Health grants for Researchers

This Notice of Funding Opportunity (NOFO) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. 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. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

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.

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites grant applications for Education and Research Centers (ERCs) that are focused on occupational safety and health training. NIOSH is mandated to provide an adequate supply of qualified personnel to carry out the purposes of the Occupational Safety and Health Act, and the ERCs are one of the primary means for meeting this mandate. ERCs are academic institutions that provide high-quality interdisciplinary graduate and post-graduate training, research training, continuing education, and outreach in the core occupational safety and health disciplines of industrial hygiene, occupational health nursing, occupational medicine, and occupational safety, as well as allied disciplines. Research and research training are integral components of ERCs, with ERC faculty and NIOSH trainees conducting research on issues related to the NIOSH National Occupational Research Agenda (NORA) and emerging issues to advance the field of occupational safety and health. NIOSH ERCs have regional presence to further diversify the occupational safety and health profession through their core values, mission statements, and outputs. ERCs serve as resources for our nation's workforce through continuing education, outreach and strong collaboration with professional associations, worker advocacy groups, businesses, industries, and public health agencies. ERCs work with other institutions and organizations, including Minority Serving Institutions and other NIOSH supported training programs to have a positive impact on worker health, safety, and well-being.

The Life Sciences Transformational R&D Investment Fund Pilot offers capital grants to support large-scale R&D projects in the UK life sciences sector (eligible projects must exceed £100 million in total costs). It aims to boost research and development within the UK's Life Sciences sector by supporting large-scale investments focused on innovation and strengthening health resilience, as well as projects with the potential to generate economic benefits. This fund complements the separate Life Sciences Innovative Manufacturing Fund (LSIMF).

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

This notice of funding opportunity (NOFO) 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 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.

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.

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.

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.

This notice of funding opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi site clinical trial (Phase III and beyond) application submitted under companion PAR-21-243. The DCC application must be specific to the companion Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this NOFO applies must be relevant to the research mission of NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website (http://www.nccih.nih.gov). Applicants are encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.

This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for investigator-initiated, multi-site, clinical trials (Phase III and beyond) to study the effects of natural products (i.e. botanicals, probiotics, and products marketed as dietary supplements) in NCCIH designated areas of high research priority. 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. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective of the Clinical Coordinating Center application is to provide the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this NOFO will utilize a two-phase, milestone-driven, cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center application, submitted under PAR-24-125, proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans).

This Notice of Funding Opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi-site clinical trial (Phase Ill and beyond) application submitted underTEMP-26943. The DCC application must be specific to the collaborating Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this NOFO applies must be relevant to the research mission of the NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (http://www.nccih.nih.gov). Applicants are strongly encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.

The purpose of the NIA Career Transition Award (CTA) is to facilitate the transition of mentored researchers to tenure-track faculty conducting research that advances the mission of NIA. This three-year award provides protected time through salary and research support and is targeted at applicants who plan to start a tenure-track faculty position within a year of the award.

The purpose of the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Predoctoral to postdoctoral Fellow Transition award (F99/K00) is to recruit exceptional graduate students from a variety of research fields to pursue postdoctoral training focused on Down syndrome related research. Talented graduate students from disciplines including, but not limited to, genetics, biochemistry, data science, imaging, engineering and neurobiology are invited to apply to this opportunity. Prospective applicants are strongly encouraged to contact the INCLUDE Program Staff prior to initiating plans for application submission.

The National Center for Advancing Translational Sciences (NCATS) invites applications for the Awards Supporting Cutting-Edge Technologies for Translational Science (ASCETTS) Notice of Funding Opportunity (NOFO) to foster investigator-initiated development of highly innovative technologies to address barriers, limitations, or bottlenecks in translational science particularly for therapeutic development. This program will support the early-stage proof of concept, high-risk and potentially high-reward studies for feasibility and exploratory technology development, which can transform or significantly improve the efficiency of therapeutic development to achieve NCATS ultimate goals - more treatments to all people more quickly. The research proposed should be for the development of technology that can break new ground or extend present technology toward new directions or novel applications. With this initiative, we expect to support the development and/or prototyping of new technologies that will lead to improved efficiency in the therapeutic development pipeline.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage institutions to propose creative and innovative institutional research career development programs which will prepare clinically trained vision scientists for independent research careers. This NOFO is intended to expand and strengthen the community of clinician investigators engaged in vision research. This Notice of Funding Opportunity (NOFO) allows the appointment of Scholars proposing to serve as the lead investigator of an independent clinical trial; or proposing 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 program. For this career development program scholars are limited to clinical trials that are minimal risk. The existing clinical trial must be a NIH-defined clinical trial that fulfills the NIH requirement for minimal risk trial. A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Applicants are strongly advised to consult with NEI program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.

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 (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

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.

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.

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

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

This 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.

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) 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 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 notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of childrens language development. The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable toolsto further our understanding of childrens language development and/or impairment, and predictors thereof.

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and/or early evaluation of strong candidate biomarkers and biomarker signatures that can be used as tools to facilitate the clinical development of neurotherapeutics and their use in clinical practice. Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical evaluation of biomarkers and biomarker signatures for neurological and neuromuscular disorders. Although research supported by this FOA can include animal studies, it must also include preliminary human evaluation using carefully standardized human samples or datasets. The goal of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.

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.

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

The 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.

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).

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 purpose of the NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00) program is to develop and maintain a strong cohort of independently funded dentist scientists dedicated to improving dental, oral and craniofacial health. This program is designed to facilitate a timely transition of outstanding dual degree dentist scientists from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions by providing support for two years of mentored training and three to five years of independent research. An option for five years of independent (R00) support is available to accommodate clinical training in a dental specialty program at no more than 3 person-months effort (25% full-time professional effort) in any year of the R00 phase.

This Notice of Funding Opportunity (NOFO) encourages applications for support of resources that will provide access to state-of-the-art equipment, technologies, research tools, materials, organisms, software, and/or services to a substantial regional (multi-state) or national user base. Only those resources with technical capabilities that fall within the NIGMS-supported program areas are eligible for awards. The resources should already be established or may be formed through consolidation of existing local or regional facilities. The intent is to provide resource access to investigators without regard to the specific biomedical focus of their research, while not duplicating or replacing resources supported by sources such as other NIH Institutes and Centers (ICs) or host institutions. The resource is expected to be maintained or upgraded to current best practices, make its capabilities and availability known to the biomedical research community through a robust web presence and outreach activities, and provide user training and support.

This Notice of Funding Opportunity (NOFO) supports projects relevant to the NIGMS mission that focus solely on the development of technologies with potential to enable acquisition of biomedical knowledge. Projects should be justified in terms of technical innovation and utility of such technical innovation for impacting future biomedical research. Outcomes or products of the proposed project should significantly advance the current state of the art and be sufficiently characterized for application in addressing a broad range of biomedical research questions.

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

The 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.

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 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 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.

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 this Notice of Funding Opportunity (NOFO) is to support the continued operation, maintenance, and dissemination of unique database bioinformatics resources that are of major importance to the research community using animal models of embryonic developmental processes. These grants will support ongoing development and enhancement of the resources, user training and services, provision of community generated data storage and curation, wide dissemination of the tools and/or resources, and expansion of interoperability with other NIH bioinformatics resources.

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 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.

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.