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Search indexed NASA NTRS and DOE OSTI research on propulsion, heat transfer, battery materials and energy systems. Follow report and document links to the original sources.

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At least 73 records · Page 4
All sourcesNASA NTRSDOE OSTI
DOE OSTI2025

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

Background/aims Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research over the past decade and characterized key regulatory and trial design elements with a focus on the primary efficacy endpoint utilized as the basis of approval. Methods Using the Food and Drug Administration’s Data Analysis Search Host database, we identified novel new drug applications and biologics license applications with orphan drug designation that were approved between 2013 and 2022 for non-oncologic indications. From Food and Drug Administration review documents and other external databases, we examined characteristics of pivotal trials for the included drugs, such as therapeutic area, trial design, and type of primary efficacy endpoints. Differences in trial design elements associated with primary efficacy endpoint type were assessed such as randomization and blinding. Then, we summarized the primary efficacy endpoint types utilized in pivotal trials by therapeutic area, approval pathway, and whether the disease etiology is well defined. Results One hundred and seven drugs that met our inclusion criteria were approved between 2013 and 2022. Assessment of the 107 drug development programs identified 150 pivotal trials that were subsequently analyzed. The pivotal trials were mostly randomized (80%) and blinded (69.3%). Biomarkers (41.1%) and clinical outcomes (42.1%) were commonly utilized as primary efficacy endpoints. Analysis of the use of clinical trial design elements across trials that utilized biomarkers, clinical outcomes, or composite endpoints did not reveal statistically significant differences. The choice of primary efficacy endpoint varied by the drug’s therapeutic area, approval pathway, and whether the indicated disease etiology was well defined. For example, biomarkers were commonly selected as primary efficacy endpoints in hematology drug approvals (70.6%), whereas clinical outcomes were commonly selected in neurology drug approvals (69.6%). Further, if the disease etiology was well defined, biomarkers were more commonly used as primary efficacy endpoints in pivotal trials (44.7%) than if the disease etiology was not well defined (27.3%). Discussion In the past 10 years, numerous novel drugs have been approved to treat non-oncologic rare diseases in various therapeutic areas. To demonstrate their efficacy for regulatory approval, biomarkers and clinical outcomes were commonly utilized as primary efficacy endpoints. Biomarkers were not only frequently used as surrogate efficacy endpoints in accelerated approvals, but also in traditionally approved rare disease drugs. The choice of primary efficacy endpoints varied by therapeutic area, approval pathway, and understanding of disease etiology.

Hong, Kyungwan [Rare Diseases Team, Office of New ↗
DOE OSTI2022

How much have adverse occupational health outcomes among construction workers improved over time? Evidence from 25 years of medical screening

Background Construction workers have always had a high risk of occupational illnesses. We used 25 years of data from a medical screening program serving older construction workers to determine how much health outcomes have improved over the past 60 years. Methods We investigated changes in relative risk for chest radiographs consistent with pneumoconiosis, COPD by spirometry, lung cancer mortality, and audiometry-assessed hearing impairment among workers participating in a medical screening program. Results were stratified by decade of first construction employment: before 1960, 1960–1969, 1970–1979, 1980–1989, and after 1990. Poisson and Cox regression analyses assessed relative risk by decade adjusted for age, sex, smoking, and years of construction trade work. Results Subjects were 94% male and, on average, 60 years old with 25 years of construction work. When compared to workers employed before 1960, those first employed after 1990 experienced the following reductions in model-adjusted relative risks: chronic obstructive pulmonary disease, 32%; all pneumoconiosis, 68%; parenchymal abnormalities, 35%; pleural abnormalities, 71%; hearing impairment, 20%; and lung cancer mortality, 48%. Risks started to decline in the 1960s with greatest reductions among workers first employed after 1970. Conclusions This study demonstrates the positive impact that adoption of occupational health protections have had over the past 60 years. The greatest risk reductions were observed for outcomes with strong regulatory and legal incentives to reduce exposures and associated risks, such as those associated with inhalation hazards (asbestos and silica), while lowest improvement was for hearing impairment, for which little regulatory enforcement and few prevention incentives have been adopted.

60 APPLIED LIFE SCIENCES↗
DOE OSTI2023

Nuclear Criticality Safety Pipeline Course with Hands-On Experimental Training at Lawrence Livermore's Inherently Safe Subcritical Assembly Training Center

The Nuclear Criticality Safety Divisions at Lawrence Livermore National Laboratory (LLNL) and Los Alamos National Laboratory (LANL) have partnered with Prof. Massimiliano Fratoni of the University of California Berkeley to offer a semester long course on nuclear criticality safety. This course is part of a larger pipeline project among many of the Department of Energy (DOE) laboratories designed to stimulate student interest in the field of criticality safety. The course focuses on teaching the fundamentals of criticality safety, familiarity with national and consensus standards, and preparing criticality safety evaluations. Students also receive hands-on experience with special nuclear material by performing experiments with the Inherently Safe Subcritical Assembly (ISSA) at LLNL. Guest lectures are taught remotely and in-person by criticality safety engineers at LLNL and LANL, giving students an opportunity to interact with professionals in the field. The students complete a semester long project involving developing and writing a criticality safety evaluation. As universities tend to focus heavily on nuclear power and advanced nuclear reactor design, this course gives students a better understanding and perspective of what criticality safety entails. The goal of this pipeline course is to introduce students to criticality safety as another available field for nuclear engineers. It is also a way for criticality safety programs to identify talented students who have the interest and aptitude to work in criticality safety for hire upon graduation. LLNL and LANL have both hosted past students as summer students, participated in student's graduate projects, and hired students as criticality safety engineers. This has provided a unique opportunity for criticality safety programs to spot young talent with better retention outcomes.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗
DOE OSTI2024

Bringing Alaska's Carbon Ore, Rare Earth, and Critical Minerals (CORE-CM) into Perspective

The final report outlines the outcomes of the Alaska CORE-CM Program, funded by the U.S. Department of Energy under award DE-FE0032050. Led by the University of Alaska Fairbanks and the Alaska Division of Geological and Geophysical Surveys, with assistance from other organizations, the project assessed Alaska's potential for Carbon Ore, Rare Earth Elements, and Critical Minerals (CORE-CM). Leveraging advanced analytical techniques, the project identified high-potential resource basins, evaluated geochemical and satellite data, and conducted targeted field investigations. Findings revealed promising concentrations of critical minerals in legacy samples and newly collected materials. The project also investigated innovative extraction technologies, including BioExtraction and use of supercritical CO2, which show significant promise for sustainable resource recovery. Additionally, the study explored the reuse of waste streams from active mining operations and coal byproducts such as using alkali-activated coal ash to manufacture concrete. Infrastructure and logistical challenges in Alaska’s remote regions are discussed, alongside strategies to establish a Technology Innovation Center aimed at advancing CORE-CM development in Alaska. The report includes actionable insights to support Alaska’s critical role in securing domestic supplies of essential minerals while addressing economic, environmental, and technological challenges.

01 COAL, LIGNITE, AND PEAT↗
DOE OSTI2020

IMPLEMENTING CYBERSECURITY INTO AN EXISTING NATIONAL NUCLEAR NON-PROLIFERATION PROGRAMME – A CASE STUDY

Cyber threat profiling and risk mitigation is critical to any nuclear state organization and should be considered as part of any comprehensive nuclear security programme. Defining and evaluating the impact of the cyber threat to mission can be challenging. An existing national nuclear non-proliferation organization undertook an effort to incorporate computer security activities into its programme to address cyber risk. One of the primary goals of this endeavour was to develop a set of prioritised recommendations for organizational follow-through. The organization dedicated subject matter expert resources in the form of a cyber task force to support this goal. Opportunities were identified where computer security could be built into each programme including office-level strategies and tools. Of course, no new identified threat vector is easily considered and incorporated into existing programmes without impact. There are many obstacles to be overcome. Technically literate subject matter experts are difficult to find, management has comparatively less experience applying computer security into its programmes, and trying to change the culture to consider computer security risk at policy and programmatic levels takes time and management attention. As an outcome of this process, a roadmap for program integration was developed, including the establishment of a cyber support team. This paper will discuss the challenges and successes associated with establishing such a team.

Cyber Security, Nuclear, Non-proliferation↗
DOE OSTI2023

Waste-to-Energy Technical Assistance for Local Governments

The goal of this project is to mobilize data, information, and knowledge generated about organic waste streams to local governments and support their decision-making. It builds on previous work related to wet organic waste resources (food waste, sludge, manure, waste fats and oils). The project provides an improved understanding of local waste challenges and priorities to inform BETO's R&D strategies and decision-making. It also supports local governments' goals and plans related to sustainable waste management, enables energy and/or resource recovery projects development at municipal level, and facilitates public-private partnerships. A key challenge is associated with more activities requested by entities than program allows which is mitigated by prioritization by requesting agency. All FY21 and FY22 TA requests have been completed. Major accomplishments include: 1). 34 requests managed in the past two years, 2) Distilled key challenges faced by communities. Key outcomes include strong community participation since inception of the program, dedicated program web site, deliverables tailored to communities' needs, and distribution materials (e.g., fact sheets, brochures) for a broader audience.

BIOMASS FUELS↗
DOE OSTI2026

Estimating Return on Investment for Energy Technical Assistance Programs

The U.S. Department of Energy's Office of State and Community Energy Programs engaged the National Laboratory of the Rockies to assess the return on investment (ROI) of technical assistance (TA) programs that support state, local, and Tribal energy planning. Although TA delivers value through capacity building, stakeholder engagement, and knowledge transfer, these benefits are often intangible and challenging to monetize. This study reviews existing ROI frameworks and synthesizes the most relevant elements into a hybrid approach tailored to energy TA programs. The proposed framework integrates monetary and non-monetary outcomes through early logic model development, baseline data collection, and the use of proxies for intangible benefits. As a case study, this paper applies this approach to the Communities Local Energy Action Program (Communities LEAP), demonstrating how ROI can inform program design, data strategy, and performance assessment. Findings underscore that ROI should be applied selectively and planned from the outset to ensure data alignment and attribution accuracy. The framework offers TA practitioners a structured approach that can be leveraged for future programs to evaluate and communicate the multifaceted value of TA investments.

29 ENERGY PLANNING, POLICY, AND ECONOMY↗
DOE OSTI2020

Herding Cats: Firm Non-Compliance in China’s Industrial Energy Efficiency Program

Here we study firm responses to a large-scale energy efficiency program in China, focusing on the quality of reporting and compliance outcomes. Using statistical methods to detect data manipulation in compliance reports, we find evidence that firms deliberately exaggerated performance during the first phase of the program (2006-2010), suggesting the high compliance rate was overstated. In its second phase (2011-2015), the number of firms in the program expanded by an order of magnitude, and the compliance rate decreased. We develop a simple model to show how the observed increase in non-compliance is consistent with reduced misreporting. Statistical tests find no evidence of manipulation in the second phase. Larger firms, especially those not controlled by the state, and firms in cities with relatively low growth were more likely to report non-compliance, which suggests a role for state control and local protectionism in shaping compliance decisions. Based on our findings, we offer several lessons for future program design.

29 ENERGY PLANNING, POLICY, AND ECONOMY↗
DOE OSTI2025

S&TR July-August: Beyond Ignition

On December 5, 2022, Lawrence Livermore’s National Ignition Facility achieved the first-ever successful positive-gain ignition shot. This scientific advance, heralded worldwide, required a multidecadal effort to synthesize physics theory, laser technologies, computation and diagnostic capabilities, as well as engineering, materials development, and other inputs. The question, “Can ignition be achieved?” had been answered. Since then, the Laboratory has answered the question, “Can we do it again?” with additional ignition shots at increasing yield. Now Lawrence Livermore researchers ask, “Can we improve ignition outcomes?” for the benefit of the Stockpile Stewardship Program. Interrelated articles presenting the Laboratory’s ignition science, the role of supercomputing in achieving ignition, the evolution of diagnostic instruments to measure ignition data, and the ambitious steps required to realize a fusion energy future lead to one answer: “Yes, we can.”

70 PLASMA PHYSICS AND FUSION TECHNOLOGY↗
DOE OSTI2022

Carbon and energy cost impacts of electrification of space heating with heat pumps in the US

In order to meet climate goals, it will be necessary to significantly reduce the greenhouse gases emitted by homes. A key factor in the US is to reduce the on-site combustion of fossil fuels for heating end-uses and to replace this with use of electric heat pump technologies connected to a low-carbon grid. The replacement of natural gas furnaces with electric heat pumps is a key home decarbonization strategy. However, the potential for space heating electrification to reduce greenhouse gas emissions depends on the carbon dioxide equivalent (CO 2 e) content of the electricity used by the heat pump. This varies considerably depending on the source of electricity, with large state to state variability. Furthermore, household energy costs are likely to be impacted by the electrification of space heating, because retail energy prices for both natural gas and electricity in each state vary by factors of seven and four, respectively. Contractors, energy programs, government and building code officials, as well as consumers need clear indications of the likely CO 2 e and energy cost impacts of proposed electrification projects, because these will affect decarbonization choices and rationales around scaled heating electrification. Government and utility programs also need to be aware of the likely outcomes of any supported/incentivized measures. Here, in this paper, we investigate these effects by looking at new metrics to analyze the change in CO 2 e emitted and the cost to meet home heating loads when switching from a natural gas furnace to a heat pump for the contiguous 48 states of the mainland US.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗
DOE OSTI2020

Study of correlation effects in nuclei at the limit of stability. Final report

Exotic nuclei far from the valley of stability are a particularly exciting testing ground to probe nucleon-nucleon correlations in a regime where the numbers of constituent protons and neutrons are out of balance and the influence of isospin-dependent terms within the nuclear force becomes amplified. The grant DE-FG02-08ER41556 has supported from 2008 to 2019 an MSU graduate student research assistantship at the heart of a research program that explored the evolution of nuclear structure in exotic nuclei with gamma-ray spectroscopy experiments in the N=40 region of neutron-rich nuclei at NSCL and at ATLAS at Argonne National Laboratory and that mounted a new low-energy Coulomb excitation program at NSCL’s ReA accelerator within the PI’s research program. This final scientific/technical report describes the results and outcomes resulting from the support by the Department of Energy, Office of Science, Office of Nuclear Physics.

73 NUCLEAR PHYSICS AND RADIATION PHYSICS↗
DOE OSTI2026

California Bridge to the Electron-Ion Collider (EIC) (Final Technical Report)

This report summarizes the activities and outcomes of DOE Grant DE-SC0022358, a traineeship program designed to prepare students for future nuclear physics research at the Electron-Ion Collider. The project leveraged the California EIC Consortium and statewide academic networks to provide immersive research experiences spanning universities and national laboratories. Participants engaged in theoretical, computational, and experimental research related to EIC physics and took part in professional meetings and collaborative research activities. The program supported student preparation for advanced study and research careers in nuclear physics.

73 NUCLEAR PHYSICS AND RADIATION PHYSICS↗
DOE OSTI2026

Final Technical Report for GROWTH-MSI at Sonoma University

This final technical report describes the goals, activities, outcomes, and broader impacts of the GROWTH-MSI program, supported through the DOE RENEW Initiative in High Energy Physics. The program established a 1.5-year traineeship for undergraduate students from six Northern California Minority Serving Institutions, connected students with DOE laboratory research mentors, provided particle physics coursework and professional development, and advanced HEP research infrastructure at CSU Stanislaus and Sonoma State University.

72 PHYSICS OF ELEMENTARY PARTICLES AND FIELDS↗
DOE OSTI2021

Who is participating in residential energy efficiency programs? Exploring demographic and other household characteristics of participants in utility customer-funded energy efficiency programs

In addition to benefiting all customers by reducing the total electric system cost, utility customer-funded energy efficiency programs provide direct benefits to the participants. Understanding the current demographic and household characteristics of participants will help assess the extent of inequities in program participation and figure out what characteristics need to be targeted to achieve equitable outcomes. This report describes how 11 demographic and household characteristics including income, race and ethnicity, and education affect participation in residential utility customer-funded energy efficiency programs. It compiles previous work on this topic and adds new primary analysis of four datasets with different levels of detail from the Residential Energy Consumption Survey (RECS), two New England states, and a Midwestern state.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗
DOE OSTI2022

Experimental demonstration of OSC at IOTA: IOTA Run #3 (Report)

Optical Stochastic Cooling (OSC) is an optical-bandwidth extension of Stochastic Cooling that could advance the state-of-the-art cooling rate in beam cooling by three to four orders of magnitude. The concept of OSC was first suggested in the early 1990s by Zolotorev, Zholents and Mikhailichenko, and replaced the microwave hardware of SC with optical analogs, such as wigglers and optical amplifiers. A number of variations on the original OSC concept have been proposed, and while a variety of proof-of-principle demonstrations and operational uses have been considered, the concept was not experimentally demonstrated up to now. An OSC R&D program has been underway at IOTA for the past several years. Run #3 of the IOTA ring, which began in Nov. 2020 and concluded in Aug. 2021, was focused on the world’s first experimental demonstration of OSC. The experimental program was successful in demonstrating and characterizing the OSC physics with the major outcomes including strong cooling in one, two and three dimensions, validation of the theoretical models of OSC and the demonstration of OSC with a single electron. This report briefly describes the activities and major milestones of the OSC program during Run #3.

42 ENGINEERING↗
DOE OSTI2025

Work In Progress: Using Internships as Means for Indirect Assessment of ABET Criteria 3 “1-7” Student Outcomes

The Electrical & Computer Engineering (ECE) Department at Portland State University (PSU) has developed a Power Engineering Internship (PEI) program that provides engineering career development pathways within the electric utility industry. The PEI is supported by several U.S. Department of Energy grants that aim to develop quality career opportunities and develop a future electric utility workforce that represents the nation’s diverse populations. The PSU ECE Department intends to use surveys of internship participants as assessment tools for its ABET accreditation process, in particular, the ABET Criteria 3 Student Outcomes (SOs). SOs relate to the knowledge, skills, and behaviors that students acquire as they progress through an engineering program [1]. They describe what engineering students are expected to know and should be able to do by the time they graduate. Engineering education literature presents multiple methods for using internships as means for assessing SOs. Methods include using self-assessments that derive from internship experiences as well as mapping survey responses from employers and interns to SOs. Such methods gain value as they are assessed over multiple years. However, the majority of this literature discusses assessment tools that were developed for the ABET 2000 Criteria 3 “a through k” SOs. One of our motivations is to provide assessment tools that can be used to assess modern Criteria 3 SOs based on students’ internship experiences.

Bass, Robert [Portland State University]↗
DOE OSTI2021

BETO 2021 Peer Review: 2.1.0.100 - Biochemical Platform Analysis

The objective of this project is to perform techno-economic analysis (TEA) to guide Biochemical Platform efforts, utilizing models for purposes of setting future R&D targets and tracking performance progress against those targets. Outcomes of our work are leveraged by BETO to guide program plans, as well as by other NREL/partner projects to quantify the impact of research on key technology barriers and to prioritize future efforts. This project provides high impact and relevance through establishing “bottom-up” TEA models as a basis for understanding the technical feasibility to meet “top-down” BETO cost targets. By providing a framework to translate technical performance to cost reductions in a biorefinery, our TEA models may be leveraged to maximize the efficiency of research funding towards the most economically impactful priorities, ultimately in support of BETO’s 2030 fuel cost targets below $2.5/GGE. In order to mitigate a key risk/challenge to this project in overly-constraining our analyses to a singular technology focus or TEA metric, our approach continuously re-assesses opportunities for better optimization and alternative technology pathway options, while maintaining close interaction with other BETO analysis partners. We have made numerous recent accomplishments rooted around identifying and working with the researchers to solve key technical and TEA/LCA challenges, reflected through notable improvements in State-of-Technology (SOT) updates over prior benchmarks.

biochemical↗