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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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All sourcesNASA NTRSDOE OSTI
DOE OSTI2021

Recommended Practices for Managing Induced Seismicity Risk Associated with Geologic Carbon Storage

The geologic storage of carbon dioxide (CO 2 ) is one method to help reduce or eliminate atmospheric CO 2 emissions. The sequestered CO 2 is originally captured from the atmosphere or from a stationary industrial source and subsequently injected into a deep subsurface porous rock formation. To facilitate the successful deployment of field scale carbon storage projects, the U.S. Department of Energy (DOE) is developing tools and protocols for defensible, science-based frameworks to quantify and mitigate risks associated with the long-term storage of CO 2 . This protocol specifically addresses the risk of induced seismicity due to injection in a geologic carbon storage (GCS) site. This integrated and risk-based protocol is a product of the U.S. DOE Fossil Energy’s National Risk Assessment Partnership (NRAP), a multi-year collaborative research effort of Los Alamos National Laboratory (LANL), Lawrence Berkeley National Laboratory (LBNL), Lawrence Livermore National Laboratory (LLNL), National Energy Technology Laboratory (NETL), and Pacific Northwest National Laboratory (PNNL). These recommended practices describe a set of 7 steps to evaluate, manage, communicate, and mitigate the risk of induced seismicity at GCS sites. The base methodology of the recommended practices follows a framework similar to the $\textit{Protocol for Addressing Induced Seismicity Associated with Enhanced Geothermal Systems}$ (Majer et al., 2012), developed for the Geothermal Technology Office of the U.S. DOE. These recommended practices present a framework to systematically assess the induced seismicity risk and quantify the associated uncertainties. These recommendations are based on current research and are sufficiently general to allow for modification and application to a variety of different types of sites. The substance of the recommended practices contained herein includes both technical and non-technical issues, and covers all operational stages of the GCS project lifecycle. They start at the preliminary risk assessment phase, continue through site assessment and characterization, include best practice communication and seismic monitoring plan methodologies, discuss the evaluation and mitigation of seismic hazard and risk, and closes with an exploration of operational management plans, which conclude when the induced seismicity risk abates back to background level. The focus of these recommendations is on actively managing the risks associated with induced seismicity by developing an actionable risk management plan that starts at the project proposal stage and continues through site closure through an iterative assessment and improvement process. The audience of this document is expected to include all interested stakeholders (e.g., operators, project developers, regulators, and the general public) and is expressly written to be accessible to this broad range of partners. This document is intended to disseminate knowledge gained through recent advances in the science of induced seismicity hazard and risk assessments, to provide updates based on recent experience gained by similar corollary injection-induced seismicity cases, and most importantly to establish a uniform framework to carry out a successful induced seismicity risk management plan for carbon storage projects in the future. These recommendations do not directly address any domestic or international regulations or standards. A complementary NRAP report makes recommendations for the assessment and management of environmental subsurface risks associated with unwanted fluid migration at GCS sites (Thomas et al., 2021) and should be referred to in order to address those additional GCS site risks

58 GEOSCIENCES↗
NASA NTRS2022

Recommendations on the Use of Commercial-Off-The-Shelf (COTS) Electrical, Electronic, and Electromechanical (EEE) Parts for NASA Missions - Phase II

This assessment had two Phases. Phase I captured NASA Centers’ current practices for commercial-off-the-shelf (COTS) Electrical, Electronic, and Electromechanical (EEE) parts 1 used in spaceflight systems and ground support equipment (available at https://ntrs.nasa.gov/citations/20205011579) [ref. 1]. The Phase II report provides guidance for selecting and using COTS parts in NASA missions. The approaches proposed in this report differ from current agency practices. This top-level executive summary touches on these new approaches for using COTS parts but does not provide the detailed information that is critical in understanding the rationale behind these new approaches. Readers will need to read the entire report to gain full understanding and effectively use the recommendations herein. NASA’s historical approach to selecting and applying parts has been to define certain parts, primarily specific classes of military specification (MIL-SPEC) parts, as “standard”, leaving all others, including COTS parts, as nonstandard. Standard parts typically are used without further testing (“use-as-is”). Nonstandard parts are subjected to initial screening and subsequent lot acceptance testing of representative samples from each procured lot per MIL-SPEC or similar requirements. Decades later, top-tier commercial part manufacturers have evolved significant manufacturing, statistical control, and technological improvements that can now provide parts as reliable or more reliable than MIL-SPEC parts, when used within their datasheet limits. Concurrently, the space science and exploration community’s needs demand technological advances unavailable with MIL-SPEC parts. This ongoing change necessitates using COTS parts for space missions. Properly selected COTS parts in appropriate applications can offer performance and supply availability advantages compared to MIL-SPEC parts. Their utility and demonstrated reliability result from large volumes and automated production and testing processes. However, careful review and a thorough understanding of their specifications (i.e., datasheet limitations) is needed, and verifying that manufacturer specifications and reliability meet space hardware application needs are necessary. This report recommends MIL-SPEC screening and non-radiation-related lot acceptance testing be reduced or eliminated in cases where evidence of sufficient quality and reliability exists for COTS parts. The extent of NASA's insight into COTS manufacturers and the amount and nature of the needed evidence will differ by mission and will likely be driven by a mission's resources and associated risk posture. To facilitate this goal, two new terminologies have been defined and described: “Industry Leading Parts Manufacturer (ILPM)” and “Established COTS parts.” An ILPM is a COTS manufacturer that produces high quality and reliable parts. Some parts produced by ILPMs, defined as Established COTS parts, do not need any additional MIL-SPEC or NASA screening and lot acceptance testing to be used in space applications. This report provides guidance for selecting, procuring, and applying COTS parts and for performing part-, board-, and system-level COTS parts verification. The recommendation to select Established COTS parts from ILPMs will assure those COTS parts will have comparable quality to corresponding MIL-SPEC parts. Selecting, applying, and verifying Established COTS parts from ILPMs requires a holistic team approach, engaging parts engineers, circuit designers, quality, reliability, and systems engineers, procurement specialists, radiation specialists, avionics leads, and program/project managers. A mission-specific approach tailored to a project’s Mission, Environment, Applications and Lifetime (MEAL) [ref. 2] requirements should be developed and approved by program/project managers. Any associated risks should be clearly identified, quantified, mitigated, and/or accepted. Different approaches are recommended according to program/project Risk Classes A, B, C, and D [ref. 3] and human-rated missions [ref. 4]: 1. Recommend Classes A and B and human-rated missions consider a “MIL-SPEC parts- based design” approach. ”MIL-SPEC parts-based design” approach is one in which most parts are MIL-SPEC parts and Established COTS parts from ILPMs are used only when an equivalent MIL-SPEC part does not meet functional or size, weight, and power (SWaP) or performance requirements, or is not available. 2. Recommend Classes D and Sub-D missions consider a “System of COTS” approach. “System of COTS” approach is one which most parts are Established COTS parts from ILPMs. 3. Recommend Class C missions determine which approach is the best for their projects; that is, use either a “MIL-SPEC parts-based design” approach, “System of COTS” approach, or a combined approach utilizing elements of both. This report intends to provide guidance in using COTS parts for NASA missions with risk classifications of A through D and human-rated missions; but it does not address the costs of using COTS parts. Costs of using COTS parts in different NASA mission classes can vary significantly even if the same parts are used in different risk postures, due to differing verification levels needed. The guidance does not distinguish between critical or non-critical systems, and a given project will need to apply the appropriate guidance based on their risk posture. The intended audience of this report are NASA personnel and commercial practitioners who support NASA’s spaceflight missions, including spaceflight program or project managers, parts engineers, parts manufacturers, radiation engineers, avionics engineers, system engineers, circuit design engineers, reliability engineers, safety and mission assurance (SMA) personnel, and parts procurement specialists. The NEPP Program will perform a pathfinder study to explore implementing the guidance in this NESC report. An ILPM verification process is not the same as conventional vendor qualification processes performed according to military standards and specifications. This NESC report intends to provide guidance in utilizing available parts data from ILPM manufacturers for parts assurance assessments needed for NASA missions. The report also captured the current practices from DoD and Federal Aviation Administration (FAA) in Section 10. Note each DoD and FAA report was provided by the corresponding agencies regarding their practices, which are independent from the NESC recommendations in the report.

Commercial-Off-The-Shelf↗
DOE OSTI2014

Constructing compact and effective graphs for recommender systems via node and edge aggregations

Exploiting graphs for recommender systems has great potential to flexibly incorporate heterogeneous information for producing better recommendation results. As our baseline approach, we first introduce a naive graph-based recommendation method, which operates with a heterogeneous log-metadata graph constructed from user log and content metadata databases. Although the na ve graph-based recommendation method is simple, it allows us to take advantages of heterogeneous information and shows promising flexibility and recommendation accuracy. However, it often leads to extensive processing time due to the sheer size of the graphs constructed from entire user log and content metadata databases. In this paper, we propose node and edge aggregation approaches to constructing compact and e ective graphs called Factor-Item bipartite graphs by aggregating nodes and edges of a log-metadata graph. Furthermore, experimental results using real world datasets indicate that our approach can significantly reduce the size of graphs exploited for recommender systems without sacrificing the recommendation quality.

97 MATHEMATICS AND COMPUTING↗
DOE OSTI2024

Exploring the role of judgement and shared situation awareness when working with AI recommender systems

Abstract AI-advised Decision Making is a form of human-autonomy teaming in which an AI recommender system suggests a solution to a human operator, who is responsible for the final decision. This work seeks to examine the importance of judgement and shared situation awareness between humans and automated agents when interacting together in the form of a recommender systems. We propose manipulating both human judgement and shared situation awareness by providing the human decision maker with relevant information that the automated agent (AI), in the form of a recommender system, uses to generate possible courses of action. This paper presents the results of a two-phase between-subjects study in which participants and a recommender system jointly make a high-stakes decision. We varied the amount of relevant information the participant had, the assessment technique of the proposed solution, and the reliability of the recommender system. Findings indicate that this technique of supporting the human’s judgement and establishing a shared situation awareness is effective in (1) boosting the human decision maker’s situation awareness and task performance, (2) calibrating their trust in AI teammates, and (3) reducing overreliance on an AI partner. Additionally, participants were able to pinpoint the limitations and boundaries of the AI partner’s capabilities. They were able to discern situations where the AI’s recommendations could be trusted versus instances when they should not rely on the AI’s advice. This work proposes and validates a way to provide model-agnostic transparency into recommender systems that can support the human decision maker and lead to improved team performance.

Srivastava, Divya↗
DOE OSTI2021

Recommended conventions for reporting results from direct dark matter searches

Abstract The field of dark matter detection is a highly visible and highly competitive one. In this paper, we propose recommendations for presenting dark matter direct detection results particularly suited for weak-scale dark matter searches, although we believe the spirit of the recommendations can apply more broadly to searches for other dark matter candidates, such as very light dark matter or axions. To translate experimental data into a final published result, direct detection collaborations must make a series of choices in their analysis, ranging from how to model astrophysical parameters to how to make statistical inferences based on observed data. While many collaborations follow a standard set of recommendations in some areas, for example the expected flux of dark matter particles (to a large degree based on a paper from Lewin and Smith in 1995), in other areas, particularly in statistical inference, they have taken different approaches, often from result to result by the same collaboration. We set out a number of recommendations on how to apply the now commonly used Profile Likelihood Ratio method to direct detection data. In addition, updated recommendations for the Standard Halo Model astrophysical parameters and relevant neutrino fluxes are provided. The authors of this note include members of the DAMIC, DarkSide, DARWIN, DEAP, LZ, NEWS-G, PandaX, PICO, SBC, SENSEI, SuperCDMS, and XENON collaborations, and these collaborations provided input to the recommendations laid out here. Wide-spread adoption of these recommendations will make it easier to compare and combine future dark matter results.

72 PHYSICS OF ELEMENTARY PARTICLES AND FIELDS↗
DOE OSTI2018

Assessing Documentation of Critical Imaging Result Follow-up Recommendations in Emergency Department Discharge Instructions

To facilitate follow-up of critical test results across transitions in patient care settings, we implemented an electronic discharge module that enabled care providers to include follow-up recommendations in the discharge instructions. We assessed the impact of this module on documentation of follow-up recommendations for critical imaging findings in Emergency Department (ED) discharge instructions. We studied 240 patients with critical imaging findings discharged from the ED before (n = 80) and after (n = 160) implementation of the module. We manually reviewed hand-written forms and electronic discharge instructions to determine if follow-up recommendations were documented. Follow-up recommendations in ED discharge instructions increased from 60.0% (48/80) to 73.8% (118/160) post-module implementation (p = 0.03), a relative increase of 23%. There was no significant change in the rate of documented critical imaging findings in the discharge instructions (77.5% [62/80] before the intervention and 76.9% [123/160] after the intervention; p = 0.91). Implementation of a discharge module was associated with increased documentation of critical imaging finding follow-up recommendations in ED discharge instructions. However, one in four patients still did not receive adequate follow-up recommendations, suggesting further opportunities for performance improvement exist.

62 RADIOLOGY AND NUCLEAR MEDICINE↗
DOE OSTI2012

Report of the Task Group 186 on model-based dose calculation methods in brachytherapy beyond the TG-43 formalism: Current status and recommendations for clinical implementation

The charge of Task Group 186 (TG-186) is to provide guidance for early adopters of model-based dose calculation algorithms (MBDCAs) for brachytherapy (BT) dose calculations to ensure practice uniformity. Contrary to external beam radiotherapy, heterogeneity correction algorithms have only recently been made available to the BT community. Yet, BT dose calculation accuracy is highly dependent on scatter conditions and photoelectric effect cross-sections relative to water. In specific situations, differences between the current water-based BT dose calculation formalism (TG-43) and MBDCAs can lead to differences in calculated doses exceeding a factor of 10. MBDCAs raise three major issues that are not addressed by current guidance documents: (1) MBDCA calculated doses are sensitive to the dose specification medium, resulting in energy-dependent differences between dose calculated to water in a homogeneous water geometry (TG-43), dose calculated to the local medium in the heterogeneous medium, and the intermediate scenario of dose calculated to a small volume of water in the heterogeneous medium. (2) MBDCA doses are sensitive to voxel-by-voxel interaction cross sections. Neither conventional single-energy CT nor ICRU/ICRP tissue composition compilations provide useful guidance for the task of assigning interaction cross sections to each voxel. (3) Since each patient-source-applicator combination is unique, having reference data for each possible combination to benchmark MBDCAs is an impractical strategy. Hence, a new commissioning process is required. TG-186 addresses in detail the above issues through the literature review and provides explicit recommendations based on the current state of knowledge. TG-43-based dose prescription and dose calculation remain in effect, with MBDCA dose reporting performed in parallel when available. In using MBDCAs, it is recommended that the radiation transport should be performed in the heterogeneous medium and, at minimum, the dose to the local medium be reported along with the TG-43 calculated doses. Assignments of voxel-by-voxel cross sections represent a particular challenge. Electron density information is readily extracted from CT imaging, but cannot be used to distinguish between different materials having the same density. Therefore, a recommendation is made to use a number of standardized materials to maintain uniformity across institutions. Sensitivity analysis shows that this recommendation offers increased accuracy over TG-43. MBDCA commissioning will share commonalities with current TG-43-based systems, but in addition there will be algorithm-specific tasks. Two levels of commissioning are recommended: reproducing TG-43 dose parameters and testing the advanced capabilities of MBDCAs. For validation of heterogeneity and scatter conditions, MBDCAs should mimic the 3D dose distributions from reference virtual geometries. Potential changes in BT dose prescriptions and MBDCA limitations are discussed. When data required for full MBDCA implementation are insufficient, interim recommendations are made and potential areas of research are identified. Application of TG-186 guidance should retain practice uniformity in transitioning from the TG-43 to the MBDCA approach.

61 RADIATION PROTECTION AND DOSIMETRY↗
DOE OSTI2015

WE-AB-201-04: The Recommendations of MPPG #5 and Practical Implementation Strategies

Treatment planning systems (TPS) are a cornerstone of modern radiation therapy. Errors in their commissioning or use can have a devastating impact on many patients. To support safe and high quality care, medical physicists must conduct efficient and proper commissioning, good clinical integration, and ongoing quality assurance (QA) of the TPS. AAPM Task Group 53 and related publications have served as seminal benchmarks for TPS commissioning and QA over the past two decades. Over the same time, continuing innovations have made the TPS even more complex and more central to the clinical process. Medical goals are now expressed in terms of the dose and margins around organs and tissues that are delineated from multiple imaging modalities (CT, MR and PET); and even temporally resolved (i.e., 4D) imaging. This information is passed on to optimization algorithms to establish accelerator movements that are programmed directly for IMRT, VMAT and stereotactic treatments. These advances have made commissioning and QA of the TPS much more challenging. This education session reviews up-to-date experience and guidance on this subject; including the recently published AAPM Medical Physics Practice Guideline (MPPG) #5 “Commissioning and QA of Treatment Planning Dose Calculations: Megavoltage Photon and Electron Beams”. Treatment Planning System Commissioning and QA: Challenges and Opportunities (Greg Salomons) This session will provide some key background and review publications describing prominent incidents relating to TPS commissioning and QA. Traditional approaches have been hardware and feature oriented. They aim to establish a functional configuration and establish specifications for regular testing of features (like dose calculation) to assure stable operation and detect failures. With the advent of more complex systems, more patient-specific testing has also been adopted. A number of actual TPS defects will be presented along with heuristics for identifying similar defects in the future. Finally, the Gamma test has become a popular metric for reporting TPS Commissioning and QA results. It simplifies complex testing into a numerical index, but noisy data and casual application can make it misleading. A brief review of the issues around the use of the Gamma test will be presented. TPS commissioning and QA: A process orientation and application of control charts (Michael Sharpe) A framework for commissioning a treatment planning system will be presented, focusing on preparations, practical aspects of configuration, priorities, specifications, and establishing performance. The complexity of the modern TPS make modular testing of features inadequate, and modern QA tools can provide “too much information” about the performance of techniques like IMRT and VMAT. We have adopted a process orientation and quality tools, like control charts, for ongoing TPS QA and assessment of patient-specific tests. The trending nature of these tools reveals the overall performance of the TPS system, and quantifies the variations that arise from individual plans, discrete calculations, and experimentation based on discrete measurements. Examples demonstrating application of these tools to TPS QA will be presented. TPS commissioning and QA: Incorporating the entire planning process (Sasa Mutic) The TPS and its features do not perform in isolation. Instead, the features and modules are key components in a complex process that begins with CT Simulation and extends to treatment delivery, along with image guidance and verification. Most importantly, the TPS is used by people working in a multi-disciplinary environment. It is very difficult to predict the outcomes of human interactions with software. Therefore, an interdisciplinary approach to training, commissioning and QA will be presented, along with an approach to the physics chart check and end-to-end testing as a tool for TPS QA. The role of standardization and automation in QA will also be discussed. The recommendations of MPPG #5 and practical implementation strategies (Jennifer Smilowitz) The recently published recommendations from Task Group No. 244, Medical Physics Practice Guideline on Commissioning and QA of Treatment Planning Dose Calculations: Megavoltage Photon and Electron Beams will be presented. The recommendations focus on the validation of commissioning data and dose calculations. Tolerance values for non-IMRT beam configurations are summarized based on established criteria and data collected by the IROC. More stringent evaluation criteria for IMRT dose calculations are suggested to test the limitations of the TPS dose algorithms for advanced delivery conditions. The MPPG encourages users to create a suite of validation tests for dose calculation for various conditions for static photon beams, heterogeneities, IMRT/VMAT and electron beams. This test suite is intended to be used for subsequent testing, including TPS software upgrades. In the past, the recommendations of some reports have not been widely implemented due to practical limitations. Implementation strategies, tools and processes developed by multiple centers for efficient and “do-able” MPPG #5 testing will be presented, as well as a discussion on the overall validation experience. Learning Objectives: Identify some of the key documents relevant for TPS commissioning and QA Understand strategies for testing TPS software Gain a practical knowledge of the Gamma test criteria Increase familiarity with the process of commissioning a TPS Learn about the use of Control Charts for TPS QA Review the role of the TPS in the overall planning process Increase awareness of the link between TPS QA and chart checking Gain an increased appreciation for the importance of interdisciplinary communication Understand the new recommendations from MPPG #5 on TPS Dose Algorithm Commissioning and QC/QA Learn practical implementation processes and tools for MPPG #5 validation recommendations.

60 APPLIED LIFE SCIENCES↗
DOE OSTI2022

Reviewing clinical considerations and guideline recommendations of C1 inhibitor prophylaxis for hereditary angioedema

Abstract Background Hereditary angioedema (HAE), a rare disease that is characterized by painful and recurring non‐allergic swelling episodes, is caused by the deficiency or dysfunction of C1 inhibitor (C1INH) protein. A comprehensive HAE management plan may require long‐term prophylaxis (LTP) in addition to on‐demand treatment to help “normalize” patients' lives so that they may fully engage in work, school, family, and leisure activities. Aim The main objective of this narrative review is to provide an overview of updated guideline recommendations specific to LTP of HAE and discuss clinical considerations and pharmacologic management options, with a focus on C1INH. Materials and Methods The authors reviewed relevant HAE literature for current recommendations regarding LTP and the role of C1NH. Results Acute HAE attacks are treated with on‐demand medication; however, there is a consensus that LTP should routinely be considered for risk reduction and prevention of future episodes. The 2017 World Allergy Organization/European Academy of Allergy and Clinical Immunology guidelines recommend that all patients with HAE be evaluated for LTP routinely and the 2020 HAE Association (HAEA) guidelines emphasize that the decision to use LTP should not be based on rigid criteria, but rather should be based on individual patient needs. Both guidelines recommend C1INH as first‐line/preferred therapy for LTP in a range of patient types including adults, children/adolescents, and pregnant/lactating patients. The HAEA also recommends the kallikrein inhibitor, lanadelumab, as a first‐line option for LTP. HAE pathway‐specific agents for LTP have not been associated with notable safety concerns. Discussion Plasma‐derived C1INH has been available for 40+ years in Europe and impacts multiple targets within the HAE pathway. C1INH has been used for on‐demand treatment and LTP. A subcutaneous formulation of plasma‐derived C1INH is approved for LTP and produces functional C1INH activity levels consistently above the threshold needed for protection from HAE attacks. Other pathway‐specific options for LTP include the plasma kallikrein inhibitors, lanadelumab‐flyo and berotralstat, approved for adults and pediatric patients aged ≥12 years. C1INH is approved for adults and pediatric patients aged ≥6 years. Conclusion Assessing the need for LTP is vital in the ongoing dialogue between clinicians and patients, as both disease‐related factors and patient preferences may change over time. Among available options for LTP, plasma‐derived C1INH is the broadly recommended first‐line option for LTP in patients with HAE, including pregnant/lactating women and pediatric patients (≥6 years).

Anderson, John↗
DOE OSTI2020

Energy impact of human health and wellness lighting recommendations for office and classroom applications

The goal of this investigation was to evaluate potential energy impacts of circadian lighting design recommendations gaining attention in a variety of common applications such as offices and classrooms. The renewed focus on health along with advances in SSL technology capabilities has underscored that there is still much to learn regarding the relationship between light and human physiology. The energy implications of designing to address these possible physiological effects are not yet fully understood. Beyond the fact that the basic metric of luminous efficacy (lumens per watt) does not cover these other effects, the emerging science seems to indicate that addressing a holistic view of the human needs in most applications may mean a need for increased light and associated energy use by electric lighting systems. Within the two applications considered, lumen output, spectral characteristics, surface reflectance distribution and desk orientation were varied to explore the magnitude of potential effects. Meeting current IES illuminance recommendations did not satisfy existing EML and CS recommendations for any of the simulations. In some cases, satisfying circadian metric recommendations required average illuminance that was more than double IES recommendations, which may negatively impact lighting quality as well. Using results from 45 unique simulation conditions, it was estimated that lighting energy use may increase between 10% and 100% due to increased luminaire light levels used to meet circadian lighting design recommendations listed in current building standards such as WELL v2 Q2 2019, UL Design Guideline 24480, and CHPS Core Criteria 3.0.

circadian lighting, lighting simulation, solid sta↗
DOE OSTI2023

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Immediate-release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the first new draft guideline on BE for IR solid oral dosage forms (M13A). To support the development of ICH M13A, we comprehensively reviewed the landscape of oral IR products approved by the U.S. Food and Drug Administration (FDA) and compared BE recommendations for these products in the current U.S. FDA and European Medicines Agency (EMA) BE guidances. We utilized databases including Drugs@FDA, Orange Book, and product-specific guidances (PSGs) published on the U.S. FDA and EMA websites to collect information. Oral IR products account for 46% of all FDA-approved new drug applications currently listed in Orange Book with 82.5% solids, 0.9% semi-solids, and 16.6% liquids. For all published U.S. FDA PSGs for solid oral IR products, in vivo BE studies with pharmacokinetic (PK) endpoints account for 88% of BE approaches recommended. Of these PK BE studies, 86.5% recommended fasting and fed BE studies, while only 15.9% EMA PSGs recommended both fasting and fed BE studies. This review helps clarify the scope of U.S. solid oral IR products impacted by the new ICH M13A draft guideline and demonstrates how recommendations in draft ICH M13A could significantly harmonize BE recommendations for IR oral products to facilitate global drug development.

60 APPLIED LIFE SCIENCES↗
DOE OSTI2014

SU-C-16A-05: OAR Dose Tolerance Recommendations for Prostate and Cervical HDR Brachytherapy: Dose Versus Volume Metrics

Purpose: HDR brachytherapy consensus dose tolerance recommendations for organs at risk (OARs) remain widely debated. Prospective trials reporting metrics must be sufficiently data-dense to assess adverse affects and identify optimally predictive tolerances. We explore the tradeoffs between reporting dose-metrics versus volume-metrics and the potential impact on trial outcome analysis and tolerance recommendations. Methods: We analyzed 26 prostate patients receiving 15 Gy HDR single-fraction brachytherapy boost to 45 Gy external beam radiation therapy and 28 cervical patients receiving 28 Gy HDR brachytherapy monotherapy in 4 fractions using 2 implants. For each OAR structure, a robust linear regression fit was performed for the dose-metrics as a function of the volume-metrics. The plan quality information provided by recommended dose-metric and volume-metric values were compared. Results: For prostate rectal dose, D2cc and V75 lie close to the regression line, indicating they are similarly informative. Two outliers for prostate urethral dose are substantially different from the remaining cohort in terms of D0.1cc and V75, but not D1cc, suggesting the choice of reporting dose metric is essential. For prostate bladder and cervical bladder, rectum, and bowel, dose outliers are more apparent via V75 than recommended dose-metrics. This suggests that for prostate bladder dose and all cervical OAR doses, the recommended volume-metrics may be better predictors of clinical outcome than dose-metrics. Conclusion: For plan acceptance criteria, dose and volume-metrics are reciprocally equivalent. However, reporting dosemetrics or volume-metrics alone provides substantially different information. Our results suggest that volume-metrics may be more sensitive to differences in planned dose, and if one metric must be chosen, volumemetrics are preferable. However, reporting discrete DVH points severely limits the ability to identify planning tolerances most predictive of adverse effects. Thus, we recommend that full OAR DVH reporting be required for future prospective trials.

60 APPLIED LIFE SCIENCES↗
DOE OSTI2022

U.S. Pacific Coast Workshop Report on Preconstruction Research Recommendations (U.S. Offshore Wind Synthesis of Environmental Effects Research (SEER) Project)

In May 2022, the U.S. Offshore Wind Synthesis of Environmental Effects Research (SEER) project team hosted a stakeholder workshop focused on preconstruction (baseline) research needs for potential floating offshore wind (OSW) energy development on the U.S. Pacific Coast, including California, Oregon, and Washington. Prior to the workshop, the SEER team developed a set of initial synthesized research recommendations that were identified based on a review of relevant, publicly available resources and with advisory group input. The workshop covered three marine life breakout groups on subsequent days to discuss research recommendations related to 1) marine mammals and sea turtles, 2) fish and invertebrates, and 3) birds and bats. As part of the workshop, over a hundred participants from the public and private sectors provided feedback on various aspects of the initial research recommendations, including associated data and knowledge gaps, benefits/limitations of available methods and technologies, and technological advancements or infrastructure needed to address the recommendation. Approximately 1,000 total comments were received on the workshop MURAL boards and were synthesized in this report. Based on workshop feedback, SEER developed a final database of over 500 specific research recommendations based on more than 40 resources. In Fall 2022, the full database and a tool with updated synthesized research recommendations were disseminated on Tethys (https://tethys.pnnl.gov) to assist with informing future funding opportunities and research programming. There is a continued need to improve awareness of the potential environmental effects, monitoring technologies, and management strategies for floating OSW energy development on the U.S. Pacific Coast. Coordination of these activities will require the sustained involvement of multiple stakeholders from across sectors. Beyond the baseline considerations discussed in this workshop, future state-of-the-science activities should be planned to consider research needs across wind energy life cycle phases for all relevant wildlife taxa and associated habitat and ecosystem processes.

17 WIND ENERGY↗
NASA NTRS1977

Recommended procedures for measuring aircraft noise and associated parameters

Procedures are recommended for obtaining experimental values of aircraft flyover noise levels (and associated parameters). Specific recommendations are made for test criteria, instrumentation performance requirements, data-acquisition procedures, and test operations. The recommendations are based on state-of-the-art measurement capabilities available in 1976 and are consistent with the measurement objectives of the NASA Aircraft Noise Prediction Program. The recommendations are applicable to measurements of the noise produced by an airplane flying subsonically over (or past) microphones located near the surface of the ground. Aircraft types covered by the recommendations are fixed-wing airplanes powered by turbojet or turbofan engines and using conventional aerodynamic means for takeoff and landing. Various assumptions with respect to subsequent data processing and analysis were made (and are described) and the recommended measurement procedures are compatible with the assumptions. Some areas where additional research is needed relative to aircraft flyover noise measurement techniques are also discussed.

Marsh, A. H.↗
NASA NTRS1992

Biological Contamination of Mars: Issues and Recommendations

The ad hoc Task Group on Planetary Protection formed by the Space Studies Board (SSB) of the National Research Council focused on making recommendations concerning the protection of Mars from forward contamination (i.e., Earth to Mars) during upcoming missions by both the United States and the former Soviet Union. In so doing, it distinguished between missions whose goals include reconnaissance and measurement and those that specifically include experiments to detect life. The task group also discussed what additional knowledge will be needed in order to assure that future recommendations regarding contamination of Earth from Mars might be made with a higher degree of certainty than is now possible. Following a short introduction to the rationale underlying planetary exploration (Chapter 1) is a brief summary of approved and contemplated missions to Mars (Chapter 2). Chapter 3 briefly reviews the state of knowledge in several areas pertinent to the problem of planetary protection, in the limits of life on Earth and the abilities of known terrestrial organisms to withstand extreme environment conditions, as well as new approaches to detecting life forms. Chapter 5 includes a review and comments (made in light of current knowledge)- on the recommendations made in 'Recommendations on Quarantine Policy for Mars, Jupiter, Saturn, Uranus, Neptune, and Titan'. Updates to the recommendations made in 1978 are also given in Chapter 5. Chapter 6 gives additional recommendations concerning collection of essential data, spacecraft sterilization and bioburden assessment, and future research, as well as legal and social issues and NASA's overall planetary protection program.

Source record↗
NASA NTRS1995

Annual report to the Chairman and Ranking Minority Members, House and Senate Committees on Appropriations. Status of open recommendations: Improving operations of federal departments and agencies

Each year, GAO's work contributes to many legislative and executive branch actions that result in significant financial savings and other improvements in government operations. Some, but not all, are identified through GAO's system for periodically following up to determine the status of actions taken on the recommendations made in its audit and evaluation reports. In fiscal year 1994, GAO made 1,450 recommendations, but, more importantly, about 4,400 GAO recommendations made over the past 5 years have been implemented. This report includes summary information on the status of all GAO recommendations that have not been fully implemented and highlights some of the key ones. This information should help congressional and agency leaders prepare for upcoming appropriations and oversight activities and stimulate further actions to achieve the desired improvements in government operations. In addition to including printed issue area summaries highlighting the ipact of GAO's work and the key open recommendations, this volume includes a set of computer diskettes with details on all open recommendations.

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NASA NTRS2004

User Evaluation of the NASA Technical Report Server Recommendation Service

We present the user evaluation of two recommendation server methodologies implemented for the NASA Technical Report Server (NTRS). One methodology for generating recommendations uses log analysis to identify co-retrieval events on full-text documents. For comparison, we used the Vector Space Model (VSM) as the second methodology. We calculated cosine similarities and used the top 10 most similar documents (based on metadata) as 'recommendations'. We then ran an experiment with NASA Langley Research Center (LaRC) staff members to gather their feedback on which method produced the most 'quality' recommendations. We found that in most cases VSM outperformed log analysis of co-retrievals. However, analyzing the data revealed the evaluations may have been structurally biased in favor of the VSM generated recommendations. We explore some possible methods for combining log analysis and VSM generated recommendations and suggest areas of future work.

Nelson, Michael L.↗
NASA NTRS2004

User Evaluation of the NASA Technical Report Server Recommendation Service

We present the user evaluation of two recommendation server methodologies implemented for the NASA Technical Report Server (NTRS). One methodology for generating recommendations uses log analysis to identify co-retrieval events on full-text documents. For comparison, we used the Vector Space Model (VSM) as the second methodology. We calculated cosine similarities and used the top 10 most similar documents (based on metadata) as recommendations . We then ran an experiment with NASA Langley Research Center (LaRC) staff members to gather their feedback on which method produced the most quality recommendations. We found that in most cases VSM outperformed log analysis of co-retrievals. However, analyzing the data revealed the evaluations may have been structurally biased in favor of the VSM generated recommendations. We explore some possible methods for combining log analysis and VSM generated recommendations and suggest areas of future work.

Nelson, Michael L.↗