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At least 793 records · Page 44

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)↗

COVID-19-associated school closures and related efforts to sustain education and subsidized meal programs, United States, February 18-June 30, 2020

Pre-emptive school closures are frontline community mitigation measures recommended by the US Centers for Disease Control and Prevention (CDC) for implementation during severe pandemics. This study describes the spatiotemporal patterns of publicly announced school closures implemented in response to the coronavirus disease 2019 (COVID-19) pandemic and assesses how public K-12 districts adjusted their methods of education delivery and provision of subsidized meals. During February 18–June 30, 2020, we used daily systematic media searches to identify publicly announced COVID-19–related school closures lasting ≥1 day in the United States (US). We also collected statewide school closure policies from state government websites. Data on distance learning and subsidized meal programs were collected from a stratified sample of 600 school districts. The first COVID-19–associated school closure occurred on February 27, 2020 in Washington state. By March 30, 2020, all but one US public school districts were closed, representing the first-ever nearly synchronous nationwide closure of public K-12 schools in the US. Approximately 100,000 public schools were closed for ≥8 weeks because of COVID-19, affecting >50 million K-12 students. Of 600 districts sampled, the vast majority offered distance learning (91.0%) and continued provision of subsidized meal programs (78.8%) during the closures. Despite the sudden and prolonged nature of COVID-19–associated school closures, schools demonstrated flexibility by implementing distance learning and alternate methods to continue subsidized meal programs.

60 APPLIED LIFE SCIENCES↗

Launching a saliva-based SARS-CoV-2 surveillance testing program on a university campus

Regular surveillance testing of asymptomatic individuals for SARS-CoV-2 has been center to SARS-CoV-2 outbreak prevention on college and university campuses. Here we describe the voluntary saliva testing program instituted at the University of California, Berkeley during an early period of the SARS-CoV-2 pandemic in 2020. The program was administered as a research study ahead of clinical implementation, enabling us to launch surveillance testing while continuing to optimize the assay. Results of both the testing protocol itself and the study participants’ experience show how the program succeeded in providing routine, robust testing capable of contributing to outbreak prevention within a campus community and offer strategies for encouraging participation and a sense of civic responsibility.

59 BASIC BIOLOGICAL SCIENCES↗

2021–2022 Can Do Colorado E-Bike Full-Scale Pilot Program Study

In 2021–2022, the Colorado Energy Office conducted a full-scale pilot program study on e-bike usage as part of the Can Do Colorado initiative, providing e-bikes to low-income participants across the state. A [2020 mini pilot program study](https://www.nlr.gov/transportation/secure-transportation-data/tsdc-2020-can-do-colorado-e-bike-pilot-program.html) informed the full-scale study. Both studies used pedal-assist e-bikes, which feature an electric motor and battery to help power the bike. The motor amplifies the power behind each pedal stroke, augmenting the energy you put into the bike. #### Data Collection Agency The Colorado Energy Office conducted the study in partnership with local organizations in Adams and Broomfield counties (Smart Commute Metro North), Boulder (Community Cycles), Durango (Four Corners Office for Resource Efficiency), Fort Collins (City of Fort Collins), Pueblo (Pueblo County), and Vail (Town of Vail). #### Survey Methodology Program participants received an e-bike and accessories at no cost and manually submitted travel data and feedback via the CanBikeCO smartphone app. Developed in partnership with NLR, the app used a customized version of the open-source [NLR OpenPATH platform](https://www.nlr.gov/transportation/openpath.html). #### Survey Records and Data Survey records include 170 participants. The six datasets contain up to 18 months of partially automated travel diaries, combining sensed and surveyed travel behavior data—patterns of multimodal, end-to-end, individual human mobility—as well as demographic information from participants. The number of e-bike trips and e-bike miles traveled per location are 1,560 and 4,179 for Adams and Broomfield counties; 8,481 and 27,000 for Boulder; 2,815 and 6,307 for Durango; 3,483 and 7,080 for Fort Collins; 4,022 and 14,887 for Pueblo, and 1,206 and 3,3361 for Vail.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

Fermilab Superconducting Nb₃Sn High Field Magnet R&D Program

Magnets based on the modern Nb₃Sn conductor are the main candidates for future high-energy hadron colliders. Fermilab as part of the U.S. MDP executes an extensive R&D program on these high-field magnets. This program includes basic conductor and material R&D, quench per-formance studies, and building a meter-long high-field demonstrator. This paper summarizes the current status of the program including its recent results.

43 PARTICLE ACCELERATORS↗

The LCLS-II HE High Q and Gradient R&D Program

The LCLS-II HE project is a high energy upgrade to the superconducting LCLS-II linac. It consists of adding twenty additional 1.3 GHz cryomodules to the linac, with cavities operating at a gradient of 20.8 MV/m with a Q₀ of 2.7·10¹⁰. Performance of LCLS-II cryomodules has suggested that operations at this high of a gradient will not be achievable with the existing cavity recipe employed. Therefore a research program was developed between SLAC, Fermilab, Thomas Jefferson National Accelerator Facility, and Cornell University in order to improve the cavity processing method of the SRF cavities and reach the HE goals. This program explores the doping regime beyond what was done for LCLS-II and also has looked to further developed nitrogen-infusion. Here we will summarize the results from this R\&D program, showing significant improvement on both single-cell and 9-cell cavities compared with the original LCLS-II cavity recipe.

43 PARTICLE ACCELERATORS↗

DIS physics at the EIC and LHeC and connections to the future LHC and $\nu$A programs

Deeply-inelastic scattering (DIS) stands to enter a golden age with the prospect of precision programs at the Electron-Ion Collider (EIC) and Large Hadron-electron Collider (LHeC). While these programs will be of considerable importance to resolving longstanding issues in (non)perturbative QCD as well as hadronic and nuclear structure, they will also have valuable implications for a wider range of physics at the Energy and Intensity Frontiers, including at the High-Luminosity LHC (HL-LHC) and future \nu A ν A facilities. In this plenary contribution, we highlight a number of salient examples of the potential HEP impact from the complementary EIC and LHeC programs drawn from their respective Yellow Report and Whitepaper. Interested readers are encouraged to consult the extensive studies and literature from which these examples are taken for more detail.

Hobbs, Timothy↗

Case for an Improved Effective-Atomic Number for the Electronic Baggage Scanning Program (Rev. 1)

Z eff , a parameter representing an “effective atomic number” for a material, plays an important role in the Electronic Baggage Scanning Program (EBSP) to detect threats in dual-energy computed tomography (CT) baggage-scanning systems. We believe that Zeff, as defined and used on this program, does not provide the most accurate representation of a material's x-ray properties.. We present the case for a new method that defines an effective atomic number for compounds and mixtures, which we refer to as Z e . Unlike Z eff , Z e is tied by definition to the x-ray absorption properties of each specific material. Use of this alternative will provide a more accurate scale for calibrating LLNL-designed Micro-CT systems and vendor-built Explosives Detection Systems (EDS) against standard reference materials, and it will provide a more accurate physical characterization of the x-ray properties of materials evaluated on those systems. This document, (1) Describes the current usage of the Z eff parameter; (2) Details problems entailed in the use of the Z eff parameter; (3) Proposes a well-defined alternative—Z e ; (4) Proposes and demonstrates an algorithm for optimally associating Z e with any specified compound or mixture; (5) Discusses issues that can impact the usefulness of an effective-Z model; and (6) Recommends that, in order that the chosen effective-Z parameter not materially impact the accuracy of data produced by the EBSP program, the use of Z eff be replaced by Z e .

42 ENGINEERING↗

Recovery Act: Finite Volume Based Computer Program for Ground Source Heat Pump Systems

This report is a compilation of the work that has been done on the grant DE-EE0002805 entitled Finite Volume Based Computer Program for Ground Source Heat Pump Systems. The goal of this project was to develop a detailed computer simulation tool for GSHP (ground source heat pump) heating and cooling systems. Two such tools were developed as part of this DOE (Department of Energy) grant; the first is a two-dimensional computer program called GEO2D and the second is a three-dimensional computer program called GEO3D.

15 GEOTHERMAL ENERGY↗

A Programming Framework for Scientific Applications on CPU-GPU Systems

At a high level, my research interests center around designing, programming, and evaluating computer systems that use new approaches to solve interesting problems. The rapid change of technology allows a variety of different architectural approaches to computationally difficult problems, and a constantly shifting set of constraints and trends makes the solutions to these problems both challenging and interesting. One of the most important recent trends in computing has been a move to commodity parallel architectures. This sea change is motivated by the industry’s inability to continue to profitably increase performance on a single processor and instead to move to multiple parallel processors. In the period of review, my most significant work has been leading a research group looking at the use of the graphics processing unit (GPU) as a general-purpose processor. GPUs can potentially deliver superior performance on a broad range of problems than their CPU counterparts, but effectively mapping complex applications to a parallel programming model with an emerging programming environment is a significant and important research problem.

99 GENERAL AND MISCELLANEOUS↗

Wyandotte Neighborhood Stabilization Program: Retrofit of Two Homes

The Wyandotte NSP2 project aims to build 20 new houses and retrofit 20 existing houses in Wyandotte, MI. This report will detail the retrofit of 2 existing houses in the program. Wyandotte is part of a Michigan State Housing Development Authority-led consortium that is funded by HUD under the NSP2 program. The City of Wyandotte has also been awarded DOE EE&CBG funds that are being used to develop a district GSHP system to service the project. This draft report examines the energy efficiency recommendations for retrofit construction at these homes. The report will be of interest to anyone planning an affordable, high performance retrofit of an existing home in a Cold Climate zone. Information from this report will also be useful to retrofit or weatherization program staff as some of the proposed retrofit solutions will apply to a wide range of projects. Preliminary results from the first complete house suggest that the technology package employed (which includes spray foam insulation and insulating sheathing) does meet the specific whole house water, air, and thermal control requirements, as well as, the project's affordability goals. Monitoring of the GSHP system has been recommended and analysis of this information is not yet available.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

Report on Sustainability Program Peer Reviews at NNSA Laboratories

In FY 2012 peer reviews were conducted at three of the National Nuclear Security Administration (NNSA) Laboratories on the implementation of sustainability programs to achieve the DOE Strategic Sustainability Performance Plan goals. The three Laboratories selected include Los Alamos National Laboratory (LANL), Lawrence Livermore National Laboratory (LLNL), and Sandia National Laboratory (SNL). These reviews were initiated by the LANS/LLNS Board of Governors Business & Operations Committee and were joined by Sandia National Laboratories to get a broad understanding of the challenges and successes experienced at the three Labs. Each review used a common approach and process for inquiry. The peer review process provided a beneficial benchmarking opportunity for each of the Laboratories. The purpose of this report summary is to bring together the mutual challenges faced across the three NNSA national labs to deepen the conversations between the sites and NNSA as the customer to work constructively toward achieving progress on the sustainability goals. The team identified many noteworthy practices and common challenges faced at each of the three sites. At each site the review team also saw a strong connection between the Environmental Management System (EMS) and the implementation of the site’s sustainability program. One common challenge was that in spite of the linkage to the EMS program the implementation efforts to achieve the sustainability goals were perceived as being the sole responsibility of the facilities and infrastructure management organizations vice an expectation for strong employee engagement. Another common challenge was perceived within the procurement organizations and demonstrated effort toward meeting the sustainable acquisition requirements throughout the organization and the various contract instruments used at each site.

29 ENERGY PLANNING, POLICY, AND ECONOMY↗

Community Solar Program Final Report for Austin Energy

Austin Energy seeks to expand its portfolio of renewable programs with an innovative community solar program. The program provides an opportunity for Austin Energy's customers, who are unable or uninterested in installing solar on their own premises, to purchase solar power.

14 SOLAR ENERGY↗

Energy Commissioning Agent/Auditor Online Training Program

The original objective of this project was to create a comprehensive training and deployment program - suitable for in-person delivery in the New York metro region – focused on educating building commissioning authorities and energy auditors. The NJIT Center for Building Knowledge was to have sole responsibility for this curriculum development and deployment plan effort. Very early in the project timeline, however, the scope of the project evolved – with DOE and NETL approval - to become a collaborative effort between NJIT and Portland Energy Conservation, Inc. (PECI). The structure of this collaboration involved PECI taking the lead on developing a comprehensive curriculum program suitable for in-person delivery, and NJIT taking the lead on turning this curriculum into a comprehensive online training program that would complement – and extend the reach of – the in-person curriculum.

Evans, Deane↗

Ecological Monitoring and Compliance Program 2012 Report

The Ecological Monitoring and Compliance Program (EMAC), funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO, formerly Nevada Site Office), monitors the ecosystem of the Nevada National Security Site (NNSS) and ensures compliance with laws and regulations pertaining to NNSS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC (NSTec), during calendar year 2012. Program activities included (a) biological surveys at proposed construction sites, (b) desert tortoise compliance, (c) ecosystem monitoring, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, (f) habitat restoration monitoring, and (g) monitoring of the Nonproliferation Test and Evaluation Complex (NPTEC). During 2012, all applicable laws, regulations, and permit requirements were met, enabling EMAC to achieve its intended goals and objectives.

2012↗

Groundwater monitoring program plan and conceptual site model for the Al-Tuwaitha Nuclear Research Center in Iraq.

The Radiation Protection Center of the Iraqi Ministry of Environment is developing a groundwater monitoring program (GMP) for the Al-Tuwaitha Nuclear Research Center located near Baghdad, Iraq. The Al-Tuwaitha Nuclear Research Center was established in about 1960 and is currently being cleaned-up and decommissioned by Iraq s Ministry of Science and Technology. This Groundwater Monitoring Program Plan (GMPP) and Conceptual Site Model (CSM) support the Radiation Protection Center by providing: A CSM describing the hydrogeologic regime and contaminant issues, recommendations for future groundwater characterization activities, and descriptions of the organizational elements of a groundwater monitoring program. The Conceptual Site Model identifies a number of potential sources of groundwater contamination at Al-Tuwaitha. The model also identifies two water-bearing zones (a shallow groundwater zone and a regional aquifer). The depth to the shallow groundwater zone varies from approximately 7 to 10 meters (m) across the facility. The shallow groundwater zone is composed of a layer of silty sand and fine sand that does not extend laterally across the entire facility. An approximately 4-m thick layer of clay underlies the shallow groundwater zone. The depth to the regional aquifer varies from approximately 14 to 17 m across the facility. The regional aquifer is composed of interfingering layers of silty sand, fine-grained sand, and medium-grained sand. Based on the limited analyses described in this report, there is no severe contamination of the groundwater at Al-Tuwaitha with radioactive constituents. However, significant data gaps exist and this plan recommends the installation of additional groundwater monitoring wells and conducting additional types of radiological and chemical analyses.

Copland, John Robin↗

Second Line of Defense Spares Program Assessment

The Office of the Second Line of Defense (SLD) is part of the Department of Energy‘s (DOE) National Nuclear Security Administration (NNSA). The SLD Program accomplishes its critical global security mission by forming cooperative relationships with partner countries to install passive radiation detection systems that augment traditional inspection and law enforcement measures by alerting border officials to the presence of special nuclear or other radiological materials in cross-border traffic. An important tenet of the program is to work collaboratively with these countries to establish the necessary processes, procedures, infrastructure and conditions that will enable them to fully assume the financial and technical responsibilities for operating the equipment. As the number of operational deployments grows, the SLD Program faces an increasingly complex logistics process to promote the timely and efficient supply of spare parts.

Henderson, Dale L.↗

A flexible framework for secure and efficient program obfuscation.

In this paper, we present a modular framework for constructing a secure and efficient program obfuscation scheme. Our approach, inspired by the obfuscation with respect to oracle machines model of [4], retains an interactive online protocol with an oracle, but relaxes the original computational and storage restrictions. We argue this is reasonable given the computational resources of modern personal devices. Furthermore, we relax the information-theoretic security requirement for computational security to utilize established cryptographic primitives. With this additional flexibility we are free to explore different cryptographic buildingblocks. Our approach combines authenticated encryption with private information retrieval to construct a secure program obfuscation framework. We give a formal specification of our framework, based on desired functionality and security properties, and provide an example instantiation. In particular, we implement AES in Galois/Counter Mode for authenticated encryption and the Gentry-Ramzan [13]constant communication-rate private information retrieval scheme. We present our implementation results and show that non-trivial sized programs can be realized, but scalability is quickly limited by computational overhead. Finally, we include a discussion on security considerations when instantiating specific modules.

Solis, John Hector↗