State Regulatory Agencies Research Articles

НЕОБХОДИМОСТЬ ВОВЛЕЧЕНИЯ ПОТРЕБИТЕЛЕЙ В СИСТЕМУ ФАРМАКОНАДЗОРА СТРАН ЕАЭС

One of the indicators of the effectiveness of the pharmacovigilance system is the number and quality of spontaneous reports of cases of adverse reactions (AR). It is important to receive spontaneous reports from both medical and pharmaceutical workers and from drug users in order to assess the true nature of the adverse reaction. This article discusses the problems of a limited number of spontaneous reports from patients and low awareness of the population on the safety and effectiveness of drugs in the countries of the Eurasian Economic Union (EAEU). The aim of this article was to analyze the attitude of drug users to the submission of spontaneous reports of adverse reactions to medications. To achieve this aim, a sociological study was conducted based on a survey of drug users. The study involved 800 drug users. This study found that in the EAEU countries, patients face adverse reactions or lack of effectiveness of therapy, but unlike the Russian Federation, consumers of the Republics of Belarus, Armenia and the Kyrgyz Republic don’t report this information to state regulatory authorities, pharmacy organizations, or manufacturers of medicines. Less than 20% of respondents know about filling out a notice of an adverse reaction or lack of therapeutic effect of a drug on the Roszdravnadzor website. In our opinion, the involvement of drug users in the spontaneous reporting system has many advantages and can help solve the current problem of underestimating data on adverse reactions.

STATE GOVERNANCE FOR UKRAINE’S GROWTH AND DEVELOPMENT: TRADE ASPECT

The quality of a country’s governance and public administration is a key factor in its economic performance and the well-being of its citizens. The objective of the paper is two-fold: first, to substantiate the importance of the good and strong state governance for efficient functioning of the national economy; second, to analyze the basic indicators of Ukraine’s economy and its foreign trade, as well as to come up with the possible solutions to the identified problems. Methodology. Careful reading and examination of the conclusions made in theoretical and empirical works on state governance and government regulation by the Ukrainian and foreign scholars served the basis of the research at the initial stage. The data, taken from the official site of the State Statistics Service of Ukraine, served as the information source for using various methods, e.g.: mathematical, statistical, etc., which resulted in the analysis of the trends of the basic indicators of the economy of Ukraine and its foreign trade: GDP and gross external debt, exports/imports/turnover of goods/services and goods and services taken together; dynamics of the balance of trade in goods/services, as well as goods and services taken together; exports to imports ratio (goods and services). Results. The share of exports of goods in all exports of goods and services of Ukraine has been increasing and in 2021 it reached 84%. The results show that: first, the trend of the volume of exports of goods for the period of 2016-2021 is y=5.11x+31.177 while that of services for the same period is y=0.5986x+9.9367; second, the balance of trade in goods has been negative since 2005 (except 2015), and continues to be negative throughout the analyzed period; third, the share of the goods with high-added value in exports has been declining. The in-depth analysis allows to conclude that in the conditions of the growing gross external debt of Ukraine (e.g., for the period of 2006 –2021 the trend is y=2811.1x+90308 while that of GDP for the same period is y=823.65x+135155) it is essential: firstly, to follow the trade strategy of the EU which focuses on exports of services as compared to goods; secondly, to improve the commodity composition of exports so that the goods are value-competitive as opposed to price-competitive. Practical implications. It’s substantiated that the trade policy is to be formulated and implemented so that foreign economic activity of Ukraine is more services-oriented and science-and-technology based. Value/originality. The country is to occupy a more decent place in the world division of labor and is to be reintegrated into the world economy in the interests of the Ukrainian people.

CRITICAL ANALYSIS OF REFLEXIVE LOSS CLAIMS IN INTERNATIONAL INVESTMENT DISPUTES

In contemporary times corporations are aggressively making international investments in diverse economic activities. Private corporations seek protection for their investments under international investment treaties. They raise claims under international investment treaties for recovery of compensations for the losses resulting from the actions of the host state regulatory agencies. The right to claim compensation should ideally be available and exercised only by investor corporations. But in certain cases, the shareholders of the investor corporation have also raised claims, for the recovery of losses incurred by the reduction in the share prices. Such claims by shareholders are called reflexive loss claims. In this paper, the authors have adopted the normative doctrinal research method, for examining the enforceability of reflexive losses claims by the shareholders of the investor corporation under an international investment treaty. Most of the matured jurisdictions practice the rule of "no reflexive losses claim" as a matter of policy in their investment law disputes. Accordingly, there is a sense of legal uncertainty internationally regarding the enforceability of reflexive losses claims under international investment treaty. Further the authors in this paper have also tested the feasibility of private ordering solutions to reflexive claims issues. To carry out the analysis, the authors have framed the following research questions – "R.Q. 1" - Whether Reflexive losses claims by the shareholders against the actions of the host state are enforceable under investor-state investment disputes? “R.Q. 2" – Is the private ordering solution feasible for preventing the shareholder from raising the Reflexive losses claims? The authors have used graphical and diagrammatic presentations for explaining the technical aspects of reflexive loss claims. The analysis has revealed that the enforceability of reflexive losses claims is under a dilemma and a sense of uncertainty prevails regarding it. Further the solution of private ordering is legally valid option to overcome reflexive losses claims. But it has chilling effect on the other treaty provisions relating to investment protection.

Отдельные особенности осуществления административных процедур и административного судопроизводства по Административному процедурно-процессуальному кодексу Республики Казахста

В статье рассмотрены отдельные особенности административных процедур и административного судопроизводства при применении норм Административного процедурно-процессуального кодекса Республики Казахстан от 29 июня 2020 года за №350–VI–ЗРК (далее — АППК), введенного в действие с 01 июля 2021 года. Цель статьи — изучение особенностей административных процедур, административного судопроизводства и примирительных процедур при разрешении публично-правовых споров в рамках АППК, а также анализ отдельных проблемных вопросов его применения. При исследовании использованы общенаучные, частно-научные юридические методы познания. Авторами рассмотрены отличительные принципы осуществления административных процедур и процессуальные особенности административного судопроизводства. С введением в действие норм АППК упорядочен порядок проведения государственными органами как внутренних, так и внешних административных процедур, а также обособлено административное судопроизводство для разрешения публично-правовых споров с участием административного (государственного) органа либо его должностного лица. В статье затронуты проблемы пассивного, на начальном этапе, применения примирительных процедур при разрешении судами публично-правовых споров. На примере существующей практики предъявления государственными контролирующими органами исков в суд об использовании запретительно-ограничительных мер предложено передать рассмотрение такой категории дел из ГПК РК в АППК, поскольку это вытекает из публично-правовых отношений. Также имеет место неравное положение сторон публично-правового спора по срокам апелляционного и кассационного обжалования судебных актов по спорам публично-правового характера по АППК и ГПК Республики Казахстан. Вместе с тем, по-мнению авторов, введение института административных судов для рассмотрения административных дел и публично-правовых споров должно стать эффективным и действенным средством обеспечения защиты прав и законных интересов граждан и юридических лиц.

An alternative generic groundwater-to-indoor air attenuation factor for application in commercial, industrial, and other nonresidential settings

ABSTRACT The default groundwater-to-indoor air attenuation factor (AF) of 10−3 (0.001) to assess the vapor intrusion (VI) pathway and generate VI screening levels for groundwater was developed by the United States Environmental Protection Agency (EPA) based on chlorinated volatile organic compound (VOC) indoor air and groundwater data collected in residential buildings and compiled in EPA’s 2012 VI database. In their VI guidance published in 2015, EPA recognized that this default AF may be overly conservative for nonresidential buildings. In 2015, the Department of Defense (DoD) began developing a first-of-its-kind VI database to assess AFs at commercial and industrial buildings at DoD installations and support the development of alternative generic AF values. This database was expanded in 2019 to include 76 buildings at 22 DoD installations across the United States and is comparable in size to the EPA VI database. The DoD database includes chlorinated VOC data from groundwater and indoor air samples collected from multiple sampling zones within these buildings. Empirical groundwater-to-indoor air AFs were calculated using similar screening methods employed by EPA, including a source strength screen, to filter out potential background source contributions unrelated to VI. Analysis of indoor air-groundwater data pairs found that there is more attenuation occurring from groundwater to indoor air in DoD commercial and industrial buildings relative to residential buildings and that the DoD buildings’ AFs are one to four orders of magnitude lower than EPA’s residential-based default of 10−3. The results support the use of a generic groundwater AF of 10−4 (0.0001) to support VI assessment and develop groundwater screening levels specific to large commercial and industrial buildings as an alternative to the residential default AF. Implications: The use of groundwater-to-indoor air attenuation factors (AFs) is a key component of vapor intrusion (VI) pathway assessments and VI screening-level development for groundwater. Currently, the United States Environmental Protection Agency (EPA) and many state regulatory agencies use a default groundwater AF of 10−3 (0.001) based on chlorinated volatile organic compound (VOC) data collected in residential buildings. VI assessment data collected at Department of Defense (DoD) installations indicate that there is significantly more groundwater-to-indoor air attenuation occurring at DoD commercial and industrial buildings. For that reason, the default AF of 10−3 results in groundwater screening levels that are overestimating VI-related risks in these types of building. The DoD data support the use of a generic groundwater AF of 10−4 (0.0001) for conducting VI assessment and developing groundwater screening levels at large commercial and industrial buildings.

Systematization of supply chain problems due to the imposition of sanctions that impede sustainable development

The authors of the scientific publication explore the supply chain problems that arose as a result of the imposition of sanctions. According to business reports, logistics in our country has been hit, and it has found itself in a crisis situation, with all types of transportation affected. The logistical problems, which have worsened with the imposition of sanctions, have been most pronounced in international supply chains. Regardless of the localization of the supply chain, the imposition of sanctions by Western countries affected the international transportation of material flow. Therefore, the problems that have arisen have led to the need for a significant transformation of supply chains in our country, both in terms of export and import material flows. The systematization of supply chain problems due to the introduction of sanctions that impede sustainable development allowed the authors of a scientific article to divide them globally into two typical sets. The identified problems that arose as a result of the imposition of sanctions were systematized by the authors of the scientific article in chronological order. This makes it possible to better assess the very fact of the immediacy of their occurrence at the beginning of the period of imposition of sanctions and the corresponding complexity of their solution. Such problems were distinguished by the fact that they required considerable time and effort to solve them, including from state regulatory bodies, including the need for a quick response to develop and implement appropriate changes in regulatory legal acts. The analysis performed showed that as we moved through the hierarchical set of problems, both business and state regulatory authorities related directly or indirectly to the transport sector were able to respond more quickly to emerging problems as sanctions were tightened, since certain experience had already been gained

Money laundering in Australian casinos

PurposeThis study aims to examine the role of Australian casinos in facilitating money laundering and Chinese capital flight.Design/methodology/approachThe reports and transcripts of evidence from government inquiries into money laundering in Australian casinos are integrated with analyses of Asian transnational crime.FindingsMoney laundering in Australian casinos is linked to transnational crime and Chinese capital flight. A central finding is that junket operators play a key role in facilitating money laundering. The casinos are particularly exposed to criminal influences in the Chinese very important person gambling market, since they have used junket operators and underground banks, many of whom are closely linked to major Chinese criminal groups from Hong Kong and Macau.Research limitations/implicationsVery little information is available on money laundering in Australian casinos and this research has relied on the government inquiries that have been conducted over the past two years on the subject.Practical implicationsThe author’s focus on money laundering in Australian casinos in the context of Asia-Pacific transnational crime is important for Federal and state government regulators grappling with the rapidly changing money laundering issues. The government inquiries recognised that the money laundering was related to transnational crime, but did not have the time and resources to explore the topic. The paper provides state government casino regulators and financial crime regulators with a broader international perspective to anticipate future money laundering and crime pressures facing Australia’s casinos.Social implicationsMoney laundering in Australian casinos has had devastating social implications on the community. My research helps to focus attention on the problems of transnational crime and money laundering.Originality/valueLittle research has examined the linkages between casinos and transnational crime. This study has found that Australian casinos were used to launder the proceeds of illegal drug trafficking and to facilitate Chinese capital flight. While casinos have been forced by damming government inquiries to tighten anti-money laundering controls, it is likely that there will be pressure to relax these controls in the future because of competitive pressure from other casinos in the Asia-Pacific region.

New York State’s WAVE Method - Evaluation of a Method for Water Quality Monitoring by Citizen Scientists using Benthic Macroinvertebrates

New York State Department of Environmental Conservation (NYSDEC) has developed a robust citizen science macroinvertebrate sampling method. The metric relies on the presence and not the absence of key macroinvertebrates and therefore is resistant to collection and sorting errors. It identifies unimpaired streams with high confidence (0.1% type 1 errors) and at a reasonable efficiency compared to NYSDEC’s multimetric index of biological integrity (54%). We rank remaining stream samples for further investigation using a calculated probability of impairment. This method is valuable as a tool for large monitoring programs with limited resources for quality assurance checks. The value of this method goes beyond data collection, however, as data of known quality is an effective communication tool between citizen scientists and state regulatory agencies and/or local decision makers.

A systematic study on occurrence, risk estimation and health implications of heavy metals in potable water from different sources of Garhwal Himalaya, India

The occurrence of heavy metals (HMs) in drinking water has been a critical water quality concern for a long time and can compromise its aesthetic value to the larger extent. Chronic exposure of human beings to these toxic and non-toxic HMs through water ingestion can result in significant health risks. To assess these associated health risks, the present study was planned, designed and carried out for analyses of nine HMs namely, Al, Cr, Mn, Co, Ni, Cu, Zn, Cd and Pb in the potable water samples collected from different sources located across the Mandakini valley of Garhwal Himalaya, India using Inductively Coupled Plasma Mass Spectrometry. The measured values of Al, Cr, Mn, Co, Ni, Cu, Zn, Cd and Pb were found in the range of BDL–27.4 µg l−1, 0.26–4.5 µg l−1, BDL–139 µg l−1, 0.02–0.9 µg l−1, 0.4–5.5 µg l−1, 0.07–9.2 µg l−1, BDL–4164 µg l−1, BDL–0.8 µg l−1, and BDL–11.2 µg l−1, respectively. The observed values of analyzed HMs except Zn and Pb were found below the reference values prescribed by the WHO, USEPA and BIS. In addition, Zn concentration exceeded its maximum permissible limit (4000 µg l−1) recommended by WHO for infants at one station only. The observed indices show that there are no health risks from HMs contamination via drinking water in the region. Moreover, the estimated hazard quotients for children and adults also revealed no potential health risks. The results of present study will be useful as baseline data for state and national regulatory agencies.

The dynamics and livelihood implications of illegal mining in Ghana: A critical assessment

AbstractDiscourses on “illegal” or informal small‐scale mining (galamsey) have presented it largely as a menace. Using Ghana as the focus of our study, we present a counter‐narrative to the predominant discourse. Employing qualitative in‐depth interviews with 193 local galamsey operators, the study found that economic factors coupled with the combative posture of state regulatory agencies explain the persistence of illegal activity. Although galamsey is not problem‐free, the study revealed it is the livelihood support base of such communities, providing jobs and incomes to many households. Since mineral‐rich local communities, at least, in part, depend on galamsey, the state and its regulatory agencies could collaboratively work with local agencies and mineral‐rich communities to fully exploit the hidden treasures in galamsey while reducing the proximate negative effects.

О некоторых проблемах квалификации правомерного причинения вреда при экоделикте

The issues related to the negative impact on the environment with the permitted use of natural resources, when the user of natural resources has a permit for nature use and a construction project that has passed the procedure for agreeing on the state environmental review, are being investigated. The purpose of the paper is to establish the possibility of qualifying the actions of a nature user within the framework of his permitted activities as lawful infliction of harm to the natural environment. The injustice and unacceptability of the approaches formed in law enforcement practice on imposing responsibility on any user of nature for harm caused to the environment in the process of carrying out permitted economic activities is revealed. In the comparative legal aspect, the inquisitorial nature of approaches in domestic law enforcement is substantiated, which contradicts modern legal guarantees for ensuring the functioning of business, which are characteristic of foreign legal orders. There is an unfair distribution of the burden of proof and the establishment of de facto legal presumptions not provided for by law in relations from environmental torts. In order to establish the fair liability of the tortfeasor, when considering cases of environmental torts, it is necessary to take into account the fact that state regulatory authorities have issued a permit for subsoil use, because such an act authorizes the use of natural resources and, accordingly, allows for environmental degradation. In the article, the author formulates the criteria for lawful infliction of harm and factors that should affect the amount of liability of the nature user in connection with causing harm to the environment.

Development and validation of a quantitative proton NMR method for the analysis of pregnenolone

Pregnenolone (PREG) is an endogenous steroid frequently sold as an over-the-counter dietary supplement touted to promote neurological and immunological health. While the PREG dietary supplement is added to the diet for health benefits, there are no FDA approved PREG drugs. However, compounded PREG drug products are available to U.S. patients. The FDA works with state regulatory authorities on the oversight of compounding activities, including developing 503A and 503B lists of bulk substances that compounders are permitted to use. PREG is one of the substances publicly nominated to be included on the 503B list. Compounded hormone therapies such as those using PREG are of interest given the lack of standardization in compounded drug products which may increase the possibility of underdosing, overdosing, or contamination. However, no USP monograph currently exists to evaluate the quality of PREG drug substance or product. To address knowledge gaps and assist in quality control, a simple and rapid quantitative proton nuclear magnetic resonance spectroscopy (qNMR) method for the identification and assay of PREG in different types of PREG products was developed and validated. PREG samples were characterized using 1D 1H and 2D 1H–13C HSQC NMR spectra. The qNMR assay method (taking approximately 10 min per NMR spectrum) was validated for precision, accuracy, specificity, robustness and linearity per ICH Q2(R1) guidance. The method was validated in a range from 0.032 to 3.2 mg/mL. As a proof of concept, seven PREG bulk substance samples, three tablet and two capsule PREG dietary supplements were assessed by the qNMR analytical procedure. NMR data from all tested samples met the expected criteria for identification and assay. The results demonstrate the potential of qNMR for the quality assessment of different types of PREG samples.

Monitoring the Subolesin Vaccine Field Trial for Safer Control of Cattle Ticks Amidst Increasing Acaricide Resistance in Uganda.

A collaboration program was established between the group of Health and Biotechnology (SaBio) of the IREC Institute of Game and Wildlife Research (CSIC-UCLM-JCCM, Spain) and the National Agricultural Research Organization of Uganda (NARO) for the development of vaccines for the control of cattle ticks in Uganda. Controlled pen trials identified a tick protective antigen, Rhipicephalus appendiculatus Subolesin, and a cross-species-effective vaccine formulation. As the next step, a controlled vaccine field trial has been approved by Ugandan state regulatory authorities, the Uganda National Council for Science and Technology (UNCST) and the National Drug Authority (NDA), to evaluate the efficacy and effectiveness of the vaccine formulation for the control of cattle tick infestations under field conditions. The results of this trial may lead to the approval of the vaccine for application in Uganda to improve cattle health and production while reducing the use of acaricides.

An analysis of the use of the relative source contribution term in derivation of drinking water standards using perfluorooctanoic acid as an example.

The relative source contribution (RSC) term has long been used by the US Environmental Protection Agency (USEPA) and state regulatory agencies in setting criteria in water. The RSC reflects the proportion of the total daily intake of a chemical that can be derived from water when all other sources of exposure (e.g., food, air) are considered. This term is applied by the USEPA and state regulatory agencies when deriving ambient water quality criteria, maximum contaminant level goals, and drinking water health advisories for noncarcinogenic and threshold carcinogenic compounds. The value assigned to the RSC term affects the calculated criteria directly, with the allowable concentration in water decreasing with a decreasing RSC. A default RSC value of 20%-applied by regulatory entities in the USA for more than 40 years-assumes that 80% of an individual's exposure to a chemical's reference dose is from nonwater sources. Although the RSC is a chemical-specific parameter, there are few instances where a value other than the default of 20% has been approved and used. In 2000, USEPA outlined the process for developing chemical-specific RSC values, yet primary use of the default RSC value has continued since then. This article reviews USEPA's methodology for deriving chemical-specific RSC values and provides a case example using perfluorooctanoic acid (PFOA) to explore how the USEPA and state regulatory agencies are applying USEPA's guidance. The case study highlights inconsistent derivation of the RSC term, rooted in limitations in the current methodology. We suggest additional clarification of and more thoughtful use of the available data that may not meet USEPA's current adequacy requirements. We also recommend that the USEPA discuss recommendations for using biomonitoring data to set RSCs. Integr Environ Assess Manag 2023;19:605-612. © 2022 SETAC.

Incobotulinum toxin A: A shelf‐stable, low‐molecular‐weight formulation

AbstractSince its development in 2005, incobotulinum toxin A (INCO) has become one of the most widely used neurotoxins worldwide for aesthetic and therapeutic indications. It was initially designed as a formulation free of complex proteins for reduced immunogenicity with an equal action and strength profile to the original and widespread onabotulinum toxin A (ONA). Multiple trials have demonstrated equivalent efficacy. Several studies have suggested a slight decrease in the time of visible treatment onset with INCO and a subsequent lack of difference in duration of effects when compared with ONA. Particularly appreciable with therapeutic doses, utilization of INCO led to significant cost savings over ONA or abobotulinum toxin A. Karschney et al. found that for the treatment of cervical dystonia and chronic migraine the cost to patients was reduced by 32.2% compared to ONA. Additionally, the ONA formulation allows for long‐term storage at room temperature along with an increased stability time once reconstituted. Limitations of INCO include a similar side effect profile to other neurotoxin formulations, more likely at therapeutic dosing. Indications approved by the Federal Drug Administration in the United States and other regulatory agencies are currently more limited than those of ONA, though this may be in direct relation to the length of time on the market. INCO has overall been demonstrated to be a safe, efficacious alternative to other common neurotoxin formulations.

Not Merely a Game of Cat and Mouse: Regulatory Categorization of Contemporary Entrepreneurial Firms

Regulatory categorization is a process which sets legal limitations to the production and sales of products or provisions of service within the jurisdiction of a regulator. Extant literature on the process is very limited and the few studies that have explored the process do not engage with contemporary entrepreneurial firms. Studies on the regulation of contemporary entrepreneurial firms suggest multiple actors influence their regulation and the dynamics between the local and central state regulatory authorities plays a significant role in how these firms navigate the process. Adopting an institutional work theoretical perspective in line with extant work, we study in detail the case of regulatory categorization of ride hailing app-based firms at the subnational level in the state of Karnataka in India. The preliminary analysis suggests that the process is a multi-actor contested negotiation unlike extant work which suggests it to be a contest between firms and regulator. We identify two sets of actors - ‘stakeholders’ and ‘third-party actors’ who engage in category work, and maintenance work on their own. This is a departure from extant work which emphasizes the agency of the firms in activating other actors to influence the regulator.

Is Mixtures' Additivity Supported by Empirical Data? A Case Study of Developmental Toxicity of PFOS and 6:2 FTS in Wildtype Zebrafish Embryos.

Per- and polyfluoroalkyl substances (PFASs) are a major priority for many federal and state regulatory agencies charged with monitoring levels of emerging contaminants in environmental media and setting health-protective benchmarks to guide risk assessments. While screening levels and toxicity reference values have been developed for numerous individual PFAS compounds, there remain important data gaps regarding the mode of action for toxicity of PFAS mixtures. The present study aims to contribute whole-mixture toxicity data and advance the methods for evaluating mixtures of two key components of aqueous film-forming foams: perfluorooctanesulfonic acid (PFOS), and 6:2 fluorotelomer sulfonic acid (6:2 FTS). Wildtype (AB) zebrafish embryos were exposed to PFOS and 6:2 FTS, both as individual components and as binary mixtures, from 2 to 122 h post-fertilization. Five treatment levels were selected to encompass environmentally relevant exposure levels. Experimental endpoints consisted of mortality, hatching, and developmental endpoints, including swim bladder inflation, yolk sac area, and larval body length. Results from dose–response analysis indicate that the assumption of additivity using conventional points of departure (e.g., NOAEL, LOAEL) is not supported for critical effect endpoints with these PFAS mixtures, and that the interactions vary as a function of the dose range. Alternative methods for quantifying relative potency are proposed, and recommendations for additional investigations are provided to further advance assessments of the toxicity of PFAS mixtures to aquatic organisms.

Case study on the novel permitting and authorization of PacWave South, a US grid-connected wave energy test facility: Development, challenges, and insights

Marine energy (i.e., energy from waves, tides, currents) in the United States is a nascent industry. In particular, permitting processes—an uncertainty for industry advancement that can be costly and time consuming to navigate—have rarely been tested and used for marine energy. The novelty of the marine energy industry and utilization of open ocean permitting processes that were not originally developed for marine energy have led to extensive efforts to gain consensus amongst state and federal regulatory agencies to authorize marine energy projects. In 2021, Oregon State University successfully completed permitting of a wave energy test facility, called PacWave South, off the coast of Oregon, which is designed to advance wave energy research and development. This article documents the multi-year process that Oregon State University used to receive federal and state authorization for a pre-permitted commercial-scale grid-connected facility by detailing the development of the test facility, management of uncertainty and challenges, and key decisions. The PacWave South case study provides insights for the larger marine energy community as the industry advances towards commercialization.

Keys to Driving Implementation of the New Kidney Care Models.

Contemporary nephrology practice is heavily weighted toward in-center hemodialysis, reflective of decisions on infrastructure and personnel in response to decades of policy. The Advancing American Kidney Health initiative seeks to transform care for patients and providers. Under the initiative's framework, the Center for Medicare and Medicaid Innovation has launched two new care models that align patient choice with provider incentives. The mandatory ESRD Treatment Choices model requires participation by all nephrology practices in designated Hospital Referral Regions, randomly selecting 30% of all Hospital Referral Regions across the United States for participation, with the remaining Hospital Referral Regions serving as controls. The voluntary Kidney Care Choices model offers alternative payment programs open to nephrology practices throughout the country. To help organize implementation of the models, we developed Driver Diagrams that serve as blueprints to identify structures, processes, and norms and generate intervention concepts. We focused on two goals that are directly applicable to nephrology practices and central to the incentive structure of the ESRD Treatment Choices and Kidney Care Choices: (1) increasing utilization of home dialysis, and (2) increasing the number of kidney transplants. Several recurring themes became apparent with implementation. Multiple stakeholders from assorted backgrounds are needed. Communication with primary care providers will facilitate timely referrals, education, and comanagement. Nephrology providers (nephrologists, nursing, dialysis organizations, others) must lead implementation. Patient engagement at nearly every step will help achieve the aims of the models. Advocacy with federal and state regulatory agencies will be crucial to expanding home dialysis and transplantation access. Although the models hold promise to improve choices and outcomes for many patients, we must be vigilant that they not do reinforce existing disparities in health care or widen known racial, socioeconomic, or geographic gaps. The Advancing American Kidney Health initiative has the potential to usher in a new era of value-based care for nephrology.

United States Pharmacopeia guidance for compounding of allergenic extracts for allergen immunotherapy.

Patient-specific allergen-specific subcutaneous immunotherapy (SCIT) has been used as a disease modifying treatment for type 1 IgE mediated allergy to inhalants for > 100 years. Traditionally, the extracts used for a treatment set have been "mixed" under the supervision of allergists in their clinics. Until 2008, there were no specific requirements for mixing procedures. Allergenic extracts are classified as biologics by the U.S. Food and Drug Administration (FDA) and are subject to the biologics license application requirements. One of the conditions is that it must be prepared in accordance with U.S. Pharmacopeia (USP) Chapter <797>, which was first published in 2008. What allergists have always considered "mixing" of allergen extracts is considered "compounding" by the FDA and other state and federal regulatory agencies. A revision of USP Chapter <797> was proposed after a series of "never events," including deaths, from compounded products. No reports of infections from SCIT have ever been reported. "Allergy" (ACAAI, AAAAI, AAOA, and other stakeholders) worked cooperatively with the USP Compounding Expert Committee to develop Section 21. "Compounding Allergenic Extracts" of what is expected to be accepted as the next version of USP Chapter <797> in mid 2022.