Funding Opportunity PAR-25-181 from the NIH Guide for Grants and Contracts. 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).

Funding Opportunity PAR-25-180 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity PAR-25-179 from the NIH Guide for Grants and Contracts. Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement supports confirmatory efficacy testing of non pharmacological therapeutic and preventive interventions for mental disorders in adults and children that address unmet therapeutic needs, and are consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change.

Funding Opportunity PAR-25-178 from the NIH Guide for Grants and Contracts. Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement encourages pilot effectiveness studies focused on 1) optimizing the effectiveness of preventive and therapeutic interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) developing and preliminary testing innovative services interventions. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support pilot studies of intervention effectiveness or service delivery approaches 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.).

Funding Opportunity PAR-25-177 from the NIH Guide for Grants and Contracts. 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).

Notice NOT-GM-25-013 from the NIH Guide for Grants and Contracts

Notice NOT-AT-25-002 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-25-288 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity PAR-25-289 from the NIH Guide for Grants and Contracts. 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.

Notice NOT-LM-24-007 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-25-238 from the NIH Guide for Grants and Contracts. The National Library of Medicine (NLM) supports innovative research and development in biomedical informatics and data science. This funding opportunity focuses on biomedical discovery and data-powered health, integrating streams of complex and interconnected research outputs that can be translated into scientific insights, clinical care, public health practices, and personal wellness to ensure the research is scalable, reproducible, and generalizable. The scope of NLM's interest in these research domains is broad, with emphasis on new and innovative methods and approaches to foster data driven discovery in the biomedical and clinical health sciences as well as domain-independent, scalable, and reusable approaches to discovery, curation, analysis, organization, and management of health-related data and digital objects.

Notice NOT-DC-25-014 from the NIH Guide for Grants and Contracts

Notice NOT-LM-24-006 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-25-292 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is to support innovative population-based research that can contribute to identifying and characterizing pathways and mechanisms through which work or occupation influences health outcomes and health status among populations with health and/or health care disparities.

Funding Opportunity PAR-25-279 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity PAR-25-272 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to encourage multidisciplinary investigators to submit applications developing exploratory, highly novel new approaches, or innovative applications of existing approaches to measure brain activity, connectivity, genomics, or other aspects across the age spectrum of neurodevelopment. The overarching goal is to extend our understanding of brain development and aging, including studies of the neurodevelopmental origins of later health and disease, by improving repeated measures across longer epochs of the lifespan to better predict outcomes at later ages. . Research can include healthy human participants of any age, specific clinical groups such those with cognitive, motor, or affective regulation challenges, and/or animal research on these domains of function. The studies can focus on longitudinal neuroanatomical or functional changes at any level, including genetics/genomics, single cells, connectomics, neural population activity patterns, and others. This funding opportunity is intended to encourage technological and conceptual innovation through this high risk, high reward funding mechanism to develop highly innovative ideas that either lack preliminary data or need additional preliminary data

Funding Opportunity PAR-25-159 from the NIH Guide for Grants and Contracts. 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).

Funding Opportunity PAR-25-158 from the NIH Guide for Grants and Contracts. 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).

Notice NOT-NR-25-008 from the NIH Guide for Grants and Contracts

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