NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Basic Experimental Studies with Humans Required)(PAR-23-288)National Cancer InstituteThe purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply.

Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required)(PAR-24-035)National Institute of Arthritis and Musculoskeletal and Skin Diseases. This Notice of Funding Opportunity (NOFO) is designed to facilitate clinical trials that can be completed within a limited time frame. A broad range of types of exploratory studies may be submitted to this NOFO. The trials must address research questions related to the mission and goals of the NIAMS and may evaluate interventions with drugs, biologics, devices, or surgical, dietary, behavioral or rehabilitation therapies.

Multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities (UG3/UH3, Clinical Trial Required)(PAR-24-053) The purpose of this NOFO is to support projects to test prospective multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities. These research projects will be part of the Multi-Sectoral Preventive Interventions (MSPI) Research Network, which will also include a Coordinating Center (RFA-OD-24-006). Funded under a cooperative agreement, projects participating in the MSPI Research Network will collaborate to share approaches, methods, and data, working closely with NIH Institutes, Offices and Centers. Applicants applying to this NOFO are encouraged to review the Coordinating Center NOFO to fully understand the MSPI Research Network structure and activities.

Phased Research to Support Substance Use Epidemiology, Prevention, and Services Studies (R61/R33 Clinical Trials Optional)(PAR-24-062) The purpose of this notice of this funding opportunity (NOFO) is to support translational research across epidemiology, addiction services, and prevention to, ultimately, reduce the burden of substance use on public health. This NOFO encourages research that facilitates rapid translation from one discipline to another (e.g., epidemiology to prevention); supports community/stakeholder engagement in substance use treatment and prevention clinical trials; or reduces the research to practice gap through the rapid transition from pilot study to clinical trial, or effectiveness to implementation study.  The goal is to support translational research improving our ability to  1) identify and characterize malleable individual, familial, behavioral, developmental, and socio-cultural/environmental factors (within the population or precise subgroups) with the potential for multi-directional transfer of knowledge;  2) prevent initiation of substance use or progression to misuse or use disorder; and  3) maximize the efficient delivery of high-quality, personalized addiction treatment and related services to ultimately inform and facilitate real world responses designed to reduce the burden of substance use, misuse and/or addiction on the health of the population. This NOFO invites projects for which preliminary feasibility or pilot data are not available. 

Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional)(PAR-23-294) This Notice of Funding Opportunity (NOFO) invites Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal and social implications (ELSI) of human genetic or genomic research. Applications may propose studies using either single or mixed methods, that break new ground, extend previous discoveries in new directions, or develop preliminary data in preparation for larger studies.

Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)(PAR-23-313) Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously.

Single Source: AIDS and Cancer Specimen Resource (ACSR; UM1 Clinical Trials Not Allowed)(RFA-CA-23-043) Through this single source, cooperative agreement Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits an application to fund a single award to George Washington University for the continuation of the AIDS and Cancer Specimen Resource (ACSR). If awarded, the applicant institution will be expected to maintain the cooperative group structure and the activities of the ACSR. The primary objective of the ACSR will be to acquire, store, and equitably distribute tumor tissues, biological fluids, and associated demographic data from patients with human immunodeficiency virus (HIV)-associated malignancies. In addition to serving acquired immunodeficiency syndrome (AIDS) and cancer researchers at large, the ACSR will specifically provide biorepository functions for another NCI supported initiative, the AIDS Malignancy Consortium (AMC). The AMC performs clinical trials research in the treatment and prevention of HIV-associated malignancies in the United States, Sub-Saharan Africa, and Latin America. It is expected that the ACSR, will strategically enrich the existing inventory of rare and difficult to obtain specimens through a series of specimen sparing and optimizing initiatives. 

Advancing Hearing and Balance Research Using Auditory and Vestibular Organoids (R21-Clinical Trial Not Allowed)(PAS-24-057)National Institute on Deafness and Other Communication Disorders. The purpose of this NIDCD initiative is to encourage research in the development, characterization, and reproducibility/reliability of human auditory and vestibular organoids. Applications investigating animal organoids are allowable but only if accompanying comparative or other integrated companion studies with human organoids. Singular animal organoid studies alone are not responsive to this funding opportunity. This funding opportunity encourages innovative, reproducible, and novel methodologies and technologies that will drive the reproducibility and holistic longevity of hearing/balance sensory organoids as model systems. The development of novel tools to deliver genes, proteins, molecules, and synthetics that might lead to the successful expansion and longer-term survivability of organoid populations in a stable, reliable, and reproducible manner is highly encouraged. Subsequent characterization of the organoid platforms must be shown to mimic and recapitulate the native correlative biological function. Applications that provide approaches that remove current barriers and lessen challenges to improve current reproducibility and stability are highly encouraged

Development of Candidate Radiation/Nuclear Medical Countermeasures (MCMs) (U01 Clinical Trial Not Allowed)(RFA-AI-23-059)National Institute of Allergy and Infectious DiseasesThe purpose of this notice of funding opportunity (NOFO) is to support investigator-initiated research at all stages of development that is specifically focused on the development of medical countermeasures (MCMs) to mitigate/treat injuries arising from radiation exposure during a public health emergency. This funding opportunity will support the development of novel approaches within the radiation research area that may be considered for future licensure by the FDA.

Engineering and Preclinical Development of Biological Products that Eliminate HIV-infected Cells (UG3/UH3 Clinical Trial Not Allowed)(RFA-AI-23-060)National Institute of Allergy and Infectious DiseasesThe purpose of this Notice of Funding Opportunity (NOFO) is to support the late-stage engineering and preclinical development of innovative biological products that safely and specifically kill HIV-infected cells. Products of interest include but are not limited to broadly neutralizing antibodies (bNAbs), their derivatives, and other soluble, antibody-like molecules.

Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II) (R61/R33 Clinical Trial Not Allowed)(RFA-AI-23-061)National Institute of Allergy and Infectious DiseasesEunice Kennedy Shriver National Institute of Child Health and Human DevelopmentNational Institute of Mental HealthThe purpose of this Notice of Funding Opportunity (NOFO) is to accelerate the development of safe and effective long-acting drug delivery systems for improved, simplified treatment of HIV-1 in children. This NOFO invites applicants engaged in the development of existing long-acting platforms at early stages of development stages to perform specific preclinical activities that enable product optimization and accelerated translation to HIV-infected children. Collaborative research partnerships with industry are required. 

Resource Center for Cannabis and Cannabinoid Research (U24 Clinical Trial Not Allowed)(RFA-AT-24-006)National Center for Complementary and Integrative HealthNational Cancer InstituteNational Institute on AgingNational Institute on Drug AbuseThe purpose of this notice of funding opportunity (NOFO) announcement is to support the development and maintenance of a Resource Center for Cannabis and Cannabinoid Research through a cooperative agreement funding mechanism (U24). Such a Center will address challenges and barriers to conducting research on cannabis and its constituents as well as to enable researchers to successfully generate more rigorous scientific evidence across a variety of research domains in both basic and clinical research. The Center is expected to be a focal point for researchers entering the cannabis research space and to support the development and establishment of research tools and studies that will improve upon and eventually change the landscape of cannabis research. Overall, the Center will facilitate research advances through synergistic interactions among experts in relevant commercial, basic science, clinical, and regulatory areas both within the Center itself and in collaboration with the extramural community. 

Research Forrest