National Institutes of Health grants

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 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.

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 Human Genome Research Institute (NHGRI) seeks to broaden the types of knowledge, skills, expertise, experience, and perspectives brought to bear in research addressing the ethical, legal and social implications (ELSI) of advances in human genetics or genomics. This Notice of Funding Opportunity (NOFO) solicits UM1 applications from domestic organizations located in the United States and its territories that received less than $30 million per year in total NIH funding for the past three fiscal years. These organizations are underrepresented among those receiving NHGRI funding for ELSI research. The Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BPAER) Program will support: 1) transdisciplinary ELSI research addressing timely, complex, and understudied topics, 2) the establishment of research teams that include representatives from relevant communities who are affected by and have an interest in the proposed research, 3) research capacity building to develop, conduct and sustain ELSI research, and 4) workforce development opportunities for early career scholars, research team members, and other research project staff. Transdisciplinary ELSI research projects require involvement from two or more fields of knowledge and use of multiple research approaches. Relevant communities must be actively and meaningfully involved on ELSI research teams across all phases of proposed research projects. Research capacity building plans must be informed by a needs assessment. Given the complex structure, a strategic management plan, evaluation plan, and sustainability plan are required to ensure successful completion of the program.

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 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 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 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.

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.

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

NIGMS will support innovative educational activities designed to equip participants with technical, operational, or professional skills required for careers in the biomedical research workforce. Activities must be open to the broader biomedical research community and may focus on participants at one or more career stages from undergraduates to professionals (for example faculty, staff scientists). Funded programs will have a robust program leadership structure, participant recruitment plan, and evaluation and dissemination plans.

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.

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.

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.

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,

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.

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 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.

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.

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, 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 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.

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 (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.

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.

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).

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 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 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.

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.

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 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) 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.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NCI 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 Notice of Funding Opportunity (NOFO) will support creative educational activities with a primary focus on Research Experiences. Applications are encouraged that propose innovative, state-of-the-art programs that address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients.

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.

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.

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 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 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 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.

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) 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 NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NCI 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 Notice of Funding Opportunity (NOFO) will support creative educational activities with a primary focus on Courses for Skills Development. Applications are encouraged that propose innovative, state-of-the-art programs that address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients.

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

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.

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 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.

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 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.

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) 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.

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 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.

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.

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 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.

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 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 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 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 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.

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

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 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.

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 initiative seeks to solicit applications for research projects that address the link between social disconnection including both objective social isolation as well as perceived social isolation (otherwise known as loneliness) and suicide in late-life. Emphasis is placed on research that identifies neurobiological and environmental mechanisms associated with social isolation and loneliness that increase risk for suicidal thoughts and behavior in late-life, that uses an experimental therapeutics approach to identify targets and develop and test interventions to prevent late-life suicide, and that develops new and modifies existing service delivery models to enhance social connection in late-life to prevent suicide.

This 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).

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.

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.

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.

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 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.

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.

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

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 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 Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

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.

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.

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 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.

This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease (GID) Research Training programs from U.S. and low- and middle-income country (LMIC) institutions. The application should propose a collaborative training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, infections that frequently occur as co-infections in HIV infected individuals or infections associated with non-communicable disease conditions of public health importance in LMICs. Training related to prevention, treatment or public health approaches to any technical area of basic, epidemiology, clinical, behavioral or social science health research may be supported. Research Training programs should incorporate didactic, mentored research and career development skills components to prepare individuals for careers that will have significant impact on the priority health research needs of LMICs. This Funding Opportunity Announcement (FOA) allows support of [trainees] as the lead investigator of an independent clinical trial; or a separate ancillary clinical trial or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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

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 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.

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 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.

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 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).

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.

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.

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.

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) 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.

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.

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 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).

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. 

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.

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 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.

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

The 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 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 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.

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).

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

Not available

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.

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).

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

The NIDCD Early Career Research (ECR) Award (R21) is intended to support both basic and clinical research from scientists who are beginning to establish an independent research career. It cannot be used for thesis or dissertation research. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or language. The NIDCD ECR Award R21 grant mechanism supports different 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 research technology. Irrespective of the type of project, the intent of the NIDCD ECR Award R21 is for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) to obtain sufficient preliminary data for a subsequent R01 application.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences for high school or undergraduate students or science teachers during the summer academic break. The proposed program needs to fit within the mission of the participating IC that the application is being submitted to and should not have a general STEM focus (see below and Table of IC-Specific Information and Points of Contact).

The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Notice of Funding Opportunity (NOFO) must not include preliminary data. Applications must include a separate attachment describing the change in research direction.

The overall goal of the Stimulating Access to Research in Residency (StARR) program is to provide resident clinicians in training with in-depth research experiences early in their careers, in order to recruit, retain and accelerate independence of a pool of clinician-investigators with both clinical and research experience necessary to perform basic, clinical and/or translational research.

The Theories, Models and Methods (TMM) initiative will support the development of computational tools for understanding dynamic brain circuits that are made broadly accessible to the greater research community. This program supports applications focused on tool building and dissemination in the domain of theories about neural circuit mechanisms, models of circuit structure and function, and/or computational methods of analysis spanning across scales from neurons to behavior. The development of novel theories, computational models and methods for understanding brain function will help characterize fundamental principles of brain function and organization, characterize cellular and circuit-level neural computations over time in different regions, and understand how interactions of multiple brain circuits enable flexible behaviors and contribute to brain-wide neural dynamics. These tools will be critical for developing treatments such as closed loop systems for brain disorders including Parkinsons disease and major depressive disorder.

This Notice of Funding Opportunity (NOFO) invites applications for P30 Cancer Center Support Grants (CCSGs) to support NCI-Designated Cancer Centers. CCSGs support three types of Cancer Centers: 1) Comprehensive Cancer Centers, which demonstrate reasonable depth and breadth of research activities in each of three major areas: basic laboratory; clinical; and prevention, control and population-based research, and which have substantial transdisciplinary research that bridges these scientific areas; and 2) Clinical Cancer Centers, which are primarily focused on basic laboratory; clinical; and prevention, cancer control, and population-based research; or some combination of these areas, and 3) Basic Cancer Centers, which focus on basic laboratory research. The purpose of all types of NCI-Designated Cancer Centers is to capitalize on all institutional cancer research capabilities, integrating meritorious research into a single transdisciplinary research enterprise across all institutional boundaries. Cancer Centers supported through this NOFO are expected to serve as major sources of discovery of the nature of cancer and of development of more effective approaches to prevention, diagnosis, and therapy; to contribute significantly to the development of Shared Resources that support research; to collaborate and coordinate their research efforts with other NCI-funded programs and investigators; and to disseminate research findings for the benefit of the community.

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.

The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligibleinstitutions to create, provide, and disseminate clinical and translational science training and career support programs for individuals seeking a PhD or an equivalent research health professional degree and help ensure a heterogenous pool of clinical and translational scientist trainees who are equipped with the knowledge, skills and abilities (KSAs) to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications aimed at improving health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities.

To support competing renewal or competitive revision of ongoing clinical trials supported by the National Institute of Dental and Craniofacial Research (NIDCR)

The Office of Research Infrastructure Programs (ORIP) encourages grant applications aimed at developing, characterizing, or improving research models of human health and diseases; developing biology based new approach methodologies (NAMs) applicable to human health and diseases; or improving access to information about or generated from the use of models of human disease. The models, including NAMs, and related biological materials developed must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate diseases and processes that impact multiple organ systems in order to align with the ORIP"s NIH-wide mission and programs. Applications must describe the need for and the potential impact of the proposed resources on the research community across a range of scientific disciplines supported by multiple NIH ICs. Applications to develop models that relate strictly to a specific disease or a select area of research or that do not have a broad impact on the NIH-wide research community will not be accepted. Projects that predominantly address the research interests of one NIH IC but are only peripherally related to the research interests of other ICs will also not be accepted, if submitted in response to this notice of funding opportunity (NOFO).

The purpose of the NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01) is to support comprehensive and rigorous postdoctoral research and career development experiences in the biomedical, behavioral, or clinical sciences of promising Au.D./Ph.D. audiologists who have the potential to become productive, independent investigators in scientific health-related research fields relevant to NIDCD's mission.

The Maximizing Investigators' Research Award (MIRA) provides support for individual investigators for research within the scientific mission of NIGMS via a single grant to achieve the following:Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; andEnable PD(s)/PI(s) to devote more time and energy to mentoring junior scientists in a more stable research environment.This NOFO invites applications from eligible NIGMS-funded investigators and from New Investigators proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows renewal applications from all current MIRA grantees (including those previously funded as Early-Stage Investigators). Current Early-Stage Investigators (ESIs) should apply through the ESI MIRA NOFO, not this NOFO.

The purpose of the NIH Independent Scientist Award (K02) is to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. The K02 award provides three to five years of salary support and "protected time" for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program must be tailored to meet the individual needs of the candidate.This Funding Opportunity Announcement (FOA) is designed specifically for applicants 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. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA

The purpose of the NIH Independent Scientist Award (K02) is to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. The K02 award provides three to five years of salary support and "protected time" for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program must be tailored to meet the individual needs of the candidate.This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA

The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers.

The purpose of this initiative is to advance the science and implementation of innovative multi-level health care research for older adults from populations that experience health disparities. The initiative will support research designed to (1) gain a better understanding of appropriate screening, diagnostic, and clinical care guidelines in a primary care setting, (2) explore shared decision-making that is needed to enhance care planning and patient agency between clinicians and care teams with the older adult and their caregiver(s), and (3) identify effective strategies for care coordination.

NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 currently TEMP-24813.

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

The Basic Instrumentation Grant (BIG) Program encourages applications from groups of NIH-supported investigators to purchase a single piece of new, costly, specialized, commercially available instrument or an integrated instrumentation system. The BIG Program is limited to institutions that have not received S10 instrumentation funding of $500,001 or greater in any of the preceding 3 Federal fiscal years (FY). Use the following to determine applicable funding periods: for submission in CY 2026, consider S10 funding in FYs 2023-2025; for submission in CY 2027, consider S10 funding in FYs 2024-2026; for submission in CY 2028, consider S10 funding in FYs 2025-2027. The minimum award is $25,000. There is no maximum price limit for the instrument; however, the maximum award is $350,000. Instruments supported include, but are not limited to, basic cell sorters, confocal microscopes, ultramicrotomes, gel imagers, or computer systems.

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

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

The High-End Instrumentation (HEI) Grant Program encourages applications from groups of NIH-supported investigators to purchase or upgrade a single item of high-end, specialized, commercially available instruments or integrated systems. The minimum award is $750,001. There is no maximum price limit for the instrument; however, the maximum award is $2,000,000. Instruments supported include, but are not limited to, nuclear magnetic resonance spectrometers, X-ray diffractometers, mass spectrometers, high throughput robotic screening systems, DNA and protein sequencers, biosensors, electron and light microscopes, flow cytometers, and biomedical imagers.

This Notice of Funding Opportunity Announcement (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support establishment of facilities at minority-serving institutions (MSIs) and Institutional Development Award (IDeA)-eligible institutions for scaled production and distribution of brain cell type-specific access and manipulation reagents. Reagents will be initially developed in pilot resource projects for brain cell type-specific access and manipulation across vertebrate species from the BRAIN Initiative Armamentarium project. Awardees under this NOFO will work with the other Armamentarium awardees to manufacture and distribute the resources for use throughout the neuroscience community. It is envisioned that the awardees will work both with the Armamentarium community as well as with the neuroscience research community to optimize the use of new reagents. The types of reagents to be produced and distributed could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to and manipulation of brain cell types. Such reagents will enable neuroscientists to probe circuit function with high precision in experimental animals and ex vivo human tissue and cells. Facilities are needed to contribute to the production and distribution of BRAIN Initiative Armamentarium project reagents broadly to neuroscience users.

The NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. 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.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The NOFO also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.

The National Center for Advancing Translational Sciences (NCATS) will award Institutional Research Career Development (K12) programs through the Clinical and Translational Science Awards (CTSA). The purpose of this Notice of Funding Opportunity (NOFO) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare an outstanding heterogeneous pool of promising later stage postdoctoral fellows and junior faculty scholars who have made a commitment to independent clinical and translational science research careers (i.e., tenure-track or equivalent faculty positions)to facilitate their timely career advancementand continued engagement in research (i.e., sectors including academia, industry, nonprofit and government).

The purpose of this Notice of Funding Opportunity (NOFO) 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 or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) 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 NOFO 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 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.

The purpose of the NIDA Animal Genetics Program is to identify genetic, genomic, and molecular (epi)genetic variants that underlie: 1. Phenotypes associated with addictive behaviors and/or vulnerability to distinct stages along the substance use disorders (SUD) trajectory (e.g. initial/acute use, escalation of use, acquisition of tolerance, dependence, uncontrolled use, abstinence and relapse or recovery); 2. Behaviors associated with SUD (e.g. impulsivity, novelty seeking, delayed discounting, and other genetically-associated phenotypes); and 3. Comorbidities that demonstrate genetic correlations with phenotypes and behaviors linked with SUD (e.g. anxiety, stress, poor maternal care, social defeat, and other paradigms). Applications may examine any type of genomic variant, including single nucleotide variants (SNVs), indels, large and small structural variants, and all types of mobile DNA. NIDA encourages applications that take genomics, multi-omics, and/or data-based approaches that integrate multi-level omics data, delineate gene networks, and/or uncover the function of known or newly discovered genetic or epigenetic variants. Other areas of interest include genomics analysis at the circuit level and the application of neuroscience to genomics studies. NIDA expects these studies to uncover novel mechanisms that contribute to various stages across the SUD trajectory and inform future studies about potential targets and therapeutic strategies for addiction.

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

To support UG3/UH3 phased, cooperative agreement research applications to plan and implement clinical trials within the mission of the National Institute of Dental and Craniofacial Research (NIDCR)

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for exploratory and early-stage projects that focus on undruggable target classes within intractable human disease. Applicants will identify a human disease relevant undruggable target class and develop a method or agent that is selective for one or more targets within that target class. This NOFO is intended to jumpstart research that demonstrates innovative strategies to modulate targets that cannot be addressed by established therapeutic types, furthering the development of methods and/or agents selective for undruggable target classes.

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

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

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

This NIDCR Small Grant Program for New Investigators supports basic and clinical research conducted by scientists who are in the early stages of establishing an independent research career in oral, dental and craniofacial research. This R03 program supports pilot or feasibility studies and developmental research projects with the intention of obtaining sufficient preliminary data for a subsequent investigator initiated Research Project Grant (R01) or equivalent application.

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

This Funding Opportunity Announcement is intended to identify and support research projects by exceptionally promising Early Stage Investigators with a long-term career interest in pursuing innovative research in genomics. This opportunity is open to research in all areas relevant to the mission of NHGRI, including genomic sciences, genomic medicine, genomic data science, and ethical, legal, and social implications of genomics.

The purpose of this initiative is to advance the science of minority health and health disparities by supporting research on family health and well-being and resilience. The NIMHD Research Framework recognizes family health, family well-being, and family resilience as critically important areas of research to decrease disparities and promote equity.

Reissue of PAR-20-119. This FOA encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders, substance use disorders (SUDs) or alcohol use disorder (AUD), and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged. This FOA supports a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach. Projects seeking support for a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies should consider the companion U01 FOA.

The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities.

The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility 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 or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent clinical feasibility 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. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. For more information see BP MedTech website.

The National Institutes of Health (NIH) hereby notify recipient organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of recipient organization status, often referred to in this announcement as Successor-In-Interest, may be submitted to this NOFO. Applications for change of recipient organization status are considered prior approval requests (as described in Section 8.1.2.8 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award.Although successor-in-interest requests may be submitted through this NOFO, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

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

This Notice of Funding Opportunity (NOFO) intends to support fundamental research that will contribute to basic understanding of skin injuries caused by chemicals that have been identified as public health threats, with an emphasis on investigating the commonalities of such injuries and identifying potential shared signaling pathways and therapeutic targets for medical countermeasure development.

This PAR is being reissued in accordance with the simplified review criteria in effect for application due dates after January 25, 2025. The objective of this funding opportunity is to support non-pharmacological interventions to promote sleep health, reduce sleep health disparities, and examine sleep as a modifiable factor to reduce health disparities for other health outcomes among populations that experience health disparities.

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required). As part of NIMH's clinical trials pipeline, this NOFO encourages pilot research developing and testing novel psychosocial interventions and/or targets. Consistent with NIMH's emphasis on the experimental therapeutics approach to intervention development, it intends to speed the translation of emergent research in basic, behavioral, cognitive, affect, and neuropsychological science into preventative or therapeutic interventions. This RFA will provide up to three years of support to replicate target engagement from prior studies and to test the association between target engagement and change in clinical outcome(s).

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Notice of Funding Opportunity Announcement requires that at lease 1 clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

The purpose of the NCI Pathway to Independence Award (K99/R00) program is to facilitate a timely transition of talented postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NCI research support during this transition in order to help awardees to launch competitive, independent research careers.

Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required). This NOFO is a key element of NIMHs set of NOFOs to support clinical trials research across the intervention development and testing pipeline. The NOFO supports (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. This NOFO is intended to support trials that: address a significant problem, such that the findings have potential to inform practice; are adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data; and are designed to examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support effectiveness trials that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial (e.g., to increase sample size, accelerate recruitment, or increase sample diversity and representation).

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

The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to facilitate transition of highly qualified dentists from NIH Intramural postdoctoral research positions to extramural academic tenure-track or equivalent faculty positions at eligible institutions. The award will provide support for two years of mentored postdoctoral research training in the NIH Intramural Research Program, and three years of independent research funding at the extramural institution.

This R61/R33 concept complements NIMHs suite of clinical trial NOFOs by supporting feasibility and infrastructure development (R61) followed by well-powered clinical trials (R33) to test the effectiveness of system interventions and strategies for improving the organization, delivery, coordination, and clinical and functional outcomes of mental health services. System interventions - which may span, for example, structural, policy, organizational, and interpersonal domains - attend to issues about the access, equity, engagement/utilization, value (cost/financing), management, or quality and safety of mental health services, with the goal of improved care processes and clinical and functional outcomes. Accordingly, the focus of system interventions may include a variety of care settings, such as health systems and organizations, mental health and community clinics, schools, and child welfare or juvenile justice systems

The purpose of this NOFO is to build research about the effectiveness, implementation, and optimization of family navigation ED diversion models for non-urgent mental health problems. Models of interest are designed to (a) utilize triage tools to identify mental health acuity, (b) facilitate engagement in mental health services and needed resources, and (c) provide support, knowledge about the mental health condition, and facilitate linkages/address barriers to help-seeking among families.

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

The purpose of this Notice of Funding Announcement (NOFO) is to encourage innovative research that will inform and support the delivery of high-quality, continuously improving mental health services to benefit the greatest number of individuals with, or at risk for developing, a mental illness. This announcement invites applications for non-clinical trial R01-level projects that address NIMH strategic priorities for mental health services research.

The purpose of the NIH Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of individuals with a clinical doctoral degree who have made a commitment to focus their research endeavors on patient-oriented research.

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty.

NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMHs Clinical Trial Pipeline, this NOFO encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. More specifically, this NOFO is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect.

The purpose of the NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrates their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The EIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards. The EIA will support the research program of NHLBI-funded investigators for up to seven years. The EIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer timeframe. Research supported by the EIA must be within the scope of the NHLBI mission (http://www.nhlbi.nih.gov/about/org/mission).

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

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

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

Reissue PAR-21-122. This NOFO provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs.

The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and "protected time" for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research.This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA ().

The purpose of this Notice of Funding Opportunity (NOFO) encourages applications that will expand knowledge of the natural history of disorders that currently are, or may become, part of statewide newborn screening programs. A comprehensive understanding of the natural history of a condition is necessary to facilitate appropriate interventions for infants identified by newborn screening. Characterization of the sequence and timing of symptom development provides information crucial for developing targeted, age-appropriate treatments and for establishing a baseline against which to assess novel interventions. In addition, for some conditions, establishment of genotype-phenotype correlations may facilitate prediction of the clinical course; for others, identification of modifying genetic, epigenetic, or environmental factors may enhance understanding of clinical outcomes. Comprehensive data on the natural history of a condition will facilitate the fields ability to: 1) identify the underlying biological mechanisms; 2) understand the genetic and clinical heterogeneity and phenotypic expression of the condition; 3) improve diagnostic accuracy; 4) facilitate clinical trials by providing comprehensive natural history data; 5) prevent, manage, and treat symptoms and complications of the condition; 6) furnish physicians and families with needed support and predictive information about the condition; and 7) establish data collection systems or patient registries to collect longitudinal data (e.g., child/family outcomes following newborn screening).

The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) provides support for biologic-based therapeutic discovery and development, from lead optimization through phase I clinical testing. This Funding Opportunity Announcement (FOA) supports preclinical discovery and development of potential therapeutic Biotechnology Products and Biologics including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies). Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, scaling, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biotherapeutic candidates developed in this program.

The National Institutes of Health (NIH) awards senior individual research training fellowships to experienced scientists who wish to make major changes in the direction of their research careers or who wish to broaden their scientific background by acquiring new research capabilities as independent investigators in research fields relevant to the missions of participating NIH Institutes and Centers.

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

The purpose of the NHLBI Career Transition Award (K22) program is to provide highly qualified postdoctoral fellows in the NHLBI Division of Intramural Research the opportunity to transition their research programs as new investigators to extramural institutions. To achieve these objectives, the NHLBI Career Transition Award will support two phases of research: a mentored intramural phase (up to two years) and an extramural phase (three years), for a total of five years of combined support. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee's research program during the mentored phase as determined by an NHLBI progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.

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

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

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

This Notice of Funding Opportunity announcement (NOFO) invites applications for the Clinical and Translational Science Award (CTSA) Program hubs that will be part of a national, collaborative consortium focused on bringing more treatments for all people more quickly through advancing clinical and translational science (CTS) by (1) developing, demonstrating, and disseminating scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination; (2) promoting partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally; (3) creating, providing, and disseminating innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all; (4) creating and implementing scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research; (5) providing a national resource for the rapid response to urgent public health needs; and (6) creating, providing, and disseminating CTS training for clinical research professionals of all disciplines on the research team.

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. The goal of this NOFO is to support proof of concept studies for feasibility and exploratory development. Feasibility must not have already been developed in the literature or with preliminary data. While unpublished data are not permitted, references and data from widely available preprints that have a Digital Object Identifier (DOI) are acceptable. Investigators who have generated unpublished preliminary data should submit a proposal to companion R01.

The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting well designed and well executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm.