Group items tagged

The Ecology and Evolution of Infectious Diseases program supports research on the ecological, evolutionary, and socio-ecological principles and processes that influence the transmission dynamics of infectious diseases. The central theme of submitted projects must be quantitative or computational understanding of pathogen transmission dynamics. The intent is discovery of principles of infectious disease transmission and testing mathematical or computational models that elucidate infectious disease systems. Projects should be broad, interdisciplinary efforts that go beyond the scope of typical studies. They should focus on the determinants and interactions of transmission among humans, non-human animals, and/or plants. This includes, for example, the spread of pathogens; the influence of environmental factors such as climate; the population dynamics and genetics of reservoir species or hosts; the cultural, social, behavioral, and economic dimensions of disease transmission. Research may be on zoonotic, environmentally-borne, vector-borne, or enteric diseases of either terrestrial or freshwater systems and organisms, including diseases of animals and plants, at any scale from specific pathogens to inclusive environmental systems. Proposals for research on disease systems of public health concern to developing countries are strongly encouraged, as are disease systems of concern in agricultural systems. Investigators are encouraged to develop the appropriate multidisciplinary team, including for example, modelers, bioinformaticians, genomics researchers, social scientists, economists, epidemiologists, entomologists, parasitologists, microbiologists, bacteriologists, virologists, pathologists or veterinarians, with the goal of integrating knowledge across disciplines to enhance our ability to predict and control infectious diseases.

The Ecology and Evolution of Infectious Diseases program supports research on the ecological, evolutionary, and socio-ecological principles and processes that influence the transmission dynamics of infectious diseases. The central theme of submitted projects must be quantitative or computational understanding of pathogen transmission dynamics. The intent is discovery of principles of infectious disease transmission and testing mathematical or computational models that elucidate infectious disease systems. Projects should be broad, interdisciplinary efforts that go beyond the scope of typical studies. They should focus on the determinants and interactions of transmission among humans, non-human animals, and/or plants. This includes, for example, the spread of pathogens; the influence of environmental factors such as climate; the population dynamics and genetics of reservoir species or hosts; the cultural, social, behavioral, and economic dimensions of disease transmission. Research may be on zoonotic, environmentally-borne, vector-borne, or enteric diseases of either terrestrial or freshwater systems and organisms, including diseases of animals and plants, at any scale from specific pathogens to inclusive environmental systems. Proposals for research on disease systems of public health concern to developing countries are strongly encouraged, as are disease systems of concern in agricultural systems. Investigators are encouraged to develop the appropriate multidisciplinary team, including for example, modelers, bioinformaticians, genomics researchers, social scientists, economists, epidemiologists, entomologists, parasitologists, microbiologists, bacteriologists, virologists, pathologists or veterinarians, with the goal of integrating knowledge across disciplines to enhance our ability to predict and control infectious diseases.

The Ecology and Evolution of Infectious Diseases program supports research on the ecological, evolutionary, and socio-ecological principles and processes that influence the transmission dynamics of infectious diseases. The central theme of submitted projects must be quantitative or computational understanding of pathogen transmission dynamics. The intent is discovery of principles of infectious disease transmission and testing mathematical or computational models that elucidate infectious disease systems. Projects should be broad, interdisciplinary efforts that go beyond the scope of typical studies. They should focus on the determinants and interactions of transmission among humans, non-human animals, and/or plants. This includes, for example, the spread of pathogens; the influence of environmental factors such as climate; the population dynamics and genetics of reservoir species or hosts; the cultural, social, behavioral, and economic dimensions of disease transmission. Research may be on zoonotic, environmentally-borne, vector-borne, or enteric diseases of either terrestrial or freshwater systems and organisms, including diseases of animals and plants, at any scale from specific pathogens to inclusive environmental systems. Proposals for research on disease systems of public health concern to developing countries are strongly encouraged, as are disease systems of concern in agricultural systems. Investigators are encouraged to develop the appropriate multidisciplinary team, including for example, modelers, bioinformaticians, genomics researchers, social scientists, economists, epidemiologists, entomologists, parasitologists, microbiologists, bacteriologists, virologists, pathologists or veterinarians, with the goal of integrating knowledge across disciplines to enhance our ability to predict and control infectious diseases.

The Ecology and Evolution of Infectious Diseases program supports research on the ecological, evolutionary, and socio-ecological principles and processes that influence the transmission dynamics of infectious diseases. The central theme of submitted projects must be quantitative or computational understanding of pathogen transmission dynamics. The intent is discovery of principles of infectious disease transmission and testing mathematical or computational models that elucidate infectious disease systems. Projects should be broad, interdisciplinary efforts that go beyond the scope of typical studies. They should focus on the determinants and interactions of transmission among humans, non-human animals, and/or plants. This includes, for example, the spread of pathogens; the influence of environmental factors such as climate; the population dynamics and genetics of reservoir species or hosts; or the cultural, social, behavioral, and economic dimensions of disease transmission. Research may be on zoonotic, environmentally-borne, vector-borne, or enteric diseases of either terrestrial or freshwater systems and organisms, including diseases of animals and plants, at any scale from specific pathogens to inclusive environmental systems. Proposals for research on disease systems of public health concern to developing countries are strongly encouraged, as are disease systems of concern in agricultural systems. Investigators are encouraged to involve the public health research community, including for example, epidemiologists, physicians, veterinarians, food scientists, social scientists, entomologists, pathologists, virologists, or parasitologists with the goal of integrating knowledge across disciplines to enhance our ability to predict and control infectious diseases.

The Ecology and Evolution of Infectious Diseases program supports research on the ecological, evolutionary, and socio-ecological principles and processes that influence the transmission dynamics of infectious diseases. The central theme of submitted projects must be quantitative or computational understanding of pathogen transmission dynamics. The intent is discovery of principles of infectious disease transmission and testing mathematical or computational models that elucidate infectious disease systems. Projects should be broad, interdisciplinary efforts that go beyond the scope of typical studies. They should focus on the determinants and interactions of transmission among humans, non-human animals, and/or plants. This includes, for example, the spread of pathogens; the influence of environmental factors such as climate; the population dynamics and genetics of reservoir species or hosts; or the cultural, social, behavioral, and economic dimensions of disease transmission. Research may be on zoonotic, environmentally-borne, vector-borne, or enteric diseases of either terrestrial or freshwater systems and organisms, including diseases of animals and plants, at any scale from specific pathogens to inclusive environmental systems. Proposals for research on disease systems of public health concern to developing countries are strongly encouraged, as are disease systems of concern in agricultural systems. Investigators are encouraged to involve the public health research community, including for example, epidemiologists, physicians, veterinarians, food scientists, social scientists, entomologists, pathologists, virologists, or parasitologists with the goal of integrating knowledge across disciplines to enhance our ability to predict and control infectious diseases.

The Ecology and Evolution of Infectious Diseases program supports research on the ecological, evolutionary, and socio-ecological principles and processes that influence the transmission dynamics of infectious diseases. The central theme of submitted projects must be quantitative or computational understanding of pathogen transmission dynamics. The intent is discovery of principles of infectious disease transmission and testing mathematical or computational models that elucidate infectious disease systems. Projects should be broad, interdisciplinary efforts that go beyond the scope of typical studies. They should focus on the determinants and interactions of transmission among humans, non-human animals, and/or plants. This includes, for example, the spread of pathogens; the influence of environmental factors such as climate; the population dynamics and genetics of reservoir species or hosts; or the cultural, social, behavioral, and economic dimensions of disease transmission. Research may be on zoonotic, environmentally-borne, vector-borne, or enteric diseases of either terrestrial or freshwater systems and organisms, including diseases of animals and plants, at any scale from specific pathogens to inclusive environmental systems. Proposals for research on disease systems of public health concern to developing countries are strongly encouraged, as are disease systems of concern in agricultural systems. Investigators are encouraged to involve the public health research community, including for example, epidemiologists, physicians, veterinarians, food scientists, social scientists, entomologists, pathologists, virologists, or parasitologists with the goal of integrating knowledge across disciplines to enhance our ability to predict and control infectious diseases.

This Funding Opportunity Announcement (FOA) invites research projects to improve understanding of the causes of high priority diseases in the United States and reducing/eliminating health disparities. Research is encouraged in the following high priority diseases within the scientific mission areas of the NIDDK: diabetes; obesity; nutrition-related disorders; hepatitis C; gallbladder disease; H. Pylori infection; sickle cell disease, specifically, studies in complications of sickle cell disease within the NIDDK mission areas; kidney diseases; urologic diseases; hematologic diseases, including studies in abnormal hemoglobin synthesis; metabolic diseases; gastrointestinal, hepatic, and renal complications from infection with HIV. Clinical trials are not permitted in response to this FOA.

The ODC is offering 38 research opportunities focusing on 29 different rare diseases. This program provides a one-year grant to support research related to a rare disease represented in the 2020 Million Dollar Bike Ride. Number of awards and dollar amounts vary per disease based on fundraising totals by each disease team. Diseases included: * Adult Polyglucosan Body Disease (APBD) * Ataxia-Telangiectasia (A-T) * BPAN- A Neurodegeneration with Brain Iron Accumulation Disorder * CADASIL * Castleman Disease * Choroideremia * Congenital Hyperinsulinism (CHI) * Congenital Muscular Dystrophy (CMD) * Charcot Maire Tooth (CMT) * Cohen Syndrome (COH) * Nonsense Mutations in Cystic Fibrosis * Dyskeratosis Congenita & Telomere Biology Disorder * Fibrous Dysplasia/McCune Albright Syndrome * Fibrodysplasia Ossificans Progressiva (FOP) * Generalized Lymphatic Anomaly (GLA; a.k.a. lymphangiomatosis) and * Gorham-Stout Disease (GSD) * Glut1 Deficiency Sundrome * Inclusion Body Myositis (IBM) * Lymphangioleiomyomatosis (LAM) * Mucopolysaccharidoses (MPS) * MPS Gene Spotlight: Mucopolysaccharidosis (MPS I) * Maple Syrup Urine Disease (MSUD) * Mitochondrial Complex 1 Deficiency Disorder - NUBPL * Neuroendocrine cell Hyperplasia of Infancy (NEHI) * Niemann Pick Type C (NPC) * Pitt Hopkins Syndrome (PTHS) * RASopathies * SETBP1 Disorder * Snyder-Robinson Syndrome (SRS) * STXBP1 Encephalopathy * TBCK Syndrome

CDC announces supplemental funding for organizations that previously were awarded funding under the Notice of Funding Opportunity (NOFO) CDC-RFA-OE-17-1701. The purpose of his supplemental NOFO is to further strengthen the nation's capacity to carry out public health activities in the area of primary immunodeficiency diseases (PID) to widen the scope of the current grant, increase and improve physician education and public health awareness for/of PID. The intent is to increase the scope of the campaign to disseminate educational information on a national level to health care providers, educators, third-party payers, impacted families, and others who may help expedite clinical recognition and improve health outcomes for Americans with primary immunodeficiency diseases. The intended outcomes of this supplemental grant include increase in scope, in direct scale to conduct the following activities: - Development of materials and implementation of displays - Providers engage in education opportunities - Skills and knowledge of health care providers about primary immunodeficiency diseases increases - Improve integration of primary immunodeficiency diseases prevention into clinical care - Expedited clinical recognition of primary immunodeficiency diseases - Increase community and provider knowledge of primary immunodeficiency diseases - Increase the number of people appropriately diagnosed with primary immunodeficiency diseases - Increase access to care for people with primary immunodeficiency diseases. This announcement is only for non-research activities supported by CDC.

A rare disease is defined by the Orphan Drug Act as a disease that affects less than 200,000 people in the US. As described in FDA draft Guidance, "Rare Diseases: Common Issues in Drug Development Guidance for Industry" (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm458485.pdf ), fit-for-purpose clinical endpoints for many rare diseases are not available. Selection or development of clinical outcome assessments for use to support efficacy of a treatment in a rare disease can be challenging due to the small sample size of possible participants for participation in instrument development and clinical trials and heterogeneity of the target patient population (e.g., phenotypic or genotypic variations, age, clinical manifestations, variations in patient experience, and rate of disease progression). However, many rare diseases share similar clinical characteristics such as decline in cognition and physical function, which offers an opportunity to explore clinical outcome assessments that may cover a spectrum of rare diseases.

This Funding Opportunity Announcement (FOA) is limited to those Program Director(s)/Principal Investigator(s) of Rare Diseases Clinical Research Consortia (RDCRC) who received an NINDS award under the Rare Diseases Clinical Research Network (RDCRN) program through RFA-TR-13-002, or an NCI award through RFA-OD-08-001. The purpose of this limited competition FOA is to allow these NINDS- and NCI-awarded consortia an opportunity to compete for another four years of participation in the RDCRN. The RDCRN is a collaborative and coordinated network of Clinical Research Consortia comprised of investigators and patient advocacy groups committed to investigation of rare diseases working in partnership with a Data Management Coordinating Center (http://grants.nih.gov/grants/guide/rfa-files/RFA-TR-13-003.html) to enhance communication and sharing of resources in a multidisciplinary approach. This FOA intends to support: 1) collaborative clinical research in rare diseases, including longitudinal studies of individuals with rare diseases, clinical studies and/or clinical trials; 2) career development and advancement opportunities for clinical investigators in rare diseases research; 3) pilot/demonstration (proof of concept) clinical research projects; and 4) access to information related to rare diseases for basic and clinical researchers, physicians, patients, and the lay public.

This Funding Opportunity Announcement (FOA) encourages R21 applications that propose to conduct secondary analyses of existing data sets relevant to diabetes and selected endocrine and metabolic diseases including thyroid, parathyroid and Cushing's diseases and acromegaly; and genetic metabolic disease including cystic fibrosis, lysosomal storage diseases, and disorders of the urea cycle, amino acid metabolism and metal transport where the focus is on peripheral metabolism or organ function; obesity, liver diseases, alimentary GI tract diseases and nutrition; kidney, urologic, and hematologic diseases. The goal of this program is to facilitate research that explores innovative hypotheses through the use of existing data sets. 

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.

This Funding Opportunity Announcement (FOA) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs). The DDRCCs are part of an integrated program of digestive and liver diseases research support provided by the NIDDK.The purpose of this Centers program is to bring together basic and clinical investigators as a means to enhance communication, collaboration, and effectiveness of ongoing research related to digestive and/or liver diseases.DDRCCs are based on the core concept, whereby shared resources aimed at fostering productivity, synergy, and new research ideas among the funded investigators are supported in a cost-effective manner.Each proposed DDRCC must be organized around a central theme that reflects the focus of the digestive or liver diseases research of the Center members. The central theme must be within the primary mission of NIDDK, and not thematic areas for which other NIH Institutes or Centers are considered the primary source of NIH funding.

This Funding Opportunity Announcement (FOA) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs). The DDRCCs are part of an integrated program of digestive and liver diseases research support provided by the NIDDK.The purpose of this Centers program is to bring together basic and clinical investigators as a means to enhance communication, collaboration, and effectiveness of ongoing research related to digestive and/or liver diseases.DDRCCs are based on the core concept, whereby shared resources aimed at fostering productivity, synergy, and new research ideas among the funded investigators are supported in a cost-effective manner.Each proposed DDRCC must be organized around a central theme that reflects the focus of the digestive or liver diseases research of the Center members. The central theme must be within the primary mission of NIDDK, and not thematic areas for which other NIH Institutes or Centers are considered the primary source of NIH funding.

This Funding Opportunity Announcement (FOA) requests submission of applications for the National Institute on Aging (NIA) Late Onset of Alzheimer's Disease (LOAD) Family Based Study (FBS). Analysis of families that are multiply affected with Alzheimer's disease (AD) provides distinct advantages for characterizing the impact of genetic variants on disease risk. First, multiplex families are likely to be enriched for genetic variants associated with increased risk, providing increased statistical power to estimate the effects. Second, analysis of multiply affected families provides insight into the remaining unknown genetic influences (i.e., the "residual heritability") as well as antecedent modifying factors that interact with identified genetic variants to influence disease risk. Third, family members at risk are followed at regular intervals, facilitating prospective investigation of the effects of the genetic variants on age-at-onset as well as the modifying effects of antecedent risk and protective factors. Finally, family data can provide information regarding the influence of known variants on the rate of disease progression and the residual heritability of disease progression.

The participating NIH Institutes and Centers invite applications to address both the origins and the effects of low level chronic inflammation in the onset and progression of age-related diseases and conditions. Chronic inflammation, as defined by elevated levels of both local and systemic cytokines and other pro-inflammatory factors, is a hallmark of aging in virtually all higher animals including humans and is recognized as a major risk factor for developing age-associated diseases. The spectra of phenotypes capable of generating low-level chronic inflammation and their defining mediators are not clear. Further, a clear understanding of how chronic inflammation compromises the integrity of cells or tissues leading to disease progression is lacking. The role of dietary supplements and/or nutritional status in chronic inflammation in age-related disease is also poorly studied. Thus, there is a critical need to establish the knowledge base that will allow a better understanding of the complex interplay between inflammation and age-related diseases. Applications submitted to this FOA should aim to clarify the molecular and cellular basis for the increase in circulating inflammatory factors with aging, and/or shed light on the cause-effect relationship between inflammation and disease, using pre-clinical (animal or cellular based) models.

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinsons disease and other Parkinsonian syndromes, as a component of the NINDS Parkinsons Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) The differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such asProgressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. In order to further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically.A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinsons disease and other Parkinsonian syndromes, as a component of the NINDS Parkinsons Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) The differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such asProgressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. In order to further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically.A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.

In May of 2013 the National Institute of Neurological Disorders and Stroke (NINDS), with input from the National Institute on Aging (NIA), held an Alzheimer's Disease-Related Dementias Conference in response to the National Plan to Address Alzheimer's Disease. The Conference brought together national and international experts and members of the public to develop research priorities for accelerating the development of therapies for the Alzheimer's disease-related dementias (ADRDs). The ADRD 2013 research recommendations that resulted are part of the National Plan to Address Alzheimer's Disease. This FOA addresses the National Plan's highest priority for human-based research on vascular contributions to cognitive impairment and dementia (VCID): to develop noninvasive markers of key vascular processes related to VCID in Alzheimer's and related dementias. The research program initiated here underscores the need to facilitate the development of biomarkers to improve the efficiency and outcome of Phase II and III clinical trials and advance therapeutic development. These companion FOAs (RFA-NS-16-019, i.e. this FOA; and RFA-NS-16-020 for the Biomarkers Development Projects) establish the Small Vessel VCID Biomarkers Consortium, and are focused on small vessel (i.e. arterioles, capillaries, and venules) VCID in vascular cognitive impairment (VCI), vascular dementia, and all mixed and pure cognitive impairment and dementias with contributing small vessel vascular disease, including such as commonly occurs in sporadic Alzheimer's disease. Awards funded under these two FOAs create a consortium and infrastructure to complete development projects as well as planning that will enable follow-up activities (to be carried out under future separate funding; for example large scale multi-site validation studies and other activities, for future FDA qualification of small vessel VCID biomarkers and use in clinical trials).

The purpose of this Limited Competition is to extend the Cure Glomerulonephropathy (CureGN) Network by continuing to support the Participating Clinical Centers (PCCs). The CureGN Network is a multicenter observational cohort study of glomerular disease patients with the goal of improving care for all glomerular disease patients. The operational components of the study include four multi-site PCCs and a Data Coordinating Center (DCC). The CureGN Network, established in 2013, has recruited nearly 2,200 of 2,400 planned study participants and followed them with annual in-person clinic visits and interim telephone contacts. The CureGN PCCs will continue to follow-up previously enrolled participants. The PCCs will optimize retention strategies, developing novel methods for "remote" or "virtual" study participation; ensure complete and accurate data collection with a focus on clinical assessment of disease activity and outcomes; and participate in the development and validation of study-wide semi-quantitative assessment of histopathologic lesions. It is expected that a focus on disease features unique to glomerulonephropathy, and outcomes relevant to the full range of patient experience, combined with carefully curated clinical and biochemical data will uncover new predictors of the disease course, pathophysiologic processes, disease subtypes and novel treatment targets.The DCC provides key leadership functions for this study in the areas of study organization, study design and implementation, overall management, data management and analysis, and biosample management. The DCC requirements are described under a separate FOA.

The purpose of this Limited Competition is to extend the Cure Glomerulonephropathy (CureGN) Network by continuing to support the Data Coordinating Center (DCC). The CureGN Network is a multicenter observational cohort study of glomerular disease patients with the goal of improving care for all glomerular disease patients. The operational components of the study include four multi-site Participating Clinical Centers (PCC) and a DCC. The CureGN Network, established in 2013, has recruited nearly 2,200 of 2,400 planned study participants and followed them with annual in-person clinic visits and interim telephone contacts. The DCC provides key leadership functions for this study in the areas of study organization, study design and implementation, overall management, data management and analysis, and biosample management. The CureGN PCCs will continue to follow-up previously enrolled participants under a separate FOA with a focus on clinical assessment of disease activity, developing novel methods for "virtual" study participation,and semi-quantitative assessment of histopathologic lesions. It is expected that a focus on disease features unique to glomerulonephropathy and outcomes relevant to the full range of patient experience, combined with carefully curated clinical and biochemical data, will uncover new predictors of the disease course, pathophysiologic processes, disease subtypes and novel treatment targets. The DCC will lead the study group to achieve the scientific goals of the next project period.

The NIAMS Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases initiative focuses on innovative research within the NIAMS mission by encouraging applicants to pursue unusual observations, test imaginative hypotheses, investigate creative concepts, and build ground-breaking paradigms, all of which deviate significantly from the current prevailing theories or practice. This FOA is particularly designed to encourage the submission of projects that are considered too risky, premature, controversial, or unconventional for other NIH mechanisms. This FOA intends to support disease-focused translational studies. We invite research studies aimed at understanding the mechanisms of diseases or conditions relevant to the NIAMS mission, as well as studies aimed at developing or testing diagnostics, therapeutic agents, or preventive interventions up to, but not including, first in human studies. The RISK X02 and R61/R33 FOAs are not intended to support clinical trials. The RISK program will support the two main scientific areas of NIAMS mission, 1) musculoskeletal diseases and 2) the skin and rheumatic diseases.