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

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

Funding Opportunity PAR-25-035 from the NIH Guide for Grants and Contracts. SRF Reissue: The overall goal of this notice of funding opportunity (NOFO) is to identify, in animals, in vivo neurophysiological and behavioral measures for use as assays in the early screening phase of treatment development. The NOFO will support efforts to optimize and evaluate measures of neurophysiological and behavioral processes that may serve as surrogate markers of neural processes of clinical interest based on available knowledge of the neurobiology of mental illnesses. The screening assays thus developed from this NOFO are expected to build upon systems neurobiology and clinical neuroscience to enhance the scientific value of preclinical animal data contributing to a therapeutic development pipeline by assessing the impact of therapeutic targets and treatment candidates on neurobiological mechanisms of clinical relevance to mental illnesses.

Funding Opportunity PAR-25-034 from the NIH Guide for Grants and Contracts. SRF Reissue: The overall goal of this initiative is to identify neurophysiological measures potential assays for treatment development research. The Notice of Funding Opportunity (NOFO) will support efforts to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline. The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. Data will also reveal assay measures where the performance between preclinical animal species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. The ultimate practical goal of this NOFO is to improve the efficiency of the therapeutic development process by identifying coherence of measures and inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders.

Funding Opportunity RFA-NS-25-016 from the NIH Guide for Grants and Contracts. The goal of this concept is to increase the impact of the BRAIN Initiative by targeted dissemination and integration of validated BRAIN Initiative tools to investigators at institutions that historically have not been major recipients of NIH support. This will be accomplished by awards to PIs at resource-limited institutions (RLIs) who pair with BRAIN technologists to facilitate training and adoption of BRAIN Initiative technologies in the recipient laboratories. Goals include two-way knowledge transfer between the PI and BRAIN technologist and to increase the participation of PIs at RLIs in BRAIN Initiative relevant research.

Funding Opportunity PAR-25-278 from the NIH Guide for Grants and Contracts. This Notice of Funding Opportunity (NOFO) encourages pilot effectiveness, implementation, data science, and services research studies that will advance data-driven learning health care in behavioral health treatment settings, leading to better knowledge and tools for implementing, sustaining, and optimizing evidence-based, high quality, and equitable mental health services in community settings. Pilot studies could examine the adoption and sustainability of evidence-based practices in community-based settings that deliver care to people with mental illness including, but not limited to, Certified Community Behavioral Health Clinics.

Funding Opportunity PAR-25-148 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity PA-25-295 from the NIH Guide for Grants and Contracts. Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) announces its interest in supporting meritorious research projects in three distinct domains related to cancer communication: 1) the utility and application of new cancer communication surveillance approaches; 2) the development and testing of rapid cancer communication pilot interventions using innovative methods and designs; and 3) the development and testing of multilevel cancer communication models emphasizing bidirectional influence between levels. For such projects, applicants should apply communication science approaches to the investigation of behavioral targets and health outcomes related to cancer prevention and control. Applications should utilize one or more innovative communication research methodologies.

Funding Opportunity PA-25-294 from the NIH Guide for Grants and Contracts. Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) announces its interest in supporting meritorious research projects in three distinct domains related to cancer communication: 1) the utility and application of new cancer communication surveillance approaches; 2) the development and testing of rapid cancer communication interventions using innovative methods and designs; and 3) the development and testing of multilevel cancer communication models emphasizing bidirectional influence between levels. For such projects, applicants should apply communication science approaches to the investigation of behavioral targets and health outcomes related to cancer prevention and control. Applications should utilize one or more innovative communication research methodologies.

Funding Opportunity PAR-25-287 from the NIH Guide for Grants and Contracts. 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 withinthe scope of this announcement.

Funding Opportunity PAR-25-286 from the NIH Guide for Grants and Contracts. 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 diverse expertise including systems neuroscience, engineering, clinical, and regulatory affairs.

Funding Opportunity PAR-25-248 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages the submission of applications that propose to advance research in cancer etiology and early detection biomarkers, utilizing the advantages of the unique biorepository resources of the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial. The PLCO Biorepository offers high-quality, prospectively collected, serial pre-diagnostic blood samples from the PLCO screened arm participants, and a onetime collection of buccal cells from the control arm participants. Available data associated with the biospecimens includes demographic, diet, lifestyle, smoking, screening results, and clinical data. This FOA supports a wide range of cancer research including, but not limited to, biochemical and genetic analyses of cancer risk, as well as discovery and validation of early detection biomarkers. The proposed research project must involve use of PLCO biospecimens; additionally, it should also take advantage of the unique characteristics of the PLCO biospecimens. Research projects that do not involve the use of PLCO biospecimens will not be supported under this FOA.

Funding Opportunity RFA-RM-24-008 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is to solicit competitive revision (formerly known as competitive supplement) applications from awardees with active U19 awards funded under RFA-RM-22-015 as part ofthe NIH Somatic Cell Genome Editing program, in order to expand the scope of the original award to allow first in human genome editing clinical trials using the therapeutic clinical candidates developed through the U19 award. RFA-RM-22-015 did not allow a clinical trial, whereas the present NOFO (RFA-RM-24-008) requires a clinical trial.

Funding Opportunity PAR-25-274 from the NIH Guide for Grants and Contracts. 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 requires a Plan for Enhancing Diverse Perspectives (PEDP).

Funding Opportunity PAR-25-254 from the NIH Guide for Grants and Contracts. This Notice of Funding Funding Opportunity (NOFO) supports research on expectancy-generating factors and measures of their effects on expectancies and subsequent cancer symptom management outcomes; and research to identify moderators of such expectancy effects. Specifically, this NOFO will solicit mechanistic research that aims to understand how and why expectancy effects occur in a cancer context, elucidate their role in cancer symptom management, and identify patients, symptoms, cancer sites, and contexts in which expectancy effects can be leveraged to improve cancer outcomes. Expectancies are defined in this context as beliefs about future outcomes, including ones response to cancer or cancer treatment. Expectancies can be evoked by social, psychological, environmental, and systemic factors. Expectancy effects are the cognitive, behavioral, and biological outcomes caused by expectancies. Expectancy effects can be generated by expectancies held by patients, clinicians, family members, caregivers, and/or dyadic/social networks. Program is particularly interested in applications that enroll individuals and groups from populations historically underrepresented or excluded from biomedical and behavioral research.

Funding Opportunity PAR-25-268 from the NIH Guide for Grants and Contracts. This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH- designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

Funding Opportunity PAR-24-290 from the NIH Guide for Grants and Contracts. The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this NEI R25 program is to support educational activities that complement and/or enhance the training of a diverse workforce to meet the nations biomedical, behavioral and clinical research needs. To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on Research Experiences The NEI supports basic, translational, and clinical research on vision and diseases of the visual system as detailed in the NEI Strategic Plan. The purpose of this funding opportunity is to encourage applications for research education programs that will significantly advance the mission of NEI. The proposed research education programs should focus on intensive hands-on research experiences to prepare recent college graduates from diverse backgrounds for biomedical doctoral degree programs. In addition to encouraging individuals from diverse backgrounds to pursue careers in biomedical research, NEI also seeks to recruit individuals without prior opportunities to participate in research in the visual sciences. Programs appropriate for this NOFO must include participants from a nationally recruited cohort. This NOFO does not allow appointed 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.

Funding Opportunity PAR-25-267 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity RFA-NS-25-027 from the NIH Guide for Grants and Contracts. This announcement provides support to eligible, domestic institutions to develop and implement effective, approaches to biomedical research education and mentoring that will keep pace with the rapid evolution of the research enterprise. This NIH Neuroscience Doctoral Readiness Program (DR Program) expects that the proposed research education programs will incorporate extensive research experiences within the NINDS mission and well-designed courses for skills development and education to prepare recent baccalaureates from diverse backgrounds to transition into and complete rigorous, research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields. This is a limited competition funding opportunity announcement to support postbaccalaureate programs that will be affiliated with a funded NIH T32 program. Eligibility is limited to PD(s)/PI(s) or MPI teams that include at least one PD/PI of a grant supported by the following FOAs: T32 - Jointly Sponsored Institutional Predoctoral Training Program (JSPTPN), PAR-20-076;NINDS T32 - Institutional Research Training Grant, PAR-21-149; or NINDS T32 - Institutional Translational Research Training Program, PAR-19-228. In all cases, a PD/PI of the T32 grant from a FOA cited above, must be the PD/PI or an MPI of this R25. This Funding Opportunity Announcement (FOA) does not allow appointed 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.

Notice NOT-AI-24-072 from the NIH Guide for Grants and Contracts