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Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (R01, Clinical Trial Required)

Funding Opportunity PAR-26-001 from the NIH Guide for Grants and Contracts. 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.

Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed)

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.

Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)

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.

BRAIN Initiative: Promoting Equity Through BRAIN Technology Partnerships (R34 - Clinical Trials Not Allowed)

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.

Advancing Learning Health Care Research in Outpatient Mental Health Treatment Settings (R34 Clinical Trial Optional)

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.

Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions (R15 Clinical Trial Required)

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.

Innovative Approaches to Studying Cancer Communication in the New Information Ecosystem (R21 Clinical Trial Optional)

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.

Innovative Approaches to Studying Cancer Communication in the New Information Ecosystem (R01 Clinical Trial Optional)

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.

Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed)

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.

Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)

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.

Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed)

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.

Limited Competition: Competing Revisions to Support Clinical Trials in Somatic Cell Genome Editing (U19 Clinical Trial Required)

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.

Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)

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).

Understanding Expectancies in Cancer Symptom Management (R01 Clinical Trial Required)

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.

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