Medical devices; neurological devices; classification of repetitive transcranial magnetic stimulation system. Final rule

The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.     

Cardiovascular devices; classification of electrocardiograph electrodes. Final rule

The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.     

Artenschutz im Gentechnikrecht Zugleich zu Problemen von Effektivit?t, Demokratie und Abw?gung im Gentechnikrecht

Der vorliegende Beitrag widmet sich der Frage, ob und inwiefern den Belangen des Artenschutzes im Rahmen der geltenden Vorschriften beim Anbau gentechnisch ver?nderter Pflanzen angemessen Geltung verschafft werden kann. Besch?ftigte sich der Beitrag in NuR 2011, Heft 2 mit dem Artenschutzrecht, nimmt der vorliegende Beitrag das Gentechnikrecht – und das Verh?ltnis von Gentechnikrecht und Artenschutzrecht zueinander in ihren jeweiligen artenschutzbezogenen Vorgaben – n?her in den Blick. Dabei kommen auch Verfassungsprobleme des subkutanen Vorrangs der grünen Gentechnik in den Blick. Sie beziehen sich auf das Demokratieprinzip, den Gesetzesvorbehalt und die vermeintliche grundrechtliche Beweislastverteilung zugunsten der Gentechnik in Bezug auf unsichere naturwissenschaftliche Tatsachenfragen – und damit auf eine Sto?richtung, die (auch) dem BVerfG bisher eher entgangen ist.     

Spatially offset Raman spectroscopy (SORS) for the analysis and detection of packaged pharmaceuticals and concealed drugs

Spatially offset Raman spectroscopy (SORS) is a powerful new technique for the non-invasive detection and identification of concealed substances and drugs. Here, we demonstrate the SORS technique in several scenarios that are relevant to customs screening, postal screening, drug detection and forensics applications. The examples include analysis of a multi-layered postal package to identify a concealed substance; identification of an antibiotic capsule inside its plastic blister pack; analysis of an envelope containing a powder; and identification of a drug dissolved in a clear solvent, contained in a non-transparent plastic bottle. As well as providing practical examples of SORS, the results highlight several considerations regarding the use of SORS in the field, including the advantages of different analysis geometries and the ability to tailor instrument parameters and optics to suit different types of packages and samples. We also discuss the features and benefits of SORS in relation to existing Raman techniques, including confocal microscopy, wide area illumination and the conventional backscattered Raman spectroscopy. The results will contribute to the recognition of SORS as a promising method for the rapid, chemically specific analysis and detection of drugs and pharmaceuticals.     

Prevalence and correlates of physical spousal violence against women in slum and nonslum areas of urban Bangladesh

This study explores the prevalence and correlates of past-year physical violence against women in slum and nonslum areas of urban Bangladesh. The authors use multivariate logistic regression to analyze data from the 2006 Urban Health Survey, a population-based survey of 9,122 currently married women aged between 15 and 49 who were selected using a multistage cluster sampling design. The prevalence of reported past-year physical spousal violence is 31%. Prevalence of past-year physical spousal violence is higher in slums (35%) than in nonslums (20%). Slapping/arm-twisting and pushing/shaking/ throwing something at the women are the most commonly reported acts of physical abuse. Multivariate analysis shows that the risk of physical spousal abuse is lower among older women, women with post-primary education, and those belonging to rich households and women whose husbands considered their opinion in decision making. Women are at higher risk of abuse if they had many children, believe that married woman should work if the husband is not making enough money, and approve wife-beating norms. This study serves to confirm the commonness of physical spousal abuse in urban Bangladesh, demonstrating the seriousness of this multifaceted phenomenon as a social and public health issue. The present findings suggest the need for comprehensive prevention and intervention strategies that capitalize on the interplay of individual and sociocultural factors that cause physical spousal violence. Our study adds to a growing literature documenting domestic violence against women in urban areas of developing south Asian nations.     

Vorauseilender Gehorsam? Zur Begründung der Zuständigkeit des Umweltsenats qua Vorrang des Unionsrechts

Nach Auffassung des VwGH verlangt das Unionsrecht, dass der Umweltsenat auch über Berufungen in Umweltvertr?glichkeitsprüfungsverfahren für Bundesstra?en und Eisenbahn-Hochleistungsstrecken entscheidet. Um zu diesem Schluss zu gelangen, musste der VwGH in seinem Beschluss vom 30. September 2010 zum einen von einem unionsrechtlich determinierten Gebot ausgehen, dass einem nachprüfenden Gericht in Umweltvertr?glichkeitsprüfungsverfahren volle Tatsachenkognition zukommt (und somit eine Beschwerdem?glichkeit an den VwGH nicht ausreicht). Zum anderen musste der VwGH den Vorrang des Unionsrechts dahingehend deuten, dass sekund?res Unionsrecht auch zust?ndigkeitsbegründend wirken kann und sich nicht darin ersch?pft, zust?ndigkeitshemmendes innerstaatliches Recht zu verdr?ngen. Da beide Annahmen aus unionsrechtlicher Sicht eine substantiierte Untermauerung vermissen lassen, w?re der VwGH nach der hier vertretenen Auffassung verpflichtet gewesen, den EuGH im Rahmen eines Vorabentscheidungsverfahrens anzurufen.     

首屆“中國法治政府奬”綜述

由中國政法大學法治政府研究院發起設立的"中國法治政府奬"自2010年3月12日正式啟動,至2011年1月15日舉行評選暨頒奬典禮並最終評選出8個"中國法治政府奬"和7個"中國法治政府奬提名奬"。     

EARLY INTERVENTION IN NEW ZEALAND FAMILY COURT CASES

In April 2010 the New Zealand Family Court introduced the National Early Intervention Process (NEIP) to diversify its previous unitary dispute resolution pathway into two tracks (standard and urgent). A “triage” model is now in use to assess and assign cases appropriately. This article outlines the key milestones in the Family Court's 30‐year history which have led to this new initiative to reduce delays and help avoid the escalation of family conflicts over the care of children into bitter and intractable disputes. NEIP represents the most overarching reform of the Family Court since the Court's inception in 1981.     

PARENTING AND CRIME: AN EVIDENCE‐BASED REVIEW WITH IMPLICATIONS FOR THE NEW ZEALAND FAMILY AND YOUTH COURT

This article explores the effect parenting can have on child development. It considers child attachment theory, various parenting styles, and specific child and family factors that contribute to a child's social and emotional development. The article concludes that good parenting and good outcomes for children do not happen by chance. The foundation must be planned and made secure.