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Climate altered terrestrial carbon and nutrient flux to the aquatic foodweb from increa... - 0 views

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    This program will investigate the base of the Selawik River basin aquatic food web, and link it to the anticipated increase in terrestrial inputs of carbon and nitrogen to the aquatic ecosystem as a result of climate change. The main objectives are: 1) assess the quality and quantity of terrestrial dissolved organic carbon (DOC), organic and inorganic nitrogen, and phosphorus released with increased soil thaw depth during spring and early summer, and its entry to the aquatic ecosystem; 2) quantify change in aquatic microbial, mainly bacterial, respiration and production rates with change in DOC quality and quantity; and 3) examine how change in terrestrial DOC and nitrogen inputs to the aquatic ecosystem might alter the rate of phytoplankton primary production, the community composition, and energy (lipid) content.
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Generic Drug Substitution in Special Populations - 0 views

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    The purpose of this study is to: 1) collect information on practice patterns in special populations to assess possible barriers to generic substitution ; 2) compare clinical practice (e.g., drug product manipulation prior to administration, co-administration with another food or drug) with labeled drug administration information in the assessed populations to identify factors that raise issues for safety and effectiveness with generic substitution; and 3) analyze the impact of product-level, patient-level, and provider-level factors on generic drug substitution. The outcome of this study will help identify research needs, support FDA's regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.
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Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Studies (Collab... - 0 views

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    The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.
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Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials... - 0 views

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    The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials.
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Beckman Center Announces History of Science Fellowships | RFPs | PND - 0 views

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    The Beckman Center for the History of Chemistry at the Chemical Heritage Foundation, an independent research library in Philadelphia, is inviting applications for short- or long-term fellowships in the history of science, technology, medicine, and industry. The research collections at CHF range chronologically from the fifteenth century to the present and include six thousand rare books, significant archival holdings, thousands of images, and a large artifact and fine arts collection, supported by over one hundred thousand reference volumes and journals. Within the collections there are many areas of special strength, including alchemy, mining & metallurgy, dyeing and bleaching, balneology, gunpowder and pyrotechnics, gas-lighting, books of secrets, inorganic and organic chemistry, biochemistry, food chemistry, and pharmaceuticals.
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DoD Autism Clinical Trial Award - 0 views

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    The ARP Clinical Trial Award supports research with the potential to have a major impact on the treatment or management of ASD. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. It is expected that the proposed clinical trial begin no later than 12 months after the award date, or 18 months after the award date for U.S. Food and Drug Administration (FDA)-regulated studies.
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RFA-FD-19-013: Convener and organizer of activities and engagements focused on the deve... - 0 views

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    This FOA, issued by the Office of Medical Policy (OMP), Center for Drug Evaluation and Research, Food and Drug Administration, solicits grant applications from neutral, independent institutions and/or organizations to support meetings (e.g., conferences, workgroups, roundtables) that convene a broad range of multiple stakeholders, including those with relevant expertise, to explore and address issues related to medical products, policy, and surveillance methods and systems. Support includes but is not limited to preliminary research of identified topics, the design, planning, execution, synthesis, summary, and communication of findings from these forums to a broad range of organizations and individuals.
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Tobacco Regulatory Science (R01 Clinical Trial Optional) - 0 views

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    The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
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RFA-OD-19-019: Tobacco Regulatory Science (R01 Clinical Trial Optional) - 0 views

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    The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.  
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NineSights Community - Request for Proposal: 2aTechnology of in vivo Fluorescence Labe... - 0 views

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    NineSigma, representing a major food manufacturer, seeks a technology of in vivo fluorescence labeling of any protein or mRNA using antibodies/probes. Specifically, the client anticipates proposals for technologies such as: Technology to design/produce fluorescence-labeled detection probes (antibodies, low molecular weight probes, etc.) Technology to easily introduce the fluorescence-labeled detection probe into living cells in a highly efficient manner
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Medications Development for the Treatment of Alcohol Use Disorder (U01 Clinical Trial O... - 0 views

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    The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement applications for research that advances promising compounds thorough the drug development pipeline for the treatment of Alcohol Use Disorder (AUD). NIAAA is seeking applications for medications development research projects from both for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, small businesses not eligible for the SBIR/STTR program and single entities able to demonstrate significant resource commitment to the proposed project. A resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material. The aim of this FOA is to move candidate compounds through Investigational New Drug (IND) requirements, Phase 1 human safety, tolerability, and dosing studies, and Phase 2 human laboratory and proof-of-concept trials. Within these phases of drug development, each proposed project should have a defined entry and exit point. Finally, this FOA will not support animal studies to prove efficacy of the candidate compound unless required by the Food and Drug Administration or peer review. Applicants are strongly encouraged to contact the NIAAA Division of Medications Development Staff prior to submitting to this FOA.
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DoD Amyotrophic Lateral Sclerosis Research, Therapeutic Development Award - 0 views

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    The Therapeutic Development Award supports research ranging from validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)- enabling studies. The proposed studies are expected to be empirical in nature and product- driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include: Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model system
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DoD Amyotrophic Lateral Sclerosis, Therapeutic Development Award - 0 views

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    The Therapeutic Development Award supports research ranging from validation of therapeutic leads to U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include: * Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds * Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses * Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods * IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model systems Validation of treatment approaches in appropriately powered and controlled studies using biological correlates of disease activity and progression in pre-existing, de-identified human specimens from well-characterized patient cohorts is encouraged. Examples of acceptable cohorts for study include controlled clinical trials, observational studies, and registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://wwwn.cdc.gov/als/).
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NSF/FDA Scholar-in-Residence at FDA (nsf18556) | NSF - National Science Foundation - 0 views

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    The National Science Foundation (NSF), through the Directorate for Engineering, the Directorate of Computer and Information Science and Engineering Division of Computer and Network Systems, and the Directorate for Mathematical and Physical Sciences Division of Materials Research, along with the U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), have established the NSF/FDA Scholar-in-Residence Program at FDA. This program comprises an interagency partnership for the investigation of scientific and engineering issues concerning emerging trends in medical device technology. This partnership is designed to enable investigators in science, engineering, and computer science to develop research collaborations within the intramural research environment at the FDA. This solicitation features three flexible mechanisms for support of research at the FDA: 1) Principal Investigators at FDA; 2) Postdoctoral Researchers at FDA; and 3) Graduate Students at FDA.
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BARD Funding Opportunities - 0 views

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    BARD projects, conducted cooperatively by American and Israeli scientists, cover all phases of agricultural research and development, including integrated projects and strategic or applied research. Cooperative research entails active collaboration between Israeli and American scientists. The following research areas were identified by the Board of Directors as top priorities for the coming years: Increased Efficiency of Agricultural Production Protection of Plants and Animals Against Biotic and Abiotic Stress Food Quality, Safety and Security Water Quality & Quantity Functional Genomics and Proteomics Sensors and Robotics Sustainable Bio-Energy Systems
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PAR-17-456: NINDS CREATE Bio Optimization Track for Biologics (U01) - 0 views

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    This Funding Opportunity Announcement (FOA) supports the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene and cell therapies) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies. Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track. The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA).
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RFA-OD-17-014: Tobacco Regulatory Science (R21) - 0 views

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    The purpose of this Funding Opportunity Announcement (FOA) is to invite research project applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. 
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Biosensing - 0 views

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    ) multiplex biosensing platforms that exceed the performance of current state-of-the-art devices; 2) novel transduction principles, mechanisms and sensor designs suitable for measurement in practical matrix and sample-preparation-free approaches, including error-free detection of pathogens and toxins in food matrices, waterborne pathogens, parasites, toxins, biomarkers in body fluids, neuron chemicals, and others that improve human condition; 3) biosensors that enable measurement of biomolecular interactions in their native states, transmembrane transport, intracellular transport and reactions, and other biological phenomena; 4) biosensing performance optimization for specific health applications such as point-of-care testing and personalized health monitoring; and 5) miniaturization of biosensors for lab-on-a-chip and cell/organ-on-a-chip applications to enable measurement of biological properties and functions of cell/tissues in vitro. The Biosensors Program does not encourage proposals addressing surface functionalization and modulation of bio-recognition molecules, development of basic chemical mechanisms for biosensing applications, circuit design for signal processing and amplification, computational modeling, and microfluidics for sample separation and filtration.
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PAR-18-827: Minor Use Minor Species Development of Drugs (R01) - 0 views

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    This Funding Opportunity Announcement (FOA) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop, or support the development of new animal drugs intended for minor use in major species or for use in minor species.
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Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials ... - 0 views

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    The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans.
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