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All sourcesNASA NTRSDOE OSTI
DOE OSTI2024

Analysis of the first ten years of FDA’s rare pediatric disease priority review voucher program: designations, diseases, and drug development

Abstract Background The Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program was enacted in 2012 to support the development of new products for children. Prior to requesting a voucher, applicants can request RPD designation, which confirms their product treats or prevents a rare disease in which the serious manifestations primarily affect children. This study describes the trends and characteristics of these designations. Details of RPD designations are not publicly disclosable; this research represents the first analysis of the RPD designation component of the program. Results We used an internal US Food and Drug Administration database to analyze all RPD designations between 2013 and 2022. Multiple characteristics were analyzed, including the diseases targeted by RPD designation, whether the product targeted a neonatal disease, product type (drug/biologic), and the level of evidence (preclinical/clinical) to support designation. There were 569 RPD designations during the study period. The top therapeutic areas were neurology (26%, n = 149), metabolism (23%, n = 131), oncology (18%, n = 105). The top diseases targeted by RPD designation were Duchenne muscular dystrophy, neuroblastoma, and sickle cell disease. Neonatology products represented 6% (n = 33), over half were for drug products and 38% were supported by clinical data. Conclusions The RPD PRV program was created to encourage development of new products for children. The results of this study establish that a wide range of diseases have seen development—from rare pediatric cancers to rare genetic disorders. Continued support of product development for children with rare diseases is needed to find treatments for all children with unmet needs.

Mease, Catherine (ORCID:000900050156198X)↗
NASA NTRS1991

Structural integrity of future aging airplanes

A multitude of design considerations is involved in ensuring the structural integrity of Boeing jet transports that have common design concepts validated by extensive analyses, tests, and three decades of service. As airplanes approach their design service objectives, the incidences of fatigue and corrosion may become widespread. Continuing airworthiness of the aging jet fleet requires diligent performance from the manufacturer, the airlines, and airworthiness authorities. Aging fleet support includes timely development of supplemental structural inspection documents applicable to selected older airplanes, teardown inspections of high-time airframes retired from service, fatigue testing of older airframes, and structural surveys of more than 130 airplanes operated throughout the world. Lessons learned from these activities are incorporated in service bulletin recommendations, production line modifications, and design manual updates. An overview of traditional Boeing fleet support activities and the anticipated benefits for future generations of commercial airplanes based on the continuous design improvement process are presented.

Aging Aircraft↗
NASA NTRS1990

Computer aided system engineering and analysis (CASE/A) modeling package for ECLS systems - An overview

An overview of the CASE/A-ECLSS series modeling package is presented. CASE/A is an analytical tool that has supplied engineering productivity accomplishments during ECLSS design activities. A components verification program was performed to assure component modeling validity based on test data from the Phase II comparative test program completed at the Marshall Space Flight Center. An integrated plotting feature has been added to the program which allows the operator to analyze on-screen data trends or get hard copy plots from within the CASE/A operating environment. New command features in the areas of schematic, output, and model management, and component data editing have been incorporated to enhance the engineer's productivity during a modeling program.

Dalee, Robert C.↗
NASA NTRS1993

IMAGE: A Design Integration Framework Applied to the High Speed Civil Transport

Effective design of the High Speed Civil Transport requires the systematic application of design resources throughout a product's life-cycle. Information obtained from the use of these resources is used for the decision-making processes of Concurrent Engineering. Integrated computing environments facilitate the acquisition, organization, and use of required information. State-of-the-art computing technologies provide the basis for the Intelligent Multi-disciplinary Aircraft Generation Environment (IMAGE) described in this paper. IMAGE builds upon existing agent technologies by adding a new component called a model. With the addition of a model, the agent can provide accountable resource utilization in the presence of increasing design fidelity. The development of a zeroth-order agent is used to illustrate agent fundamentals. Using a CATIA(TM)-based agent from previous work, a High Speed Civil Transport visualization system linking CATIA, FLOPS, and ASTROS will be shown. These examples illustrate the important role of the agent technologies used to implement IMAGE, and together they demonstrate that IMAGE can provide an integrated computing environment for the design of the High Speed Civil Transport.

Hale, Mark A.↗
DOE OSTI2021

A White Paper on Design and Fabrication of SRF Deflecting Cavities for Elletra-2

Synchrotron Trieste (ST) operates an X-ray light source Elettra and plans to upgrade it to a low-emittance high-brightness X-ray source Elettra-2.0 based on a multi-bend achromat lattice. There is also a significant interest among Elettra users to pursue time-resolved studies of matter choosing the appropriate X-ray pulse duration in the range from 20 picoseconds to a few picoseconds FWHM. Recently, X. Huang (SLAC) and A. Zholents (ANL) performed a study sponsored by ST and proposed modifications to the Elettra-2.0 design that will allow production of picosecond x-ray pulses on many beamlines. They showed that two radio frequency deflecting cavities with slightly different frequencies can be installed in the ring’s sector 8 and produce time-dependent orbit deflection to a few dedicated electron bunches without affecting other regular bunches. These special bunches produce X-ray pulses in which transverse position or angle, or both, are correlated with time. The short X-ray pulse is then obtained by using a narrow slit positioned downstream in the beamline. Many technical details of the proposed modification to Elettra-2.0 are discussed in the supplemental report. We present here the design of a multicell superconducting deflecting cavity for the purpose of the ST Short Pulse X-ray (SPX) project.

43 PARTICLE ACCELERATORS↗
DOE OSTI2025

Quantifying Climate Change Effects of Bioenergy and BECCS: Critical Considerations and Guidance on Methodology

Bioenergy is a critical element in many national and international climate change mitigation efforts, including as a carbon dioxide removal strategy combined with the capture and durable geological storage of flue gas emissions (BECCS). However, divergent results on the effectiveness of bioenergy as a climate change mitigation measure are reported in the scientific literature. Climate impacts of bioenergy depend on case-specific factors, primarily biophysical features of the biomass production system, and the design and efficiency of conversion and capture processes. Estimates of climate impacts are also strongly affected by methodological choices and assumptions, and much of the divergence between studies derives from differences in the assumed alternate use of the land or feedstock, the alternate energy source and the system boundaries applied. We present a methodology to support robust estimates of the climate change effects of bioenergy systems, updating the standard methodology developed by the International Energy Agency's Technology Collaboration Program on Bioenergy. We provide guidance on the key choices including the reference land use and energy system that bioenergy is assumed to displace, spatial and temporal system boundaries, co-product handling, climate forcers considered, metrics applied and time horizon of impact assessment. Researchers should consider the whole bioenergy system including all life cycle stages, and choose system boundaries, reference systems and treatment of co-products that are consistent with the intended application of the results. The assessment should be normalised to a functional unit that can be compared with other systems delivering an equivalent quantity of the same function. All significant climate forcers should be included, and climate effects should be quantified using appropriate impact assessment methods that distinguish the impact of time. Consistency in methodology and interpretation will facilitate comparison between studies of different bioenergy systems.

09 BIOMASS FUELS↗
NASA NTRS1973

Surface electrical properties experiment, part 1

The design evolution, hardware development, and production history of the surface electrical properties (SEP) experiment are discussed. The SEP transmitter and receiver were designed to be used on the lunar surface during the Apollo 17 mission. The equipment was used to measure lunar surface electrical properties over traverses totalling more than 8 kilometers, for a duration of more than 100 minutes. A comprehensive outline of the techniques, is given along with a simplified detailed breakdown of equipment description and function to outline the principles of operation. A history of the design evolution with trade-off criteria and emphasis on changes caused by decisions reached in solving problems inherent in a fast-paced development program are presented from the viewpoint of overall design concept and in detail for each item of deliverable hardware. There is a brief account of lunar operations.

Kupfer, W. S.↗
NASA NTRS2013

Development of Hybrid Product Breakdown Structure for NASA Ground Systems

The Product Breakdown Structure is traditionally a method of identification of the products of a project in a tree structure. It is a tool used to assess, plan, document, and display the equipment requirements for a project. It is part of a product based planning technique, and attempts to break down all components of a project in as much detail as possible, so that nothing is overlooked. The PBS for ground systems at the Kennedy Space Center is being developed to encompass the traditional requirements including the alignment of facility, systems, and components to the organizational hierarchy. The Ground Operations Product Breakdown Structure is a hybrid in nature in that some aspects of a work breakdown structure will be incorporated and merged with the Architecture Concept of Operations, Master Subsystem List, customer interface, and assigned management responsibility. The Ground Operations Product Breakdown Structure needs to be able to identify the flexibility of support differing customers (internal and external) usage of ground support equipment within the Kennedy Space Center launch and processing complex. The development of the Product Breakdown Structure is an iterative activity Initially documenting the organization hierarchy structure and relationships. The Product Breakdown Structure identifies the linkage between the customer program requirements, allocation of system resources, development of design goals, and identification logistics products. As the Product Breakdown Structure progresses the incorporation of the results of requirement planning for the customer occurs identifying facility needs and systems. The mature Product Breakdown Structure is baselined with a hierarchical drawing, the Product Breakdown Structure database, and an associated document identifying the verification of the data through the life cycle of the program/product line. This paper will document, demonstrate, and identify key aspects of the life cycle of a Hybrid Product Breakdown Structure. The purpose is to show how a project management and system engineering approach can be utilized for providing flexible customer service in an evolving manned space flight launch processing environment.

Monaghan, Mark W.↗
NASA NTRS2013

Development of Hybrid Product Breakdown Structure for NASA Ground Systems

The Product Breakdown Structure is traditionally a method of identification of the products of a project in a tree structure. It is a tool used to assess, plan, document, and display the equipment requirements for a project. It is part of a product based planning technique, and attempts to break down all components of a project in as much detail as possible, so that nothing is overlooked. The PBS for ground systems at the Kennedy Space Center is being developed to encompass the traditional requirements including the alignment of facility, systems, and components to the organizational hierarchy. The Ground Operations Product Breakdown Structure is a hybrid in nature in that some aspects of a work breakdown structure will be incorporated and merged with the Architecture Concept of Operations, Master Subsystem List, customer interface, and assigned management responsibility. The Ground Operations Product Breakdown Structure needs to be able to identify the flexibility of support differing customers (internal and external) usage of ground support equipment within the Kennedy Space Center launch and processing complex. The development of the Product Breakdown Structure is an iterative activity Initially documenting the organization hierarchy structure and relationships. The Product Breakdown Structure identifies the linkage between the customer program requirements, allocation of system resources, development of design goals, and identification logistics products. As the Product Breakdown Structure progresses the incorporation of the results of requirement planning for the customer occurs identifying facility needs and systems. The mature Product Breakdown Structure is baselined with a hierarchical drawing, the Product Breakdown Structure database, and an associated document identifying the verification of the data through the life cycle of the program/product line. This paper will document, demonstrate, and identify key aspects of the life cycle of a Hybrid Product Breakdown Structure. The purpose is to show how a project management and system engineering approach can be utilized for providing flexible customer service in an evolving manned space flight launch processing environment.

Monaghan, Mark W.↗
NASA NTRS2016

Characterization of Carbon Dioxide Washout Measurement Techniques in the Mark-III Space Suit

Providing adequate carbon dioxide (CO2) washout is essential to the reduction of risk in performing suited operations. Long term CO2 exposure can lead to symptoms such as headache, lethargy, dizziness, and in severe cases can lead to unconsciousness and death. Thus maintaining adequate CO2 washout in both ground testing and during in flight EVAs is a requirement of current and future suit designs. It is necessary to understand the inspired CO2 of suit wearers such that future requirements for space suits appropriately address the risk of inadequate washout. Testing conducted by the EVA Physiology Laboratory at the NASA Johnson Space Center aimed to characterize a method for noninvasively measuring inspired oronasal CO2 under pressurized suited conditions in order to better inform requirements definition and verification techniques for future CO2 washout limits in space suits. Prior work conducted by the EPL examined several different wearable, respirator style, masks that could be used to sample air from the vicinity surround the nose and mouth of a suited test subject. Previously published studies utilized these masks, some being commercial products and some novel designs, to monitor CO2 under various exercise and flow conditions with mixed results for repeatability and/or consistency between subjects. Based on a meta-analysis of those studies it was decided to test a nasal cannula as it is a commercially available device that is placed directly in the flow path of the user as they breathe. A nasal cannula was used to sample air inhaled by the test subjects during both rest and exercise conditions. Eight subjects were tasked with walking on a treadmill or operating an arm ergometer to reach target metabolic rates of 1000, 2000, and 3000 BTU/hr. Suit pressure was maintained at 4.3 psid for all tests, with supply flow rates of 6, 4, and 2 actual cubic feet per minute depending on the test condition. Each test configuration was conducted twice with subjects breathing either through their nose only, or however they felt comfortable. By restricting breathing through a single orifice, we are able to more accurately define exactly what flow stream the sampled CO2 is taken from. Oronasal CO2 was monitored using real time infrared gas analyzers fed via sample tubes connected to the nasal cannula within the suit. Two additional sampling tubes were placed at the head and chin of the test subject, in an effort to capture CO2 concentrations across the entire flow stream of the Mark-III vent system (flow path is head to neck). Metabolic rate was calculated via the exhaust CO2 concentration and used to adjust subject workload on either the treadmill or arm ergometer until the target was reached. Forward work will aim to characterize the historically accepted minimum ppCO2 in suit during EVA by repeating this study in the Extravehicular Mobility Unit (EMU) space suit. This will help to define washout requirements for future suits, be they NASA (e.g. Z-2) or Commercial Crew designed. Additionally it is important to determine the functional consequences of CO2 exposure during EVA. Severe CO2 symptoms are a result of very high concentration, acute exposures. While long term, low concentration exposures have been shown to result in slight cognitive decline, symptoms resolve upon quickly returning to nominal concentrations and it remains unknown the impact that minor deficits in cognitive performance can have on EVA performance.

Norcross, J.↗
DOE OSTI2023

Editorial: Synthetic metabolism for the third-generation (3G) biorefineries

The demand for energy has increased significantly to meet the development of the economy and the increasing population. With the continuous consumption of energy, the shortage of non-renewable resources and the greenhouse effect have aroused worldwide attention. Therefore, the conversion of one-carbon substrates such as formate, methanol, and carbon dioxide (CO 2 ) as sustainable feedstocks into high-value-added products is a potential way to address such concerns. Although one-carbon substrates can be converted into organics by natural pathways, these pathways may not be optimal due to the multiple enzymes involved and remarkable amounts of energy consumption. Thus, synthetic biology, as an emerging field, offers a new approach to boost one-carbon bioconversion.

09 BIOMASS FUELS↗
DOE OSTI2020

Computational Fluid Dynamics of Bioreactors with Micro-Aeration

Recent work has probed the potential for using Zymomonas mobilis as a flexible platform for the production of advanced fuels and intermediates. One set of recombinant organisms requires a micro-aerobic environment to promote the production of the desired product (2,3-BDO), but the economics and process-control implications of this approach are uncertain at industrial scale. Computational multi-physics models have the potential to describe the fermentation in detail at multiple scales, reducing the risk of scale-up. A two-phase Euler-Euler CFD model is used alongside a simple model of oxygen uptake to describe this bioreaction. A few reactor vessels, including airlift and CSTR bioreactors, are analyzed at multiple scales, regions of oxygen-depletion and over-oxygenation are characterized, and the bioreactors are compared. We show that it is difficult to achieve homogenous oxygen concentrations in industrial-scale CSTR reactors and that advanced bioreactor designs are needed for economical operation.

09 BIOMASS FUELS↗
DOE OSTI2022

Development of an open-source segmented blade design tool

As wind turbines continue to grow ever larger to reduce the cost of energy, their blades follow suit, with the largest commercial offshore blades extending past 100 m. Massive blades such as these raise key transportation and manufacturing challenges, especially for land-based turbines. Segmented blades are one solution and are garnering increased industry and research interest. In this work, a detailed mechanical joint model is integrated into the Wind-Plant Integrated System Design and Engineering Model (WISDEM ® ), which will facilitate future segmented blade research and optimization. WISDEM is used to design a wind turbine with 100-m segmented blades. This wind turbine design is compared to other machines with 100-m monolithic blades designed for rail-transportability. The designs are compared in terms of blade mass and cost, turbine capital cost, annual energy production, and levelized cost of energy, with monolithic designs being the lightest and most economical. However, this result may vary by wind plant location. A variety of segmentation joint types exist, and they will inevitably vary in parameters such as cost, spanwise location, and physical characteristics. This work examines the sensitivity of wind turbine design drivers and annual energy production to a variety of the aforementioned parameters, using the open-source wind turbine design codes OpenFAST and WISDEM, finding that joint mass, stiffness, and location can have significant effects on design drivers.

17 WIND ENERGY↗
DOE OSTI2025

Microwave-Assisted Activation of Mo/HZSM5 in Methane Dehydroaromatization

Natural gas flaring is a significant challenge for oil and gas producers. One viable option to mitigate flaring is the conversion of natural gas into valuable chemicals. Applying microwave energy to heterogenous catalyst materials offers advantages in terms of higher rates and product selectivities in comparison to traditional thermal systems which can be designed for on-demand chemical production in modular reactor systems. Methane dehydroaromatization (MDHA) produces transportable, liquid aromatic products directly from natural gas, which is ideal for remote production but is hindered by low thermodynamic yields and rapid deactivation. The stability and performance of the Mo/ZSM5 catalyst is often determined by the state and nature of Mo in the catalyst, which in turn is dictated by the temperature and gaseous environment during catalyst activation. In this study, the Mo/HZSM5 catalyst was activated under three different heating modes (thermal, microwave E-field, and microwave H-field) and four different gas environments (CO, He, CH4+H2, and H2). All the activated catalysts were characterized using different tools and performance evaluated in MDHA.

methane dehydroaromatization↗
NASA NTRSDate not supplied

Gateway Program Safety And Mission Assurance Integration - The Future Of Safe Deep Space Human Exploration

This next wave of lunar exploration will be fundamentally different than the past. The goal today is long term human presence in Earth orbit, exploration around the Moon, exploration anywhere on the Moon, and challenging exploration missions beyond the Moon. Sustainability is the key to enabling human expansion across the solar system and bringing back to Earth new knowledge and opportunities, and requires the early engagement of scientific, international, and U.S. commercial interests, innovations, and new approaches. The Gateway’s agile acquisition strategy will shape the entire system life cycle, from design and analysis through production, verification, launch, logistics and operations. This strategy will encourage new ways of doing business to accommodate new techniques, technologies and approaches; improving affordability and maximizing Gateway utility. The full range of acquisition authorities and contracting mechanisms available to NASA will be considered and appropriately tailored in response to the unique demands of each procurement activity. Gateway will provide scientific and research benefits, in addition to providing a sustainable staging location for crewed lunar surface landings and technology demonstrations that help NASA develop the knowledge and technology needed for Mars missions. These payloads are expected to provide operational and scientific benefit for the duration of their stay on Gateway, as the hardware will provide data during the transit to the Gateway and while in lunar orbit as changes in solar activity occur over time. Gateway is designed to support a variety of utilization activities during both crewed and uncrewed periods and is planned for continuous operations throughout its lifetime. These operations include demonstrating key exploration capabilities in a relevant deep space environment, conducting science beyond the influence of Earth, and providing opportunities for Gateway partners and customers for deep space exploration. Located in cislunar orbit, the Gateway capabilities can be further leveraged to enhance lunar and Mars exploration. With the Gateway and other elements of the Artemis Program, NASA is encouraging new ways of doing business to accommodate new techniques, technologies and approaches, consider affordability, and encourage innovation from U.S. industry.

Helen Vaccaro↗
NASA NTRSDate not supplied

Gateway Program Safety and Mission Assurance IAASS Conference Keynote Presentation

This next wave of lunar exploration will be fundamentally different than the past. The goal today is long term human presence in Earth orbit, exploration around the Moon, exploration anywhere on the Moon, and challenging exploration missions beyond the Moon. Sustainability is the key to enabling human expansion across the solar system and bringing back to Earth new knowledge and opportunities, and requires the early engagement of scientific, international, and U.S. commercial interests, innovations, and new approaches. The Gateway’s agile acquisition strategy will shape the entire system life cycle, from design and analysis through production, verification, launch, logistics and operations. This strategy will encourage new ways of doing business to accommodate new techniques, technologies and approaches; improving affordability and maximizing Gateway utility. The full range of acquisition authorities and contracting mechanisms available to NASA will be considered and appropriately tailored in response to the unique demands of each procurement activity. Gateway will provide scientific and research benefits, in addition to providing a sustainable staging location for crewed lunar surface landings and technology demonstrations that help NASA develop the knowledge and technology needed for Mars missions. These payloads are expected to provide operational and scientific benefit for the duration of their stay on Gateway, as the hardware will provide data during the transit to the Gateway and while in lunar orbit as changes in solar activity occur over time. Gateway is designed to support a variety of utilization activities during both crewed and uncrewed periods and is planned for continuous operations throughout its lifetime. These operations include demonstrating key exploration capabilities in a relevant deep space environment, conducting science beyond the influence of Earth, and providing opportunities for Gateway partners and customers for deep space exploration. Located in cislunar orbit, the Gateway capabilities can be further leveraged to enhance lunar and Mars exploration. With the Gateway and other elements of the Artemis Program, NASA is encouraging new ways of doing business to accommodate new techniques, technologies and approaches, consider affordability, and encourage innovation from U.S. industry.

Terri Castillo↗
NASA NTRS1989

Flexibility in space solar cell production

The wide range of cells that must be available from present-day production lines for space solar cells are described. After over thirty years of space-cell use, there is very little standardization in solar cell design. It is not generally recognized what a wide range of designs must remain available on cell production lines. This range of designs is surveyed.

Khemthong, Scott↗
NASA NTRSDate not supplied

Detecting and Characterizing Patterns of Failure in Complex Engineered Systems: an Ontology Development and Clustering Approach

While the causes of failures in complex engineered systems are often clear in hindsight, it can be challenging to predict failures proactively during the design of novel engineered products or systems. Identifying patterns can be useful for capturing common characteristics that may lead to failure. In this paper, we present a methodology for identifying patterns of failure from NASA’s publicly available Lessons Learned Information System (LLIS). We apply an ontology development and clustering approach to identify representative patterns leading to failures in historical lessons learned. A joint inductive-deductive approach reveals the key themes in lessons that lead to failure, which are formalized and recorded as an ontology of complex systems failure causes. Documents from the LLIS are manually tagged with relevant characteristics from the ontology. From the tagged set, clustering is used to capture co-occurring sets of characteristics that lead to failure. The primary contribution of this work is a method for extracting a set of generic failure patterns in complex engineered systems and characteristics for these patterns that can be identified at design time, knowledge of which can be used to plan mitigation strategies.

Systems Engineering↗