National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)

The purpose of this Funding Opportunity Announcement is to invite proposals for funding from Tribal Colleges and Universities, Tribal Serving Institutions, Community Colleges on or near Tribal Lands, and other Trade Schools on or near Tribal Lands interested in providing innovative hands-on, in-person manufacturing training and technical assistance through rapid reskilling of employees for 8(a) and HUBZone eligible small businesses , under the U.S. Small Business Administration's Empower to Grow Program (formerly known as 7(j) Management and Technical Assistance Program).

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 encourage individuals who have not had substantial biomedical research experience, or who have the potential to significantly benefit from additional biomedical research experience to pursue further studies or careers in research. To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on: (1) Research Experiences, (2) Curriculum or Methods Development and (3) Outreach. The NCI’s mission is to conduct and support research, training, health information dissemination, and other programs concerning cancer. This funding opportunity seeks to facilitate educational activities that encourage students to become knowledgeable about cancer and available to focus on cancer later in their careers. To promote broad interest in pursuing a career in biomedical research via early intervention strategies, the NCI Youth Enjoy Science (YES) Program will support efforts to create and maintain an institutional program to engage grades 6-12 and/or undergraduate students in cutting edge cancer research experiences. The proposed institutional programs may also provide research experiences for the grade 6-12 teachers and undergraduate faculty members. The goals are to inspire interest in biomedical sciences, help envision research as a career path, and strengthen practical research and career skills. In alignment with these goals, institutions may develop unique programs that capitalize on their research strengths and are responsive to their target populations.

This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs that propose to support intensive supervised research training and career development experiences for clinician scientists (Scholars) leading to research independence in the area of substance use and substance use disorder research.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for projects to expand, improve, or transform the utility of mammalian cancer and tumor models for translational research. With this NOFO, the NCI intends to encourage submission of projects devoted to demonstrating that mammalian models or their derivatives used for translational research are robust representations of human biology, are appropriate to test questions of clinical importance, and provide reliable information for patients' benefit. These practical goals contrast with the goals of many mechanistic, NCI-supported R01 projects that employ mammals, or develop and use mammalian cancer models, transplantation tumor models, or models derived from mammalian or human tissues or cells for hypothesis-testing, non-clinical research. Among many other possible endeavors, applicants in response to this FOA could propose demonstrations of how to overcome translational deficiencies of mammalian oncology models, define new uses of mammalian models or their genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and 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 also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research.

This notice of funding opportunity (NOFO) seeks to establish a course to equip researchers studying drug use, drug misuse, and drug addiction with the skills, knowledge, and practical tools needed to translate their scientific discoveries into impactful real world solutions. The course is envisioned to focus on building capacity in product development, entrepreneurship, and innovation pathways so participants can more effectively move biomedical ideas from early research toward implementation, or commercialization. By combining structured training, mentorship, and hands-on experience, the course is envisioned to accelerate the development of biomedical products that address the complex challenges of drug use, drug misuse, and drug addiction, while fostering an interdisciplinary community of investigators prepared to navigate the scientific, regulatory, and business aspects of this unique research field.

This notice of funding opportunity (NOFO) invites applications from eligible organizations to establish a Data Coordination and Integration Center (DCIC) for the NIH HEAL Initiative. This Center will support the coordination and integration of data from both the HEAL INTERACT program and progressively facilitate broader integration of related musculoskeletal datasets and programs. The Data Coordination and Integration Center will lead efforts for managing and integrating complex pain-associated data types and information from the INTERACT Consortium and progressively related datasets. It will also establish a web-accessible information system and disseminate datasets that can facilitate hypothesis generation and be widely used throughout the research community.

This Notice of Funding Opportunity (NOFO) invites exploratory grant applications, hereafter referred to as the Novel Experiential Technologies Assisting Individual learning Hubs or NExT AI Hubs (formerly Learning Disabilities Innovation Hubs), to address the impact of Artificial Intelligence (AI) technologies on developmental outcomes in children diagnosed with or at risk for developing a specific learning disability (SLD) impacting reading, writing, and mathematics. NExT AI Hubs include a single Research Project and a Leadership Core that support the goals and aims of the Hub. This NOFO seeks to serve as a catalyst to 1) speed the maturation of nascent/novel, high-impact, high-risk research that advances understanding of the role AI technology plays in supporting, improving, or limiting the learning, cognitive, and socio-emotional needs of children at risk for or diagnosed with SLDs, 2) build an evidence base for the SLD community to inform policy or practice, and 3) provide project-embedded, career-enhancing research and professional development opportunities to support the next generation of transdisciplinary SLD scientists. This initiative provides opportunities to support planning and building a body of research and corresponding intellectual infrastructure to enable NExT AI investigators to compete for large research and program project opportunities in the future.This NOFO aims to integrate research topics that are of relevance to various research programs at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and align with the NICHD Strategic Plan. The NOFO intends to build cross-programmatic, transdisciplinary and cross-cutting scientific research, and critically nurture the development of early career investigators capable of conducting this research.

The purpose of this Notice of Funding Opportunity (NOFO) is to provide continuing support for specific pathogen-free (SPF) macaque colonies previously funded under the auspices of PAR-21-089 and PAR-18-669 that support Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) research. Breeding colonies are essential to sustain appropriate SPF macaques for research related to HIV/AIDS. Pedigree SPF macaques are free of certain viruses, which may confound the results of HIV/AIDS-related investigations or present a risk to the personnel who care for the animals. The SPF macaques are genetically characterized for major histocompatibility complex (MHC) class I types, because MHC class I genotypes have large effects on macaque immune responses to Simian Immunodeficiency Virus (SIV) that can induce AIDS in nonhuman primates (NHPs) and on human immune responses to HIV.