Discover Funding Opportunities

This Notice of Funding Opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi-site clinical trial (Phase III and beyond) application. The DCC application must be specific to the collaborating Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this NOFO applies must be relevant to the research mission of the NCCIH (National Center for Complementary and Integrative Health) and considered a high priority by the Center. The funding supports multi-site clinical trials focused on natural products and complementary and integrative health research.

Rapid advances in genotyping and next generation sequencing technologies have led to the identification of genetic variants that are associated with a wide variety of congenital defects including human congenital anomalies (HCAs), intellectual developmental disabilities (IDDs) and inborn errors of metabolism (IEMs). Large quantities of genomic data collected from pediatric congenital anomalies cohorts are available to the research community through several databases such as the Database of Genotypes and Phenotypes (dbGaP), the Gabriella Miller Kids First Data Resource Portal, the European Genome-Phenome Archive and Clinical Genome Resource (ClinGen). The purpose of this initiative is to promote the screening, functional validation and characterization of congenital anomaly-associated genetic variants identified through public facing databases and individual efforts using in-silico tools, appropriate animal models, in vitro systems or multi-pronged approaches. This initiative addresses a challenging gap between identifying sequence variations of potential interest and recognizing which of those variations have functional effects on the phenotype of interest.

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications must be within the scope of the mission of one of the participating NIH Institutes/Centers. This R21 grant mechanism supports exploratory/developmental research and is designed for projects where preliminary data may be limited.

NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials.

NIMH seeks applications for research projects to evaluate the effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions affecting youth, adults, and older adults. This Notice of Funding Opportunity (NOFO) encourages clinical trials to establish the effectiveness and test hypotheses regarding moderators, mediators, and mechanisms of action of post-acute phase therapeutic and services interventions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden for promoting optimal longer-term outcomes. This NOFO is intended to support effectiveness trials testing post-acute phase interventions that are statistically powered to provide a definitive answer regarding the study intervention's effectiveness. The funding instrument is an R01 grant, which requires clinical trials as part of the research design.

The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate precision probiotic interventions using a milestone-driven, biphasic award mechanism, R61/R33 Phased Innovation Award. Specifically, this NOFO solicits applications that will characterize person-specific features affecting probiotic responses to identify subgroups of probiotic responders and to enhance probiotic clinical outcomes. The ultimate goal of this NOFO is to identify, understand, and develop strategies to address barriers in precision probiotic therapies to account for the heterogenicity in humans that causes inconsistent probiotic responses. The first phase, funded by the R61, will provide for up to 2 years to identify unique host biological patterns (e.g., native microbiome, immune system, gender, diet, age, genetic background, lifestyle, and health history) that are correlated with heterogeneity of probiotic clinical effects using observational or secondary data analysis studies. The second phase, funded under the R33, will support studies to assess the ability of the unique patterns determined in the R61 phase to detect the improvement of probiotic responsiveness in rigorously designed mechanistic studies in relevant animal models or in human subjects. The combined R61/R33 should not exceed 5 years. Transition from the R61 to the R33 phase of the award will be administratively reviewed and will be determined based on successful completion of Transition Milestones that need to be clearly specified in the R61 phase application.

The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate precision probiotic interventions. Specifically, this NOFO solicits R33 applications that will characterize person-specific features affecting probiotic responses to identify subgroups of probiotic responders and to enhance probiotic clinical outcomes. The ultimate goal is to identify, understand, and develop strategies to address barriers in precision probiotic therapies to account for the heterogenicity in humans that causes inconsistent probiotic responses. This NOFO will support studies to assess the ability of the unique patterns of host biology (e.g., native microbiome, immune system, gender, diet, age, genetic background, lifestyle, and health history) that are correlated with probiotic usage to detect the improvement of probiotic responsiveness. Well-suited applications must offer rigorously designed mechanistic studies using relevant/innovative animal models or in human subjects. This NOFO is intended to support projects where potential host biological patterns that are correlated with probiotic usage have been identified, as demonstrated with supportive preliminary data, but require further mechanistic studies to test for their causality or predictability.

This funding opportunity invites applications for basic research projects on chemical warfare agents, toxic industrial chemicals, and pesticides that have primary or secondary effects on the nervous system. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. Projects supported by this NOFO are expected to generate data that elucidate mechanisms of toxicity of these agents, possible new manifestations of toxic exposures, and potential new targets for therapeutic development. The program is part of the NIH CounterACT (Countermeasures Against Chemical Threats) initiative, focusing on understanding how these chemical threats affect the nervous system and identifying pathways for developing countermeasures. This R01 grant mechanism supports basic research and explicitly excludes clinical trials.

This NOFO provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs. The grant mechanism is R61/R33, which is a phased innovation award designed to support high-impact projects. Clinical trials are not allowed under this funding opportunity.

The purpose of this funding opportunity is to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. The suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue. Preparatory studies may fill information gaps and address unknowns, improving trial design and knowledge of trial feasibility and thus saving NCI time and money.

The purpose of this FOA is to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. Further, the suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue. Preparatory studies may fill information gaps and address unknowns, improving trial design and knowledge of trial feasibility and thus saving NCI time and money.

This NIH funding opportunity encourages investigators to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. The program is part of the BRAIN Initiative and focuses specifically on next-generation devices for recording and modulation in the human central nervous system.

This funding opportunity encourages investigators to pursue small clinical trials to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Clinical studies may consist of acute or short-term procedures deemed Non-Significant Risk (NSR) by an IRB, or Significant Risk (SR) studies requiring an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments due to the novelty of the device or its intended use. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements with device manufacturers willing to make such devices available, including devices not yet market approved but appropriate for clinical research.

The objective of the NIA Academic Leadership Career Award (K07) is to provide support for established investigators who have the expertise and leadership skills to enhance aging and/or Alzheimer's Disease (AD) and Alzheimers Disease Related Dementias (ADRD) research capacity within their academic institution. Through this award, investigators will endeavor to develop research and educational infrastructure, mentorship, and career development activities in support of new or emerging areas of aging and/or AD/ADRD research. These may include, but are not limited to, courses, curricula, research support, pilot funding, travel awards, visiting scholars, or networks. This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator.

The purpose of this Notice of Funding Opportunity (NOFO) is to invite research grant applications (R01) for the development and use of current and emerging molecular imaging methods to gain fundamental insights into cancer inflammation in vivo. The motivation for this initiative is that much of current imaging research into the role of inflammation in cancer is largely based on in vitro and ex vivo methods with limited utilization of imaging approaches that could lead to significant new insights relevant to dynamic cancer and inflammation interactions. Utilization of molecular imaging probes in pre-clinical and clinical investigations for precise temporal resolution at the molecular and cellular level are valuable approaches for identification and characterization of in vivo inflammatory cellular physiology in cancers and of molecular changes in response to treatment. This FOA encourages applications that focus on developing integrated imaging approaches to interrogate the role of inflammation in cancer through strong cross-field collaboration between cancer basic science researchers and imaging scientists. These collaborations are expected to advance science and understanding of cancer inflammation interactions.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) seeks research project (R01) grant applications describing projects that integrate imaging and fluid-based tumor monitoring (liquid biopsy) assays during cancer therapy in patients to determine the optimal use of those modalities in the characterization of therapy response and/or emergence of resistance. This funding opportunity supports research that combines advanced imaging techniques with liquid biopsy methods to better understand cancer treatment effectiveness and the development of treatment resistance in patients undergoing therapy. The program aims to optimize the use of these complementary monitoring approaches to improve cancer care outcomes.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for projects to expand, improve, or transform the utility of mammalian cancer and tumor models for translational research. The NCI intends to encourage submission of projects devoted to demonstrating that mammalian models or their derivatives used for translational research are robust representations of human biology, are appropriate to test questions of clinical importance, and provide reliable information for patients' benefit. These practical goals contrast with the goals of many mechanistic, NCI-supported R01 projects that employ mammals, or develop and use mammalian cancer models, transplantation tumor models, or models derived from mammalian or human tissues or cells for hypothesis-testing, non-clinical research. Among many other possible endeavors, applicants in response to this FOA could propose demonstrations of how to overcome translational deficiencies of mammalian oncology models, define new uses of mammalian models or their genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally.

The purpose of this Funding Opportunity Announcement (FOA) is to support collaborative research projects designed to address adverse sequelae of cancer therapies that persist and become chronic comorbidities or develop as delayed posttreatment effects. This FOA supports basic, translational, and clinical research projects that seek to identify the mechanisms of therapy-induced adverse sequelae, clinically characterize the adverse sequelae, or translate the mechanistic understanding into therapeutic approaches to prevent or minimize the development of long-term sequelae. Research projects should focus on mechanistic studies with translational endpoints and longitudinal clinical phenotyping to identify and validate clinical endpoints (biomarkers, imaging, patient-reported outcomes, or combined elements) for future use in clinical trials that will evaluate the efficacy of interventions designed to prevent or reduce specific adverse sequelae.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications for identification of small molecules that function to elucidate the biology of disease as chemical probes or function as agonists or antagonists of disease target(s) for therapy or immunotherapy. The NOFO is intended to support discovery research for the identification of validated hits relevant to health-related outcomes of participating NIH Institutes. Stages of discovery research covered by this NOFO include: 1) assay development for specific biological targets and disease mechanisms relevant to the mission of participating NIH Institutes with the intent to screen for small molecule compounds that show potential as probes for use in advancing knowledge about the known targets, identifying new targets, or as pre-therapeutic leads; 2) screen implementation high throughput target-focused approaches or moderate throughput phenotypic- and fragment-based approaches to identify initial screening hits; 3) hit validation, including implementation of secondary assays that are orthogonal to the primary assay, advanced cheminformatics analysis and initial medicinal chemistry inspection to prioritize the hit set, and follow-up assays to characterize mode and mechanism of action of the validated hits; 4) hit-to-lead optimization, including SAR to optimize target engagement, selectivity and to minimize chemical liabilities, ADME, PK and PD studies, and, if appropriate, in vivo modeling to test efficacy or biological effects.

This Notice of Funding Opportunity (NOFO) encourages applications that will expand knowledge of the natural history of disorders that currently are, or may become, part of statewide newborn screening programs. A comprehensive understanding of the natural history of a condition is necessary to facilitate appropriate interventions for infants identified by newborn screening. Characterization of the sequence and timing of symptom development provides information crucial for developing targeted, age-appropriate treatments and for establishing a baseline against which to assess novel interventions. The program aims to establish genotype-phenotype correlations and identify modifying genetic, epigenetic, or environmental factors to enhance understanding of clinical outcomes. Comprehensive data will facilitate identifying underlying biological mechanisms, understanding genetic and clinical heterogeneity, improving diagnostic accuracy, facilitating clinical trials, managing and treating symptoms, furnishing physicians and families with predictive information, and establishing data collection systems or patient registries to collect longitudinal data on child and family outcomes following newborn screening.

This Notice of Funding Opportunity (NOFO) invites research grant applications that propose the development and evaluation of novel radioligands for positron emission tomography (PET) or single photon emission computed tomography (SPECT) imaging in human brain and the incorporation of, pilot or clinical feasibility evaluation from previously collected data in pre-clinical studies. These studies are expected to provide the requisite data needed to advance promising PET ligands for use in clinical research. The program supports the development of innovative imaging biomarkers that can be used for drug discovery and for understanding the pathophysiology of central nervous system (CNS) disorders. Funded projects will contribute to advancing neuroimaging technologies that enable better diagnosis, treatment monitoring, and understanding of brain disorders.

The Stimulating Hematology Investigation: New Endeavors (SHINE) program is intended to promote innovative, high-quality nonmalignant hematology research relevant to the missions of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Aging (NIA), and the National Heart, Lung, and Blood Institute (NHLBI). Investigator-initiated research project grant applications (R01s) in specific areas of basic and early translational hematology research are invited to this program that supports growth in the nonmalignant hematology research domain. Specific emerging topics that are at the leading edge of the field will change over time and will be updated annually through the NIH Guide to Grants and Contracts.

This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to accelerate the development and adoption of promising bioengineering tools and technologies that can address important biomedical problems. The objectives are to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need and are capable of enhancing our understanding of life science processes or the practice of medicine. Awards will focus on supporting multidisciplinary teams that apply an integrative, quantitative bioengineering approach to developing technologies. The goal of the program is to support technological innovations that deliver new capabilities which can realize meaningful solutions within 5 to 10 years.

The objective of this Notice of Funding Opportunity (NOFO) is to stimulate research in 1) discovery and development of novel, small molecules for their potential use in studying disease treatment relevant to psychiatric disorders; and 2) to generate new insight into the biology of relevant diseases and processes that have yet to be validated as important drug targets. This R01 grant supports fundamental research to develop assays and screen chemical compounds that could lead to new therapeutic approaches for brain disorders and mental health conditions. The program specifically excludes clinical trial activities and focuses on the discovery phase of drug development and target validation.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate translation of scientific discoveries and engineering developments in imaging, data science and/or spectroscopic technologies into methods or tools that address contemporary problems in understanding the fundamental biology, potential risk of development, diagnosis, treatment, and/or disease status for cancer or other disease. This R01 grant opportunity supports academic-industrial partnerships focused on translating imaging systems into clinical or research applications. The program aims to bridge the gap between technological innovation and practical implementation in cancer research and diagnosis.

This Notice of Funding Opportunity (NOFO) aims to support research on interdisciplinary population approaches to increasing awareness of the relationship between alcohol and cancer risk, understanding and changing social norms related to alcohol consumption, developing and/or evaluating alcohol policy approaches, and the development, testing, and implementation of population-level interventions to reduce alcohol-related cancer risk. Applications that address multiple levels of consumption, such as moderate and heavy drinking, are of particular interest, as well as those focusing on alcohol use disorder (AUD) from the perspective of cancer prevention and control. The program seeks to advance scientific understanding of how population-level strategies can effectively reduce cancer risk associated with alcohol consumption through evidence-based interventions and policy development.

The purpose of this Notice of Funding Opportunity (NOFO) is to advance the development of novel informatics and data science approaches that can help individuals understand and improve their health through actionable insights. NLM seeks applications that further the science of personal health informatics by providing meaningful and actionable insights to individuals through innovative personal health data collection, integration, analysis, and personalized risk assessments and interpretation. Applications seeking to advance the understanding of how informatics tools, systems, and platforms can best present the results, interpretation, and limitations of personalized assessments for the benefit of individuals are encouraged. Applications should include end user engaged approaches and real-world evaluation to inform the design of generalizable, reusable, and scalable personal health informatics tools, systems, and platforms for the benefit of individuals in understanding and improving their health.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages applications promoting transformative discoveries in cancer biology and/or oncology through the use of nanotechnology. Proposed projects should address major barriers in cancer biology and/or oncology using nanotechnology and should emphasize mechanistic studies toward fundamental understanding of nanomaterial and/or nanodevice interactions with biological systems. These studies should be performed in context of research concerning the delivery of nanoparticles and/or nano-devices to desired and intended cancer targets in vivo and/or characterization of detection and diagnostic devices in vitro. IRCN awards are expected to produce fundamental knowledge to aid future and more informed development of nanotechnology-based cancer interventions. The clinical translation of these interventions is outside of the scope of this NOFO.

This Notice of Funding Opportunity (NOFO) encourages applications for research in cancer control and population sciences. The overarching goal is to provide support to promote research efforts on novel scientific ideas that have the potential to substantially advance cancer research in statistical and analytic methods, epidemiology, cancer survivorship, cancer-related behaviors and behavioral interventions, healthcare delivery, and digital health and data science, and implementation science. This R01 grant supports innovative research projects that address critical questions in cancer control and population sciences, with the flexibility to include clinical trials as an optional component.

NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions. This NOFO is intended to support the development of digital health test beds that leverage well-established digital mental health platforms, to rapidly refine and optimize existing evidence-based digital health interventions and conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness. The program aims to advance the field of digital mental health by creating robust testing environments for evidence-based interventions and supporting definitive clinical trials that can provide clear answers about intervention effectiveness.

The purpose of this award is to support outstanding scientific training of highly promising postdoctoral candidates with outstanding mentors. Candidates are eligible to apply for support from this program from approximately 12 months prior to the start of the proposed postdoctoral position to within 12 months after starting in postdoctoral position. Based on the early timeframe of eligibility, and the discouragement of inclusion of preliminary data, this NINDS F32 seeks to foster early, goal-directed planning and to encourage applications for bold and/or innovative projects by the candidate that have the potential for significant impact. Applications are expected to incorporate strong training in quantitative reasoning and the quantitative principles of experimental design and analysis. Support by this program is limited to the first 3 years of a candidate's activity in a specific laboratory or research environment, so as to further encourage early fellowship application and timely completion of mentored training of the postdoctoral candidate in a single environment.

This announcement encourages applications for multi-center clinical trials focused on neurological emergencies. Successful applicants will collaborate and conduct the trial within the NIH SIREN Network. The NIH SIREN Clinical Coordinating Center (CCC) will work with the successful applicants to implement the proposed trial efficiently and the SIREN Data Coordinating Center (DCC) will provide statistical and data management support. The NIH SIREN hubs and their affiliated clinical sites will provide on-site implementation of the clinical protocols. The NIH SIREN Network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for neurological emergencies. Multi-center clinical trials in stroke treatment, recovery, or prevention supported by NINDS will be conducted in the NIH StrokeNet, and not within SIREN. Applicants do not need to be part of the existing SIREN infrastructure to apply under this FOA.

This funding opportunity announcement (FOA) encourages the submission of exploratory/developmental research grant (R21) applications that focus on different aspects of cancer control by modifying behavior, screening, and understanding etiologic factors contributing to the development of cancer, and developing ways to control cancer. The overarching goal is to provide support to promote the early and conceptual stages of research efforts on novel scientific ideas that have the potential to substantially advance population-based cancer research, such as the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of cancer research (epidemiologic, biomedical, behavioral, health care delivery or clinical).

The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to facilitate transition of highly qualified dentists from NIH Intramural postdoctoral research positions to extramural academic tenure-track or equivalent faculty positions at eligible institutions. The award will provide support for two years of mentored postdoctoral research training in the NIH Intramural Research Program, and three years of independent research funding at the extramural institution. This career development award is specifically designed for dentists conducting research in oral diseases and disorders, enabling them to establish independent research programs at academic institutions after completing their intramural NIH training.

Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated clinical trials that have the potential to reduce the burden of cancer through improvements in early detection, screening, prevention and interception, healthcare delivery, quality of life, and/or survivorship related to cancer. Applications submitted to this NOFO must include studies that meet the National Institutes of Health (NIH) definition of a clinical trial and provide specific clinical trial information. This NOFO does not and will not support clinical trials for studies of cancer diagnosis and/or oncologic therapy in patients. The proposed investigator-initiated projects should be related to the programmatic interests of the NCI Division of Cancer Prevention and/or the NCI Division of Cancer Control and Population Sciences. With such attributes, the proposed studies should also have the potential to improve clinical practice and/or public health.

Through this Notice of Funding Opportunity, the National Cancer Institute (NCI) seeks research projects that implement early phase (Phase 0, I, and II) investigator-initiated clinical trials focused on cancer-targeted diagnostic and therapeutic interventions of direct relevance to the research mission of DCTD and OHAM. The proposed project must involve at least one clinical trial related to the scientific interests of one or more of the following research programs: Cancer Therapy Evaluation Program, Cancer Imaging Program, Cancer Diagnosis Program, Radiation Research Program, Complementary and Alternative Medicine Program and/or the HIV and AIDS Malignancies Research Programs. Applicants may propose to conduct an early phase trial by itself, or in combination with another research aim(s) as appropriate. This R01 grant mechanism requires a clinical trial component and supports investigator-initiated research in cancer treatment and diagnosis.

The purpose of this Notice of Funding Announcement (NOFO) is to support development of biomarkers or clinical outcomes derived from digital health technology (DHT) for use in clinical trials for remote monitoring as primary or secondary endpoints. To improve clinical impact, increase statistical feasibility, and promote standardization, applicants will be expected to develop and test the digitally derived assessments in populations from at least three different diseases or conditions. Partnerships with non-profit patient advocacy organizations will be required. This cooperative agreement supports research in digital health technologies for biomarker development and clinical outcome assessment, with applications across multiple disease areas including aging, neurosciences, and cancer control.

This Notice of Funding Opportunity (NOFO) supports projects relevant to the NIGMS mission that focus solely on the development of technologies with potential to enable acquisition of biomedical knowledge. Projects should be justified in terms of technical innovation and utility of such technical innovation for impacting future biomedical research. Outcomes or products of the proposed project should significantly advance the current state of the art and be sufficiently characterized for application in addressing a broad range of biomedical research questions. This R01 grant mechanism is specifically designated as clinical trial not allowed, focusing on fundamental technology development rather than clinical applications.

This Notice of Funding Opportunity (NOFO) supports exploratory research leading to proof of concept for the development of new technologies relevant to the NIGMS mission. Projects should entail a high degree of risk and/or novelty, and have a high future potential impact in biomedical research. The R21 mechanism is designed for early-stage technology development research that establishes the feasibility and proof of concept for innovative biomedical technologies. This funding opportunity encourages high-risk, high-reward projects that have the potential to transform biomedical research capabilities.

This Notice of Funding Opportunity Announcement (NOFO) invites grant applications for Environmental Health Sciences Core Centers (EHSCC). As intellectual hubs for environmental health science research, the EHSCC's are expected to be the thought leaders for the field and advance the goals of the 2025-2029 NIEHS Strategic Plan. The Core Centers provide critical research infrastructure, shared facilities, services and/or resources, to groups of investigators conducting environmental health sciences research. An EHSCC enables researchers to conduct their independently-funded individual and/or collaborative research projects more efficiently and/or more effectively. The overall goal of an EHSCC is to identify and capitalize on emerging issues that advance improving the understanding of the relationships among environmental exposures, human biology, and disease. The EHSCC supports community engagement and translational research as key approaches to improving public health.

The goal of this NOFO is to support applications for novel theory and methods development that enable better understanding of how genetic and non-genetic factors contribute to complex trait variation across individuals, families, and populations. Approaches should be interdisciplinary drawing from the natural and social sciences, account for interdependencies across scales of biological, social, and ecological organization, and make extensive use of theory, modeling, and validation with available large-scale datasets. This R01 grant from the National Institutes of Health supports research that advances the understanding of genetic architecture and complex human traits through innovative theoretical and methodological approaches. The funding mechanism is designed to promote interdisciplinary collaboration that integrates multiple levels of biological, social, and ecological analysis.

The goal of this NOFO is to support R21 applications for novel theory and methods development that better delineate how genetic and non-genetic factors contribute to complex trait variation across individuals, families, and populations. Approaches should be interdisciplinary across the natural and social sciences, account for interdependencies across scales of biological, social, and ecological organization, and make extensive use of theory, simulations, and validation using available large-scale datasets. This funding opportunity announcement from the National Institutes of Health supports research that advances understanding of complex human genetic architecture through innovative theoretical and methodological approaches. The program encourages applications that integrate multiple scientific disciplines to address fundamental questions about trait variation at individual, family, and population levels.

The purpose of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is to encourage applications that will develop and validate novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application. The development of new genetic and non-genetic tools for delivering genes, proteins and chemicals to cells of interest or approaches that are expected to target specific cell types and/or circuits in the nervous system with greater precision and sensitivity than currently established methods are encouraged. Tools that can be used in a number of species/model organisms rather than those restricted to a single species are highly desired. Applications that provide approaches that break through existing technical barriers to substantially improve current capabilities are highly encouraged.

This notice of funding opportunity (NOFO) encourages innovative research to develop, improve, characterize, and preserve animal models as well as animal model related biological materials, technologies, and new approach methodologies (NAMs) for studies relevant to human health and disease. This NOFO also seeks projects aimed at improving the diagnosis and control of diseases that could confound or interfere with animal use in biomedical research. The proposed project must have broad applicability to multiple NIH Institutes or Centers (ICs) to align with the NIH-wide mission of the Office of Research Infrastructure Programs (ORIP). The proposed studies must include animal models and explore multiple body systems or multiple categories of diseases. Applications that develop models focused on a specific disease or area of research, or only propose studies primarily relevant to a single NIH IC, will be considered not acceptable to this NOFO and will be withdrawn.

The National Institutes of Health (NIH) awards Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) to eligible, domestic institutions to develop and/or enhance predoctoral and postdoctoral research training, including short-term research training. The program helps ensure that a highly trained workforce is available to meet the needs of the Nation's biomedical, behavioral, and clinical research agenda. Research training programs are expected to incorporate engaging, didactic, research, and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the Nation. Programs proposing only short-term predoctoral research training should apply to the Kirschstein-NRSA Short-Term Institutional Research Training Grant Program (T35) instead. This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

The NICHD Small Research Grant Program (R03 Basic Experimental Studies with Humans Required) supports clinical trials that fall within the NICHD mission and also meet the criteria for basic science experimental studies involving humans (BESH), referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. The program is administered by the National Institute of Child Health and Human Development (NICHD) as part of the National Institutes of Health. This funding opportunity (PA-25-126) provides support for basic experimental research involving human participants that aligns with NICHD's mission to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability.

The NICHD Small Research Grant Program (Clinical Trial Required) supports clinical trials that fall within the NICHD mission. This NIH grant program provides funding for small research projects focused on child health and human development through clinical trial research. The program is designed to support investigators conducting clinical trials in areas aligned with the National Institute of Child Health and Human Development's research priorities. Applications are accepted through a program announcement system with funding available through grants.nih.gov.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIDA R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs. This NOFO is intended to support research education activities that enhance the knowledge of substance use and substance use disorder research. The program is intended for those in clinically focused careers and/or those training for careers as clinicians/health service providers, clinical researchers, or optimally a combination of the two. This mechanism may not be used to support non-research-related clinical training.

This Notice of Funding Opportunity (NOFO) encourages research on the biology of high confidence risk factors associated with complex brain disorders, with a focus on the intracellular, transcellular and circuit substrates of neural function. For the purposes of this NOFO, the term complex can refer to a multifactorial contribution to risk (e.g., polygenic and/or environmental) and/or highly distributed functional features of the brain disorder. Studies may be either hypothesis-generating (unbiased discovery) or hypothesis-testing in design and may utilize in vivo, in situ, or in vitro experimental paradigms, e.g., model organisms or human cell-based assays. While behavioral paradigms and outcome measures can be incorporated into the research design to facilitate the characterization of intracellular, transcellular and circuit mechanisms, these are neither required nor expected. Studies should not attempt to model disorders but instead should aim to elucidate the neurobiological impact of individual or combined risk factor(s), such as the affected molecular and cellular components and their relationships within defined biological process(es). The R21 activity code is intended for early stage, high-risk, exploratory approaches or to establish proof-of-concept where there is little or no preliminary data. The resulting paradigms, component pathways and biological processes should be disseminated with sufficient detail to enrich common and/or federated data resources to bridge the gap between disease risk factors, biological mechanism and therapeutic target identification.

Although the majority living with schizophrenia and related disorders are over 35 years old, including those first diagnosed and those aging with the illness, the mechanisms underlying the generation and trajectory of the illness remain poorly understood. The purpose of this initiative is to advance translational research to better understand the emergence and trajectory of schizophrenia and related disorders in mid to late life, and to identity targets for future development of prevention and treatment efforts. This R01 grant supports clinical trial optional research in mental health focusing on individuals in mid to late life with schizophrenia and related psychiatric disorders.

This Notice of Funding Opportunity (NOFO) encourages research on the biology of high-confidence risk factors associated with complex brain disorders, with a focus on the intracellular, transcellular, and circuit substrates of neural function. Studies may be either hypothesis-generating or hypothesis-testing in design and may utilize in vivo, in situ or in vitro experimental paradigms, including model organisms or human cell-based assays. Studies should aim to elucidate the neurobiological impact of individual or combined risk factors, such as the affected molecular and cellular components and their relationships within defined biological processes. The resulting paradigms, component pathways, and biological processes should be disseminated with sufficient detail to enrich common and/or federated data resources to bridge the gap between disease risk factors, biological mechanism and therapeutic target identification. This R01 activity code is for applications to further develop lines of inquiry where feasibility or proof-of-concept has been established.

Although the majority living with schizophrenia and related disorders are over 35 years old, including those first diagnosed and those aging with the illness, the mechanisms underlying the generation and trajectory of the illness remain poorly understood. The purpose of this initiative is to advance translational research to better understand the emergence and trajectory of schizophrenia and related disorders in mid to late life, and to identity targets for future development of prevention and treatment efforts. This R21 grant mechanism supports exploratory and developmental research projects in this critical area of mental health.

This National Institutes of Health funding opportunity supports translational and clinical research to advance precision medicine in pregnant women, lactating women, and children through the development of novel tools, models, and other technologies that could have a direct clinical or health impact. The program aims to enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy and lactation. It also seeks to discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating women, neonates, and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women, fetuses, neonates, and children, including those with disabilities.

The purpose of this notice of funding opportunity (NOFO) is to support translational and clinical research to advance precision medicine in pregnant women, lactating women, and children through the development of novel tools, models, and other technologies that could have a direct clinical or health impact. The program aims to enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy and lactation. Additionally, it seeks to discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating women, neonates, and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women, fetuses, neonates, and children, including those with disabilities.

The purpose of this notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of children's language development. The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable tools to further our understanding of children's language development and/or impairment, and predictors thereof. This R01 grant supports research projects that develop innovative measurement approaches for assessing language development in children and environmental factors that influence it.

The purpose of this notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of children's language development. The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable tools to further our understanding of children's language development and/or impairment, and predictors thereof. This R21 grant mechanism supports exploratory and developmental research projects that have the potential to contribute to significant scientific advances.

This Notice of Funding Opportunity (NOFO) encourages grant applications from investigators interested in conducting basic, mechanistic research into the biological/genetic causes of cancer health disparities. These research project grants will support innovative studies designed to investigate biological/genetic bases of cancer disparities, such as (1) mechanistic studies of biological factors associated with cancer disparities, including those related to basic research in cancer biology or cancer prevention strategies, (2) the development and testing of new methodologies and models, and (3) secondary data analyses. This NOFO is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research who can expand available resources and tools, such as biospecimens, patient derived models, and methods that are necessary to conduct basic research in cancer health disparities.

This Notice of Funding Opportunity (NOFO) encourages grant applications from investigators interested in conducting basic, mechanistic research into the biological/genetic causes of cancer health disparities. These research project grants will support innovative studies designed to investigate biological/genetic bases of cancer health disparities, such as (1) mechanistic studies of biological factors associated with cancer health disparities, including those related to basic research in cancer biology or cancer prevention strategies, (2) the development and testing of new methodologies and models, and (3) secondary data analyses. This NOFO is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research who can expand available resources and tools, such as biospecimens, patient derived models, and methods that are necessary to conduct basic research in cancer health disparities.

The purpose of this funding opportunity announcement (FOA) is to invite applications for a broad range of research efforts in computational genomics, data science, statistics, and bioinformatics relevant to one or both of basic or clinical genomic science, and broadly applicable to human health and disease. This FOA supports fundamental genomics research developing innovative analytical methodologies and approaches, early-stage development of tools and software, and refinement or hardening of software and tools of high value to the biomedical genomics community. Work supported under this FOA should be enabling for genomics and be generalizable or broadly applicable across diseases and biological systems. All applications should address how the methods would scale to address increasingly larger data sets.

The purpose of this funding opportunity announcement (FOA) is to invite applications for a broad range of research efforts in computational genomics, data science, statistics, and bioinformatics relevant to one or both of basic or clinical genomic science, and broadly applicable to human health and disease. This FOA supports fundamental genomics research developing innovative analytical methodologies and approaches, early-stage development of tools and software, and refinement or hardening of software and tools of high value to the biomedical genomics community. Work supported under this FOA should be enabling for genomics and be generalizable or broadly applicable across diseases and biological systems. All applications should address how the methods would scale to address increasingly larger data sets. This is an R21 grant mechanism which supports exploratory research projects.

This initiative seeks to solicit applications for research projects that address the link between social disconnection including both objective social isolation as well as perceived social isolation (otherwise known as loneliness) and suicide in late-life. Emphasis is placed on research that identifies neurobiological and environmental mechanisms associated with social isolation and loneliness that increase risk for suicidal thoughts and behavior in late-life, that uses an experimental therapeutics approach to identify targets and develop and test interventions to prevent late-life suicide, and that develops new and modifies existing service delivery models to enhance social connection in late-life to prevent suicide. This is an R01 grant mechanism from the National Institutes of Health with clinical trials optional. The funding opportunity aims to advance understanding of how social isolation and loneliness contribute to suicide risk in older adults and to develop interventions that can prevent late-life suicide through enhanced social connection.

This initiative seeks to solicit applications for research projects that address the link between social disconnection including both objective social isolation as well as perceived social isolation (otherwise known as loneliness) and suicide in late-life. Emphasis is placed on research that identifies neurobiological and environmental mechanisms associated with social isolation and loneliness that increase risk for suicidal thoughts and behavior in late-life, that uses an experimental therapeutics approach to identify targets and develop and test interventions to prevent late-life suicide, and that develops new and modifies existing service delivery models to enhance social connection in late-life to prevent suicide. This R21 grant mechanism supports exploratory and developmental research projects in mental health with a focus on addressing critical gaps in understanding late-life suicide risk factors and developing innovative prevention strategies.

The goal of this Funding Opportunity Announcement (FOA) is to encourage applications for studies that will enhance knowledge of mechanisms associated with neuropsychiatric symptoms (NPS) in persons with Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD). The findings are expected to advance mechanistic understanding of both biobehavioral and neurobiological pathways leading to NPS. Findings may also provide insight into novel therapeutic targets that can be advanced into interventions to treat and prevent the development of NPS in AD and/or ADRD. This R01 grant mechanism supports investigator-initiated research projects and may optionally include clinical trials.

This funding opportunity announcement encourages applications for studies that will enhance knowledge of mechanisms associated with neuropsychiatric symptoms (NPS) in persons with Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD). The findings are expected to advance mechanistic understanding of both biobehavioral and neurobiological pathways leading to NPS. Findings may also provide insight into novel therapeutic targets that can be advanced into interventions to treat and prevent the development of NPS in AD and/or ADRD. This is an R21 grant mechanism that allows for clinical trials as an optional component.

This NIDCR Small Grant Program for New Investigators supports basic and clinical research conducted by scientists who are in the early stages of establishing an independent research career in oral, dental and craniofacial research. This R03 program supports pilot or feasibility studies and developmental research projects with the intention of obtaining sufficient preliminary data for a subsequent investigator initiated Research Project Grant (R01) or equivalent application. The program is specifically designed for early-career investigators to help them build their research foundation in dental and craniofacial sciences through small-scale exploratory studies.

The goal of this funding announcement is twofold: to promote preclinical and patient based studies examining the mechanism(s) through which incretin mimetics (including agonists or antagonists of GLP-1, GIP-1, or dual GLP-1/GIP-1 agents) impact cancer risk, and to draw talented scientists who understand the dynamic changes caused by these agents to investigate the mechanisms of how these agents influence cancer risk rather than shorter term outcomes such as weight loss and diabetes. The data thus far suggests that these agents may increase the risk of some, while decreasing the risk of other obesity related cancers. This is an R01 grant opportunity, which is the NIH's most commonly used grant program supporting discrete, specified, circumscribed research projects. Applicants may propose clinical trials as optional components of their research projects.

The goal of this funding announcement is twofold: to promote preclinical and patient-based studies examining the mechanism(s) through which incretin mimetics (including agonists or antagonists of GLP-1, GIP-1, or dual GLP-1/GIP-1 agents) impact cancer risk, and to draw talented scientists who understand the dynamic changes caused by these agents to investigate the mechanisms of how these agents influence cancer risk rather than shorter term outcomes such as weight loss and diabetes. The data thus far suggests that these agents may increase the risk of some, while decreasing the risk of other obesity-related cancers. This R21 research grant mechanism supports innovative, high-risk, high-reward projects that may lack preliminary data but have the potential to lead to breakthroughs in understanding cancer mechanisms. This opportunity is specifically designed to explore the complex relationship between incretin mimetic drugs and cancer development, encouraging novel approaches to understanding these important mechanisms. The funding will support both preclinical laboratory studies and patient-based research to elucidate the biological pathways involved.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research. This R01 grant mechanism supports investigator-initiated research projects that demonstrate significant potential to advance cancer research through secondary analysis of existing data.

The National Center for Medical Rehabilitation Research (NCMRR) Early Career Research (ECR) Award (R03) is intended to support both basic and clinical research from rehabilitation scientists who are establishing independent research careers. The research must be focused on one or more of the areas within the mission of NCMRR. The NCMRR ECR Award R03 grant mechanism supports various types of projects including secondary analysis of existing data; small, self-contained research projects; development of research methodology; translational research; outcomes research; and development of new technology. Irrespective of the type of project, the intent of the NCMRR ECR Award R03 is for the Program Director(s)/Principal Investigator(s) to obtain sufficient preliminary data for a subsequent R01 application. This award is specifically designed to help early career researchers establish independent research careers in medical rehabilitation research.

The purpose of this NOFO is to announce support for meritorious research projects that address research questions relevant to human dental, oral, or craniofacial (DOC) biology, and diseases and conditions, through analysis of existing and publicly available genomic data, with or without other types of complementary data, using statistical and computational approaches. Data analysis for each project can be performed using existing and/or novel methods to be developed in the proposed project(s), including methods for data and metadata mining, data integration, and Artificial Intelligence (AI)/Machine Learning (ML)/Deep Learning (DL) methods. In addition to analysis of existing data, experimental or in silico work is required to validate the results of the proposed analysis, or to validate a newly developed analytic method. Projects aimed at understanding oral health disparities to inform strategies for improving health for all individuals are a priority. Projects focused on investigating and/or characterizing human biological pathways to inform identification of intervention targets or defining the pathogenicity of known genetic variants are encouraged.

This NOFO announces support for meritorious research projects that address research questions relevant to human dental, oral, or craniofacial (DOC) biology, and diseases and conditions, through analysis of existing and publicly available genomic data, with or without other types of complementary data, using statistical and computational approaches. Data analysis for each project can be performed using existing and/or novel methods to be developed in the proposed project(s), including methods for data and metadata mining, data integration, and Artificial Intelligence (AI)/Machine Learning (ML)/Deep Learning (DL) methods. In addition to analysis of existing data, experimental or in silico work is required to validate the results of the proposed analysis, or to validate a newly developed analytic method. Projects aimed at understanding oral health disparities to inform strategies for improving health for all individuals are a priority. Projects focused on investigating and/or characterizing human biological pathways to inform identification of intervention targets or defining the pathogenicity of known genetic variants are encouraged.

The Office of Research Infrastructure Programs (ORIP) within the Division of Program Coordination, Planning, and Strategic Initiatives announces an opportunity to apply for small grant support for ORIP-supported Special Emphasis Research Career Award (SERCA) K01 recipients who have completed the first two years (24 months) of the SERCA K01 award. ORIP seeks to enhance the ability of ORIP SERCA K01 awardees to conduct research as they transition to fully independent investigator status. The R03 mechanism supports projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is intended to support research projects that can realistically be completed in two years and that require limited levels of funding. This Funding Opportunity Announcement does not accept applications proposing clinical trials.

This notice of funding opportunity (NOFO) will support research towards understanding and mitigating the deleterious effects of acute exposure to Ultra-Potent Synthetic (UPS) opioids (e.g., fentanyl, carfentanil, nitazenes) and their combinations (fentanyl and xylazine). This NOFO will also support research on the persistent and/or delayed pathophysiological effects after acute exposure to such agents. The program aims to advance scientific understanding of how acute exposure to ultra-potent synthetic opioids affects human health and to develop potential countermeasures. This R01 grant mechanism supports basic research projects and does not allow clinical trials.

This Notice of Funding Opportunity (NOFO) encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

The purpose of the NCI Pathway to Independence Award (K99/R00) program is to facilitate a timely transition of talented postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NCI research support during this transition in order to help awardees to launch competitive, independent research careers. This prestigious award from the National Cancer Institute supports early career researchers as they move from postdoctoral training to faculty positions, providing funding during the critical transition period. The K99/R00 mechanism consists of two phases: the mentored (K99) phase during the postdoctoral period and the independent (R00) phase after securing a faculty position.

The Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is designed to support small scale research grants at institutions that do not receive substantial funding from the NIH. The program emphasizes providing biomedical research experiences primarily for undergraduate students while enhancing the research environment at applicant institutions. Eligible institutions must award baccalaureate science degrees and have received no more than $6 million dollars per year of NIH support in 4 of the last 7 fiscal years. This Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of participating NIH institutes. Minimal risk clinical trials are defined as those that do not require FDA oversight, do not intend to formally establish efficacy, and have low risks to potentially cause physical or psychological harm. The program is specifically designed to engage undergraduate students in biomedical research and strengthen research capacity at institutions with limited NIH funding. The award covers a wide range of health-related research areas including cancer research, cardiovascular diseases, drug use and addiction, mental health, aging research, human genome research, and various other biomedical fields. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole.

The goal of this funding opportunity is to increase the impact of the BRAIN Initiative by targeted dissemination and integration of validated BRAIN Initiative tools to investigators at institutions that historically have not been major recipients of NIH support. This will be accomplished by awards to PIs at resource-limited institutions (RLIs) who pair with BRAIN technologists to facilitate training and adoption of BRAIN Initiative technologies in the recipient laboratories. Goals include two-way knowledge transfer between the PI and BRAIN technologist and to increase the participation of PIs at RLIs in BRAIN Initiative relevant research. The program aims to bridge the gap between cutting-edge neuroscience technology development and its application at underserved research institutions, fostering broader participation in brain research across diverse institutional settings.

The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICOs) are issuing this notice of funding opportunity (NOFO) seeking applications to test innovative approaches to implementing SBIRT/P for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities. SBIRT/P involves screening individuals for risk of ATOD use and misuse, briefly intervening with a conversation about harmful substance use, and referring individuals for treatment or preventive services, as needed. Proposed research should include prospective tests of SBIRT/P and should leverage collaborations with healthcare and community partners. This is an R01 grant mechanism that requires a clinical trial component.

This notice of funding opportunity invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIH's mission. The proposed research should demonstrate that the feasibility study is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial. Under this R01, the data collected should be used to fill gaps in scientific knowledge, including assessing whether the intervention can be delivered with fidelity across sites, demonstrating feasibility of recruitment and retention across sites, refining protocolized multimodal interventions, and demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficacy or effectiveness trial. The need for multisite feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trials or the published literature.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH-designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. This funding opportunity supports research aligned with assistance listing 93.213 for Research and Training in Complementary and Integrative Health.

This Notice of Funding Opportunity (NOFO) supports research on expectancy-generating factors and measures of their effects on expectancies and subsequent cancer symptom management outcomes; and research to identify moderators of such expectancy effects. Specifically, this NOFO will solicit mechanistic research that aims to understand how and why expectancy effects occur in a cancer context, elucidate their role in cancer symptom management, and identify patients, symptoms, cancer sites, and contexts in which expectancy effects can be leveraged to improve cancer outcomes. Expectancies are defined in this context as beliefs about future outcomes, including ones response to cancer or cancer treatment. Expectancies can be evoked by social, psychological, environmental, and systemic factors. Expectancy effects are the cognitive, behavioral, and biological outcomes caused by expectancies. Expectancy effects can be generated by expectancies held by patients, clinicians, family members, caregivers, and/or dyadic/social networks. This R01 grant mechanism supports mechanistic clinical trials required to investigate expectancy effects in cancer symptom management.

The goal of this notice of funding opportunity (NOFO) is to support feasibility trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) for conditions that have been identified by NCCIH as high-priority research topics. This funding opportunity is intended to support feasibility clinical trials that provide new information that are scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIH's mission. NCCIH expects that applications will describe the planned future clinical trial and demonstrate that the proposed R34 research is scientifically necessary to design or plan the subsequent competitive full-scale clinical trial. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including examining feasibility and acceptability of interventions lacking published data; tailoring or adapting the content or structure of an intervention to a specific population, modality, or setting; refining the intervention to determine the most appropriate frequency or duration; determining feasibility of recruitment, retention, and data collection procedures; refining and assessing the feasibility of protocolized multi-component interventions; or examining acceptability and adherence of control conditions. The subsequent full-scale clinical trial should have the potential to make a significant impact on public health.

This Funding Opportunity Announcement (FOA) encourages the submission of applications that propose to advance research in cancer etiology and early detection biomarkers, utilizing the advantages of the unique biorepository resources of the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial. The PLCO Biorepository offers high-quality, prospectively collected, serial pre-diagnostic blood samples from the PLCO screened arm participants, and a onetime collection of buccal cells from the control arm participants. Available data associated with the biospecimens includes demographic, diet, lifestyle, smoking, screening results, and clinical data. This FOA supports a wide range of cancer research including, but not limited to, biochemical and genetic analyses of cancer risk, as well as discovery and validation of early detection biomarkers. The proposed research project must involve use of PLCO biospecimens and should take advantage of the unique characteristics of the PLCO biospecimens.

This Notice of Funding Opportunity (NOFO) encourages applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either develop novel brain stimulation devices or significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices are not within the scope of this announcement. Applications should be submitted by multi-disciplinary teams with a variety of expertise including systems neuroscience, engineering, clinical, and regulatory affairs.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates) are not within the scope of this announcement.

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Enabling Technologies and Transformative Platforms initiative will support rigorously validating transformative, multi-use platforms or technologies. Well-suited applications must offer the potential to significantly accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, behavior, prevention or epidemiology. Proposed platforms and technologies may have widespread applicability but must be able to improve the outlook for HLBS-related diseases and disorders.

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative provides early stage translational support for activities required to develop and test device prototypes, identify diagnostic disease targets and develop associated assays, and develop research tools to treat HLBS diseases and disorders. This is a phased initiative for early stage projects. The R61 phase provides support to identify and test initial prototype designs, to identify a disease target and generate experimental design, and to identify, test and pilot research tools. The R33 phase provides support for continued prototype development and testing, in addition to modifying design features and user feedback, diagnostic product generation, exploration of assay components, and characterization of a load design, and research tool improvement, large trial testing and data integration. Following successful completion of the program, it is expected that the potential products will be poised to move forward for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. This initiative has a companion initiative that supports development of therapeutics and combination products and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.

The NHLBI Catalyze Program provides comprehensive support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates cleared for human testing, while developing translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative provides early stage translational support for prototype testing and design modification, assay development for diagnostic disease targets, and development of research tools for treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders. Following successful completion, potential products are expected to be positioned for in vivo testing with additional support from NIH and other federal and private programs. This initiative is part of a suite of innovation grants to advance projects to meet entry criteria for the NHLBI Catalyze Preclinical Program.

The purpose of this Notice of Funding Opportunity (NOFO) is to advance translational research to better understand the emergence and worsening of mood and psychotic disorders (e.g., perimenopausal depression (PMD), generalized anxiety disorder, bipolar disorder and schizophrenia) during the menopause transition (MT) in an effort to identify targets for future development of novel treatment interventions. This funding opportunity aims to advance novel and innovative translational research to better comprehend the underlying neurobiological and behavioral mechanisms of mood and psychosis disorders and related symptoms during MT. This funding opportunity encourages interdisciplinary researchers to collaborate on studies of mood and psychosis during the MT. Aspects of mood and psychosis disorders that are of interest include classic depressive symptoms in combination with menopause symptoms (e.g., hot flashes, night sweats, sleep disturbance) and psychological challenges, the role of reproductive steroids in the regulation of mood and behavior during the MT, diagnosis of mood and psychosis symptoms at menopausal stage, investigation of co-occurring psychiatric and menopause symptoms, appreciation of psychosocial factors common in midlife, and differential diagnoses. Review criteria will focus on the comprehensiveness of the neurobiology and mechanisms of action underlying mood and psychosis symptoms and hypothesis-driven work.

The purpose of this Notice of Funding Opportunity (NOFO) is to advance translational research to better understand the emergence and worsening of mood and psychotic disorders during the menopause transition. This includes conditions such as perimenopausal depression, generalized anxiety disorder, bipolar disorder, and schizophrenia, with the goal of identifying targets for future development of novel treatment interventions. The funding opportunity aims to advance novel and innovative translational research to better comprehend the underlying neurobiological and behavioral mechanisms of mood and psychosis disorders and related symptoms during the menopause transition. It encourages interdisciplinary researchers to collaborate on studies of mood and psychosis during this critical period. Aspects of interest include classic depressive symptoms in combination with menopause symptoms such as hot flashes, night sweats, and sleep disturbance, the role of reproductive steroids in mood and behavior regulation, diagnosis of symptoms at various menopausal stages, investigation of co-occurring psychiatric and menopause symptoms, psychosocial factors common in midlife, and differential diagnoses. Review criteria will focus on the comprehensiveness of the neurobiology and mechanisms of action underlying mood and psychosis symptoms through hypothesis-driven work.

The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to latter stages of clinical development.

This Notice of Funding Opportunity (NOFO) encourages applications to pursue invasive neural recording studies focused on mental health-relevant questions. Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate via the same electrodes allows for direct causal tests by modulating network dynamics. This funding opportunity aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential. Development of new technologies and therapies are outside the scope of this NOFO. This is a reissue of RFA-20-351.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications to pursue invasive neural recording studies focused on mental health-relevant questions. Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate, via the same electrodes, allows for direct causal tests by modulating network dynamics. This funding opportunity aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential. Development of new technologies and therapies are outside the scope of this NOFO.

This Notice of Funding Opportunity (NOFO) focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances prevention approaches to reduce prenatal alcohol exposure and the incidence of FASD and interventions for FASD. These objectives will be accomplished with the Exploratory/Developmental Phased Award (R61/R33) mechanism, clinical trial optional. The R61 phase will support pilot studies or secondary data analysis for hypothesis development and feasibility, and research testing the hypotheses can be expanded in the R33 phase. The transition to the R33 phase will be determined by NIAAA program staff after evaluation of the achievement of specific milestones set for the R61 phase. Highest priority will be given to applications with clinical trials.

This Notice of Funding Opportunity (NOFO) for R34 planning grant applications focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances (1) prevention approaches to reduce prenatal alcohol exposure and incidence of FASD and (2) interventions for FASD. It is expected that research conducted via this mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale FASD prevention or intervention studies. This planning grant opportunity is designed to support exploratory research and pilot projects that will lead to more comprehensive studies of FASD prevention and intervention.

The purpose of this funding opportunity is to encourage multidisciplinary investigators to submit applications developing exploratory, highly novel new approaches, or innovative applications of existing approaches to measure brain activity, connectivity, genomics, or other aspects across the age spectrum of neurodevelopment. The overarching goal is to extend our understanding of brain development and aging, including studies of the neurodevelopmental origins of later health and disease, by improving repeated measures across longer epochs of the lifespan to better predict outcomes at later ages. Research can include healthy human participants of any age, specific clinical groups such those with cognitive, motor, or affective regulation challenges, and/or animal research on these domains of function. The studies can focus on longitudinal neuroanatomical or functional changes at any level, including genetics/genomics, single cells, connectomics, neural population activity patterns, and others. This funding opportunity is intended to encourage technological and conceptual innovation through this high risk, high reward funding mechanism to develop highly innovative ideas that either lack preliminary data or need additional preliminary data.

The purpose of this funding opportunity is to encourage multidisciplinary investigators to develop new approaches or apply existing approaches in novel ways to measure brain activity, connectivity, genomics, or other aspects across the age spectrum of neurodevelopment. The overarching goal is to extend our understanding of brain development and aging, including studies of the neurodevelopmental origins of later health and disease. Research can include healthy human participants of any age, specific clinical groups such as those with cognitive, motor, or affective regulation challenges, and/or animal research on these domains of function. The studies can focus on longitudinal neuroanatomical or functional changes at any level, including genetics/genomics, single cells, connectomics, neural population activity patterns, and others. This funding opportunity is intended to encourage technological and conceptual innovation to improve repeated measures across longer epochs of the lifespan, to better predict outcomes at later ages.

The purpose of this Notice of Funding Opportunity (NOFO) is to support innovative population-based research that can contribute to identifying and characterizing pathways and mechanisms through which work or occupation influences health outcomes and health status among populations with health and/or health care disparities. This R01 grant supports investigator-initiated research projects across multiple NIH institutes focusing on understanding how occupational factors contribute to health disparities in the United States. The program encourages research that examines the complex relationships between work environments, occupational exposures, employment conditions, and health outcomes in populations experiencing health disparities. Clinical trials are optional under this funding opportunity.

This NOFO builds research about the effectiveness, implementation, and optimization of family navigation ED diversion models for non-urgent mental health problems. The program is designed to utilize triage tools to identify mental health acuity, facilitate engagement in mental health services and needed resources, and provide support, knowledge about the mental health condition, and facilitate linkages/address barriers to help-seeking among families. This R01 funding opportunity requires clinical trials and is offered by the National Institutes of Health to support research that can improve emergency department diversion strategies for mental health concerns.

The purpose of this Notice of Funding Opportunity (NOFO) is to build research about the effectiveness, implementation, and optimization of family navigation ED diversion models for non-urgent mental health problems. Models of interest are designed to (a) utilize triage tools to identify mental health acuity, (b) facilitate engagement in mental health services and needed resources, and (c) provide support, knowledge about the mental health condition, and facilitate linkages/address barriers to help-seeking among families. This is a clinical trial required R34 grant mechanism from the National Institutes of Health focused on mental health research grants. The program aims to develop and test innovative approaches to divert individuals with non-urgent mental health concerns from emergency departments to more appropriate community-based care settings.