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At least 55 records · Page 3

Shape-dependent control of cell growth, differentiation, and apoptosis: switching between attractors in cell regulatory networks

Development of characteristic tissue patterns requires that individual cells be switched locally between different phenotypes or "fates;" while one cell may proliferate, its neighbors may differentiate or die. Recent studies have revealed that local switching between these different gene programs is controlled through interplay between soluble growth factors, insoluble extracellular matrix molecules, and mechanical forces which produce cell shape distortion. Although the precise molecular basis remains unknown, shape-dependent control of cell growth and function appears to be mediated by tension-dependent changes in the actin cytoskeleton. However, the question remains: how can a generalized physical stimulus, such as cell distortion, activate the same set of genes and signaling proteins that are triggered by molecules which bind to specific cell surface receptors. In this article, we use computer simulations based on dynamic Boolean networks to show that the different cell fates that a particular cell can exhibit may represent a preprogrammed set of common end programs or "attractors" which self-organize within the cell's regulatory networks. In this type of dynamic network model of information processing, generalized stimuli (e.g., mechanical forces) and specific molecular cues elicit signals which follow different trajectories, but eventually converge onto one of a small set of common end programs (growth, quiescence, differentiation, apoptosis, etc.). In other words, if cells use this type of information processing system, then control of cell function would involve selection of preexisting (latent) behavioral modes of the cell, rather than instruction by specific binding molecules. Importantly, the results of the computer simulation closely mimic experimental data obtained with living endothelial cells. The major implication of this finding is that current methods used for analysis of cell function that rely on characterization of linear signaling pathways or clusters of genes with common activity profiles may overlook the most critical features of cellular information processing which normally determine how signal specificity is established and maintained in living cells. Copyright 2000 Academic Press.

Review↗

Regulatory Considerations in the Development of Radiation-Drug Combinations

Radiation therapy remains a fundamental treatment for patients with cancer. Despite an increasing number of targeted molecular therapies that are US Food and Drug Administration (FDA)-approved for the treatment of patients with metastatic disease, there has been very little progress made in terms of drugs used concurrently with radiation. This article reviews the existing regulatory framework in which cancer drugs may be developed for use in combination with radiation therapy from the perspective of the FDA. To briefly summarize: (1) nonclinical studies are a critical first step to ensure that drugs are safe for use in humans; however, additional nonclinical studies of a drug with radiation may not be required before a clinical trial in combination with radiation as long as the safety profile of the drug has been characterized in humans. The FDA determines the quality of evidence required before studying a drug in combination with radiation on a case-by-case basis. (2) Although often impractical to consider late toxicities during dose-escalation, late adverse events should be captured and taken into consideration when determining the final dose and schedule to take forward during drug development. (3) There are a number of expedited programs for cancer drug development, including accelerated approval, a conditional approval that allows for use of earlier clinical endpoints when the data suggests a clinically meaningful improvement over available therapy. (4) The Agency encourages sponsors to discuss their development plan with the appropriate FDA review division in formal regulatory meetings.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

WTEC monograph on instrumentation, control and safety systems of Canadian nuclear facilities

This report updates a 1989-90 survey of advanced instrumentation and controls (I&C) technologies and associated human factors issues in the U.S. and Canadian nuclear industries carried out by a team from Oak Ridge National Laboratory (Carter and Uhrig 1990). The authors found that the most advanced I&C systems are in the Canadian CANDU plants, where the newest plant (Darlington) has digital systems in almost 100 percent of its control systems and in over 70 percent of its plant protection system. Increased emphasis on human factors and cognitive science in modern control rooms has resulted in a reduced workload for the operators and the elimination of many human errors. Automation implemented through digital instrumentation and control is effectively changing the role of the operator to that of a systems manager. The hypothesis that properly introducing digital systems increases safety is supported by the Canadian experience. The performance of these digital systems has been achieved using appropriate quality assurance programs for both hardware and software development. Recent regulatory authority review of the development of safety-critical software has resulted in the creation of isolated software modules with well defined interfaces and more formal structure in the software generation. The ability of digital systems to detect impending failures and initiate a fail-safe action is a significant safety issue that should be of special interest to nuclear utilities and regulatory authorities around the world.

Uhrig, Robert E.↗

Risk-Informed Initiating Events and Accident Response

Emerging nuclear technologies and advanced reactor developments have brought proposed changes to the regulatory framework which can be leveraged to improve safety implementation and regulatory oversight processes at existing operating nuclear power plants. Specifically, opportunities exist to make plants’ regulatory compliance processes more efficient. This can be done by decreasing reliance on purely deterministic and prescriptive approaches and expansion of the use of risk informed and performance-based approaches to demonstrate reactor safety while achieving economic gains and efficiencies. In this report, we researched possibilities of economic benefits potentially available from the application of concepts associated with a modernized regulatory framework developed for advanced reactors to the existing light water reactors. We used timing factors to demonstrate the complexity of the existing risk assessments and described how these complexities affect regulatory compliance activities at the plants. We also investigated regulatory framework for both existing and new reactors and provided an overview of potential improvements. Lastly, we evaluated various areas of existing plant operations where modernization of compliance activities can offer substantial benefits.

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

Non-LWR Regulatory Framework Modernization

This report provides a summary of Fiscal Year 2025 activities performed in the Regulatory Framework Modernization work package through July 2025. This reflects the progress and status of Idaho National Laboratory?s activities concerning the development of an advanced reactor regulatory framework and its implementation in the United States. This report includes discussions of the progress that NRC has made on the ADVANCE Act requirements as well as the newly issued Presidential Executive Orders from May 2025. It provides a summary of the additional work packages added in July 2025 because of the executive orders. The report also provides recommendations for work to be performed in Fiscal Year 2026. This work was supported by the U.S. Department of Energy Office of Nuclear Energy Regulatory Development subprogram. These activities are managed by Idaho National Laboratory on behalf of the Department of Energy.

11 - NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

ORNL Package Testing Program Overview

When transporting radioactive or hazardous materials, safety and security are top priorities. Packaging and transportation regulations require reliable evidence that containers have passed rigorous performance tests to ensure that the public and the environment are protected from the hazardous nature of the cargo. Because of its long history in energy and security research, Oak Ridge National Laboratory (ORNL) has needed to ship hazardous packages for the past 65 years. Since the 1940s, ORNL has made significant contributions to transportation regulations and has been at the forefront of regulatory testing development. Today, ORNL is a leader in standards development and testing of designs of radioactive material packages. ORNL plays a critical role in ensuring the safe transportation of radioactive materials across the United States by executing rigorous testing campaigns of packages that contain radioactive materials. Early testing activities focused on supporting the development of transportation regulations established by both the International Atomic Energy Agency (IAEA) and the United States. Currently, all package testing activities are performed under the Package Testing Program (PTP) at the Package Evaluation Facility (PEF) located at the National Transportation Research Center (NTRC), which is about 10 miles from the main ORNL campus. The PTP develops and evaluates testing solutions, ensuring that they are safe efficient, and in compliance with regulatory requirements. The vision for the PTP is to be a world-class leader in the evaluation and testing of radioactive and hazardous material packages. The key elements necessary to fulfill this mission are an experienced and professional staff; state-of-the-art facilities, equipment, and instrumentation; and completion of challenging programs and projects important to package transportation. Collaborations with other internal and external organizations play a significant role in building stronger teams and achieving this vision. By adhering to and advancing regulatory standards, ORNL’s PTP supports development of safe and compliant packaging, safeguarding the transportation process from potential risks associated with radioactive material logistics.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Bioenergy sorghum nodal root bud development: morphometric, transcriptomic and gene regulatory network analysis

Bioenergy sorghum’s large and deep nodal root system and associated microbiome enables uptake of water and nutrients from and deposition of soil organic carbon into soil profiles, key contributors to the crop’s resilience and sustainability. The goal of this study was to increase our understanding of bioenergy sorghum nodal root bud development. Sorghum nodal root bud initiation was first observed on the stem node of the 7 th phytomer below the shoot apex. Buds were initiated near the upper end of the stem node pulvinus on the side of the stem opposite the tiller bud, then additional buds were added over the next 6-8 days forming a ring of 10-15 nascent nodal root buds around the stem. Later in plant development, a second ring of nodal root buds began forming on the 17 th stem node immediately above the first ring of buds. Overall, nodal root bud development can take ~40 days from initiation to onset of nodal root outgrowth. Nodal root buds were initiated in close association with vascular bundles in the rind of the pulvinus. Stem tissue forming nascent nodal root buds expressed sorghum homologs of genes associated with root initiation (WOX4), auxin transport (LAX2, PIN4), meristem activation (NGAL2), and genes involved in cell proliferation. Expression of WOX11 and WOX5, genes involved in root stem niche formation, increased early in nodal root bud development followed by genes encoding PLTs, LBDs (LBD29), LRP1, SMB, RGF1 and root cap LEAs later in development. A nodal root bud gene regulatory network module expressed during nodal root bud initiation predicted connections linking PFA5, SPL9 and WOX4 to genes involved in hormone signaling, meristem activation, and cell proliferation. A network module expressed later in development predicted connections among SOMBRERO, a gene involved in root cap formation, and GATA19, BBM, LBD29 and RITF1/RGF1 signaling. Overall, this study provides a detailed description of bioenergy sorghum nodal root bud development and transcriptome information useful for understanding the regulation of sorghum nodal root bud formation and development.

09 BIOMASS FUELS↗

Direct broadcast satellite-radio: Portable and mobile reception trade-offs

There has been considerable international effort in the areas of system studies, system development, and regulatory work for a Direct Broadcast Satellite Radio (DBS-R). An important milestone will be the 1992 World Radio Administrative Conference (WARC 1992) consideration of frequency allocation in the 500 - 3000 MHz range for such a service. There is an interagency agreement between Voice of America and the National Aeronautics and Space Administration for a coordinated program in DBS-R. This program includes seven tasks: systems tradeoff studies, propagation measurements, satellite experiment and demonstration, receiver development, market studies, regulatory studies, and WARC preparations. The findings of ongoing work under the first task, systems tradeoff studies, are discussed. Topics covered include digital bit rate and audio quality, propagation considerations and link margin estimates for portable reception, link margin estimates for mobile reception, coverage, and satellite size and cost estimates for a regional DBS-R coverage example.

Golshan, Nasser↗

Bridging Equipment Reliability Data and Risk Informed Decisions in a Plant Operation Context

Industry equipment reliability and asset management programs are essential elements that help ensure the safe and economical operation of nuclear power plants. The effectiveness of these programs is addressed in several industry-developed and regulatory programs. The Risk-Informed Asset Management (RIAM) project is tasked to develop tools in support of the equipment reliability and asset management programs at nuclear power plants. These tools are designed to create a direct bridge between component health/lifecycle data and decision making (e.g., maintenance scheduling and project prioritization). The goal of this article is to provide a guide for specific use cases that the RIAM project is targeting. We have grouped uses cases into three main areas. The first area focuses on the analysis of equipment reliability data with a particular emphasis on condition-based data, such as test/surveillance reports and component monitoring data. The second area focuses on the integration of equipment reliability into system/plant reliability models to determine system/plant health and identify the components that are critical to maintain an operational system. Lastly, the third area manages plant resources, such as maintenance activities and replacement scheduling using optimization methods. Here the primary focus is on supporting typical system engineer decisions regarding maintenance activity scheduling and component aging management. This is performed in a risk-informed context where the term “risk” is broadly constructed to include both plant reliability and economics. This framework combines data analytics tools to analyze equipment reliability data with risk-informed methods designed to support system engineer decisions (e.g., maintenance and replacement schedules, optimal maintenance posture) in a customizable workflow.

97 - MATHEMATICS AND COMPUTING↗

Vulcan Test Platform: Demonstrating the Data Center as a Flexible Grid Asset

Explosive data center demand is outpacing grid infrastructure development. AI workloads and hyperscale cloud growth are creating unprecedented power requirements, while traditional grid expansion faces multi-year development timelines, regulatory hurdles, and decarbonization challenges. Sidewalk Infrastructure Partners recognized this impending crisis years ago and founded Verrus to develop an innovative solution: data centers that function as grid assets rather than passive loads. The Verrus approach integrates proprietary grid-aware controls with battery energy storage systems (BESS) in a medium-voltage architecture that delivers three critical capabilities: Fast-responding demand flexibility that can service requests from the utility within 10 seconds, Uninterrupted transition to islanded operation during grid disturbances, Continuous uptime assurance while maintaining all customer service level commitments Through Verrus' strategic partnership with the National Renewable Energy Laboratory (NREL), we validated these capabilities on Vulcan, a 70 MW utility-scale test platform powered by NREL's ARIES Virtual Emulation Environment. This deployment-ready technology has successfully demonstrated that Verrus data centers can deliver meaningful grid services while maintaining mission-critical reliability. This technical report outlines the design, methodology, and results of this emulated deployment, demonstrating that data centers can play a pivotal role in enhancing grid flexibility and reliability, without sacrificing service level guarantees.

24 POWER TRANSMISSION AND DISTRIBUTION↗

Airborne Windshear Detection and Warning Systems. Fifth and Final Combined Manufacturers' and Technologists' Conference, part 1

The Fifth (and Final) Combined Manufacturers' and Technologists' Airborne Windshear Review Meeting was hosted jointly by the NASA Langley Research Center (LaRC) and the Federal Aviation Administration (FAA) in Hampton, Virginia, on September 28-30, 1993. The purpose of the meeting was to report on the highly successful windshear experiments conducted by government, academic institutions, and industry; to transfer the results to regulators, manufacturers, and users; and to set initiatives for future aeronautics technology research. The formal sessions covered recent developments in windshear flight testing; windshear modeling, flight management, and ground-based systems; airborne windshear detection systems; certification and regulatory issues; development and applications of sensors for wake vortex detection; and synthetic and enhanced vision systems.

Delnore, Victor E.↗

Proposed Solutions to Regulatory Barriers to Tribal Solar Development

Tribal land in the United States represents approximately 2% of the country's total landmass and holds more than 5% percent of solar photovoltaic potential. This resource is largely untapped, and Tribes often cite regulatory hurdles to achieving solar goals. This presentation provides an opportunity for interested stakeholders to better understand those hurdles and possible solutions to help advance Tribal solar adoption as well as weigh in on the findings of the Tribal Solar Initiative.

ENERGY PLANNING, POLICY, AND ECONOMY,SOLAR ENERGY↗

Best Practices for Regulatory Engagement and Relationship Building – 26129

In the initiation of a new project or facility, the management team should begin to engage with appropriate regulators, early and often. However, if this did not occur and new issues arise, new challenges develop, or regulatory impacts become a concern, the regulatory engagement process should be reconsidered and reevaluated. Regulators are key in the siting, construction, and continued operations of a new facility. Municipalities often seek to attract new initiatives, projects, or facilities that will have a significant positive impact on the community. Even though this is typically the goal, there are many hurdles along the path that may cause negative impacts leading to regulatory concerns and hurdles that may delay or stop work. Additionally, early and frequent engagement with regulators can have a significant positive impact on the successful siting, permitting, and construction of a facility, including meeting needed schedules that are important to economic viability. Further, it is essential for ongoing operations for regulators to be effectively and meaningfully engaged throughout the life of the project or facility due to the potential of changing factors during the construction and/or operation. Regular and consistent engagement builds relationships and helps ensure that potential topics of concern are addressed early before they become problems. In this paper, we will discuss best practices in engaging with regulators, how to initiate effective regulatory interactions, and building lasting relationships.

Jacobs, Stephanie [Savannah River National Laborat↗

Towards engineering hybrid incompatibility in plants

The potential for gene flow between genetically modified organisms (GMOs) and non-GMO relatives poses a significant challenge to the development and regulatory approval of GMO crops (Wedger et al., 2024), for example, the spread of herbicide resistance transgenes from crops such as rice or sorghum to cross-pollinating weedy species. Addressing this concern, we developed Engineered Genetic Incompatibility (EGI) (Maselko et al., 2017), a system that establishes species-like barriers to gene flow between otherwise sexually compatible populations. EGI employs Programmable Transcriptional Activators (PTAs) to drive lethal over- and/or ectopic expression of tightly regulated genes following undesired hybridization events (Figure 1a,b). A benign mutation of the target promoter in the EGI organism protects it from ill effects of the PTA, which acts as a sentinel for the wild-type (WT) promoter sequence. Given numerous potential PTA targets, multiple mutually incompatible subpopulations are feasible (Maselko et al., 2020). EGI has been demonstrated in yeast as a proof-of-concept (Maselko et al., 2017) and in insects as a strategy for genetic biocontrol of pests (Maselko et al., 2020; Upadhyay et al., 2022). EGI in plants would provide a strategy to halt gene flow between engineered crops and their domestic and wild relatives without altering normal cultivation or propagation practices. Here, we present promising results towards the demonstration of EGI in plants and highlight technical challenges that still need to be overcome.

CRISPRa↗

Simultaneous carbon catabolite repression governs sugar and aromatic co-utilization in Pseudomonas putida M2

ABSTRACT Pseudomonas putida have emerged as promising biocatalysts for the conversion of sugars and aromatic compounds obtained from lignocellulosic biomass. Understanding the role of carbon catabolite repression (CCR) in these strains is critical to optimize biomass conversion to fuels and chemicals. The CCR functioning in P. putida M2, a strain capable of consuming both hexose and pentose sugars as well as aromatic compounds, was investigated by cultivation experiments, proteomics, and CRISPRi-based gene repression. Strain M2 co-utilized sugars and aromatic compounds simultaneously; however, during cultivation with glucose and aromatic compounds ( p- coumarate and ferulate) mixture, intermediates (4-hydroxybenzoate and vanillate) accumulated, and substrate consumption was incomplete. In contrast, xylose-aromatic consumption resulted in transient intermediate accumulation and complete aromatic consumption, while xylose was incompletely consumed. Proteomics analysis revealed that glucose exerted stronger repression than xylose on the aromatic catabolic proteins. Key glucose (Eda) and xylose (XylX) catabolic proteins were also identified at lower abundance during cultivation with aromatic compounds implying simultaneous catabolite repression by sugars and aromatic compounds. Reduction of crc expression via CRISPRi led to faster growth and glucose and p -coumarate uptake in the CRISPRi strains compared to the control, while no difference was observed on xylose+ p -coumarate. The increased abundances of Eda and amino acid biosynthesis proteins in the CRISPRi strain further supported these observations. Lastly, small RNAs (sRNAs) sequencing results showed that CrcY and CrcZ homologues levels in M2, previously identified in P. putida strains, were lower under strong CCR (glucose+ p -coumarate) condition compared to when repression was absent ( p -coumarate or glucose only). IMPORTANCE A newly isolated Pseudomonas putida strain, P. putida M2, can utilize both hexose and pentose sugars as well as aromatic compounds making it a promising host for the valorization of lignocellulosic biomass. Pseudomonads have developed a regulatory strategy, carbon catabolite repression, to control the assimilation of carbon sources in the environment. Carbon catabolite repression may impede the simultaneous and complete metabolism of sugars and aromatic compounds present in lignocellulosic biomass and hinder the development of an efficient industrial biocatalyst. This study provides insight into the cellular physiology and proteome during mixed-substrate utilization in P. putida M2. The phenotypic and proteomics results demonstrated simultaneous catabolite repression in the sugar-aromatic mixtures, while the CRISPRi and sRNA sequencing demonstrated the potential role of the crc gene and small RNAs in carbon catabolite repression.

59 BASIC BIOLOGICAL SCIENCES↗

Institutional and environmental problems in geothermal resource development

A number of regulatory and institutional impediments to the development of geothermal energy exist. None of these seem likely to prevent the development of this energy source, but in the aggregate they will pace its growth as certainly as the technological issues. The issues are associated with the encouragement of exploration and development, assuring a market for geothermal steam or hot water, and accomplishing the required research and development in a timely manner. The development of geothermal energy in the United States at a high level is apt to cause both favorable and unfavorable, though manageable, impacts in eight major areas, which are discussed.

Maslan, F.↗