yield function of a neu- tron monitor, we obtain the expected neutron monitor count rates for different values of the modulation strength. Finally, inverting this relation, we calculate the modula- tion strength using the actually recorded neutron monitor count rates. We present the reconstructed annual heliospheric modulation strengths for the neutron monitor era (1953­2000) using several neutron monitors from different latitudes, covering a large range of geomagnetic rigidity cutoffs from polar to equatorial regions. The estimated modulation strengths are shown to be in good agreement with the corresponding esti- mates reported earlier for some years.

Biological monitoring and standard setting in the USA: a critical appraisal.

PubMed

Rappaport, S M

1995-05-01

Occupational exposure limits (OELs) issued in the US by the Occupational Safety and Health Administration (OSHA) require measurements of toxic substances in air rather than in biological samples. Most of OSHA's limits were adopted from the 1968 list of the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLVs). Although there are no formal requirements to monitor exposures to these substances, it is implicit in the standards that air sampling will be performed. Of the 13 OELs which OSHA has set de novo, 2 (i.e., those for lead and cadmium) require biomonitoring after air sampling has identified the heavily exposed workers. OSHA appears to value biomonitoring in some circumstances but has apparently not found a consistent rationale for using biomarkers to set and enforce its standards. This paper discusses 2 valuable features of biomarkers which should be exploited by OSHA to further its regulatory agenda. The first relates to controversies associated with dose rate which have come into play in setting short-term exposure limits (STELs) when acute effects do not provide the necessary justification. OSHA has not provided evidence that its STELs are needed to reduce the risks of disease (as in the cases of benzene and ethylene oxide). By investigating the exposure-biomarker relationship, it is possible to determine whether the rate of exposure has any influence on the uptake and elimination of toxic substances and, therefore, whether STELs is needed. This is illustrated with data from 2 studies on styrene exposure. The second feature concerns biomonitoring as the primary means of exposure assessment in situations where the biomarker is accumulated over months or years (as in the cases of lead and cadmium). Using data from the lead-battery industry, it is shown that 'correct' compliance decisions are more likely to arise from evaluation of blood lead measurements than from traditional air monitoring.

40 CFR 63.2163 - If I monitor fermenter exhaust, what are my monitoring installation, operation, and maintenance...

Code of Federal Regulations, 2010 CFR

2010-07-01

...-accuracy test PS 8 requires. (3) If you continuously monitor VOC emissions using gas chromatography, you... percent of the span value (or more than 10 percent of the calibration gas value if your CEMS is a gas... calibration drift exceeds 5 percent of the span value (or more than 20 percent of the calibration gas value...

40 CFR 63.2163 - If I monitor fermenter exhaust, what are my monitoring installation, operation, and maintenance...

Code of Federal Regulations, 2011 CFR

2011-07-01

...-accuracy test PS 8 requires. (3) If you continuously monitor VOC emissions using gas chromatography, you... percent of the span value (or more than 10 percent of the calibration gas value if your CEMS is a gas... calibration drift exceeds 5 percent of the span value (or more than 20 percent of the calibration gas value...

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

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

76 FR 61124 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-03

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65408; File No. SR-FINRA-2011-049] Self...)(1). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule.... Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule...

Double phosphorylation of the myosin regulatory light chain during rigor mortis of bovine Longissimus muscle.

PubMed

Muroya, Susumu; Ohnishi-Kameyama, Mayumi; Oe, Mika; Nakajima, Ikuyo; Shibata, Masahiro; Chikuni, Koichi

2007-05-16

To investigate changes in myosin light chains (MyLCs) during postmortem aging of the bovine longissimus muscle, we performed two-dimensional gel electrophoresis followed by identification with matrix-assisted laser desorption ionization time-of-flight mass spectrometry. The results of fluorescent differential gel electrophoresis showed that two spots of the myosin regulatory light chain (MyLC2) at pI values of 4.6 and 4.7 shifted toward those at pI values of 4.5 and 4.6, respectively, by 24 h postmortem when rigor mortis was completed. Meanwhile, the MyLC1 and MyLC3 spots did not change during the 14 days postmortem. Phosphoprotein-specific staining of the gels demonstrated that the MyLC2 proteins at pI values of 4.5 and 4.6 were phosphorylated. Furthermore, possible N-terminal region peptides containing one and two phosphoserine residues were detected in each mass spectrum of the MyLC2 spots at pI values of 4.5 and 4.6, respectively. These results demonstrated that MyLC2 became doubly phosphorylated during rigor formation of the bovine longissimus, suggesting involvement of the MyLC2 phosphorylation in the progress of beef rigor mortis. Bovine; myosin regulatory light chain (RLC, MyLC2); phosphorylation; rigor mortis; skeletal muscle.

Responsibilities of regulatory agencies in the marketing of antimicrobials.

PubMed

Grein, K

2012-04-01

The regulatory agencies' main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respectto antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.

Quaternion Based Thermal Condition Monitoring System

NASA Astrophysics Data System (ADS)