Agency Requirements Research Articles

Strategic Approach for the Elaboration of a Safety Design Basis for Nonreactor Nuclear Facilities in Brazil

A nonreactor nuclear facility (NRNF) for maritime activities is being designed as part of the Brazilian naval nuclear propulsion program. The absence of national regulations for the design and licensing of naval NRNFs presents a challenge that must be addressed. This study aims to present an initial proposal for developing a safety design basis for NRNFs in Brazil. This proposal is based on the collection and analysis of national and international standards (documentary research), as well as articles, dissertations, and theses (bibliographic research) that discuss the criteria and safety requirements relevant to the licensing and design of NRNFs. This research develops a strategy for applying U.S. Department of Energy (DOE) regulations derived from the U.S. Code of Federal Regulations, Title 10, “Energy,” Part 830, “Nuclear Safety Management,” in conjunction with CNEN (National Nuclear Energy Commission, Brazil) regulation NE 1.04, “Licensing of Nuclear Installations,” aligned with International Atomic Energy Agency requirements to develop a safety design basis for naval NRNFs. The first step of the proposed strategy involves categorizing facility hazards conducted in accordance with DOE-STD-1027. The process continues for facilities categorized as hazard categories 1, 2, and 3. The directive DOE O 420.1C, “Facility Safety,” and the invoked standards serve as foundational elements for developing the safety design basis. The results of this research demonstrate that the DOE regulatory framework for NRNFs is a suitable alternative to address the national regulatory gap and improve the national licensing process by incorporating the safety-in-design concept.

Well-Characterized Polyethyleneimine-/Carboxylated-Polyethylene-Glycol-Functionalized Gold Nanoparticles as Prospective Nanoscale Control Materials for In Vitro Cell Viability Assays: Particle Characterization and Toxicity Tests in Eight Mammalian Cell Lines.

The safety screening of manufactured nanomaterials (MNMs) is essential for their adoption by consumers and the marketplace. Lately, animal-based testing has been replaced by mechanistically informative in vitro assays due to the requirements of regulatory agencies. Cell viability assays are widely employed for manufactured nanomaterial hazard screening as a first-tier approach. Critical parts of such assays are positive and negative controls that serve as measurement benchmarks. We present the cellular viability and corresponding particle characterization obtained with eight different cell lines that were exposed to Au-PEI and Au-PEG-COOH nanoparticles. We showed that polyethyleneimine- and carboxylate-polyethylene-glycol-conjugated gold nanoparticles (AuPEI and Au-PEG-COOH) qualified for positive and negative controls in the in vitro cell viability assays used for MNM toxicological screening.

LC-HRMS screening procedure for the detection of 11 different classes of prohibited substances in dried urine spots for doping control purposes.

Dried urine spots have recently been proposed as an alternative matrix in the anti-doping field. Drying urine may open the opportunity to limit microbial and thermal degradation of the prohibited substances during transportation to the anti-doping laboratories without the need for refrigeration or freezing. In this study, a multi-targeted initial testing procedure was developed for the determination of 237 prohibited drugs/metabolites from 11 different classes in dried urine spots. The comparability between two different microsampling techniques (i.e., Whatman® FTA DMPK-C cards and Mitra® tips) was evaluated. The developed method was then used to evaluate the stability of the target compounds in urine for 7days under different environmental conditions to simulate the transportation of the urine samples from the collection sites to anti-doping laboratories. Sample preparation consists of (i) extraction of the analytes from the collection device using a mixture of acetonitrile/methanol (1/1) for 30min at 40°C, (ii) enzymatic hydrolysis, and (iii) sample concentration by solid-phase extraction. Analysis was performed using liquid chromatography coupled to high-resolution mass spectrometry. The entire workflow was validated in terms of specificity (analytes were distinguishable from the matrix interferences), sensitivity (only with the Mitra® tips the limits of detection comply with the World Anti-Doping Agency's requirements for the majority of the target compounds), carry-over (no signals in the negative urine injected after the positive urine), matrix effect (16-28% for Mitra® tips and 22-35% for DMPK-C cards), and extraction yield (Mitra® tips: 51-88%; DMPK-C cards: 40-76%). As proof of concept, authentic urine samples were analyzed: results obtained in dried urine were compared with those of fluid urine, providing good agreement. Stability studies showed that the target compounds were stable for the whole duration of the study (7days) at -20 and 4°C in both fluid and dried urine. At 50°C or at 20-25°C, several thiazide-based compounds were completely degraded to their degradation product in the first 24h or after 3-4days in fluid urine, whereas in dried urine the compounds were detectable for the entire duration of the study.

Challenges and Supports for Implementing Health Equity During National Accreditation Among Small Local Health Departments in the United States.

This article focuses on supports and challenges to health equity that small local health departments (LHDs) experienced while working toward national reaccreditation or Pathways Recognition with the Public Health Accreditation Board's Standards & Measures Version 2022 (PHAB S&M v2022). The study team conducted 22 qualitative interview sessions with members of health department leadership teams. In the spring of 2024, participants from 4 small LHDs in the western and midwestern regions of the United States participated in individual remote interview sessions. Participants were members of leadership teams in LHDs with population jurisdictions less than 50000. Common challenges relating to the health equity measures in the PHAB S&M v2022 included external influences on equity language; lack of small population data; and racially and ethnically homogeneous populations and staff. The main support was the national equity standards provided justification for pursuing equity work. Strategies to overcome challenges associated with the equity measures included staff training, seeking alternative equity language, and examining socioeconomic inequities in addition to race and ethnicity. Internal workforce understanding of health equity was improved through department-wide training initiatives. When working under restrictive language requirements for state agencies, grants, and other funding sources, staff suggested using alternative phrases and keywords such as level playing field and equal access. When addressing racially and ethnically homogenous populations, staff pursued equity in terms of income and focused on those living with pre-existing conditions (ie, diabetes). Ensuring that LHDs can work toward health equity is crucial for reducing health inequities. While the equity focus of PHAB S&M v2022 proved challenging, for this selection of LHDs, participants affirmed that PHAB accreditation allowed them to solidify their equity work to better serve their communities.

Acceleration of Chronic Wound Healing With Galenic cream of Snail Seromucoid, Durian Peel Extract Polysaccharides And chitosan

The treatment of chronic wounds take a relatively long time so a wound care process or wound management using traditional or modern medical therapy is needed. Objective: The objective of this study is to investigate the effectiveness of galenic cream of snail seromucoid, durian peel extract and chitosan as anti-inflammatories in vitro and in vivo for chronic wound healing. Theoretical Framework: Snail seromucoid, durian peel extract, and chitosan and their combinations can be developed as galenic cream preparations for the treatment of chronic wounds Method: The research method was based on the experimental design with the research stages covering bioformulation of galenic cream preparations of snail seromucoid, durian peel extract, and chitosan as well as testing the quality of galenic preparations physically, chemically, and microbiologically. Results and Discussion: Bioformulation galenic preparation of 2% snail seromucoid, 2% polysaccharide of durian peel extract; 2% chitosan and their combination with ratio 1:1:1 according to the requirements of Food and Drug Monitoring Agency, Republic of Indonesia No. 32 of 2019, it meets the requirements for the quality test of cream preparations in a physicochemical manner including pH, antioxidant activity, dispersion, and adhesion and microbiologically includes Total Plate Number, Yeast Mold Number, and no microbial pathogens Staphylococcus aureus, Pseudomonas aeruginosa,and Candida albicans. Research Implications: The galenic of 2% snail seromucoid, 2% polysaccharide of durian peel extract and 2% chitosan 2% is effective as an anti-inflammatory cream. The results of this study indicate implications for the acceleration of chronic wound healing rates. Originality/Value: Harti et al's research results of the Basic Research Program Higher Education, Ministry of Research and Technology Republic of Indonesia, 2019-2022 fiscal years and the Simple Patent No. S00202010479 showed a synergistic effect of bioactive compounds seromucoid snails and chitosan as biological response modifiers or bioimmunostimulators and antimicrobial agents so that it can be developed as anti-inflammatory galenic preparations

Design and Development of Budget Absorption Discipline Notification Application using SDLC Method

Optimal budget absorption in a region requires streamlined solutions. One such solution is simplifying the budget submission process through technology-based approaches. This study utilizes the SDLC methodology to create a durable application for Public Housing, Settlement Areas, and Human Settlement Offices, meeting their requirement for an effective budget submission tool. The SDLC method allows for continuous evaluation and development according to agency requirements. The outcome is APPA, a Budget Absorption Notification Application designed for the Public Housing, Settlement Areas, and Human Settlements Office in Jember. This application has helped to ensure that the budget approval process is not a sync point in achieving project deadlines. One of the aims of this research was to develop a technology-driven solution that could be implemented to increase optimal regional absorption which is expected can facilitate and accelerate budget execution and public service delivery more prettily than ever.

Becoming a ‘Professional’: Researching the development of career practitioners’ professional identity in a New Zealand context

This paper outlines my current PhD research which examines how career practitioners’ professional identity construction is affected by their environment. The research takes a post-structural approach, focusing on the issue from the perspective of the ‘subjects’ or careers practitioners, rather than the structural, ‘top-down’ requirements of policy-makers and other agencies. The paper introduces the research, identifies the research problem, gives a brief insight into the literature, sets out the aims and methodology, and identifies the potential contribution to understanding the effect of the environment on career practitioners’ professional identity. Once my PhD is completed, I hope the outcomes of the research will contribute to understanding how practitioners construct their identity in relation to the discourse of professionalisation.

Toward Equity and Transparency: A Content Analysis of Florida Elementary Acceleration Policies

In 2012, Florida adopted the Academically Challenging Curriculum to Enhance Learning (ACCEL) statute establishing minimum requirements for local education agencies to provide access to accelerated learning options for eligible K–12 public school students. This study examined Florida public school district acceleration policies for elementary students one decade after the enactment of the statute. We analyzed Student Progression Plans, school board policies, and district websites to explore the status of acceleration policy in the state, compare the accessibility of acceleration information across districts, and identify policy elements that support equity and those that create potential barriers for elementary students with advanced learning needs who could benefit from acceleration. The findings of this study indicated several areas for improvement, including the accessibility of acceleration information, the service options available to K–5 students, the protocols districts use, criteria for decision-making, and the implementation of acceleration. In addition, we discuss implications for school districts developing or revising acceleration policies and several avenues for future research. The preregistration and open-access materials for this study are available at https://osf.io/yc3xd/ .

Grouping research proposals with funding agency requirements: A contextualized language model and constrained K-means clustering approach

As the volume of research proposals increases and the interdisciplinary nature of research fields exacerbates the complexity of manual proposal grouping, the grouping of research proposals becomes increasingly vital in funding agencies’ evaluation procedures. Although previous ontology- and word embedding-based approaches have made valuable contributions to the advancement of research proposal grouping, their practical utility has been limited due to a lack of consideration of funding agencies’ requirements. This study proposes a systematic approach for grouping research proposals that aligns with three common requirements: size, cannot-link, and must-link constraints. The proposed approach utilizes KLUE-RoBERTa for proposal vectorization and constrained K-means clustering for proposal grouping with size constraints. We introduce a proposal pre-partitioning and a proposal vector centralization to simultaneously consider the cannot- and must-link constraints in grouping proposals. An empirical analysis of 3,665 proposals submitted to the National Research Foundation of Korea demonstrates the effectiveness and practicality of the proposed approach. Additionally, we conduct a comparative analysis of various combinations of methodological components to optimize this approach. The proposed approach is considered a valuable complementary tool for grouping proposals, enhancing the overall efficiency and effectiveness of the proposal evaluation system.

Assessment of Navy Provider Knowledge of Women's Mental Health Services, Treatment Practices, and Training.

As female active duty populations increase in all military environments, it is critical that women's health be addressed in a comprehensive manner. The study's results will be utilized to assist Navy health care leaders in addressing female force readiness policies, treatment gaps, and training specific to women's mental health. In total, 212 active duty participants were recruited from the Navy's mental health specialties. The survey was hosted on the U.S. Government's MAX.gov survey website and received Institutional Review Board and Survey Review Board approval per Navy and Defense Health Agency requirements. Participants recorded their experiences with various patient presentations using Likert scale assessments, indicated their comfort in prescribing medication to patients with 11 distinct presenting concerns, and responded to six questions regarding their training and clinical experience in the field of women's mental health. Differences were noted for provider gender, treatment setting, patient sex, provider rank, and years of independent practice. Female providers were more likely than males to report that their female patients presented with 15 of the 21 measured issues. Providers located at MTFs were significantly more likely than providers in operational billets to report female patients presenting with certain conditions and reported being more comfortable prescribing medication. Eighty percent of respondents authorized to prescribe medicine rated themselves as very or extremely comfortable prescribing medications to their patients for all specified conditions except two: women who are breastfeeding and women who are pregnant. Senior officers reported the most comfort prescribing medication to women who are planning to become pregnant and women who have experienced perinatal loss. Only a minority of providers (20%, female; 33%, males) reported receiving women's mental health education during their training. Of those who did receive training, it was limited to post-partum and pregnancy. Most participants (93%) agreed that women's mental health should be incorporated into training programs for military providers. This exploratory study highlights that provider variables impact assessment and treatment of and for patients. The study highlights the interplay of gender, treatment setting, experiences, and level of comfort are associated with provider assessment of presenting concerns. The authors hope this study will help in prioritizing women's mental health practices, mental health training, and research, and in informing policy and decision-making.

2022 개정 교육과정에 나타난 ‘주체성’의 재개념화

Purpose: This study aims to reinterpret the concept of agency that appeared in the 2022 revised curriculum, and to clarify that teacher agency and student agency are compatible by identifying the relationship between teacher agency and student agency. Methods: In this study, subject analysis is conducted focusing on literature review in order to re-conceptualize the agency revealed in the 2022 revised curriculum and the OECD Education 2030 project. Accordingly, in the light of Palmer's educational philosophy, the concept and establishment requirements of agency are defined to explore the relationship between teacher agency and student agency. Results: As a result of this study, it was confirmed that agency was established from a holistic self-understanding. However, according to Palmer's educational philosophy, teachers' holistic self- understanding for the realization of teacher agency can have a positive effect on students' holistic self-understanding for the realization of student agency because teachers' self-understanding is closely related to students' self-understanding through educational situations. Conclusion: Accordingly, it is suggested as the conclusion of this study that teacher agency and student agency are not a relationship that avoids each other, but rather can increase student agency through teacher agency.

An Environmental Audit of Aracari Resort

Tourism impacts the economy, the natural and built environment, the immediate population, and even tourists – the very resource needed by the industry to remain viable. Regular assessment of the environmental performance of the industry is necessary to ascertain compliance with national standards and regulations. This is achieved with an environmental audit. To this end, an environmental audit was conducted at the Aracari Resort, almost a decade after it began operations. The Resort’s operations should have minimal impact on public health and the environment, as evidenced by good sanitation, safety measure implementation, and adherence to the Public Health Legislation and Occupation Health & Safety Act. The methodology used included monitoring of water quality and use, noise, and energy; and direct observation of waste and safety management. The results showed that water quality parameters such as pH, temperature, phosphorus and ammonium were in compliance with the national effluent discharge guidelines; however, chlorides, chemical oxygen demand, and total suspended solids were not. Water metre readings revealed an average daily water consumption of 22.5m3 and an average weekly water consumption of 135m3. Noise produced from the Resort was in compliance with the daytime limits of 75 dB based on the national standard, but exceeded residential nighttime limits (from Friday to Sunday) of 60 dB. The average (55.6 kW), maximum (83.85 kW), and minimum (51.9 kW) power demands across a 7-day period were obtained from Fluke Monitoring System readings. Solid waste management was observed to be inadequate on days of planned events, with overflowing bins evident on the premises. Safety measures were implemented for food, chemical handling and storage, swimming pool safety, and fire safety, which were observed to be consistent with the standards. The facility’s overall performance was satisfactory based on the evaluation criteria, and some environmental practices of Aracari Resort conformed to the Environmental Protection Agency requirements and other established guidelines. Areas identified for improved compliance and enhanced environmental management included the implementation of an environmental policy, regular monitoring of environmental parameters, and staff training on the terms and conditions of the Environmental Permit.

Evaluation of Learning Media Creation Based on Results of Computational Chemistry Calculations Visualised

The objective of this study is to determine the outcomes of the requirements analysis and learning materials for electrolyte and non-electrolyte solution materials. Additionally, learning materials will be developed utilising computational chemical calculations and visualisation of the results to create learning media based on the National Education Standards Agency (BSNP) requirements. This kind of study uses the ADDIE development model and is referred to as development research. There are five steps in the current ADDIE model: analysis, design, development, implementation, and evaluation. The entire student body of one of the senior high schools in Padangsidempuan City, North Sumatera, Indonesia, served as the study's population. The participants in this research were senior high school students from Padangsidempuan City, North Sumatera, Indonesia. The use of a purposive sampling technique yields grade X as the research sample. An inquiry form derived from the National Education Standards Agency was used as the research tool. Utilising a significance level of 5%, the data analysis was conducted using the SPSS 22 for Windows software. The investigation's findings demonstrate the need for educational materials to help pupils struggling with learning. Based on 95% validation findings, the learning materials for both electrolyte and non-electrolyte solutions visualise the outcomes of computational chemical calculations.

Assessment of Solid Waste Management Practices Following Private Partnership Operations in Zaria Urban Area of Kaduna, Nigeria

The safe disposal of municipal waste is very important in promoting a healthy environment. High-quality public services and promoting competition in the waste management sector leads to the formation of private sector participation (PSP) to handle solid waste management in Kaduna. A multi-stage sampling technique was adopted which involves dividing the local government into localities. Stage two involves the purposive sampling technique which was adopted in selecting locality with high population and low population density areas, a total of 400 households from both strata were interviewed. Descriptive statistics was used to analyse the information from the questionnaires and results were presented using frequency tables and charts. The findings revealed that quality of service among the PSP operators recorded high success in the high-income areas and much less in the low and medium-income areas. On average, industry productivity was 5.63 tonnes per day per vehicle. 12 out of which in the study area were above this average and in meeting increased productivity, year of experience in operations, number of trips made, number of times trucks were serviced, and adhering to regulatory agency requirements were among the factors influencing company’s productivity in the state. It also shows less effectiveness of the system in waste management in the area. The study, therefore, recommends that regulatory agency should be more aggressive in playing their statutory roles of managing the PSP operators.

Актуальные проблемы спортивного права. Проблемы совершенствования антидопингового законодательства: пути решения

The article is devoted to the development of recommendations for improving Russian anti-doping legislation at the present stage. The requirements of the World Anti-Doping Agency to bring the anti-doping legislation of the Russian Federation into compliance with the World Anti-Doping Code are taken into account.

International Society for Cell and Gene Therapy Clinical Translation Committee recommendations on mesenchymal stromal cells in graft-versus-host disease: easy manufacturing is faced with standardizing and commercialization challenges

Mesenchymal stromal cells (MSCs) have been used in multiple clinical trials for steroid-refractory moderate-severe (grade II–IV) acute graft-versus-host disease (aGVHD) across the world over the last two decades. Despite very promising results in a variety of trials, it failed to get widespread approval by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency. What lessons can we learn from this for future studies on MSCs and other cell therapy products? Broad heterogeneity among published trials using MSCs in aGVHD was likely the core problem. We propose a standardized approach in regards to donor-related factors, MSCs-related characteristics, as well as clinical trial design, to limit heterogeneity in trials for aGVHD and to fulfill the requirements of regulatory agencies. This approach may be expanded beyond MSCs to other Cell and Gene therapy products and trials in other diseases.

Next Generation Tools in mRNA Purification: The Role of Continuous Raman Spectroscopy Testing with Pretreatment of the Sample

In the biopharmaceutical production field, the purification process is a crucial step in order to obtain Drugs with an impurity profile according to the regulatory agency requirement. The aim of this work is to verify some relevant and recent literature and after analysis to submit to the researcher new Solutions in order to improve global safety and the toxicological profile: Submit a project related to the continuous testing of the purified materials using Raman spectroscopy – with pre-treatment of the sample: using solvents. Nanolipis Payload of Biopharmaceutical is not efficiently detected by direct Raman spectroscopy allowed by the regulatory agency for PAT process analytical technology.

LC-MS/MS measurement of endogenous steroid hormones and phase II metabolites in blood volumetric absorptive microsampling (VAMS) for doping control purposes

BackgroundVolumetric Absorptive Microsampling (VAMS) is emerging as a valuable technique in the collection of dried biological specimens, offering a potential alternative to traditional sampling methods. The objective of this study was to assess the suitability of 30 μL VAMS for the measurement of endogenous steroid hormones. MethodsA novel LC-MS/MS method was developed for the quantification of 18 analytes in VAMS samples, including main endogenous free steroids and phase II metabolites of androgens. The method underwent validation in accordance with ISO/IEC 17025:2017 and World Anti-Doping Agency (WADA) requirements. Subsequently, it was applied to authentic VAMS samples obtained from 20 healthy volunteers to assess the stability of target analytes under varying storage conditions. ResultsThe validation protocol assessed method’s selectivity, matrix effect, extraction recovery, quantitative performance, carry-over and robustness. The analysis of authentic samples demonstrated the satisfactory stability of monitored steroids in VAMS stored at room temperature, 4 °C, −20 °C and −80 °C for up to 100 days and subjected to up to 3 freezing-thawing cycles. ConclusionsThe validated LC-MS/MS method demonstrated its suitability for the measurement of steroids in dried blood VAMS. The observed stability of steroidal compounds suggests promising prospects for future applications of VAMS, both in anti-doping contexts and clinical research.

A Novel LIBS Sensor for Sample Examinations on a Crime Scene.

In this work, we present a compact LIBS sensor developed for characterization of samples on a crime scene following requirements of law enforcement agencies involved in the project. The sensor operates both in a tabletop mode, for aside measurements of swabbed materials or taken fragments, and in handheld mode where the sensor head is pointed directly on targets at the scene. The sensor head is connected via an umbilical to an instrument box that could be battery-powered and contains also a color camera for sample visualization, illumination LEDs, and pointing system for placing the target in focus. Here we describe the sensor's architecture and functionalities, the optimization of the acquisition parameters, and the results of some LIBS measurements. On nano-plotted traces at silica wafer and in optimized conditions, for most of the elements the detection limits, in term of the absolute element masses, were found to be below 10 picograms. We also show results obtained on some representative materials, like fingerprints, swabbed soil and gunshot residue, varnishes on metal, and coated plastics. The last, solid samples were used to evaluate the depth profiling capabilities of the instrument, where the recognition of all four car paint layers was achieved.

Non-destructive environmental safety assessment of threatened and endangered plants in weed biological control.

Assessing the risk of nontarget attack (NTA) for federally listed threatened and endangered (T&E) plant species confamilial to invasive plants targeted for classical biological control, is one of the most important objectives of pre-release environmental safety assessments in the United States. However, evaluating potential NTA on T&E species is often complicated by restrictive agency requirements for obtaining propagules, or the ability to propagate plants and rear agents to the appropriate phenostages synchronously for testing, or both. Here, we assessed whether plant cues associated with a host recognition can be used for testing the attractiveness of four T&E and one rare single population plant species non-destructively for a candidate biocontrol agent. We used the seed-feeding weevil, Mogulones borraginis, a candidate for the biological control of the invasive plant, Cynoglossum officinale (Boraginaceae) as the study system. We collected olfactory and visual cues in the form of flowering sprigs from T&E plant species confamilial to the invasive plant in a non-destructive manner and used them to measure behavioral responses and searching time of weevils. Female weevils preferred C. officinale to all tested plant species in dual-choice bioassays using either olfactory or visual cues in a modified y-tube device. Furthermore, female weevils were repelled by the combined olfactory and visual cues from all tested T&E plant species in a dual-choice test against controls (e.g., purified air in an empty arm), indicating that it would be extremely unlikely for the weevil to attack any of these species upon release in the United States. Principal component analysis based on 61 volatile organic compounds effectively separated the five confamilial plant species and C. officinale, corroborating the results of behavioral bioassays. We conclude that studies on pre-alighting host selection behavior and the underlying physiological mechanisms of how organisms select host plants they exploit can aid in environmental safety testing of weed biological control agents.