Funding Opportunity PAR-25-214 from the NIH Guide for Grants and Contracts. The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project encourages exploratory and innovative research to develop, characterize, or improve animal models and related biological materials for Down syndrome (DS) related research and to improve access to information about or from the use of animal models for DS research. The animal models and related biological materials developed must have utility in targeted or basic science studies in areas highly relevant to DS. With this funding opportunity announcement, the INCLUDE Project encourages, but is not limited to, projects focusing on development of various animal models, genetic resources, atlases at a single cell or subcellular level, advanced informatics technologies including artificial intelligence (AI) or machine learning (ML), and integration of multiple animal models and technology platforms for enhancing rigor and reproducibility of preclinical DS research.

Funding Opportunity PAR-25-282 from the NIH Guide for Grants and Contracts. 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 identity 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 also 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.

Funding Opportunity PAR-25-281 from the NIH Guide for Grants and Contracts. 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 identity 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 also 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.

Funding Opportunity RFA-HL-26-020 from the NIH Guide for Grants and Contracts. 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 will provide the early stage translational support needed for prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of HLBS diseases and disorders. 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.

Funding Opportunity RFA-HL-26-019 from the NIH Guide for Grants and Contracts. 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 will provide the early stage translational support needed for the 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.

Funding Opportunity RFA-HL-26-018 from the NIH Guide for Grants and Contracts. 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 will provide the early stage translational support needed for the activities required to identify and characterize potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This initiative has a companion initiative that supports development of devices and diagnostics 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.

Funding Opportunity RFA-HL-26-017 from the NIH Guide for Grants and Contracts. 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 will provide the early stage translational support needed for the activities required to identify and characterize potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This initiative has a companion initiative that supports development of devices and diagnostics 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.

Funding Opportunity RFA-AI-24-076 from the NIH Guide for Grants and Contracts. The purpose of this notice of funding opportunity (NOFO) is to support preclinical activities for the development of safe and effective long-acting/sustained release (LA/SR) technologies for prevention and treatment of HIV and HIV-associated tuberculosis (TB), hepatitis B (HBV) and hepatitis C (HCV), and to ultimately advance these products toward submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). Solicited LA/SR products will have demonstrated strong rationale, competitive advantage, and effectiveness in appropriate non-clinical or animal models at intermittent dosing from either a single administration (injection, topical, oral administration) or continuous dosing regimen (implant, transdermal patch, etc.).

Funding Opportunity PAR-25-171 from the NIH Guide for Grants and Contracts. Through this Notice of Funding Opportunity (NOFO), the National cancer Institute (NCI) will support the development and characterization of state-of-the-art biomimetic tissue-engineered technologies for cancer research. Collaborative, multidisciplinary projects that engage the fields of regenerative medicine, tissue engineering, biomaterials, and bioengineering with cancer biology will be essential for generating novel experimental models that mimic cancer pathophysiology in the context of a testable cancer research hypothesis. The projects supported by this NOFO will collectively participate in the Cancer Tissue Engineering Collaborative (TEC) Research Program. The Cancer TEC Program will (1) catalyze the advancement of innovative, well characterized in vitro and ex vivo systems available for cancer research, (2) expand the breadth of these systems to several cancer types, and (3) promote the exploration of cancer phenomena with biomimetic tissue-engineered systems.

Notice NOT-DK-25-006 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-HL-26-016 from the NIH Guide for Grants and Contracts. 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 needed to rigorously validate transformative, multi-use platforms or technologies that can enable. 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.

Notice NOT-GM-25-003 from the NIH Guide for Grants and Contracts

Notice NOT-DK-25-007 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-25-290 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity PAR-25-291 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity PAR-25-226 from the NIH Guide for Grants and Contracts. 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 for example, 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.

Notice NOT-HL-24-035 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-NR-25-002 from the NIH Guide for Grants and Contracts. This Notice of Funding Opportunity (NOFO) invites applications from multidisciplinary teams of experts in firearm injury prevention research across departments and institutions to develop and provide research resources and support to build capacity among United States (U.S.) nurse researchers for rigorous, high-impact research in firearm injury prevention aligned with the NINR mission and scientific framework. These R24 awards are intended to: 1) build research resources that respond to the specific needs of the nurse researcher community; 2) train and attract new nurse researchers into the field; 3) support potential pilot project programs to accelerate research progress toward an NIH award; and 4) advance firearm injury prevention research infused with a social determinants and health equity perspective.

Funding Opportunity RFA-DA-26-017 from the NIH Guide for Grants and Contracts. This notice of funding opportunity (NOFO) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research and development of medical devices specifically indicated for pediatric population (i.e., 0-21 years old, as defined by the FDA Center for Devices and Radiological Health) affected by substance use and addiction.

Funding Opportunity RFA-DA-26-016 from the NIH Guide for Grants and Contracts. This notice of funding opportunity (NOFO) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research and development of medical devices specifically indicated for pediatric population (i.e., 0-21 years old, as defined by the FDA Center for Devices and Radiological Health) affected by substance use and addiction.