Recommended Guidelines for the Design of the Federal Docket Management System (FDMS)

The Administration's eRulemaking Initiative will have important implications for access to regulatory information, both for those who work on rules and those organizations and citizens who are affected by rules. These scholars of rulemaking suggest priorities that should guide the eRulemaking Initiative so that all interested parties can better understand and contribute to this common and important mode of policymaking. Collectively,they have studied rulemaking at dozens of regulatory agencies across the federal government. Based ontheir extensive experience using agencies' rulemaking dockets and accessing information from them fortheir research,they believe three principles are vital in designing the forthcoming Federal Docket Management System (FDMS): Consistency in Data: Every effort should be made to keep data fields consistent, both across agencies and over time. Consistency over time is especially important, so that information available in a post-Regulations.Gov era can be matched with earlier information. Flexibility of Search: Users should be able to define their own searches using any of the fields within the docket system. They should also be able to combine different fields. Ease of Access: Users should be able not only to search docket data in a self-defined way, but should be able to download and export search results in commonly used formats, such as comma-separated or Excel or both. Additional signatories of this letter include: Richard N. L. Andrews, Michael Asimow, Bernard W. Bell, Lori Snyder Bennear, Barbara H. Brandon, John Brehm, Gary Bryner, Professor Johnny C. Burris, Mariano-Florentino Cu

Responding to Mass, Computer-Generated, and Malattributed Comments

A number of technological and political forces have transformed the once staid and insider dominated notice-and-comment process into a forum for large scale, sometimes messy, participation in regulatory decisionmaking. It is not unheard of for agencies to receive millions of comments on rulemakings; often these comments are received as part of organized mass comment campaigns. In some rulemakings, questions have been raised about whether public comments were submitted under false names, or were automatically generated by computer “bot” programs. In this Article, we examine whether and to what extent such submissions are problematic and make recommendations for how rulemaking agencies should respond as a matter of law, policy, and technology.Our overarching conclusion is that agencies should adopt both low- and high-tech measures to limit the negative impact of these sorts of comments. Mass, malattributed, and computer-generated comments, however, do not represent a crisis for the regulatory state at this time. They have not been found to violate federal law and do not generally undermine the integrity of notice-and-comment rulemaking, and we are not aware of evidence of widespread substantive harms in particular rulemaking efforts or to the rulemaking system overall. However, appropriate responses, especially those that take advantage of new technology, could reduce the cost and negative impacts of technology-enabled comments. Adopting such techniques could, for example, improve the opportunity for a diverse public to participate in the federal rulemaking process meaningfully and augment current practices with new forms of citizen engagement. Indeed, in addition to exploring how new technologies—the very same technologies that enable mass, malattributed, and computer-generated comments—can help with analyzing those comments, we also explore throughout how technology can help regulatory officials make sense of public input and draw greater insights from public comments of all kinds. Finally, other jurisdictions at the state and local level and internationally are turning to new technology to enable innovative forms of public participation, thus improving the quality of rule and policymaking. These activities illustrate hopeful opportunities for future experimentation.This Article, based on a report commissioned by the Administrative Conference of the United States, expresses the authors’ views only and does not necessarily reflect those of the Administrative Conference or the federal government

Prostate cancer assessment using MR elastography of fresh prostatectomy specimens at 9.4 T

Purpose: Despite its success in the assessment of prostate cancer (PCa), in vivo multiparametric MRI has limitations such as interobserver variability and low specificity. Several MRI methods, among them MR elastography, are currently being discussed as candidates for supplementing conventional multiparametric MRI. This study aims to investigate the detection of PCa in fresh ex vivo human prostatectomy specimens using MR elastography. Methods: Fourteen fresh prostate specimens from men with clinically significant PCa without formalin fixation or prior radiation therapy were examined by MR elastography at 500 Hz immediately after radical prostatectomy in a 9.4T preclinical scanner. Specimens were divided into 12 segments for both calculation of storage modulus (G ' in kilopascals) and pathology (Gleason score) as reference standard. Sensitivity, specificity, and area under the receiver operating characteristic curve were calculated to assess PCa detection. Results: The mean G ' and SD were as follows: all segments, 8.74 ± 5.26 kPa; healthy segments, 5.44 ± 4.40 kPa; and cancerous segments, 10.84 ± 4.65 kPa. The difference between healthy and cancerous segments was significant with P ≤ .001. Diagnostic performance assessed with the Youden index was as follows: sensitivity, 69%; specificity, 79%; area under the curve, 0.81; and cutoff, 10.67 kPa. Conclusion: Our results suggest that prostate MR elastography has the potential to improve diagnostic performance of multiparametric MRI, especially regarding its 2 major limitations: interobserver variability and low specificity. Particularly the high value for specificity in PCa detection is a stimulating result and encourages further investigation of this method

Tungsten oxide thin film for room temperature nitrogen dioxide gas sensing

Tungsten oxide (WO3) thin films for gas sensing have been successfully deposited using reactive direct current (DC) magnetron sputtering at different deposition temperatures (300 °C, 400 °C and 500 °C). The structural, morphological properties, thickness and composition have been investigated using X-ray diffraction (XRD), scanning electron microscopy (SEM) and Rutherford backscattering spectrometry (RBS) techniques. To investigate the effect of deposition temperature on the gas sensing properties of deposited thin films on alumina substrates, was conducted using the Kenosistec gas sensing unit. WO3 thin film deposited at 500 °C exhibited a higher response when sensing Nitrogen dioxide (NO2) at room temperature as compared to the thin films prepared at 300 °C and 400 °C, respectively. However, as deposited WO3 thin films exhibited low sensitivity when sensing reducing gases such as hydrogen (H2) and ammonia (NH3), which was an indication of good selectivity properties of WO3 related sensors

Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial

Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. Objective: The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. Methods: The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. Conclusions: This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. Trial Registration: ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313 International Registered Report Identifier (IRRID): DERR1-10.2196/2090

Burnout among surgeons before and during the SARS-CoV-2 pandemic: an international survey

Background: SARS-CoV-2 pandemic has had many significant impacts within the surgical realm, and surgeons have been obligated to reconsider almost every aspect of daily clinical practice. Methods: This is a cross-sectional study reported in compliance with the CHERRIES guidelines and conducted through an online platform from June 14th to July 15th, 2020. The primary outcome was the burden of burnout during the pandemic indicated by the validated Shirom-Melamed Burnout Measure. Results: Nine hundred fifty-four surgeons completed the survey. The median length of practice was 10 years; 78.2% included were male with a median age of 37 years old, 39.5% were consultants, 68.9% were general surgeons, and 55.7% were affiliated with an academic institution. Overall, there was a significant increase in the mean burnout score during the pandemic; longer years of practice and older age were significantly associated with less burnout. There were significant reductions in the median number of outpatient visits, operated cases, on-call hours, emergency visits, and research work, so, 48.2% of respondents felt that the training resources were insufficient. The majority (81.3%) of respondents reported that their hospitals were included in the management of COVID-19, 66.5% felt their roles had been minimized; 41% were asked to assist in non-surgical medical practices, and 37.6% of respondents were included in COVID-19 management. Conclusions: There was a significant burnout among trainees. Almost all aspects of clinical and research activities were affected with a significant reduction in the volume of research, outpatient clinic visits, surgical procedures, on-call hours, and emergency cases hindering the training. Trial registration: The study was registered on clicaltrials.gov "NCT04433286" on 16/06/2020

Food, Nutrition and Agrobiodiversity Under Global Climate Change

Available evidence and predictions suggest overall negative effects on agricultural production as a result of climate change, especially when more food is required by a growing population. Information on the effects of global warming on pests and pathogens affecting agricultural crops is limited, though crop–pest models could offer means to predict changes in pest dynamics, and help design sound plant health management practices. Host-plant resistance should continue to receive high priority as global warming may favor emergence of new pest epidemics. There is increased risk, due to climate change, to food and feed contaminated by mycotoxin-producing fungi. Mycotoxin biosynthesis gene-specific microarray is being used to identify food-born fungi and associated mycotoxins, and investigate the influence of environmental parameters and their interactions for control of mycotoxin in food crops. Some crop wild relatives are threatened plant species and efforts should be made for their in situ conservation to ensure evolution of new variants, which may contribute to addressing new challenges to agricultural production. There should be more emphasis on germplasm enhancement to develop intermediate products with specific characteristics to support plant breeding. Abiotic stress response is routinely dissected to component physiological traits. Use of transgene(s) has led to the development of transgenic events, which could provide enhanced adaptation to abiotic stresses that are exacerbated by climate change. Global warming is also associated with declining nutritional quality of food crops. Micronutrient-dense cultivars have been released in selected areas of the developing world, while various nutritionally enhanced lines are in the release pipeline. The high-throughput phenomic platforms are allowing researchers to accurately measure plant growth and development, analyze nutritional traits, and assess response to stresses on large sets of individuals. Analogs for tomorrow’s agriculture offer a virtual natural laboratory to innovate and test technological options to develop climate resilience production systems. Increased use of agrobiodiversity is crucial to coping with adverse impacts of global warming on food and feed production and quality. No one solution will suffice to adapt to climate change and its variability. Suits of technological innovations, including climate-resilient crop cultivars, will be needed to feed 9 billion people who will be living in the Earth by the middle of the twenty-first century