National Institutes of Health grants

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Technology Integration Center, which will enable the development of standards and best practices for applying new and emerging molecular methods in rare disease diagnosis. A major deliverable of the Center will be a multidimensional dataset that can be used for the development and benchmarking of novel tools and strategies that facilitate rare disease diagnosis.

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this NOFO is to solicit applications for the creation of a Validation Center to serve as a dedicated hub for the comprehensive evaluation and characterization of AI-enabled, image-based, multimodal CDS tools developed by the PRIMED-AI Consortium, to ensure these tools are reliable, reproducible, and generalizable. The Validation Center will focus on verification, validation, interoperability, and uncertainty quantification to comprehensively characterize performance of the CDS tools developed by the program. The core functions of the Validation Center will involve the systematic validation of PRIMED-AI Consortium deliverables, including those emerging from award recipients under the Playbook, Data-to-Model Academic-Industrial Partnerships, and Model-to-Clinic NOFOs.

This Notice of Funding Opportunity (NOFO) invites applications from clinical centers to participate in a consortium to test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs. Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The clinical centers may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscripts. This NOFO uses a cooperative agreement mechanism (U01) and runs in parallel with a companion NOFO (RFA-DK-27-136).

This Notice of Funding Opportunity (NOFO) invites applications from institutions/organizations that propose to establish core centers that are part of an integrated and existing program of nutrition and/or obesity research. The Nutrition Obesity Research Centers (NORC) program is designed to support and enhance the national research effort in nutrition and obesity. NORCs support three primary research-related activities: Research Core services, a Pilot and Feasibility (P and F) program, and a Scientific Catalyst program. All activities pursued by Nutrition Obesity Research Centers are designed to enhance the efficiency, productivity, effectiveness, and multidisciplinary nature of research in nutrition and obesity.

This Notice of Funding Opportunity (NOFO) invites a single cooperative agreement application for the Resource Center for the Cardiovascular Repository for Type 1 Diabetes (CaRe-T1D). The purpose of CaRe-T1D is to support innovative, discovery and mechanistic research through the study of human cardiovascular (CV) tissue. This research seeks to better understand cardiovascular disease (CVD) in type 1 diabetes, highlight differences compared to type 2 diabetes, and ultimately guide the development of therapies to treat this major cause of morbidity and mortality for individuals with type 1 diabetes. To achieve these goals, the Resource Center will expand the CaRe-T1D biorepository of human CV tissue, further develop the data commons for data sharing and for artificial intelligence (AI) tools, coordinate the research activities of the investigative teams in the CaRe-T1D consortium, and make CaRe-T1D resources accessible to the broader research community. This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Data Coordination and Outreach Center. The Data Coordination and Outreach Center will act as the central point of coordination for the GREGoRi Research Program, and will be responsible for ensuring that the protocols, data, metadata, computational tools and other resources developed as part of GREGoRi are made available to the broader research community.

The purpose of this Notice of Funding Opportunity (NOFO) is to support the next 5-year award period of the Clinician-Scientist Transdisciplinary Aging Research Coordinating Center (Clin-STAR CC), whose mission is to serve as a national resource for clinician-investigators across specialties and disciplines who are focusing their careers on aging research. This NOFO intends to build upon NIA's substantial investments to foster the development of clinician-scientists across specialties and disciplines. The specific goals of this initiative are to convey scientific and research knowledge on aging research; foster networking and collaboration between clinician-scientist leaders in aging research and clinician-investigators across specialties and disciplines who wish to focus on aging research; provide mentoring and career development support for emerging clinician-scientists committed to pursuing aging research in their clinical specialty or discipline; and advance interdisciplinary research projects in aging. Ultimately, the Clin-STAR CC is intended to provide a multi-faceted national research platform leading to improved patient-centered care for older adults across specialties and disciplines.

This Notice of Funding Opportunity (NOFO) invites applications for advanced development and enhancement of emerging informatics technologies to improve the acquisition, analysis, visualization, and interpretation of data across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on advancing emerging informatics technology, defined as one that has passed the initial prototyping and pilot development stage, has demonstrated potential to have a significant and broader impact, has compelling reasons for further improvement and enhancement, and has not been widely adopted in the cancer research field. To be successful, proposed development plans must have a clear rationale for why the proposed technology is needed and how it will benefit the cancer research field. In addition, mechanisms to solicit feedback from driving cancer research projects as well as the broader user community throughout the development process must be included.This NOFO invites applications for the enhancement and dissemination of emerging, user-friendly informatics technologies that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis is on uniqueness and potential impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following general attributes:Potential to advance driving cancer research projects and the cancer research field in general;Offers clear advantages over competing technologies in the targeted cancer research domain;Provides compelling plans and processes for supporting and engaging end users to evaluate and apply the tool or resource;Provides plans for advancing use of the tool or resource by the targeted community through collaboration, outreach, and training;Provides a realistic timeline and milestones for technology development.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications for research on developing a comprehensive and cohesive understanding of cancer metastasis. Towards this goal, the NCI will support U54 Specialized Centers that together will continue to serve as the hub of the Metastasis Research Network (MetNet). Each MetNet Center should propose an overarching scientific theme that will be pursued through two or three scientific inter- and multidisciplinary basic research projects. The projects should use integrative system level approaches to elucidate and integrate a mechanistic understanding of the non-linear, dynamic, and emergent processes in metastasis. Overarching themes should encompass the interplay between at least two central elements in the metastatic process such as early dissemination, cellular, soluble and/or physical microenvironment crosstalk, dormancy, or mechanisms of responses by metastatic cells to therapies. Studies on all types of cancer are welcome, including rare and pediatric metastatic cancers.Research proposed by MetNet Centers is expected to advance our understanding towards a more comprehensive appreciation of metastasis as a whole body, systems-level problem.

This Notice of Funding Opportunity (NOFO) solicits applications for the continued development and sustainment of high value informatics research resources to improve the acquisition, management, analysis, and dissemination of data and knowledge across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on sustaining operations and maintaining and evolving the scientific relevance of existing, widely-adopted informatics tools and resources. This is in contrast to early-stage and advanced development efforts to generate these tools and resources that will be supported by companion ITCR NOFOs. The central mission of ITCR is to promote research-driven informatics technology across the development lifecycle to address priority needs in cancer research. In order to be successful, the application must provide clear justification for why the research resource should be maintained and how it has benefited and will continue to benefit the cancer research field. In addition, mechanisms for assessing and maximizing the value of the resource to researchers and supporting close engagement between the resource and the targeted research community should be described.This NOFO invites applications to support the sustained operations of informatics technology resources that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis is on sustaining resources that have had a demonstrated impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following general attributes:Evidence that the technology has had significant impact on cancer research to date and the sustainment plan will lead to the continued advancement of cancer researchRobust plans for supporting the end-user community including documentation, training, and other outreach activitiesClear processes for engaging end users to address emerging needs of the targeted research communities to ensure that the research resource maintains relevance to the research it supports

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications for research on novel therapies for adult glioblastoma (GBM). The goal is to improve the treatment of adult GBM by developing novel effective agents that can cross the blood brain barrier (BBB) and testing them clinically. Successful early-stage trials of new drugs from this NOFO would transition seamlessly to later stage trials using well-established NCI clinical trial mechanisms.To implement this concept, a highly collaborative GBM Therapeutics Network (GTN) of cross-cutting teams will be established, each team capable of driving therapeutic agent(s) from pre-clinical development, through investigational new drugs (IND) studies, into pilot clinical studies in humans. Appropriate therapeutic agents include: (1) novel agents or (2) agents or combinations approved for other indications and repurposed for treatment of GBM following appropriate preclinical studies. The scope of the NOFO, from late pre-clinical through early (Phase 0/1) clinical studies, uniquely spans a gap in the GBM drug development process.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to engage the same target; or study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this NIDCD R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

This funding opportunity aims to support high risk clinical trials for the development of in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed projects should focus on improving the resolution of current imaging techniques or developing new imaging techniques that can visualize inner ear structures in vivo with significantly greater detail and accuracy than currently possible. Structural and functional aspects, including visualizing dynamic elements, are important to developing new and improved techniques. Projects may also focus on developing new imaging probes or contrast agents that can enhance visualization of the inner ear structures. Research supported in response to this RFA is expected to significantly advance the ability to visualize auditory and vestibular components, such as hair cells, otoliths, membranes, ions, and vasculature, in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multidisciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans must be proposed to develop,advance, or test the needed technology. Any intermediate studies must articulate a clear path of the proposed methodology to application in awake humans or define the limitations and the usefulness in anesthetized humans.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. This Notice of Funding Opportunity is intended to stimulate the development and testing of highly innovative experimental or computational approaches for rare disease diagnosis, that have the potential to make transformative improvements to the current state of the art.

This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs that propose to support intensive supervised research training and career development experiences for clinician scientists (Scholars) leading to research independence in the area of substance use and substance use disorder research.

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges.The purpose of this NOFO is to create a Logistics Center for the PRIMED-AI Program to facilitate and coordinate PRIMED-AI activities to maximize impact for the PRIMED-AI community. Within the Logistics Center, three integrated Cores will serve the functions of Administration, Evaluation, and Outreach for the PRIMED-AI Consortium. It is expected that the Logistics Center will work closely with other PRIMED-AI consortium members to collect, curate and disseminate information regarding tools developed by the PRIMED-AI award recipients, and will facilitate widespread access and awareness across the relevant scientific, patient, and clinical communities.

This funding opportunity aims to support the development of in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed projects should focus on improving the resolution of current imaging techniques or developing new imaging techniques that can visualize inner ear structures in vivo with significantly greater detail and accuracy than currently possible. Both structural and functional aspects, including visualizing dynamic elements are important to development of new and improved techniques. Projects may also focus on developing new imaging probes or contrast agents that can enhance visualization of the inner ear structures. Ultimately, research supported in response to this RFA is to encourage technologies that allow, for example, structures such as hair cells, otoliths, membranes, ions, and vasculature to be viewed in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multi-disciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans and intermediate studies in animals, but not non-mammalian species, may be proposed to develop or advance the needed technology. Any intermediate studies must articulate a clear path of the proposed methodology to application in awake humans or define the limitations and the usefulness in anesthetized humans.

This announcement 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 NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to encourage individuals who have not had substantial biomedical research experience, or who have the potential to significantly benefit from additional biomedical research experience to pursue further studies or careers in research. To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on: (1) Research Experiences, (2) Curriculum or Methods Development and (3) Outreach. The NCI’s mission is to conduct and support research, training, health information dissemination, and other programs concerning cancer. This funding opportunity seeks to facilitate educational activities that encourage students to become knowledgeable about cancer and available to focus on cancer later in their careers. To promote broad interest in pursuing a career in biomedical research via early intervention strategies, the NCI Youth Enjoy Science (YES) Program will support efforts to create and maintain an institutional program to engage grades 6-12 and/or undergraduate students in cutting edge cancer research experiences. The proposed institutional programs may also provide research experiences for the grade 6-12 teachers and undergraduate faculty members. The goals are to inspire interest in biomedical sciences, help envision research as a career path, and strengthen practical research and career skills. In alignment with these goals, institutions may develop unique programs that capitalize on their research strengths and are responsive to their target populations.

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this NOFO is to solicit applications for the design, development, and preliminary validation of robust frameworks for the application of multimodal-artificial intelligence (AI) models for clinical use. Frameworks developed through these awards would populate a "playbook", defined as a collection of actionable guidelines, standardized protocols, and/or standard operating procedures (SOPs) for reliable and effective development and deployment of multimodal AI tools. It is expected that the frameworks delineated in this playbook will directly address PRIMED-AI objectives and needs, while also remaining flexible enough to enable sufficient extensibility and interoperability for use across a broad spectrum of multimodal biomedical AI applications, both internal and external to the PRIMED-AI Program.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.

The NIH Director"s Pioneer Award supports individual scientists of exceptional creativity who propose bold and highly innovative research projects with the potential to produce a major impact on broad, important areas relevant to the mission of NIH. To be considered pioneering, the proposed research must reflect substantially different scientific directions from those already being pursued in the investigator"s research program or elsewhere. Applications in all topics relevant to the broad mission of NIH are welcome. Research may involve basic, translational, or clinical research. The NIH Director"s Pioneer Award is a component of the High-Risk, High-Reward Research (HRHR) program of the NIH Common Fund.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive,

This Notice of Funding Opportunity (NOFO) invites eligible academic or research institutions to apply for funding support to purchase latest scientific equipment that will enhance and modernize research-supporting operations of existing shared biomedical research facilities. Targeted are laboratory research core facilities, animal research facilities, and other similar shared-use research spaces. The goal of this NOFO is to strengthen research-auxiliary activities of biomedical research facilities and to enhance the efficiency of their operations. The NOFO does not support the purchase of scientific research instruments or their components, nor components of building-level infrastructure equipment that indirectly support research activities.

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.

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. With this NOFO, 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 initiative is to: (1) support the efforts by R15-eligible Principal Investigators (PIs) to conduct rigorous basic and/or mechanistic pain research projects; (2) promote integrated, interdisciplinary research partnerships between R15-eligible PIs and additional investigators from U.S. domestic institutions, and (3) enhance the pain research environment at the R15-eligible institution for health professional trainees or undergraduate and/or graduate students by actively engaging them in the proposed pain research projects.

The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R01 Clinical Trial Required mechanism focusing on alcohol treatment and recovery research. This NOFO will focus broadly on topics relevant for treatment of and recovery from alcohol use disorder (AUD), including: medications development, precision medicine, behavioral therapies and mechanisms of behavioral change (MOBC), recovery, translational research, and innovative methods and technologies for AUD treatment and recovery.

The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R01 Clinical Trial Optional mechanism focusing on alcohol health services. This NOFO will broadly focus on closing the treatment gap for individuals with alcohol use disorder (AUD); within this focus, there are five major areas of emphasis: (1) increasing access to treatment for AUD, (2) making treatment for AUD more appealing, (3) examining cost structures and insurance systems, (4) conducting studies on dissemination and implementation of existing evidence-based approaches to treating AUD, and (5) reducing health disparities as a means of addressing the treatment gap in AUD for health disparity populations.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites grant applications proposing exploratory research projects focused on further development and technical validation of emerging technologies offering novel capabilities for the molecular or cellular characterization of cancer or for improved handling and quality control of biospecimens used for basic, clinical, or epidemiological cancer research. This NOFO solicits R33 applications where major feasibility gaps for the technology or methodology have been overcome, as demonstrated with supportive preliminary data, but still require further development and rigorous technical validation to encourage adoption by the research community. Well-suited applications must propose the development of technologies that offer the potential to accelerate and/or enhance research in the areas of cancer biology, early detection and screening, clinical diagnosis, treatment, cancer control, epidemiology. Technologies proposed for development may have potential for widespread applicability but must be focused in this proposal on cancer-relevant use cases. Projects proposing to apply or use existing technologies for hypothesis-driven research where the novelty resides in the biological or clinical target/question being pursued are not responsive to this solicitation and will not be reviewed.This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

This notice of funding opportunity (NOFO) 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 submitted under this NOFO 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 NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R01) research 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, but not limited to the following: assessing whether the intervention can be delivered with fidelity across sites; demonstrating feasibility of recruitment, accrual, and randomization of participants across sites; demonstrating participant adherence to the intervention, as well as retention of participants throughout the study across sites; refining and assessing the feasibility of protocolized multimodal interventions, and/or 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 trial(s) or the published literature. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multisite clinical trial that has the potential to make a significant impact on public health.

The NIH Director's Early Independence Award helps talented new researchers begin their own independent research program soon after finishing their doctoral degree or clinical training, without first doing postdoctoral training.The award accepts applications on any topic fitting the NIH mission. It is part of the NIH Common Fund's High-Risk, High-Reward Research program.

The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite. Applicants applying for funding under this NOFO should be ready to initiate the clinical trial within the first quarter of the project period. Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award. If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion NOFO which utilizes an R61/R33 phased approach.

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.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits grant applications proposing to develop innovative technologies offering new capabilities for the molecular or cellular characterization of cancer or for improved handling and quality control of biospecimens for basic, clinical, or epidemiological cancer research. The NOFO solicits R61 applications for early-stage projects proposing proof-of-concept/pilot studies to test the technical feasibility of the proposed method, tool, assay, platform, or instrument. Technologies proposed for development may have potential for widespread applicability but must be focused for this program on cancer-relevant use cases. Projects proposing to apply or use existing technologies for hypothesis-driven research where the novelty resides in the biological or clinical target/question being pursued are not responsive to this solicitation and will not be reviewed.This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

The purpose of this NOFO is to enhance the capability of NCATS CTSA Program KL2 scholars and recipients of re-entry supplements supported by the CTSA Program to conduct research as they complete the transition to fully independent academic translational scientists. These R03 grants will support different clinical and translational science research projects, including pilot and feasibility studies; secondary data analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Research proposed in the R03 application may or may not include patient-oriented research. The R03 is, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that provide preliminary data to support submission of a subsequent R01, or equivalent, application.

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 Notice of Funding Opportunity (NOFO) invites applications for Diabetes Research Centers (DRCs) that are designed to support and enhance the national research effort in diabetes, its complications, and related endocrine and metabolic diseases. The purpose of this Centers program is to bring together basic and clinical investigators to enhance communication, multidisciplinary collaboration, and effectiveness of ongoing research in Diabetes Research Center topic areas. By providing shared access to specialized technical resources (research cores) and supporting a Pilot and Feasibility Program (P&F), DRCs are intended to create an environment that provides the capability for accomplishments greater than those that would be possible by individual research project grant support alone. New Center programs that bring in diverse perspectives, propose unique scientific themes, or provide innovative resources are encouraged. Emphasis will be placed on Center programs that propose enhanced synergies with other NIDDK-funded programs as well as providing a rich mentoring environment for future diabetes researchers.

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 1 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.

The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students and 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 both direct and F and A/indirect costs) in 4 of the last 7 fiscal years. 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.This Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of the participating NIH institutes. For the purpose of this NOFO, 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.

Awarded activities will facilitate the translation of novel recording and modulation technologies that can be used to treat and/or diagnose central nervous system (CNS) diseases and disorders and to better understand the human CNS, from proof of concept up to the stage of readiness for first in human (FIH) studies. Technologies may incorporate any signal modality (e.g., electrical, optical, magnetic, acoustic) or a combination thereof. Diverse team-based applications that integrate appropriate domains of expertise are encouraged.

This funding opportunity is part of a suite of NOFOs within the NIH HEAL Initiative to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal is to encourage initial translational efforts that will support a drug discovery program and advance projects to the point where they meet the entry criteria for the Pain Therapeutics Development Program. The scope will therefore be focused on development of assays to support a distinct testing funnel, screening efforts to identify hits, and initial characterization of hits and potential therapeutic agents (including small molecules, biologics, and natural products).

The purpose of this Notice of Funding Opportunity (NOFO) is to invite Small Research Grant (R21) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Direct involvement of key stakeholders where appropriate is encouraged. These applications should be for small research projects, such as those that involve single investigators. Of particular interest are projects that propose normative or conceptual analyses, including focused legal, economic, philosophical, anthropological, or historical analyses of new or emerging issues. This mechanism can also be used for the collection of preliminary data and the secondary analysis of existing data.

This Notice of Funding Opportunity (NOFO) solicits applications to develop shared-use research facilities or research-supporting facilities that enable collaborative research and benefit broad research communities at large. The NOFO supports two existing construction programs: the Biomedical Research Facilities (BRF) program and the HIV/AIDS Research Facilities (HRF) program.The BRF program supports the construction or modernization of biomedical research facilities that advance basic, translational, clinical, or behavioral science research in all areas. Intended facilities include shared research spaces, core facilities, biorepositories, or other shared-use resource facilities that serve a broad scientific community with a significant, long-term impact on biomedical research.The HRF program funds the development of HIV/AIDS research or research-supporting resources that the empowered research activities must align with the NIH Office of AIDS Research (OAR) priorities, as outlined at OAR HIV/AIDS Research Priorities, including research focusing on the long-term health consequences of HIV infection.NIH encourages applications from institutions across all geographic regions of the country, including Institutions of Emerging Excellence (IEE) in biomedical research, to strengthen the nation"s research capacity.

The Biomedical Research Environment and Sponsored Programs Administration Development (BRE-SPAD) Program aims to promote broad participation in the biomedical research ecosystem by supporting resource limited organizations to conduct research, enhance the research environment, and increase sponsored programs administration capacity.This program intends to support eligible, domestic organizations with limited research resources and few biomedical doctoral students.

The purpose of this Funding Opportunity Announcement (FOA) is to support high priority research at the intersection of HIV and substance use. This FOA invites innovative research projects with the potential to open new areas of HIV/AIDS research and/or lead to new avenues for prevention, treatment and cure of HIV among people who use drugs (PWUD). Applications submitted under this FOA are required to have a detailed research plan, preliminary data, and a clear description of the nexus with substance use. This FOA is open to both individual researchers and research teams and includes all areas of research from basic science to clinical and implementation research. All studies must focus on NIH HIV/AIDS Research Priorities: NOT-OD-20-018: UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.

Invasive surgical procedures in humans offer the unique opportunity to intracranially record and stimulate neuronal activity within precisely localized brain structures, enabling high-impact human neuroscience investigations. This NOFO seeks exploratory research projects, from newly formed or established multi-disciplinary teams, to understand how dynamic activity of single cells and ensembles of neurons in spatially organized networks gives rise to the internal states we experience as sensations, perceptions, emotions, thoughts, and memories, and to observable motor and social behaviors. The research should be proposed as exploratory research and planning activities to establish feasibility and early-stage development that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent research project grant applications using invasive neural recording and stimulation technologies in the human brain. Projects should maximize opportunities to conduct innovative in vivo human neuroscience research made available by direct access to the brain from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and by quantitative, mechanistic models where appropriate. Recipients will join a consortium working group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

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.

The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating women, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD.

This Notice of Funding Opportunity (NOFO) supports transdisciplinary research teams seeking to develop mechanistic, biologically grounded explanations of how neural circuits and their cellular building blocks give rise to central nervous system (CNS) function. Teams must integrate expertise spanning molecular and cellular through systems neuroscience, with strong collaboration between experimental and computational investigators, to bridge cells, circuits, and behavior in a unified framework that yields mechanistic insight.Applications must explicitly connect three core elements: (1) characterization of circuit components (e.g., cell types and/or connectivity); (2) measurement of dynamic circuit activity, incorporating in vivo CNS recordings at cellular and sub-second temporal resolution; and (3) analyses of a tractable behavior or functional output.To address this significant challenge in neuroscience, proposed studies are expected to leverage innovative conceptual or theoretical frameworks, predictive models, and/or cutting-edge approaches that unify these three levels of analysis and bridge experimental and computational components.Recipients are expected to participate in BRAIN consortia activities to identify standards of practice towards multi-level integration.

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

This Notice of Funding Opportunity (NOFO) announces the restructured Shared Instrumentation Grant (SIG) Program that consolidates three existing shared-use instrumentation programs, i.e., the Shared Instrumentation Grant program, the High-End Instrumentation Grant program, and the Basic Instrumentation Grant program. The NOFO invites applications from groups of NIH-supported investigators to purchase or upgrade a single state-of-the-art commercially available instrument or an integrated instrumentation system. The instruments purchased through the SIG Program are required to be optimally shared among the users to ensure efficient and cost-effective research operations, enable rigorous and reproducible measurements, and encourage collaborative research and benefit broad research communities at large. The minimum award is $300,000. There is no cap on the total cost of the instrument; however, the maximum award is $5,000,000. Cost sharing is required for premium instruments or special use instruments.

The purpose of this Funding Opportunity (NOFO) is to solicit grant applications to support research on the discovery and development of interventions to prevent and/or treat substance use disorders (SUDs) and overdose, including medications and medical devices to treat co-morbid SUDs. This includes preclinical and clinical research studies that will have high impact and quickly yield the necessary results to advance candidate interventions closer to regulatory approval or clinical adoption. This NOFO will utilize the UG3/UH3 activity code.

Responding to the needs of the scientific community to bolster a vibrant and sustainable research workforce, the Division of Kidney, Urologic, and Hematologic Diseases (KUH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has incorporated additional flexibilities for institutional training programs serving the mission interests of non-malignant kidney, urologic, and hematologic diseases, encompassing both adult and pediatric conditions. The purpose of this notice of funding opportunity is to invite applications for Institutional Network Awards (U2C-TL1) to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead. To maximize integration and promote a highly connected trainee community, institutions are invited to submit a single, unified U2C-TL1 application. Representation across all kidney, urologic, and hematologic disciplines is not expected or required. If feasible, applications may include multiple departments within and across institutions. It is expected that each U2C-TL1 award will actively participate in the Kidney, Urology and Hematology Research-Training Network (KUHR-TN), a nationwide coalition of individual U2C-TL1 awards.

The NIH Cardiovascular Repository for Type 1 Diabetes (CaRe-T1D) was created to improve research on type 1 diabetes (T1D) and cardiovascular disease (CVD). Cardiovascular complications remain the top cause of death among people with T1D and greatly shorten lifespan. The mechanisms underlying atherosclerosis, cardiomyopathy, endothelial dysfunction, and cardiac autonomic neuropathy in T1D remain poorly understood. While managing traditional risk factors—such as high blood glucose, high blood pressure, and elevated cholesterol lower cardiovascular risk, a significant residual risk remains even with optimal control. In addition to atherosclerosis, both diastolic and systolic diabetic cardiomyopathy play a major role in morbidity and mortality among these patients. Currently, no therapies are specifically approved to prevent or treat these common and severe cardiovascular issues in T1D. The purpose of this NOFO is to promote collaborative and interdisciplinary research aimed at enhancing the understanding of the development of CVD in individuals with T1D and the differences with CVD in T1D by continuing the efforts of the CaRe-T1D consortium.This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.

The National Institute of Environmental Health Sciences (NIEHS) is announcing the continuation of the Superfund Hazardous Substance Research and Training Program, referred to as Superfund Research Program (SRP) Centers. SRP Center grants will support problem-based, solution-oriented research Centers that consist of multiple, integrated projects representing both the biomedical and environmental science and engineering disciplines; as well as cores tasked with administrative (which includes Center leadership, data management, and training); translational research and engagement; and research support functions. The scope of the SRP Centers is taken directly from the Superfund Amendments and Reauthorization Act of 1986, which limits competition for this program to accredited institutes of higher education.Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs).Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.

The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials.

This Notice of Funding Opportunity (NOFO) invites applications that propose to use mouse models to conduct rigorous preclinical testing of drugs or drug combinations currently used for other conditions, as well as investigational drugs at various stages of clinical development, predicted to be efficacious in AD/ADRD. This initiative will also support preclinical testing of repurposable or investigational drug candidates in combination with non-pharmacologic interventions leading to robust translational outcomes. The central goal is to establish robust proof of concept that will enable rational drug repurposing and combination therapy development for the treatment and prevention of AD/ADRD.

This funding opportunity announcement (FOA) encourages the development and validation of animal models and human/animal tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder. The goal of this FOA is to promote a significant improvement in the translational relevance of animal models or ex vivo systems that will be utilized to facilitate future development of neurotherapeutics. Ideally, models proposed for this FOA would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program focused on enabling the exploratory and early stages of drug discovery.

This funding opportunity announcement (FOA) encourages research grant applications to develop in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological or neuromuscular disorders. 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 (BPN) or other translational programs.

The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond. This Notice of Funding Opportunity (NOFO) invites investigator-initiated applications to develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that increase the impact of research across diseases, transform the field of translational science, and bring more treatments for all people more quickly.

This Funding Opportunity Announcement (FOA) is intended to provide an avenue for basic scientists, clinicians and clinical scientists to jointly initiate and conduct translational research projects which translate basic research findings into clinical tools for better human health. The scope of this FOA includes a range of activities to encourage translation of basic research findings which will impact the diagnosis, treatment and prevention of communication disorders. Connection to the clinical condition must be clearly established and the outcomes of the grant must have practical clinical impact.

This Notice of Funding Opportunity (NOFO) encourages collaborations between the life and physical sciences that: 1) apply a multidisciplinary bioengineering approach to the solution of a biomedical problem; and 2) integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods, and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice. An application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research and is appropriate for small teams applying an integrative approach to increase our understanding of and solve problems in biological, clinical, or translational science. This NOFO will support clinical trials that test functionality or validate performance in the chosen setting. This NOFO is not intended to support conventional clinical trials that lack translation as the primary motivation. Applications that propose phase III clinical trials in any area of research are not sought by and will not be supported through this NOFO. This NOFO does not support commercial production.

This Notice of Funding Opportunity (NOFO) invites applications for innovative research on the factors that cause human behaviors and the oral-systemic health impacts of those behaviors to enhance health, lengthen life, and reduce illness and disability among people with chronic conditions. Causal hypotheses may include biological, biopsychosocial, congenital, environmental, interpersonal, neurological, psychological, and comorbidity factors that individually, sequentially, or in combination trigger human behaviors and oral-systemic health outcomes, with impacts that may be direct or traceably distal. Applications that propose projects to develop or refine causal hypotheses also are encouraged.

The National Cancer Institute's (NCI) Metastasis Research Network (MetNet) is a collection of U54 Research Centers that support using systems-level approaches to understand pressing questions in metastasis. The overall goal of the MetNet is to advance our understanding of metastasis as a whole body, systems-level problem to develop a comprehensive and cohesive picture of the processes involved. Through this Notice of Funding Opportunity (NOFO), the NCI invites applications for MetNet Research Projects. These Research Projects should be defined as discrete entities that use systems-level approaches to address gaps and opportunities in metastasis research to integrate into the MetNet and complement ongoing research across the Network.

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.

The National Institute on Deafness and Other Communication Disorders (NIDCD), with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) aims to support the development and/or adaptation of transformative in vivo high-resolution/high specificity imaging of the human olfactory system. Currently, there are limited non-invasive/minimally invasive technologies available for imaging the living human peripheral and central olfactory system with high spatial and temporal resolution. Imaging the olfactory system in the laboratory and in the clinic is essential to understanding underlying biological mechanisms as well as the etiology of an olfactory disorder. Such imaging has proven challenging due to the olfactory system"s unique anatomical and functional characteristics such as restricted accessibility, multiple cell types, and low signal resolution. Addressing these challenges requires multimodal approaches including leveraging existing advanced tools and technologies and developing new tools tailored for the olfactory system. Recent advances in minimally invasive and non-invasive imaging technologies, such as cell specific biomarkers, fluorescence imaging, specialized endoscopes, optical and acoustic imaging, molecular imaging, and hemodynamic and diffusion imaging have the potential to transform our ability to image and investigate the peripheral and central olfactory system in the living human with superior temporal and spatial resolution and eventually improve diagnostic accuracy of olfactory disorders. Applications must leverage advanced non-invasive/minimally invasive imaging technologies to visualize peripheral (e.g., olfactory- and non-olfactory epithelium) and central olfactory (e.g., olfactory bulb) targets at a level previously unattainable. In addition, projects should engage multidisciplinary teams combining expertise in olfaction, biomedical imaging, biochemistry, bioengineering, and biophysics, as appropriate.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated studies addressing mechanisms by which bariatric surgery impacts cancer risk, and seeks to draw in talented scientists who study bariatric surgery to investigate its effects on cancer, rather than shorter-term outcomes such as weight loss and diabetes.

This NOFO encourages applications for the Lasker Clinical Research Scholars Program. The program supports the research activities of clinical researchers during the early stages of their independent careers as they work to improve human health. The program offers the opportunity for a unique bridge between the NIH intramural and extramural research communities and contains two phases. In the first phase, Lasker Scholars will receive appointments for up to 5-7 years as tenure-track investigators within the NIH Intramural Research Program with independent research budgets. In the second phase, successful scholars will receive up to 3 years of NIH support for their research at an extramural research institute, or can remain as an investigator within the intramural program.

This Notice of Funding Opportunity (NOFO) will support, through the cooperative agreement mechanism, investigator-initiated observational studies or biomarker validation studies that require prospective collection of data/biospecimens or continued analysis of data/biospecimens.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage UG3/UH3 phased cooperative agreement research applications to plan and implement behavioral and social intervention clinical trials. Studies appropriate for this announcement include clinical trials to develop and test behavior change interventions related to dental, oral, or craniofacial conditions. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a clinical trial implementation phase (UH3) of up to five years. Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated study procedures (e.g., acceptability of study content or mode of delivery; feasibility of proposed data collection procedures; preliminary testing of intervention training and fidelity monitoring procedures). Operational planning activities include, at a minimum, development of: the final clinical protocol; the intervention manual or equivalent; the data management system and other tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents. The UH3 phase will support the conduct of investigator-initiated intervention research at all stages, from early mechanistic research and intervention development (e.g., Stages 0/ I) through implementation and cost-effectiveness research (Stages IV/V).

The purpose of this initiative is to support the development of innovative research centers to foster nursing-led programs that promote community-partnered research to address persistent health challenges. Center applications developed in response to this RFA should propose strategies to strengthen the research infrastructure by establishing or expanding centralized research resources in School or College of Nursing (SON/CON), developing and enhancing nurse-led interdisciplinary teams, and building expertise in community-partnered research through conducting pilot research that applies NINR's research lenses. Center strategies should be informed by NINRs mission and should meaningfully engage the community throughout all activities.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes.

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) intends to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. The purpose of this Notice of Funding Opportunity (NOFO) is to solicit Transformative Research Award applications to support individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research that has the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies related to Down syndrome. Applications are welcome in all topics relevant to Down syndrome-related research or its co-occurring conditions. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in research related to Down syndrome.

The purpose of the Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for health professional, undergraduate and graduate students and enhancing the research environment at applicant institutions.Eligible institutions must award baccalaureate or advanced science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F&A/indirect costs) in 4 of the last 7 fiscal years. 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 schools and colleges within the institution as a whole.Help determining the Organization Funding Level can be found here or https://grants.nih.gov/grants/funding/r15.htmThis REAP Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of the participating NIH institutes. For purposes of this NOFO, 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 purpose of this Notice of Funding Opportunity (NOFO) is tofurther elucidate the mechanisms of early immune development in utero, during the early post-natal period and during early childhood in neonates, infants, and children and adolescents with or without in-utero exposure to HIV or Anti-Retroviral Therapeutics (ART).This initiative aims to understand intricate mechanisms of immune cells at the maternal-fetal interface, T and B cell development and maturation in offspring, and local immune responses and the role of systemic immunity.

The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutionsis to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students, and 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 both direct and F and A/indirect costs) in 4 of the last 7 fiscal years. 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. See Part II. Section 3.1 Eligible Organizations for more information.

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.

This Notice of Funding Opportunity (NOFO) aims to build new research capacity and develop a sustainable research program by supporting the purchase of a single commercially available biomedical research instrument currently unavailable in the institution. Instruments funded through this program must be shared among the users to create new research opportunities, enable reproducible data generation, encourage collaborative research and training, and strengthen long-term research capabilities. The minimum award is $50,000. While there is no limit on the total cost of the instrument, the maximum award is $400,000.

This Notice of Funding Opportunity Announcement (NOFO) invites R25 applications to support the development and implementation of research education programs for recent baccalaureates from all backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. It is essential to expand and broaden the skilled Alzheimers Disease (AD) and Alzheimers Disease and Related Dementias (ADRD) research workforce and provide exposure to AD/ADRD research to individuals early in their careers. The proposed research education programs will support intensive research experiences in the AD/ADRD field with the goal of preparing recent baccalaureates to transition into strong, research-focused advanced degree programs or competitive private sector research careers in AD-related disciplines.

The purpose of the Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools is to stimulate basic and clinical research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. REAP grants create opportunities for scientists and institutions otherwise unlikely to participate extensively in NIH research programs to contribute to the Nation's biomedical and behavioral research effort. REAP grants are intended to support small-scale research projects proposed by faculty members of eligible, domestic institutions, to expose undergraduate and/or graduate students at health professional schools or graduate schools to meritorious research projects, and to strengthen the research environment of the applicant institution.Eligible institutions must award NIH-relevant baccalaureate or advanced degrees in health professions and have received less than $6 million per year of NIH support (total costs) in 4 of the last 7 fiscal years. In this NOFO, a college is a stand-alone entity and not a component of a university system.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit basic research applications to investigate the pathological mechanisms of skin injuries caused by toxic Chemicals of Concern (CoC) identified as public health threats by the United States Government. This NOFO supports the goal of the trans-NIH Chemical Countermeasures Research Program (CCRP) and is intended to spur the discovery and early development of broad-spectrum medical countermeasures (MCMs) to advance the nation's medical and public health preparedness for, response to, and recovery from high consequence chemical disasters and emergencies.

The Instrumentation Grant Program for Resource-Limited Institutions supports the purchase of state-of-the-art scientific instruments to enhance the research and educational missions of resource-limited institutions. Requested instruments may support biomedical research and education in basic, translational, biomedically-related behavioral or clinical fields. This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered.

The National Library of Medicine (NLM) seeks applications for research projects that drive groundbreaking innovation and advanced development in the fields of bioinformatics, translational bioinformatics, and computational biology. The primary goal of this initiative is to support the creation and implementation of cutting-edge methods, tools, and approaches that can transform the landscape of biomedical data science. This NOFO aims to address the growing need to leverage transformative technologies — such as artificial intelligence (AI), machine learning, and large-scale computational platforms — to extract actionable knowledge from vast, diverse, and complex biological datasets. By enabling more effective interpretation and integration of multi-dimensional biological and biomedical data, this research will ultimately contribute to improving individual and population health outcomes.

NLM wishes to accelerate access to, and availability of, secure, complete datasets and computational models that can serve as the basis for transformative biomedical discoveries. Innovative at-scale computational approaches that increase the speed and scope of curation processes are needed for data mining and knowledge discovery from growing quantities of biomedical data being produced from ongoing data science advances.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit UG3/UH3 phased, cooperative agreement research applications to evaluate, implement, and/or test population-based interventions to policies, programs, and/or practices for promoting integration of services, systems, and/or values by leveraging cross-sector partnerships in communities. Such interventions must address social and chronic disease common risk factors and/or barriers driving oral disease burden in communities. Projects funded through this funding opportunity and a separately funded Community Engagement Evaluation and Data Coordination hub (CEED) will form a Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT), which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people across the lifespan.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on: Courses for Skills Development

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

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.

This Notice of Funding Opportunity (NOFO) solicits applications for the development of enabling informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on early-stage development from prototyping to initial dissemination. Early-stage development is defined for the purpose of this NOFO as initial tool development or the significant modification of existing tools for new applications. The central mission of ITCR is to promote research-driven informatics technology across the development lifecycle to address priority needs in cancer research. In order to be successful, proposed development plans must have a clear rationale for why the proposed technology is needed and how it will benefit the cancer research field. In addition, mechanisms to solicit feedback from driving research projects and other users throughout the development process must be included.This NOFO encourages applications that involve the development of new, user-friendly informatics technologies that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis is on uniqueness and potential impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following general attributes:Potential to advance driving cancer research projects and the cancer research field in generalNovel informatics capabilities for the targeted cancer research domainCompelling plans and processes for engaging end users to evaluate and apply the tool or resourceA realistic timeline and milestones for technology development

The National Library of Medicine (NLM) seeks applications for innovative research in clinical informatics. The overarching goal of this forthcoming program is to catalyze the development and advancement of novel informatics methodologies that empower clinicians, patients, and the broader public to better understand, manage, and improve health and health care delivery. This NOFO will support research focused on the design, implementation, and evaluation of clinical informatics tools and methods that enable data-driven discovery, promote evidence-based decision-making, and support personalized and precision health care. Emphasis will be placed on domain-independent, scalable, and reusable/reproducible approaches for the discovery, analysis, organization, and management of health-related digital objects—including electronic health records (EHRs), clinical notes, imaging data, and patient-generated data. The aim is to transform raw and heterogeneous health data into actionable knowledge, to develop innovative tools, and to implement practical applications that can be generalized across multiple clinical settings and populations. Projects should demonstrate the potential to accelerate scientific insights, improve clinical workflows, and ultimately lead to improved health outcomes.

This FOA encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for "high priority" genetic conditions where screening may be possible in the near future.Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a "high priority" condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of new exploratory and developmental research projects that address critical needs for Down syndrome projects, as articulated in the INCLUDE Project objectives. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

This Notice of Funding Opportunity (NOFO) invites R25 applications to support the development and implementation of summer research education programs for high school students, undergraduates, or science teachers from all backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. It is essential to expand and broaden the skilled Alzheimer's Disease (AD) and Alzheimers Disease Related Dementias (ADRD) research workforce and provide exposure to AD/ADRD research to individuals early in their careers. The proposed research education programs will support intensive summer research experiences in the AD/ADRD field with the goal of exposing participants to AD/ADRD research and encourage further study or participation in biomedical and behavioral research. This NOFO does not allow participants 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 purpose of this Notice of Funding Announcement (NOFO) is to encourage pilot research that is not an immediate precursor to testing a service intervention but is consistent with NIMH priorities for services research. While NIMH now requires use of an experimental therapeutics model for all intervention studies, there is recognition that some mission-relevant areas of services research do not involve clinical trials.

The purpose of this Funding Opportunity is to address the needs of the maternal and pediatric HIV scientific community for research data translation and sharing.This initiative will support secondary data analyses using archived HIV/AIDS data and specimens. The goal of this initiative is to encourage the scientific community to utilize HIV/AIDS archived data sets and specimen collections to answer important questions about the epidemiology, pathogenesis, treatment, clinical manifestations, and HIV-associated co-infections and co-morbidities in maternal, pediatric and adolescent populations.

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 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: Applicants are encouraged to refer to the NIH Research Plan on Rehabilitation for strategic priorities (https://www.nichd.nih.gov/newsroom/news/110121-NIH-rehab-plan). 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) (PD(s)/PI(s)) to obtain sufficient preliminary data for a subsequent R01 application.

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.

The National Institute on Drug Abuse (NIDA) Cutting-Edge Basic Research Award (CEBRA) is designed to foster highly innovative or conceptually creative research related to the etiology, pathophysiology, prevention, or treatment of substance use disorders (SUDs). It supports high-risk and potentially high-impact research that is sparse or not included in NIDA's current portfolio that has the potential to transform SUD research. The proposed research should: 1. develop, and/or adapt, revolutionary techniques or methods for addiction research or that show promising future applicability to SUD research; and /or 2. test an innovative and significant hypothesis for which there are scant precedent or preliminary data and which, if confirmed, would transform current thinking.

The NEI supports large-scale clinical vision research projects, including randomized clinical trials and epidemiologic studies on eye/vision conditions. At the time of submission, applications requesting support for these activities are expected to provide detailed information regarding the study rationale, design, analytic methods, protocols and procedures, facilities and environment, organizational structure, and collaborative arrangements. This information is best conveyed in a study protocol and Manual of Procedures (MOP), the development of which represents a costly and time-consuming activity. This clinical research planning grant funding opportunity supports applicants in their planning efforts to conduct collaborative clinical research. The grant may be used to support the development of a study protocol and MOP, as well as to conduct preliminary studies to refine study procedures or document recruitment potential. The grant must not be used to generate data on the effects of a proposed intervention. This NEI NOFO is applicable to both epidemiologic and clinical trial research studies.

The purpose of the NIAID Career Transition Award program is to assist postdoctoral fellows' transition to positions of assistant professor or equivalent and initiate a successful biomedical career as an independent research scientist.

This Notice of Funding Opportunity Announcement (NOFO) is designed to encourage and facilitate the entry of investigators to the area of brain imaging research. This NOFO will support both newly independent investigators and established investigators who are seeking to develop and adopt neuroimaging tools and methodologies in their research programs and conduct small "proof-of-concept" studies relevant to substance use disorders and addiction. This NOFO is intended to support Small Research Grant (R03) projects that can be carried out in a short period of time with limited resources.

Data science is an important cross-cutting research approach in the 2022 - 2026 NIDA Strategic Plan and increasing the capacity of experts in addiction related data science is critical. The purpose of this Notice is to facilitate the entry of investigators to the area of addiction-related data science, including newly independent data scientists or established investigators seeking to incorporate novel and cutting-edge data science methodologies into their research programs for the first time. Through this opportunity, investigators will propose to apply emerging data science methods to answer critical questions requiring advanced data analytic strategies. Projects should be small in scale and answer specific research questions or provide preliminary data for a larger scale project. Applicants are encouraged to use existing datasets, follow FAIR principles, and, when applicable, attend to ethical concerns in the conduct of research involving human subjects. Ultimately, the aim is to expedite the development of robust research programs focused on the convergence of innovative data science techniques and addiction research, with initial projects serving as precursors for subsequent, more expansive research projects.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to elucidate a role for understudied proteins in rare disease. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s). A list of eligible proteins is provided and are members of druggable protein families that have a known association with a rare disease. This NOFO is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins within the context of rare disease.

The goal of the Grants for Early Medical/Surgical Specialists' Transition to Aging Research (GEMSSTAR) program is to provide support for early-career clinician-scientists trained in medical or surgical specialties to launch careers as future leaders in aging- or geriatric-focused research. In support of the program's goal, this GEMSSTAR Notice of Funding Opportunity (NOFO) invites applications that propose to conduct transdisciplinary aging research that will yield pilot data and experience for subsequent aging research projects. The GEMSSTAR program encourages candidates to seek out a supportive research environment to further the program's objectives of fostering the development of early-career clinician-scientists in aging- or geriatric-focused research, particularly as it applies to their clinical specialty/discipline. Toward this end, GEMSSTAR candidates should include a Professional Development Plan that reflects this supportive research environment. In selecting GEMSSTAR recipients, the National Institute on Aging (NIA) will consider the extent to which a candidate's environment is supportive of aging- or geriatric-focused research.

The SuRE program supports research capacity building at eligible higher education institutions by funding investigator-initiated biomedical research inbasic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE awards is to provide support for investigator-initiated research at resource-limited institutions by full-time faculty who are not currently funded by any NIH Research Project Grants (RPGs) with the exception of SuRE or SuRE-First awards, to furnish students with high-quality undergraduate and/or graduate research experiences, and to enhance the institutional scientific research culture.

The SuRE program supports research capacity building at eligible higher education institutions through funding investigator-initiated biomedical research inbasic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE-First awards is to provide support for investigator-initiated research at resource-limited institutions by full-time faculty who have not had any prior independent, peer-reviewed, external research grants, to furnish students with high-quality undergraduate and/or graduate research experiences, and to enhance the institutional scientific research culture.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces a program that provides NIDDK-supported K01, K08, K23, and K25 recipients the opportunity to apply for Small Grant (R03) support at some point during the latter years of their award period of their K award. Through the use of this mechanism, the NIDDK is seeking to enhance the capability of its K01, K08, K23, and K25 award recipients to conduct research as they complete their transition to fully independent investigator status. The R03 grant mechanism supports different types of 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, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that may provide preliminary data to support a subsequent R01, or equivalent, application.

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that invites applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered. The purpose of this NOFO is to solicit current or recently completed NHLBI K01, K08, K23, and K25 awardees for small grant support to expand their current research objectives or to branch out to a new study emerging from their K award research. This NOFO is intended to facilitate the transition to research independence for these NHLBI K awardees. Current NHLBI K01, K08, K23, and K25 awardees may apply for this R03 support starting in the third year of their K award Project Period. Recently completed NHLBI K01, K08, K23, and K25 award recipients are eligible to apply or resubmit A1 applications if the earliest potential R03 award start date is within two years of the end of their K award Project Period.The R03 grant mechanism supports research projects that can be completed within two years and with limited resources. These projects are expected to generate preliminary data to bolster a subsequent R01-equivalent application. Eligible projects include, but are not limited to, pilot or feasibility studies; proof of concept studies; secondary analysis of existing data; small, self-contained research projects; development of new research methodologies or technologies, or creation of novel experimental model systems.Applicants are required to maintain a minimum of 40% protected research effort during the R03 award period. This requirement can be fulfilled through a combination of effort on the proposed R03 project and other research projects, irrespective of funding source.For current and former K23 awardees, the research proposed in the R03 application may or may not include patient-oriented research.

The NIH Small Research Grant Program supports small research projects that can be carried out in a short period of time with limited resources. This program supports different types of 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. This Notice of Funding Opportunity does not accept applications proposing clinical trial(s).

The NICHD Small Research Grant Program (Clinical Trial Required) supports clinical trials that fall within the NICHD mission.

The goal of this NOFO is to support doctoral candidates studying high-priority areas of child health for the completion of their doctoral dissertation research project. This NOFO seeks to advance research in child health by stimulating the use of Environmental Influences on Child Health (ECHO) Cohort data by doctoral students in relevant scientific areas. This RFA will provide students working on dissertations the opportunity to access the ECHO data within the NICHD Data and Specimen Hub (DASH) repository. ECHO"s DASH dataset integrates de-identified longitudinal data from more than 71,000 participants across the U.S. Prenatal and child exposure data include physical, chemical, social, behavioral, and biological factors. ECHO"s five primary pediatric outcome areas are pre-, peri-, and postnatal outcomes, upper and lower airway, obesity, neurodevelopment, and positive health. This award will facilitate the entry of promising new investigators into the field of early environmental exposures and child health research, enhancing the pool of highly talented researchers.

The purpose of this Notice of Funding Opportunity (NOFO) is to seek applications for a Community Engagement Evaluation and Data coordination hub (CEED) for the Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT) for Optimizing Oral Health for All. In addition to CEED, the ADAPT consortium will include separately funded CBPR projects, which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people. The CEED hub will coordinate communications and various activities in support of CBPR projects and consortium functions in three domains:1) Data Planning, Consultation, and Technical Assistance for Research Methodology and Analytics; 2) Community Engagement Evaluation; and 3) ADAPT Infrastructure and Operational Support.

The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply. This notice of funding opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to the 'Independent Clinical Trial Not Allowed' companion NOFO (PAR-23-286).

Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this NOFO encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this Notice of Funding Opportunity (NOFO) is to catalyze the development and testing of Artificial Intelligence (AI)-enabled, image-centered, multimodal Clinical Decision Support (CDS) tools, developed in pursuance as Software as a Medical Device (SaMD). These projects are expected to have high potential for demonstrable, positive impact on patient outcomes and/or healthcare processes.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This FOA will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this NOFO supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientist.

The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply. This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO candidates are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFOs (PAR-23-287 or PAR-23-288).

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges.The purpose of this NOFO is to catalyze the translation of Artificial Intelligence (AI)-enabled, image-centered, multimodal CDS tools, developed as Software as a Medical Device, from training and testing of prototypes towards clinical applications that address unmet health challenges in precision medicine. These projects are expected to have high potential for demonstrable, positive impact on patient outcomes and/or healthcare processes.

The purpose of this notice of funding opportunity (NOFO) is to foster research that will inform and support the optimization, delivery, sustainability, and effectiveness of empirically-supported practices for addressing the mental health needs of older adults with serious mental illness (SMI). To this end, NIMH seeks applications that propose work that is focused on practice-relevant questions and conducted within and/or across settings where older adults with SMI are likely to be identified as needing care (e.g., primary care and geriatric specialty clinics, assisted living and long-term care facilities, and community centers). Applications may propose research related to adapting, optimizing, and implementing efficacious treatment and services interventions and strategies to improve clinical and functional outcomes among aging populations; examining mutable factors that impact fair and impartial mental health care access, utilization, quality, and outcomes and may serve as targets for intervention development for older adults with SMI; and developing and testing innovative treatment and service interventions that address barriers to accessing quality mental health care. Projects may also focus on systems-level factors and approaches for addressing SMI and improving access to evidence-based interventions in later life, such as evaluation of health system policies and practices, interventions that facilitate care transitions and continuity across settings, and strategies to improve care linkages and coordination across systems.

The purpose of this notice of funding opportunity (NOFO) is to elucidate the key components of the therapeutic effects of rapid-acting psychotropic interventional drugs (RAPIDs) by addressing the methodological challenges involved with these clinical trials. In addition, this NOFO seeks to advance understanding of how RAPIDs and adjunctive psychosocial interventions can be optimally delivered, monitored, and sustained over time to enhance effectiveness and generalizability. The NOFO will support studies designed to enhance the rigor of RAPID clinical trial design, which will ultimately increase the interpretability of the data and the generalizability of the results.

NIMH seeks applications for pilot research to adapt, optimize, and test behavioral interventions that address common sleep problems in adolescents and young adults with or at risk for a mental health disorder. This notice of funding opportunity (NOFO) supports pilot clinical trials designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach in real world settings. Applications should aim to conduct a preliminary test of the intervention's impact on sleep and mental health outcomes, as well as an examination of the mechanisms that underlie the intervention's effectiveness, and to obtain preliminary data needed as a prerequisite for larger-scale effectiveness trials. In addition, interdisciplinary, collaborative teams of investigators from the fields of mental health, sleep medicine, developmental science, clinical trials research methods, behavioral economics, implementation science, data science, and human computer interaction are encouraged.

This notice of funding opportunity (NOFO) invites applications designed to examine the efficacy and clinical effectiveness of multimodality digital health technology approaches to the remote management of diabetes.

This Notice of Funding Opportunity (NOFO) invites applications for a Research Coordinating Center (RCC) to participate in a consortium of clinical centers that will test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs. Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The clinical centers may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscriptsThe RCC will lead, manage, and harmonize efforts for the Consortium including 1) providing management and administrative support; 2) providing leadership and expertise on statistical design and analysis, 3) providing research coordination with a central laboratory, 4) harmonizing data collection methods and use of common data elements, 5) developing the database; 6) conducting data management and data analyses for Consortium studies; and 7) fostering research collaborations. This NOFO uses a cooperative agreement mechanism (U24) and runs in parallel with a companion NOFO (RFA-DK-27-121).

The Population Assessment of Tobacco and Health (PATH) Study provides the scientific community with biospecimens (urine, plasma, serum, and genomic DNA) and related research data on behaviors, attitudes, biomarkers and health outcomes associated with tobacco use in the U.S. This opportunity allows investigators to apply for access to the biospecimens from the PATH Study. Information about the PATH Study and this resource may be found on the PATH Study series page (https://doi.org/10.3886/Series606) at the University of Michigans National Addiction and HIV Data Archive Program (NAHDAP) website, part of the Inter-University Consortium for Political and Social Researchs (ICPSR) website.

The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human sensory and communication disorders. For this announcement, Clinical Research is defined as research involving individuals with a sensory and/or communication disorder, or data/tissues from individuals with a sensory and/or communication disorder. Examples of such research include but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language. Although the intent is that all the research will involve individuals with sensory and/or communication disorders or data/tissues from individuals with sensory and/or communication disorders, when the clinical research goal(s) warrant(s) limited departures from this intent, alternatives (e.g., non-human research, human subjects without a sensory or communication disorder, human at risk for a sensory and/or communication disorder) are possible with appropriate and strong scientific justification and in consultation with NIDCD staff. Applications may propose a low-risk clinical trial but are not required to (optional).Non-responsive applications will not be reviewed. Prospective applicants are strongly encouraged to read this funding opportunity carefully and communicate with the scientific/research contact listed at the end of this award as early as possible to discuss their application plans.

The purpose of this Notice of Funding Opportunity (NOFO) is to provide continuing support for specific pathogen-free (SPF) macaque colonies previously funded under the auspices of PAR-21-089 and PAR-18-669 that support Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) research. Breeding colonies are essential to sustain appropriate SPF macaques for research related to HIV/AIDS. Pedigree SPF macaques are free of certain viruses, which may confound the results of HIV/AIDS-related investigations or present a risk to the personnel who care for the animals. The SPF macaques are genetically characterized for major histocompatibility complex (MHC) class I types, because MHC class I genotypes have large effects on macaque immune responses to Simian Immunodeficiency Virus (SIV) that can induce AIDS in nonhuman primates (NHPs) and on human immune responses to HIV.

The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require 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 (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device.As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

This notice of funding opportunity (NOFO) seeks to establish a course to equip researchers studying drug use, drug misuse, and drug addiction with the skills, knowledge, and practical tools needed to translate their scientific discoveries into impactful real world solutions. The course is envisioned to focus on building capacity in product development, entrepreneurship, and innovation pathways so participants can more effectively move biomedical ideas from early research toward implementation, or commercialization. By combining structured training, mentorship, and hands-on experience, the course is envisioned to accelerate the development of biomedical products that address the complex challenges of drug use, drug misuse, and drug addiction, while fostering an interdisciplinary community of investigators prepared to navigate the scientific, regulatory, and business aspects of this unique research field.

The National Heart, Lung, and Blood Institute (NHLBI) Program Project Grant (P01) supports research related to fundamental processes and diseases of the heart, blood and lymphatic vessels, lungs, and blood, including transfusion medicine, blood resources, and sleep disorders other programs including implementation science, health disparities, and translation research that address the mission of the Institute. This FOA requires a minimum of three interrelated research projects that investigate a complex biomedical theme or research question. The projects may be supported by core units, if justified, to facilitate economy of effort, space, and equipment. The NHLBI provides support for Program Project Grants (PPGs) in the belief that collaborative research efforts can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects that have no interaction or thematic integration. NHLBI is particularly interested in encouraging new scientific directions in PPGs. Use of the P01 activity code is viewed as an opportunity to attract scientists who have not traditionally been supported by the NHLBI. Further, the PPG environment presents an opportunity for emerging scientific leaders to gain insight into how to lead a successful scientific Program, and applicants will have the opportunity to include a project led by an Early Stage Investigator (ESI). All projects in the Program must be interrelated and have objectives that address a central theme within the scientific mandate of the NHLBI.

This is a non-competitive funding opportunity intended to fund a single award. The National Institute of Neurological Disorders and Stroke is announcing its intent to issue a single source cooperative agreement award to Massachusetts General Hospital to support the renewal of the Post-Stroke Vascular Cognitive Impairment & Dementia (VCID) program, an ongoing, multi-site clinical research initiative designed to elucidate mechanisms linking stroke to subsequent cognitive impairment and dementia. The award will enable completion of the scientific aims initiated under the original U19 cooperative agreement (RFA-NS-19-012) and advance national priorities described in the National Plan to Address Alzheimer"s Disease.This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite an application from Massachusetts General Hospital. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application will be peer-reviewed, and only meritorious application(s) will be considered for funding.

The purpose of this notice of funding opportunity (NOFO) is to establish a Center that trains researchers in formal product development for new substance use disorder (SUD) pharmacotherapeutics and to advance the best concepts through initial experiments via technical and financial support.

The purpose of this announcement is to encourage 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 (e.g., bench top or animal studies) 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 goal of the NIGMS Predoctoral Basic Biomedical Sciences Research Training Program is to develop a pool of well-trained scientists available to address the Nations biomedical research agenda. Specifically, this funding opportunity announcement provides support to eligible, domestic institutions to develop and implement effective, evidence-informed approaches to biomedical graduate training and mentoring that will keep pace with the rapid evolution of the biomedical research enterprise. NIGMS expects that the proposed research training programs will incorporate 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.

This Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review]. The Simplified Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.

The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications for Centers within the NIDDK Cooperative Centers of Experimental in Hematology (CCEH) Program. Each Center will support one to three Biomedical Research Cores and an Administrative Core, including an Enrichment Program. Each Center is expected to work collaboratively with NIDDK, the Hematology Coordinating Center (HCC), and the other CCEH Centers. The CCEH Program is designed to increase access to critical research resources and expertise unique to nonmalignant hematology research. By providing innovative technology, resources, and expertise to the greater hematology research community, the program will serve as a national hub, aimed at recruiting and retaining both junior scientists just beginning their careers in the field as well as established investigators from other domains.

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.

The Office of Research Infrastructure Programs (ORIP) invites grant applications from core facilities, resource centers, animal vivaria, or individual investigators of other shared resources to systematically study the roles of critical environmental extrinsic factors in biological, behavioral, and treatment studies using animal model species, with the objective of enhancing the rigor and reproducibility of animal research. The research area must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate the biological processes that impact multiple organ systems in order to align with the ORIPs NIH-wide mission and programs. The program supports the acquisition or update of modern equipment for measuring, monitoring, recording, and reporting environmental, biological or biobehavioral variables. The equipment requested must be capable of recording and reporting multiple parameters simultaneously.

The purpose of the Resource-Related Research Projects (R24) grant is to support investigator-initiated resources designed to provide materials and services to support and advance biomedical research on a national basis. An R24 resource grant mechanism is a non-hypothesis-driven activity to provide data, materials, tools, or services that are essential to making timely, high quality, and cost-efficient progress in a field. Hypothesis-driven research applications should not be submitted in response to this program announcement but to another mechanism that encourages this type of research. The resource should be available to any qualified investigator, and should be highly quality controlled, and not duplicate resources available commercially or through other sources. Resources should be designed to provide services to the broad alcohol research community and should not be limited by any specific regional focus.

This funding opportunity announcement (FOA) encourages grant applications that support the activities of the National Primate Research Centers (NPRCs). Nonhuman primates (NHPs) are most closely related to humans, both physiologically and genetically. Therefore, NHPs are critical animal models for basic and translational research aimed at understanding human biology, both in normal and diseased states. Proper husbandry and management of NHPs require specialized physical and intellectual resources, which are most effectively and economically provided in centralized primate centers, the resources of which are made available to investigators on a national basis. The NPRCs provide these resources to investigators/grantees who utilize NHPs in biomedical research and thereby complement and help enable the missions of the NIH Institutes and Centers.

This Notice of Funding Opportunity (NOFO) invites exploratory grant applications, hereafter referred to as the Novel Experiential Technologies Assisting Individual learning Hubs or NExT AI Hubs (formerly Learning Disabilities Innovation Hubs), to address the impact of Artificial Intelligence (AI) technologies on developmental outcomes in children diagnosed with or at risk for developing a specific learning disability (SLD) impacting reading, writing, and mathematics. NExT AI Hubs include a single Research Project and a Leadership Core that support the goals and aims of the Hub. This NOFO seeks to serve as a catalyst to 1) speed the maturation of nascent/novel, high-impact, high-risk research that advances understanding of the role AI technology plays in supporting, improving, or limiting the learning, cognitive, and socio-emotional needs of children at risk for or diagnosed with SLDs, 2) build an evidence base for the SLD community to inform policy or practice, and 3) provide project-embedded, career-enhancing research and professional development opportunities to support the next generation of transdisciplinary SLD scientists. This initiative provides opportunities to support planning and building a body of research and corresponding intellectual infrastructure to enable NExT AI investigators to compete for large research and program project opportunities in the future.This NOFO aims to integrate research topics that are of relevance to various research programs at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and align with the NICHD Strategic Plan. The NOFO intends to build cross-programmatic, transdisciplinary and cross-cutting scientific research, and critically nurture the development of early career investigators capable of conducting this research.

The specific purpose of this Notice of Funding Opportunity (NOFO) is to promote the development of a diverse, interdisciplinary workforce needed to conduct translational research on Alzheimer's disease and Alzheimer's-related dementias from target discovery through clinical development. This NOFO will support institutional training programs for predoctoral and postdoctoral level researchers with diverse educational backgrounds (i.e., basic biology, translational and clinical research, data science). The program invites eligible institutions to develop interdisciplinary training programs that will provide trainees with the knowledge and skills in data science, disease biology, behavioral research, and traditional and emerging drug discovery disciplines necessary to conduct rigorous and cutting-edge basic, translational, and clinical research for AD/ADRD.

This Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) PAR, a re-issue of PAR-24-035, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review]. The Simplify Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.

This notice of funding opportunity (NOFO) invites applications from eligible organizations to establish a Data Coordination and Integration Center (DCIC) for the NIH HEAL Initiative. This Center will support the coordination and integration of data from both the HEAL INTERACT program and progressively facilitate broader integration of related musculoskeletal datasets and programs. The Data Coordination and Integration Center will lead efforts for managing and integrating complex pain-associated data types and information from the INTERACT Consortium and progressively related datasets. It will also establish a web-accessible information system and disseminate datasets that can facilitate hypothesis generation and be widely used throughout the research community.

Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPORE). The program will fund P50 SPORE grants to support state-of-the-art investigator-initiated translational research that will contribute to improved prevention, early detection, diagnosis, and treatment of an organ-specific cancer or a highly related group of cancers. For the purpose of this FOA, a group of highly related cancers are those that are derived from the same organ system, such as gastrointestinal, neuroendocrine, head and neck, and other cancers. Other programmatically appropriate groups of cancers may include those centered around a common biological mechanism critical for promoting tumorigenesis and/or cancer progression in organ sites that belong to different organ systems. For example, a SPORE may focus on cancers caused by the same infectious agent or cancers promoted and sustained by dysregulation of a common signaling pathway. In addition, a SPORE may focus on cross-cutting themes such as pediatric cancers or cancer health disparities. The research supported through this program must be translational and must stem from research on human biology using cellular, molecular, structural, biochemical, and/or genetic experimental approaches. SPORE projects must have the goal of reaching a translational human endpoint within the project period of the grant.

The purpose of the High Impact Specialized Innovation Programs (SIPs) is to support the development and demonstration of unique hub capabilities, research platforms and/or resources to address in a timely manner critical gap areas and/or roadblocks in clinical and translational science at awarded UM1 Clinical and Translational Science Awards (CTSA) Program Hubs (PAR-24-272). Successful programs supported through this funding opportunity are expected to lay a strong foundation for future adoption and/or dissemination of capabilities to additional CTSA Program Hubs.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for an Infectious Diseases Clinical Trials Network (IDCTN). The IDCTN, comprised of the Clinical Trial Evaluation Units (CTEUs) and a Network Coordination Center (NCC), supports the evaluation of interventions for emerging and chronic infections. The CTEUs design and implement clinical trials and studies, while the NCC provides the administrative and operational framework for a collaborative, integrated network and engages with experts in the field to solicit and generate clinical trial concepts. The NCC and CTEUs will collaboratively create opportunities to advance investigators early in their careers and those new to the field.

The purpose of this notice of funding opportunity (NOFO) is to support a Clinical Research Network (CRN) on Antimicrobial Resistance (AMR). The program aims to design, implement, and manage clinical research that addresses pivotal clinical questions related to AMR through a coordinated and integrated CRN. The CRN will comprise four centers: the Scientific Leadership Center (SLC), the Clinical Operations Center (COC), the Laboratory Center (LC), and the Statistics and Data Coordination Center (SDCC).

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. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products(i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived. Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This NOFO will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NO

This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human subject research study results through accrual in a variety of community settings. The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.NCORP is a community-based research network that:Designs and conducts clinical trials and other human subject studies for adults and children in cancer control, prevention, screening, and care delivery, as well as quality-of-life studies embedded within treatment trials;Enhances patient and provider access to treatment and imaging trials conducted under the National Clinical Trials Network (NCTN);NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below:NCORP Research Bases (UG1 Clinical Trials Required)(covered by this NOFO);NCORP Community Sites (UG1 Clinical Trials Not Allowed); andNCORP Academic Community Sites (UG1 Clinical Trials Not Allowed).NCORP Research Bases will serve as the program's research hubs and are expected to:Provide an established organizational structure, with scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer control, prevention, and care delivery (CCP&CD) clinical research, as well as quality-of-life studies embedded in treatment and imaging studies.Assume responsibility for study operations and data management, including efficient protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; auditing; training; quality assurance; and support to Community Sites and Academic Community Sites.Be based at institutions with comprehensive cancer clinical research expertise (e.g., NCI-designated Cancer Center, or healthcare research organization – including NCI's National Clinical Trials Network (NCTN) Group Operations Centers, or a cancer foundation associated with a NCTN Group).

This Notice of Funding Opportunity (NOFO) invites applications proposing a Data Coordinating Center that integrates and disseminates multiscale mouse brain datasets for the aging and Alzheimer's disease (AD) research community. The Data Coordinating Center will establish the Aging and AD Mouse Brain Atlas (AD-MBA), which will serve as a central, unified research resource for multi-omic and connectomic mouse brain datasets emerging from the NIA AD Multimodal Atlas Projects (AD-MAPs). The Data Coordinating Center will (1) leverage the NIA-supported AD Knowledge Portal data infrastructure to facilitate hosting, deposition, and dissemination of multimodal datasets generated by the AD-MAPs program, (2) facilitate collaborative analyses among the data-contributing teams, (3) develop/optimize and incorporate tools for multiscale integration of multi-omics and connectomics datasets, and (4) create a broadly accessible web-based interface for the visualization and dissemination of integrated multiscale data.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products as described in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb). These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for the Atopic Dermatitis Research Network (ADRN) program. The ADRN program will support Centers that integrate clinical and translational research to improve our understanding and management of atopic dermatitis with emphasis on chronic skin inflammation and the defense mechanisms of the skin.

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 NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent competitive full-scale clinical trial. Under this R34, the data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including, but not limited to the following: 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. Prior to submitting to this NOFO, applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact person for the science area of the planned application.

This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human subject research study results through accrual in a variety of community settings. The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.NCORP is a community-based research network that:Designs and conducts clinical trials and other human subject studies for adults and children in cancer control, prevention, screening, and care delivery, as well as quality-of-life studies embedded within treatment trials;Enhances patient and provider access to treatment and imaging trials conducted under the National Clinical Trials Network (NCTN)NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below:NCORP Research Bases (UG1 Clinical Trials Required);NCORP Community Sites (UG1 Clinical Trials Not Allowed)(covered by this NOFO); andNCORP Academic Community Sites (UG1 Clinical Trials Not Allowed).The NCORP Community Sites is a healthcare system, a consortium of healthcare systems, or a consortia of community hospitals and/or oncology practices, public hospitals, and/or health care centers that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research conducted through NCORP and NCTN.

This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human subject research study results through accrual in a variety of community settings. The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.NCORP is a community-based research network that:Designs and conducts clinical trials and other human subject studies for adults and children in cancer control, prevention, screening, and care delivery, as well as quality-of-life studies embedded within treatment trials;Enhances patient and provider access to treatment and imaging trials conducted under the National Clinical Trials Network (NCTN);NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below:NCORP Research Bases (UG1 Clinical Trials Required);NCORP Community Sites (UG1 Clinical Trials Not Allowed); andNCORP Academic Community Sites (UG1 Clinical Trials Not Allowed)(covered by this NOFO)NCORP Academic Community Sites are a consortium led by an academic center with a network of community hospitals and/or oncology practices, public hospitals, and/ or other healthcare centers that serve a patient population that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research. The academic medical center should have a robust infrastructure to support the accrual of participants across their affiliate organizations.

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 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). This can include the fundamental biology of these factors, components and processes. The resulting paradigms, component pathways and biological processes should be disseminated with sufficient detail to enrich common and/or federated data resources (e.g., those contributing to the Gene Ontology, Synaptic Gene Ontology, FAIR Data Informatics) in order to bridge the gap between disease risk factors, biological mechanism and therapeutic target identification. The present NOFO (R21 activity code) can be used for applications to develop early stage, high-risk, exploratory approaches or establish proof-of-concept where there is little or no preliminary data. Applicants proposing to develop lines of inquiry where feasibility or proof of concept has been established should apply to the companion R01 NOFO (PAR-xx-xxx).

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.

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.

The National Institutes of Health (NIH) hereby notifies NIH award recipients that funds may be available for revision applications to support the expansion of existing projects and/or programs within the awarding IC identified in the competitive revision Notice of Special Interest (NOSI). Applications for Revisions will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Only applications submitted in response to a NOSI published by an NIH Institute or Center will be allowed to apply to this NOFO.

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.

The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R34 Clinical Trial Optional mechanism focusing on alcohol health services. This NOFO will broadly focus on closing the treatment gap for individuals with alcohol use disorder (AUD); within this focus, there are five major areas of emphasis: (1) increasing access to treatment for AUD, (2) making treatment for AUD more appealing, (3) examining cost structures and insurance systems, (4) conducting studies on dissemination and implementation of existing evidence-based approaches to treating AUD, and (5) reducing health disparities as a means of addressing the treatment gap in AUD for health disparity populations.

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 Funding Opportunity Announcement (FOA) encourages grant applications for Biomedical Technology Resource Centers (BTRCs). BTRCs are national resource centers for conducting research and development on new technologies that are driven by the needs of basic, translational, and/or clinical researchers. BTRCs also make their technologies available to other investigators, train members of the research community in the use of the technologies, and disseminate the technologies broadly.

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 (1) prevention approaches to reduce prenatal alcohol exposure and the incidence of FASD and that (2) 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. Applicants interested in planning clinical trials or adding to current projects may also consider NOFO (TEMP-23832, the R34 option).

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.

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 advanceadavnce mechanistic understanding of both biobehavioral and neurobiologfical 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.

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 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 National Institute on Alcohol Abuse and Alcoholism solicits applications for an R34 Clinical Trial Optional mechanism focusing on alcohol health services. This NOFO will broadly focus on closing the treatment gap for individuals with alcohol use disorder (AUD); within this focus, there are five major areas of emphasis: (1) increasing access to treatment for AUD, (2) making treatment for AUD more appealing, (3) examining cost structures and insurance systems, (4) conducting studies on dissemination and implementation of existing evidence-based approaches to treating AUD, and (5) reducing health disparities as a means of addressing the treatment gap in AUD for health disparity populations.

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). This can include the fundamental biology of these factors, components, and processes. The resulting paradigms, component pathways, and biological processes should be disseminated with sufficient detail to enrich common and/or federated data resources (e.g., those contributing to the Gene Ontology, Synaptic Gene Ontology, FAIR Data Informatics) in order to bridge the gap between disease risk factors, biological mechanism and therapeutic target identification. The present NOFO (R01 activity code) can be used for applications to further develop lines of inquiry where feasibility or proof-of-concept has been established. Applicants proposing exploratory research at the early and conceptual stages of project development should apply to the companion R21 NOFO PAR-24-025

The goal of this NOFO is to support doctoral candidates from a variety of academic disciplines for up to two years for the completion of the doctoral dissertation research project. Research projects should align with NIDA funding priorities detailed here (https://www.drugabuse.gov/funding/funding-priorities). This award will facilitate the entry of promising new investigators into the field of substance use/substance use disorder (SU(D) research, enhancing the pool of highly talented SU(D) researchers.

The purpose of this NOFO is to invite Research Project (R01) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Applications without a PEDP will not be reviewed.

The purpose of this NOFO is to invite Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information. 

This NOFO seeks to advance research and training in high-priority areas of child health by stimulating the use of Environmental Influences on Child Health Outcomes (ECHO) Cohort data by postdoctoral fellows from relevant scientific disciplines. This RFA will provide opportunities for fellows to study child health outcomes through the analysis of ECHO's large longitudinal data sets within the NICHD Data and Specimen Hub (DASH) repository. ECHO's DASH dataset integrates de-identified longitudinal data from more than 71,000 participants across the U.S. Prenatal and child exposure data include physical, chemical, social, behavioral, and biological factors. ECHO's five primary pediatric outcome areas are pre-, peri-, and postnatal outcomes, upper and lower airway, obesity, neurodevelopment, and positive health.

The NIH Director"s Transformative Research Award supports individual scientists or groups of scientists proposing bold, groundbreaking, exceptionally innovative, original, and/or unconventional research with the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies. Applications in any area within the biomedical sciences are welcome; topics may involve basic, translational, or clinical research. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in a broad area of relevance to the NIH. The NIH Director"s Transformative Research Award is a component of the High-Risk, High-Reward Research (HRHR) program of the NIH Common Fund.

The purpose of this notice of funding opportunity (NOFO) is to provide salary support for exceptional Research Software Engineers (RSEs) that contribute their skills to the development and dissemination of biomedical, behavioral or health related software, tools, and algorithms as well as to the training of prospective users of these tools.

The goal of the proposed 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.

The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.

This Notice of Funding Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.

The goal of the proposed 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.

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; with such attributes, the proposed studies should also have the potential to improve clinical practice and/or public health. Applications submitted to this NOFO must include studies that meet the National Institutes of Health (NIH) definition of a clinical trial (see NOT-OD-15-015 for details) and provide specific clinical trial information as described in this FOA. 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.

This NOFO is a call to action in response to the mental health crisis in the United States. We seek applications that will study methods to increase access to evidence-based interventions and services for youth mental health, including those living in rural areas, inner cities, and other under-resourced areas, and youth experiencing housing and food insecurities and out-right homelessness. Applications should address research related to optimizing assessment, intervention and service strategies, overcoming challenges related to the workforce shortage, wait lists for treatment, integration of treatment and preventive interventions into settings where people are most likely to be best identified as needing care (eg: schools, social service, pediatric medicine and justice), and service interventions that address systemic barriers to access and quality of mental health care (structural, policy, organizational, value (cost/financing), management).

The purpose of this notice of funding opportunity (NOFO) is to support research on interventions to improve health in Native American (NA) populations. This includes 1) etiologic research, where there is a significant gap in knowledge, that will directly inform intervention development or adaptations, 2) research that develops, adapts, or tests the efficacy or effectiveness of health promotion and disease prevention interventions, 3) research that tests culturally informed treatment or recovery interventions and 4) where a sufficient body of knowledge on intervention efficacy exists, research on dissemination and implementation that develops and tests strategies to overcome barriers to the adoption, integration, scale-up, and sustainability of effective interventions. Existing data suggest that significant acute and chronic disease inequities exist for NA populations. Concurrently, NA populations experience unique sociopolitical, historical, and environmental stressors and risks that may exacerbate health conditions and/or impact the effectiveness of existing solutions to address the conditions. They also possess unique strengths and resiliencies that can mitigate stressors or inform intervention strategies. Through this initiative, intervention and related research is sought to build upon community knowledge, resources, and resilience to test science-based, culturally appropriate solutions to reduce morbidity and mortality through identification and remediation of precursors to diseases and disorders and through culturally informed treatment. Interventions should be designed with a consideration for sustainability within the communities where they are tested, and have the flexibility to be readily adapted, disseminated, and scaled up to other communities where culturally appropriate. For the purposes of this NOFO, NA includes the following populations: Alaska Natives, American Indians (whose ancestral lands fall at least partially within the U.S. main land).

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. Applicants interested in exploratory phased projects may consider NOFO (TEMP-23833, the R61/R33 option).

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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

The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICs) are issuing this R01 to solicit applications to address barriers and facilitators that impede use or uptake of cancer screening and preventive services in populations that experience health disparities.  Interventions should include screening, preventive services, or other healthcare processes, including timely follow-up of abnormal findings, and referral to accessible care. Projects are encouraged to leverage collaborations with community partners and service providers. Interventions should address barriers and facilitators at two or more of the following levels: patient, clinician, healthcare setting, and neighborhood/community. Specific research interests of participating NIH ICs are detailed within.

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.

As part of the Gabriella Miller Kids First Pediatric Research Program (Kids First Program), the NIH invites applications to submit samples from pediatric cohorts for whole genome sequencing at a Kids First Program supported genomic data generating centers. Applicants are encouraged to propose sequencing of existing pediatric cancer or congenital anomaly cohorts to elucidate the genetic contribution (somatic and/or germline) to childhood cancers, to investigate the genetic etiology of congenital anomalies, to study the molecular basis of the associations between congenital anomalies and increased cancer risk, or to expand the range of pediatric disorders included within the Kids First Data Resource. The program will accept applications that propose whole genome, exome, and transcriptome sequencing, as well as clinical-grade sequencing, long-read sequencing, proteomics, and epigenomic assays of tumor or affected tissue, when justified. Applicants are encouraged to propose cohorts to increase representation of existing Kids First Program projects. These data, and associated clinical and phenotypic data, will become part of the Kids First Data Resource Center for sharing with the research community.

The purpose of the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program is to fund federally recognized American Indian/Alaska Native (AI/AN) Tribes, tribal colleges or universities, Tribal health programs, or Tribal organizations (collectively termed, eligible Tribal Entities) to identify and develop a pool of scientists to conduct research on AI/AN health and health disparities. Through this Notice of Funding Opportunity (NOFO), NIGMS will provide support for a phased award to eligible AI/AN Tribal Entities to develop (UE5) and implement (T34) effective training and mentoring activities for research-oriented individuals earning a bachelor's degree in a biomedically-relevant field at a variety of institutions across the United States and territories. The overall purpose is to support the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in a culturally appropriate, ethically responsible and rigorous manner, to complete a bachelor's degree in a biomedical field, and ultimately to transition into careers in the biomedical research workforce.

The goal of the Medical Scientist Training Program (MSTP) is to develop a broad pool of highly trained physician-scientist leaders available to meet the needs of the Nations biomedical research agenda. Specifically, this Notice of Funding Opportunity (NOFO) provides support to eligible domestic institutions to develop and implement effective, evidence-based approaches to integrated dual-degree training leading to the award of both professional medical doctorate degrees and research doctorate degrees (Ph.D. or equivalent). With the dual qualification of rigorous scientific research and clinical practice, graduates will be equipped with the skills to develop research programs that accelerate the translation of research advances to the understanding, detection, treatment and prevention of human disease, and to lead the advancement of biomedical research. Areas of particular importance to NIGMS are the iterative optimization of MSTP training efficacy and efficiency, and fostering the persistence of MSTP alumni in research careers. NIGMS expects that the proposed research training programs will incorporate didactic, research, mentoring and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the Nation.

The purpose of the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program is to fund federally recognized American Indian/Alaska Native (AI/AN) Tribes, tribal colleges or universities, Tribal health programs, or Tribal organizations (collectively termed, eligible Tribal Entities) to identify and develop a pool of scientists to conduct research on AI/AN health and health disparities. Through this Notice of Funding Opportunity (NOFO), NIGMS will provide support for a phased award to eligible AI/AN Tribal Entities to develop (UE5) and implement (T32) effective training and mentoring activities for research-oriented individuals earning a doctoral degree in a biomedical research field at a variety of institutions across the United States and territories. The overall purpose is to support the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in a culturally appropriate, ethically responsible and rigorous manner, to complete Ph.D.s in a biomedical field, and to transition into careers in the biomedical research workforce.