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The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase Ib studies of novel Agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drug's impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private funding for further clinical development as FDA-approved treatments.

The Navy Experimental Diving Unit (NEDU) is soliciting pre-proposals and proposals for applied Biomedical Research and Diving Equipment Development with a focus on Submarine Escape and Rescue, Diving Safety, and Diving Effectiveness.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small businesses to address the technological needs of the Kidney Precision Medicine Project (KPMP). The KPMP will obtain and evaluate kidney biopsies from participants with acute kidney injury (AKI) and chronic kidney disease (CKD), create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies. Proposed technologies are expected to improve the safety of the human kidney biopsy or enhance interrogation of human kidney tissue, thus ensuring that the kidney biopsy yields useful research or clinical information.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small businesses to address the technological needs of the Kidney Precision Medicine Project (KPMP). The KPMP will obtain and evaluate kidney biopsies from participants with acute kidney injury (AKI) and chronic kidney disease (CKD), create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies. Proposed technologies are expected to improve the safety of the human kidney biopsy or enhance interrogation of human kidney tissue, thus ensuring that the kidney biopsy yields useful research or clinical information.

The purpose of the SCRI program is to address the critical needs of the specialty crop industry by awarding grants to support research and extension that address key challenges of national, regional, and multi-state importance in sustaining all components of food and agriculture, including conventional and organic food production systems. Projects must address at least one of five focus areas: Research in plant breeding, genetics, genomics, and other methods to improve crop characteristics; Efforts to identify and address threats from pests and diseases, including threats to specialty crop pollinators; Efforts to improve production efficiency, handling and processing, productivity, and profitability over the long term (including specialty crop policy and marketing) New innovations and technology, including improved mechanization and technologies that delay or inhibit ripening; and Methods to prevent, detect, monitor, control, and respond to potential food safety hazards in the production efficiency, handling and processing of specialty crops.

The purpose of the SCRI program is to address the critical needs of the specialty crop industry by awarding grants to support research and extension that address key challenges of national, regional, and multi-state importance in sustaining all components of food and agriculture, including conventional and organic food production systems. Projects must address at least one of five focus areas: Research in plant breeding, genetics, genomics, and other methods to improve crop characteristics; Efforts to identify and address threats from pests and diseases, including threats to specialty crop pollinators; Efforts to improve production efficiency, handling and processing, productivity, and profitability over the long term (including specialty crop policy and marketing) New innovations and technology, including improved mechanization and technologies that delay or inhibit ripening; and Methods to prevent, detect, monitor, control, and respond to potential food safety hazards in the production efficiency, handling and processing of specialty crops.

The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy.  FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a "rare disease or condition" and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.

The Environmental Health Specialists Network (EHS-Net) is a collaborative forum of environmental health specialists who work together to improve environmental health practice. EHS-Net seeks to improve the practice of environmental health service programs by developing and sustaining a network of environmental health specialists (EHS) who collaborate with epidemiologists, laboratorians and other public health professionals to conduct practice-based research to identify and prevent environmental risk factors contributing to foodborne illness. For information on EHS-Net activities, please visit http ://www .cdc .gov /nceh /ehs /EHSNe t / index.htm. This announcement will fund EHS-Net-related research projects for food safety activities under the jurisdiction of departments of health or other agencies responsible for regulatory oversight of retail food service including restaurants, delis, cafeterias, schools, etc.

The purpose of the Funding Opportunity Announcement (FOA) is to promote the assessment and further development of simulation technologies intended to improve patient safety and healthcare outcomes provided by practicing patient care providers and experienced (not trainee) physicians. The FOA seeks applications directed toward three areas of research: 1) Skill Acquisition: to evaluate strategies and protocols for simulation-based methods for skill acquisition and maintenance by experienced clinicians; 2) Outcomes Assessment: to assess the relationship of simulation-based assessments of skills demonstrated by experienced clinicians with the quality of clinical care delivered by those clinicians, and to identify strategies to increase the quality of simulation-based assessments of skills; and 3) Technology Development: to develop virtual coaches by incorporating intelligent technologies into existing simulators to provide adaptive, cognitive assistance to coach experienced practitioners in retaining, retraining and improving performance levels in the context of the user environment (and physiological system as appropriate).

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this National Institute of Environmental Health Sciences (NIEHS) Superfund Research Program (SRP) Occupational and Safety Education Programs on Emerging Technologies R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs.

The purpose of the notice is to inform all NIAAA grant applicants of the revised Data and Safety Monitoring Plan (DSMP) requirements for all extramural NIAAA-funded clinical trials. The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (https://grants.nih.gov/grants/glossary.htm#ClinicalTrial.) The revised DSMP guidelines provide better alignment with local Institutional Review Board (IRB) requirements and provide NIAAA with enhanced oversight of NIAAA-funded clinical trials.

This Funding Opportunity Announcement (FOA) solicits Small Business Innovation Research (SBIR) Fast Track grant applications that propose to test and/or validate novel, state-of-the-art candidate biomarker platforms for predicting the onset and progression of inflammatory diseases of interest to the NIAMS and for determining the pharmacodynamics, safety and/or efficacy of therapeutic agents targeting those diseases. 

The National Institute of Allergy and Infectious Diseases (NIAID) solicits applications from single institutions and consortia of institutions to participate in the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) program. The NHPCSG is a multi-center, cooperative program for research on nonhuman primate (NHP) models of kidney, pancreatic islet, heart, and lung transplantation. The goals of the NHPCSG are to evaluate the preclinical safety and efficacy of existing and newly developed immune tolerance induction regimens and to elucidate the underlying mechanisms of the induction, maintenance, and/or loss of tolerance in these models. The long-range goal of this program is to develop and evaluate immune tolerance induction regimens that will result in enhanced long-term graft survival in clinical transplantation.

The specific objective of the "E-Rare-3" call is to promote clinical and pre-clinical proof of concept studies for the potential application of medicinal products that are either already marketed or have achieved a significant stage in the development process in rare indications. Projects should aim at discovering new therapeutic uses for agents whose clinical safety has already been characterized to move quickly into proof of concept trials in the selected rare diseases' patient population.

The Colgate-Palmolive Grant for Alternative Research will identify and support efforts that promote, develop, refine, or validate scientifically acceptable animal alternative methods to facilitate the safety assessment of new chemicals and formulations. Scientists at any stage of career progression may submit a proposal.

PEPFAR South Sudan works in collaboration with the Government of South Sudan (GOSS) Ministry of Health (MOH) in implementing the HIV/AIDS National Strategic Plan (NSP) based on a priority action approach and strong collaboration and coordination among different stakeholders. PEPFAR South Sudan has prioritized supporting the MOH in strengthening their national laboratory system with the primary objective of supporting the diagnosis, treatment, prevention and surveillance of HIV through high-quality laboratory services. This funding opportunity announcement (FOA) solicits technical assistance (TA) to strengthen the GOSS MOH laboratory and blood transfusion services systems. Outcomes will include the overall strengthening of the National Reference Lab, implementing and achieving accreditation for quality assurance systems; strengthening service delivery through increased technical assistance to lab testing programs, and training and accreditation for the national blood safety programs. The ultimate outcome is a national integrated quality-assured network of tiered laboratories providing quality clinical laboratory services with the capacity to support the diagnosis, treatment, prevention and surveillance of HIV and other diseases and support the establishment of the National Public Health Laboratory (NPHL) and the National Blood Transfusion Services (NBTS).

The purpose of this program is to investigate and evaluate advanced fuels and fuel technologies, fuel system component development, advanced combustor and augmentor designs, advanced fuel properties measurements, fuel system component development and safety and combustion emissions along with their integration into advanced aerospace applications and advanced technologies to prevent and mitigate fuel biodeterioration.

The U.S. Department of Agriculture (USDA) established the  Agriculture and Food Research Initiative (AFRI) under which the Secretary of Agriculture may make competitive grants for fundamental and applied research, education, and extension to address food and agricultural sciences (as defined under section 1404 of the National  Agricultural Research, Extension, and Teaching Policy Act of 1977 (NARETPA) (7 U.S.C. 3103)), as amended, in six priority areas. The six priority areas include: 1) plant health and production and plant products; 2) animal health and production and animal products; 3) food  safety, nutrition, and health; 4) renewable energy, natural resources, and environment; 5) agriculture systems and technology; and 6) agriculture economics and rural communities. 

The purpose of this Funding Opportunity Announcement (FOA) is to support research to develop and pilot test strategies to assist transition-age youth with autism spectrum disorder (ASD) and their families or caretakers in planning for and smoothly transitioning into adult functioning and adult services.The ultimate goal is to develop models for transition to adult supports and services that effectively prevent lapses in services and supports; enhance functioning in community settings such as educational, social, familial, and other settings; maintain or improve health, safety, and quality of life; and reduce or maintain reductions in ASD-related symptoms.

This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Cooperative Agreement (U01) Research Projects for research on the identification of small molecule or biologic lead compounds that are excellent candidates for therapeutic development. The mission of the CounterACT program is to foster and support research and development of new and improved therapeutics for chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. The scope of research supported by this FOA includes confirmation of molecular targets for therapeutic development, demonstration of in vitro activity of candidate therapeutics, preliminary in vivo proof-of-concept efficacy data, preliminary adsorption, distribution, metabolism, excretion, and toxicity (ADME/Tox) evaluations and pharmacokinetics/pharmacodynamics (PK/PD) data. These studies should result in the identification of at least one lead compound ready for optimization. Lead compounds are biologically active and synthetically feasible compounds where specificity, affinity, potency, target selectivity, efficacy, and safety have been established. Lead compounds should be ready for more advanced development under possible support from other programs such as the one described in the companion FOA "CounterACT Optimization of Therapeutic Lead Compound (U01)" (PAR-18-NNN). The scope of this FOA encompasses Technical Readiness Level (TRL) 1-3 - see TRLs. Each project must include annual milestones that create discrete go or no-go decision points in a progressive translational study plan.

The purpose of this FOA is to identify and support a Clinical Coordination Center (CCC) for the Common Fund Acute to Chronic Pain Signatures (A2CPS) Program. The Clinical Coordinating Center is expected to serve as the hub for the Multisite Clinical Centers (below) to support study design, efficiency, progress, and quality, and to coordinate and monitor study implementation across the clinical sites. The Clinical Coordinating Center will lead the consortium in developing and implementing standardized protocols, safety standards, staff training protocols, electronic health record (EHR) data standards, patient phenotyping and testing, and regulatory processes.

The purpose of this Funding Opportunity Announcement (FOA) is to support the development of innovative technologies to non-invasively label and monitor genome edited cells in vivo. The ultimate goal for these technologies is to inform on safety and efficacy of in vivo genome editing over time.