Regulatory Definition Research Articles

THE ABILITY OF OLDER WORKERS WITH IMPAIRMENTS TO ADAPT TO NEW JOBS: CHANGING THE AGE CRITERIA FOR SOCIAL SECURITY DISABILITY INSURANCE

AbstractMany applications for Social Security Disability Insurance cannot be evaluated based on medical criteria alone. In specific cases, the current regulatory structure dictates that applicants who can no longer do past jobs are expected to adapt to new jobs up to the age of 55, but not after. As the proportion of these cases has grown and life expectancy among beneficiaries has increased, policymakers have considered whether expectations for adapting to new jobs above age 55 should be adjusted. Some recent reform proposals call for increasing the age cutoffs in the regulations. Although prior research predicts reduced program costs, the capacity of potentially affected applicants to continue working is unclear. Filling this gap, we evaluate the work capacity of applicants above age 55 using an instrumental variables strategy. Our estimates indicate that, for applicants on the margin of allowance, at most an additional 11.2 percent would work above the regulatory definition of meaningful employment (known as Substantial Gainful Activity) in the absence of Disability Insurance benefits. We explore the implications for adapting to new jobs above age 55 under the proposed policy regime.

Legal and practical challenges in classifying nanomaterials according to regulatory definitions.

The European Union (EU) has adopted nano-specific provisions for cosmetics, food and biocides, among others, which include binding definitions of the term "nanomaterial". Here we take an interdisciplinary approach to analyse the respective definitions from a legal and practical perspective. Our assessment reveals that the definitions contain several ill-defined terms such as "insoluble" or "characteristic properties" and/or are missing thresholds. Furthermore, the definitions pose major and so far unsolved analytical challenges that, in practice, make it nearly impossible to classify nanomaterials according to EU regulatory requirements. An important purpose of the regulations, the protection of human health and the environment, may remain unfulfilled and the development of innovative applications of nanomaterials may be facing a path full of (legal) uncertainties. Based on our findings, we provide five recommendations for a more coherent and practical approach towards the regulation of nanomaterials.

Comparative bioavailability study of phenytoin in healthy Nepalese volunteers

Our study aimed to assess and compare the bioavailability of Eptoin 100 mg and Epileptin 100mg tablets in Nepalese healthy volunteers. A randomized, two-treatment cross-over study with two weeks’ wash-out period was conducted in 12 healthy non-smoker and non-alcoholic Nepalese male volunteers over a period of 6 months in the department of Clinical Pharmacology and Therapeutic at B. P. Koirala Institute of Health Sciences, Dharan, Nepal after approval from the Institutional Review Committee. The participants were randomized using sealed envelope system and received a single 100 mg oral tablet of either of the formulations with a two week washout period. Blood samples were collected predose and at regular intervals postdose upto 72 hours. Plasma phenytoin levels were estimated by reverse phase high performance liquid chromatography. The analytical method was validated prior to the start of study. Cmax (Peak Plasma Concentration), Tmax (Time to achieve maximum Plasma Concentration), AUC0-72 (Area under plasma concentration time curve 0 to 72 hours), AUC0-∞ (Area under plasma concentration time curve 0 to ∞) and T½ (Elimination half-life) and Kel (Elimination rate constant) were calculated and 80-120% margin (90% confidence interval) was used to assess bioequivalence. ANOVA test was used to analyze the data at P-value of 0.05. All volunteers completed the study. The log-transformed values of Cmax, Tmax, AUC0-t, and AUC0-∞ of the both formulations were within the specified limits and were bioequivalent according to the regulatory definition of bioequivalence based on the rate and extent of absorption. Both products can be considered equally effective in medical practice.
 Keywords: Bioavailability, Bioequivalence, healthy volunteer, Nepal, phenytoin sodium.

НОРМАТИВНОЕ ОПРЕДЕЛЕНИЕ ОФИЦИАЛЬНОГО ДОКУМЕНТА КАК ПРОБЛЕМА ЮРИДИЧЕСКОЙ ФОРМЫ ПРАВООТНОШЕНИЙ

НОРМАТИВНОЕ ОПРЕДЕЛЕНИЕ ОФИЦИАЛЬНОГО ДОКУМЕНТА КАК ПРОБЛЕМА ЮРИДИЧЕСКОЙ ФОРМЫ ПРАВООТНОШЕНИЙ

Problems of regulatory definition of particular kinds of a punishments, which are alternative to imprisonment

Problems of regulatory definition of particular kinds of a punishments, which are alternative to imprisonment

TYPES OF INCENTIVES FOR THE NATIONAL POLICE OF UKRAINE

Work is everyone’s right. The content of which is the ability of each person to earn a living by work, which he freely selects or freely agrees. Employees of the National Police of Ukraine are a rather “complex” category of workers, due to the specific nature of their activity. It is clear that their job functions are significantly different from the duties of ordinary workers, as are the differences and their rights. In addition, as well as any employee, police officers have the right to be promoted (which also has certain differences). In the modern period of development of Ukrainian society, when extensive socio-economic and political transformations are taking place in the country, the problem of incentives becomes especially relevant. At the same time, the widespread use by the legislator of the dispositive method of legal regulation creates the preconditions for the active and creative use by the subjects of the right given to them the opportunities to achieve the desired legal result on their own, which in modern conditions can and should be ensured by the wider use of such legal means as promotion measures. Encouragement is a positive stimulating influence of subjects (official, body, etc.) on the needs, interests, consciousness, will, behavior of employees, and therefore on the result of their work. The promotion is legal and must be timely, meaningful, and meaningful. It is worth noting that the basis for applying the promotion is their direct prediction and definition in the relevant normative act: Labor Code of Ukraine, rules of internal labor regulations that apply to a particular enterprise, institution, organization, regulations, charters, employment contract. Therefore, the legal basis for the application of incentives is the regulatory definition of such a possibility in a specific legal act. During the analysis of the scientific literature, a study was conducted that focused on identifying and disclosing the types of incentives for employees of the National Police of Ukraine. Analyzes of scientific opinions are conducted, which reveal the main features of legal incentives, analyze the views of scientists on the classification of incentives as a whole, identify the aspects by which the classification of incentives that apply to police, investigate the incentives set by law, for law enforcement. Keywords: promotion, employee, National Police of Ukraine, service relations, police officer, labor relations.

State Conservation Efforts of Seasonal Wetlands along the Mississippi River

Since a 2001 US Supreme Court decision that permanently altered the federal protection of non-navigable waters, scientists and policy-makers have struggled to determine whether state agencies are conserving wetlands and which wetlands no longer receive protection. Subsequent court cases have also made protection of non-navigable waters difficult as the regulatory definition of “navigable waters” continues to change. This study compares regulations and the administrative actions of ten states along the Mississippi River corridor to protect and conserve isolated wetlands. It uses GIS methodology to determine differences in wetland area change for a twenty-year period, and compares past and recent wetland destruction and wetland buffer zone loss using nationally established Land Use/Land Cover (LULC) categories. The results show that conservation of the wetlands and buffer zones have only been successful in places where agricultural area or urban sprawl did not statistically increase. The findings indicate that some biological functions and ecological values of federal wetlands have been conserved by a few state agencies and local governments that have clarified the regulations about small, ephemeral, and seasonal wetlands. The study highlights the need for trustworthy data for sensitive or at risk wetlands so that conservation stakeholders have robust evidence for developing appropriate mitigation policies and implementation strategies.

The Legal Challenges of Unmanned Ships in the Private Maritime Law: What Laws Would You Change?

Maritime law is in many ways a traditional area of law, were traditions are not easily discarded. Even so, maritime law has over the years proved itself flexible and able to adapt to new phenomena. Recent technological developments indicate that the concept of unmanned cargo vessels could be a reality in the near future. This paper aims to tackle the following objectives. Firstly, is the unmanned ship, with no captain or crew on board, still a ship? Numerous conventions dealing with private or public maritime law are applicable to seagoing vessels, and either apply their own definitions or do not provide any definition. National maritime laws give an equally heterogeneous picture. It may be concluded with a considerable degree of certainty that having a crew on board, including a master, is not generally regarded as an essential part of the notion of a ship in the regulatory definitions of the ship. The second part of this paper aims to give an overview of the seaworthiness understanding. To begin with, is the unmanned ship, with no captain or crew on board, still a seaworthy ship? By way of methodology, this research’s scope embraces the concept of seaworthiness under the Carriage of Goods Conventions and our Spanish Maritime Navigation Act. A particular focus is given to the human element as a significant aspect of seaworthiness. This part will come to the conclusion that the current legal framework considers the ship’s crew as a prerequisite to qualify a ship as seaworthy, but is still necessary a “ship’s crew” on board the ship? Finally, we will briefly look at how the unmanned vessel will affect private maritime law, including transportation of goods at sea, chartering of vessels and marine insurance. Issues concerning liability will have to be considered and dealt with in a number of areas, including the aforementioned concept of seaworthiness for the carriage of goods by sea, the concept of duty of care with respect to collisions, salvage operations, limitations of liability for maritime claims or the particular provisions concerning the liability of the master. Additionally, the IMO is now putting the issue of autonomous ships on the agenda, so the work to review the legal implications of the unmanned vessel on existing international maritime law regulatory framework is underway. However, maritime law appears to be relatively well armed for the introduction of unmanned (either remotely operated or autonomous) merchant ships. Most existing public and private maritime law (and law of the sea) can in principle still be applied. A systematized study of the unmanned ship’s incidence on legal issues (apart from operational ones) is necessary, but it will mean that, as in extraordinary cases takes place, the Law will be ahead of the technology.

КРИПТОВАЛЮТА КАК АБСТРАКТНОЕ ОБЯЗАТЕЛЬСТВО И УСЛОВИЕ ЭМИССИИ БАНКОМ КРЕДИТНЫХ ДЕНЕГ

Formulation of the problem. The article is devoted to a comparative analysis of the essence of cryptocurrency and fiduciary money in the context of the historical prerequisites for the emergence of an abstract obligation as a condition for issuing credit money. The aim of the research is to characterize the cryptocurrency as an abstract obligation and condition for the issuance of credit money by the bank. The object of the research is the process of forming cryptocurrency as an abstract obligation and the conditions for issuing credit money by a bank. The methods used of the research: logical, comparison, modeling, induction and dudection methods. The hypothesis of the research. Cryptocurrency does not have the universal property of measuring the value of economic goods, as it is a passive measured object. To assess the beneficial effects of market benefits in the international market, hard money is needed. The statement of basic materials. Money in the article is presented not as universal unconditional bank obligations and requirements for repayment, but as a “number in the database”. Bank operations are reduced to keeping money for someone who essentially increases the number in the database, debiting and crediting it and making a payment. Originality and practical significance of the research consists in substantiating the miner who produces cryptocurrency as a digital commodity asset for sale in the commodity market. The identification of the economic nature of cryptocurrency is relevant for the purposes of its legal legalization in the economy of Belarus and the search for its adequate legal and regulatory definition in the legal system. Conclusions of the research. Credit money is used in the deferred payment function. At the same time, physical movement of inventories between subjects is not necessary, since property rights are moving in the form of universal unconditional financial requirements and obligations.

Use of Wearable, Mobile, and Sensor Technology in Cancer Clinical Trials.

As the availability and sophistication of mobile health (mHealth) technology (wearables, mobile technology, and sensors) continues to increase, there is great promise that these tools will be transformative for clinical trials and drug development. This review provides an overview of the current landscape of potential measurement options, including the various types of data collected, methods/tools for collecting them, and a crosswalk of available options. The opportunities and potential drawbacks of mHealth in cancer clinical trials are discussed. Specific concerns related to data accuracy, provenance, and regulatory issues are highlighted, with suggestions for how to address these in future research. Next steps for establishing mHealth methods and tools as legitimate and accepted measures in oncology clinical trials include continuation of regulatory definition by the FDA; establishment of security standards and protocols; refinement and implementation of methods to establish and document data accuracy; and finally, creation of feedback loops wherein regulators receive updates from researchers with better and more timely data, which should decrease trial times and lessen drug development costs. Implementing mHealth technologies into cancer clinical trials has the potential to transform and propel oncology drug development and precision medicine to keep pace with the rapidly increasing developments in genomics and immunology.

Energy or carbon? Exploring the relative size of universal zero carbon and zero energy design spaces

One aim of zero carbon, or zero energy, buildings is to help slow climate change. However, regulatory definitions frequently miss substantial emissions, for example ones associated with the materials the building is constructed from, thereby compromising this goal. Unfortunately, including such emissions might restrict the design space, reduce architectural freedom or greatly increase costs. This work presents a new framework for examining the problem. The zero carbon/energy design and regulatory space forms a sub-space of the hyper-volume enclosing all possible designs and regulatory frameworks. A new mathematical/software environment was developed which allows the size and shape of this sub-space to be investigated for the first time. Twenty-four million building design/regulatory standard combinations were modelled and assessed using a tree classification approach. It was found that a worldwide zero standard that includes embodied emissions is possible and is easier to achieve if a carbon rather than an energy metric is adopted, with the design space twice the size for a carbon metric. This result is important for the development of more encompassing regulations, and the novel methods developed applicable to other aspects of construction controlled by regulation where there is the desire to examine the impact of new regulations prior to legislation. Practical application: As energy standards become more strict, and given the growth in non-regulatory standards (such as Passivhaus), there is the need to study the potential impact of any element of a standard on the range of designs that can be built or the materials that can be used. This work sets out a general framework and method for doing this. The approach and results will be of interest to policy makers, but also to engineers and architects wondering what the key constraints to design the adoption of various philosophies to low energy/carbon standards might have within their work. For example, the implications of the building standard (or client) requiring embodied emissions to be included or the energy balance period for renewable generation to be monthly, not annual.

Medical Nutrition Terminology and Regulations in the United States and Europe—A Scoping Review: Report of the ISPOR Nutrition Economics Special Interest Group

BackgroundThe term medical nutrition (MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN. ObjectivesAscertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued. MethodsISPOR’s Nutrition Economics Special Interest Group conducted a scoping review of scientific literature on European and US MN terminology and regulations, published between January 2000 and August 2015, and pertinent professional and regulatory Web sites. Data were extracted, reviewed, and reconciled using two-person teams in a two-step process. The literature search was updated before manuscript completion. ResultsOf the initial 1687 literature abstracts and 222 Web sites identified, 459 records were included in the analysis, of which 308 used MN terms and 100 provided definitions. More than 13 primary disease groups as per International Classification of Disease, Revision 10 categories were included. The most frequently mentioned and defined terms were enteral nutrition and malnutrition. Less than 5% of the records referenced any MN regulation. The health economic impact of MN was rarely and insufficiently (n = 19 [4.1%]) assessed, although an increase in economic analyses was observed. ConclusionsMN terminology is not consistently defined, relevant European and US regulations are rarely cited, and economic evaluations are infrequently conducted. We recommend adopting consensus MN terms and definitions, for example, the European Society for Clinical Nutrition and Metabolism consensus guideline 2017, as a foundation for developing reliable and standardized medical nutrition economic methodologies.

The Contract Dispute Act's Statute of Limitations

The Contract Dispute Act's Statute of Limitations

Does energy efficiency matter to real estate-consumers? Survey evidence on willingness to pay from a cost-optimal analysis in the context of a developing country

In most countries, energy efficiency at the residential level has been largely delegated to the dynamics of real-estate markets after setting a minimum level. This regulatory definition is in certain cases supplemented by energy performance certificates, such as in the case of the European Union. This approach is based on the understanding that avoided energy-consumption costs positively affect the willingness to pay for them, thus leading to higher prices capable of offsetting production costs and thereby encouraging developers. The case of the private housing market in Santiago de Chile was selected as a reference for a developing country in which energy performance certificates, although they exist as an instrument, are not required to be applied in property transactions. However, unlike most of the research performed in developed countries, it is difficult to analyse price formation using methods based on observed preferences in areas in which there are few energy-certified buildings. Using the technique of contingent valuation, such as the method based on stated preferences, enables one to overcome this difficulty. This article investigates willingness to pay for improvements in the energy efficiency of buyers for new homes based on a representative investment/operation cost analysis. This approach has been addressed to open the debate on the convenience of modifying the national construction code and rethinking the energy certification scheme as well as an exploratory study to undercover further research lines to support the aforementioned discussion. The results suggests that there is a number of potential home buyers ready to pay for energy efficiency when they are informed on the cost savings associated to structural modifications and the cost of providing such improvements and such willingness to pay is not monolithic across the respondents, but seems to be influenced by the education level plausibly associated to the purchase power.

Girls’ Work in a Rural Intercultural Setting

In this article I explore the meaning of work for girls in rural northeastern Argentina as formative experience that forges their identity as peasants in the contemporary world. Based on ethnographic research conducted from 2008 to the present in rural areas of San Ignacio (Misiones), I examine, from the perspective of regulatory definitions regarding children’s work, the ways in which young girls gradually participate in the social reproduction of families. Girls’ participation in these activities should not be romanticized as part of a socialization process, but, rather, critically considered as formative experience in which class, age, gender, and ethnic distinctions define certain tasks as girls’ peasant skills. Using data from participant observations made on three farms, I show how girls have an active role in the appropriation of knowledge through shared activities with boys, although such learning is overshadowed by the prevailing socio-historic construct of male dominance.

Do jobs matter more than nations? Cultural constraints on organizational performance

PurposeThe purpose of this paper is to introduce new perspectives on the job position analysis practice rooted in the traditional person-job fit approach. It highlights selected theoretical assumptions and the case of a company challenged by hidden cultural constraints on the work environment. The author attempts to show how human resources management may benefit from incorporating the aspect of cultural traits in job position analysis. Next, the author provides a regulatory definition of a job position culture, followed by practical guidelines to facilitate a better person-job fit across various work environments.Design/methodology/approachThe paper opts for a conceptual contribution by introducing a new term “job position culture” as, companies are challenged by new management difficulties when creating universal job position descriptions and a better person-job fit. The paper highlights the need of including additional, cultural aspects of the work environment to better manage organizational change.FindingsThe paper shows how cultural traits could be implemented in human resources management such as recruitment and selection, as well as efficient job position management. A regulatory definition of job position culture is proposed, and some practical implications for a more complete organizational change management in job cultures.Research limitations/implicationsThe regulatory definition for the job position culture, presented in the paper, is at the preliminary and theoretical stage. It requires being operationalized and implemented it in each job analysis case.Practical implicationsThe new, cultural perspective on the job analysis may serve for the more adequate fit of personnel to the work environment and better manage organizational change including distinct job cultures.Social implicationsThe cultural perspective on a job analysis may serve a more adequate fit and work satisfaction of workers resulting in job attachment and better work performance.Originality/valueThe paper shows the need to study additional work environment traits on the bases of the regulatory definition of job position culture.

PHP143 - Do Words Matter? Patient Perspetives on Conceptually Similar Symptoms and Impacts Frequently Utilized in Patient-Reported Outcome (PRO) Measures

Patients often use a variety of words to describe similar disease experiences, leading to challenges during analysis and concept selection for patient-reported outcome (PRO) measures. This study aimed to determine if conceptually similar symptoms and impacts are defined as the same or different among patients with different diseases. 400 subjects were sampled 1:1:1:1 across four disease areas: diabetes, chronic obstructive pulmonary disease, depression, and osteoarthritis. Recruitment employed population sampling methods in Boston, MA. Eligible participants were screened to confirm diagnosis. Participants were presented with 14 pairs of conceptually similar symptoms and impacts and asked to indicate if the concepts were the same or different. A total of 419 subjects were enrolled, with n=104 for all disease groups except depression (n=107). More than two-thirds of the sample identified “annoyed” and “irritated” (87.3%), “tired” and “fatigued” (86.3%), “irritated” and “aggravated” (82.2%), “frustrated” and “aggravated” (75.9%), and “sad” and “depressed” (67.7%) as conceptually the same. The only words categorized as different by more than two-thirds of the sample were “not confident” and “embarrassed” (80.8%). Subjects did not provide definitive responses (i.e., no group achieved two thirds agreement in either direction) for the remaining pairs. Results showed little variation across disease groups. Words patients use to describe disease concepts do not always align with clinical and regulatory definitions. As patients use words interchangeably, concept-level analysis can help narrow the selection of items and produce more concise questionnaires. The homogeneity of results across disease groups suggests that patients’ vocabulary is not impacted by the underlying disease state (e.g., a depressed patient is as likely to report “sad” and “depressed” as conceptually the same as a non-depressed patient). For words identified as conceptually the same, factors like readability or translatability should be considered and perhaps prioritized when selecting language used in PRO measures.

NUTRACEUTICALS - A REGULATORY REVIEW

The Nutraceuticals are the emerging sector in the Pharma Industry. As people are more and more concerned about their health and diseases caused by the malnutrition, the growth of the Nutraceuticals worldwide are inevitable. Despite of the growth and the need of the Nutraceuticals by global market there is no apparent regulatory definitions and pathways or procedures for the approval process of Nutraceuticals. The article deals with the regulatory perspective of Nutraceuticals.

Redefining environmental nanomaterial flows: consequences of the regulatory nanomaterial definition on the results of environmental exposure models

This article shows the influence of the nanomaterial definition on the estimation of the mass transfers of nanomaterials into the environment.

Low rates of patient-reported outcome claims for orphan drugs approved by the us food and drug administration

ABSTRACTBackground: Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs’ benefits and risks.Objective: We sought to assess the usage of patient-reported outcome (PRO) claims in a comprehensive set of US FDA orphan drug approvals dated between 1/1/2012 and 31/12/2016, and characterize them.Study design: Orphan drug approval documentation was obtained from the US FDA website. Drug Package Inserts (PI) were analyzed to extract information on PRO-related language.Results: Among 178 drugs that met inclusion criteria, 16 (9%) products approved for 16 orphan indications contained PRO language in the Clinical Studies section of the PI. All PRO instruments concerned disease symptoms, and two also referred to patient functioning. The most common PRO instrument was a bleed-specific rating scale for four products approved for the treatment or prevention of bleeding episodes in patients with genetic bleeding disorders.Conclusions: There is a need to implement public incentives for academic development of PRO instruments for rare conditions and for regulatory policies that mandate the collection of PRO endpoints in pivotal trials of orphan drugs.