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The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing the innovative analysis of existing social science, behavioral, administrative, and neuroimaging data to study the etiology and epidemiology of drug using behaviors (defined as alcohol, tobacco, prescription and other drug) and related disorders, prevention of drug use and HIV, and health service utilization. This FOA encourages the analyses of public use and other extant community-based or clinical datasets to their full potential in order to increase our knowledge of etiology, trajectories of drug using behaviors and their consequences including morbidity and mortality, risk and resilience in the development of psychopathology, strategies to guide the development, testing, implementation, and delivery of high quality, effective and efficient services for the prevention and treatment of drug abuse and HIV.

This Funding Opportunity Announcement (FOA) encourages applications focused on the use the Osteoarthritis Initiative (OAI) database, clinical data and images. This FOA seeks to expand the use of these resources by investigators in the broader research community. Examples of possible topics are: identification and validation of risk factors for knee and hip OA, including both modifiable and non-modifiable risk factors; utilization of biospecimens in conjunction with research efforts to determine biochemical markers of early and/or progressive disease; analyses of existing OAI data to assess the effectiveness of biobehavioral, pharmacological, and other interventions that subjects use in response to OA pain; determination of predictive role of MRI changes for subsequent radiographic and clinical outcome changes related to development of knee OA; development of novel and efficient tools for analysis of MR images and x rays that can be applied to large numbers of images with high degrees of reproducibility for diagnosis and monitoring of OA-related changes; and research focused on the trajectory of disease including effects on other joint structures such as muscles, ligaments, and bone, with regard to points where interventions could be made, especially for subsets, to reduce OA severity. The publication of this FOA to the research community indicates to investigators and peer reviewers the importance that the NIAMS and other partners have placed on the use of the OAI resources.

The purpose of the Colgate-Palmolive Award for Student Research Training in Alternative Methods is to enhance graduate student research training using in vitro methods or alternative techniques to reduce, replace or refine use of animals in toxicological research. The training may include, but is not limited to, use of in vitro and ex vivo procedures, nonmammalian animal models, computer modeling, and structure-activity relationships. Graduate students may propose to develop expertise in relevant methodologies 1) at a laboratory away from their home institution, 2) at a laboratory at their home institution that would not be available to them otherwise, or 3) at approved workshops, symposia or continuing education programs where hands-on training will be received. The training should help toxicology graduate students enhance their thesis or dissertation research. The overall goal is to support the replacement, reduction, or refinement of currently used animal models in toxicology research and testing. The proposal will include a budget of up to $3,750 to defray travel, per diem, training expenses, and research costs.

This Notice supersedes NOT-OD-15-024 about the NIH and AHRQ requirement for use of a new biosketch format and provides some latitude in the transition for those who have already been compiling biosketches for their large grant applications with deadlines in early in 2015. NIH and AHRQ encourages applicants to use the newly published biosketch format for all grant and cooperative agreement applications submitted for due dates on or after January 25, 2015, and will require use of the new format for applications submitted for due dates on or after May 25, 2015. Applicants may submit using the new biosketch format for due dates before January 25, 2015, if they wish.

This Funding Opportunity Announcement (FOA) will support rigorous, pre-clinical studies that establish the rationale for a clinical trial, where the hypothesis originates from use of a published or publicly available method for identifying new indications for existing drugs or biologics (therapeutics). The goal of an individual project will be to explore the potential new use of an existing investigational, phase 2a-ready, or FDA-approved drug or licensed biologic; a pre-clinical study funded through this initiative will serve as a use case to demonstrate the utility of an independent crowdsourcing effort or of a computational algorithm to predict new uses of a drug or biologic.

The intention of this Funding Opportunity Announcement is to improve the prevention, diagnosis, and treatment of vulvodynia.  By definition, vulvar discomfort or pain without a clear etiology is termed vulvodynia. Some organizations use the term vulvodynia to indicate vulvar pain of unknown etiology for more than 3 months.  For the purposes of this announcement, vulvodynia and vulvar pain will be used interchangeably.  The overall incidence of vulvodynia has been reported as 4.2 cases per 100 person-years in one population based study, with others estimating that persistent vulvar pain affects 9 to 18 percent of women at some point during their lifetime. Current evidence suggests that incidence rates vary by age, ethnicity and marital status.

The intention of this Funding Opportunity Announcement is to improve the prevention, diagnosis, and treatment of vulvodynia.  By definition, vulvar discomfort or pain without a clear etiology is termed vulvodynia. Some organizations use the term vulvodynia to indicate vulvar pain of unknown etiology for more than 3 months.  For the purposes of this announcement, vulvodynia and vulvar pain will be used interchangeably.  The overall incidence of vulvodynia has been reported as 4.2 cases per 100 person-years in one population based study, with others estimating that persistent vulvar pain affects 9 to 18 percent of women at some point during their lifetime. Current evidence suggests that incidence rates vary by age, ethnicity and marital status.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research to develop and validate new screening methods for autism spectrum disorders (ASD) that can be used in infancy (0-12 months of age). This FOA uses the R01 grant mechanism, while RFA-MH-19-121 uses the R21 grant mechanism. Pilot or exploratory projects with minimal preliminary data, or those proposing early-stage feasibility testing, may be most appropriate for the R21 mechanism. Applicants with strong preliminary data proposing validation, refinement or final stages of testing of existing tools or methods may wish to use this FOA (R01 mechanism).

NIOSH uses cooperative agreements to arrange collaborative surveillance and research opportunities with state health departments, universities, labor unions, and nonprofit organizations. NIOSH funds a broad array of cooperative agreements to develop knowledge for preventing occupational diseases, injury, and death. The U24 cooperative agreement mechanism will be used to provide tribal nations, states, and large municipalities with technical assistance and services to build occupational safety and health (OSH) program capacity and promote the use of multiple-source surveillance data. The awardee(s) will advance education and translation through the operation of an open-access online repository for occupational health information and surveillance data. States, Non-governmental organizations (NGOs), and tribes will draw upon relationships with their stakeholders to use surveillance data to take action such as identify or support tribal and state priorities, and guide coordinated, targeted efforts to protect workers; monitor statistical and other trends and progress over time (i.e., burden and impact); propose pilot and evaluation activities for addressing disease burden or impact; conduct educational and outreach activities; and to develop prevention and intervention recommendations.

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing research that will promote the development and use of alternative test methods and strategies that address the "3Rs" of toxicity testing: 1) reduce, 2) refine, and/or 3) replace vertebrate animal testing. For the purposes of this RFA, alternative test methods refer to those that incorporate the "3Rs" principles. Pertinent research includes approaches such as analog/read-across techniques, mathematical models, and tiered testing approaches that integrate evidence from multiple sources to help accomplish these goals. In addition to the development of new alternative test methods and strategies, translational science approaches that use available data to develop and/or advance actionable approaches for risk assessment of chemicals are also critical. In this context, approaches that facilitate the use of existing animal data sources to reduce, refine, or replace the need for new vertebrate animal tests are as welcome as those that provide new data streams. The research activities to be funded under this announcement are intended to advance the science underpinning the use of non-vertebrate test methods, and to develop actionable alternative approaches to: 1) developmental toxicity tests in humans; 2) reproductive toxicity tests in humans; and/or 3) ecotoxicity tests.

This funding opportunity announcement (FOA) seeks to facilitate the entry of both newly independent and early career investigators to the area of drug use and use disorder research and HIV/AIDS. This FOA, AIDS-Science Track Award for Research Transition (A-START), encourages Small Research Grant (R03) applications to support research projects on drug misuse and/or use disorder and HIV/AIDS that can be carried out in a short period of time with limited resources. This FOA welcomes applications integrating drug misuse and/or use disorder and HIV/AIDS across all areas of research supported by NIDA.

The purpose of this FOA is to fund research centers that will establish longitudinal cohorts in rare HLBS diseases to investigate unaddressed research questions using epidemiologic study designs and methods that are appropriate for conditions affecting fewer than 200,000 persons in the US. These observational cohort studies should be designed to provide an evidence base for future interventional studies, including clinical trials; for developing better diagnostics than those that are currently available; for answering early translational questions; or for broader implementation of guidelines for managing these diseases. This program will provide opportunities to advance rare disease research using genetics and deep phenotyping to characterize the disease and to identify disease sub-types; to use data science methods that integrate clinical and patient-reported outcomes (PROs) with laboratory, imaging, environmental and -omics data to understand the natural history of disease; to generate data that differentiate patients with the same morphological phenotype but different genetic mutations and severity of outcomes; to elucidate genotype-phenotype interactions and multisystem phenotyping to develop reliable and valid predictive tools to determine who will respond to which treatments and when to intervene; and to encourage innovative methods such as telemedicine to include participants with rare diseases located in remote locations.

What we will consider funding: Innovative ideas for improving measurement of coverage and equity data for use by program staff and managers. Specifically, their ability to collect and deliver the right data at the right time to the appropriate audiences would benefit from: Incorporating advances in technology to support decision makers in planning and executing program strategies Integration of immunization data systems, as well as the ability to address data use demands from multiple stakeholders. Enabling a culture that supports data quality and use e.g. provides feedback on data at multiple levels. Alignment of incentives to promote reporting of accurate data above coverage estimates. Innovations in process efficiency toward improved service delivery. These may stem from lean healthcare, or other approaches, but should have the end goal of improving the experience of healthcare workers, caregivers, or both.

A primary focus of these programs is on the use of in vitro methods and assays using lower organisms to screen thousands of chemicals for toxicity in order to identify mechanisms of compound-induced biological activity, characterize toxicity pathways, facilitate cross-species extrapolation, and provide input to models for low-dose extrapolation.  Data generated by these methods will be used to prioritize compounds for more extensive toxicological evaluation and to develop predictive models for biological response in humans. Current approaches are limited in terms of incorporating genetic variability in toxicity testing and in assessing the effects of chemicals in multiple normal tissue and cell types, relying on immortalized cell lines or primary cell lines derived from tissues. Thus, there is a need for novel, medium- to high-throughput assays (at least a 96-well format) to evaluate the effects of chemical compounds on the differentiation of pluripotent or multi-potent stem cells as well as the effects of chemical exposures on differentiated cell types representative of various in vivo tissues. Approaches can include the use of human induced pluripotent stem (iPS) cells, approved human embryonic stem (ES) cell lines, or ES or iPS cells derived from genetically characterized mouse strains. Assays should be able to measure the effects of toxicants on the differentiation process and/or on the differentiated cells themselves; cell types of high priority include but are not limited to cardiomyocytes, neural cells, hepatocytes, endothelial cells, lung (airway or alveolar) cells, and hormonally-responsive tissues such as reproductive tissues or breast epithelial cells.

Drug development tools (DDTs) are methods, materials, or measures that can potentially facilitate drug development. To support DDT development efforts, FDA established qualification programs for animal models for use under the Animal Rule, biomarkers, and clinical outcome assessments. Examples of DDTs may include but are not limited to: a biomarker used for clinical trial enrichment, a clinical outcome assessment (COA) used to evaluate clinical benefit, or an animal model used for efficacy testing of medical countermeasures under the regulations commonly referred to as the Animal Rule.

As a key activity, INL promotes the development of a professional network of substance use disorder prevention and treatment service providers, policymakers, academic professionals, and other stakeholders (the "workforce") to encourage and promote evidence-based, effective drug demand reduction around the world. The purpose of this project is to support the development of an international membership organization that can provide online support and materials for networking and professionalization of the workforce, partner and collaborate with existing organizations to promote the dissemination of evidence-based best practices, and convene periodic global events that create opportunities for the substance use prevention and treatment workforce to receive training and meet other stakeholders. The recipient will also be responsible for maintaining a database of education providers and training activities carried out using materials developed by INL Demand Reduction programs, including those offered by other recipients of INL Demand Reduction program funding.

This Funding Opportunity Announcement (FOA) encourages applications for research awards that are focused on the use of the Osteoarthritis Initiative (OAI) database, clinical data and images. This FOA seeks to expand the use of these resources by investigators in the broader research community. The publication of this FOA to the research community indicates to investigators and peer reviewers the importance that the NIAMS and others have placed on the use of the OAI resources.

Background Generic drug products demonstrate BE to the (brand name) reference listed drug (RLD) and/or reference standard (RS) product by showing that they can deliver the same amount of the same drug to the site(s) of therapeutic action at the same rate and to the same extent as the RLD/RS drug product. For many systemically-acting drug products, BE is evaluated based upon plasma PK studies, which U.S. regulations consider to provide the most accurate, sensitive and reproducible evidence for establishing BE. This PK-based evaluation of BE also has the potential to be relatively efficient, and is well suited to generic drug development. Evaluating the PK of a locally-administered drug in a solid tissue like the skin can be scientifically and technically challenging. An in vitro cutaneous PK-based approach has been developed to support the evaluation of BE using an in vitro permeation test (IVPT) with excised human skin mounted in diffusion cells. In vivo cutaneous PK-based approaches have also been explored over the last several decades, including some using microdialysis/microperfusion probes inserted in the skin, or using non-invasive spectroscopic/imaging technologies. However, there is currently no in vivo cutaneous PK-based method that has been established to evaluate topical BE, and further research is needed.

The purpose of this funding opportunity announcement (FOA) is to (1) promote preclinical, translational, clinical and epidemiological research in pain medications use in children or in pregnant women to fill knowledge gaps in safe use of the pain medications in these special populations; and (2) develop effective instruments or approaches to assess and evaluate maternal and child outcomes of pain medication treatments. There is a need for data on pain medications used in children and pregnant women to be shared and made available to the scientific community for future studies and to encourage replication of findings and meeting the goal of further advancing research in this area. Also listed under R03

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the discovery and development of medications to treat Cannabis Use Disorders (CUDs) using the UG3/UH3 mechanism. The objective is to advance medications toward the ultimate goal of obtaining FDA approval. Advances in understanding the cannabinoid systems and the effects of marijuana on the brain, coupled with the availability of both novel and marketed medications that may be efficacious to treat these disorders, offer unprecedented opportunities to develop safe and effective pharmacotherapies for CUDs. The compounds to be evaluated can be small molecules or biologics. They can be tested in pre-clinical models and/or for the clinical manifestations of CUDs or their consequences such as withdrawal, craving, or cannabis use relapse. Applications may focus on the development of new chemical entities, new formulations of marketed medications available for other indications, or combinations of medications that hold promise for the treatment of CUDs. The UG3/UH3 Phase Innovation Awards Cooperative Agreement involves 2 phases. The UG3 is to support a project with specific milestones to be accomplished by the end of the 2-year period. The UH3 is to provide funding for 3 years to a project that successfully completed the milestones set in the UG3. UG3 projects that have met their milestones will be administratively considered by NIDA and prioritized for transition to the UH3 phase. Investigators responding to this FOA must address both UG3 and UH3 phases.

This Funding Opportunity Announcement (FOA) encourages applications for research awards that are focused on the use the Osteoarthritis Initiative (OAI) database, clinical data and images. This FOA seeks to expand the use of these resources by investigators in the broader research community. Examples of possible topics are: identification and validation of risk factors for knee and hip OA, including both modifiable and non-modifiable risk factors; utilization of biospecimens in conjunction with research efforts to determine biochemical markers of early and/or progressive disease; analyses of existing OAI data to assess the effectiveness of biobehavioral, pharmacological, and other interventions that subjects use in response to OA pain; determination of predictive role of MRI changes for subsequent radiographic and clinical outcome changes related to development of knee OA; development of novel and efficient tools for analysis of MR images and x rays that can be applied to large numbers of images with high degrees of reproducibility for diagnosis and monitoring of OA-related changes; and research focused on the trajectory of disease including effects on other joint structures such as muscles, ligaments, and bone, with regard to points where interventions could be made, especially for subsets, to reduce OA severity. The publication of this FOA to the research co