Notice NOT-TR-24-004 from the NIH Guide for Grants and Contracts

Notice NOT-TR-24-005 from the NIH Guide for Grants and Contracts

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

Funding Opportunity RFA-HD-25-008 from the NIH Guide for Grants and Contracts. The purpose of this notice of funding opportunity announcement (NOFO) is to support and facilitate multidisciplinary research approaches for the development of novel nonsteroidal contraceptive products for men and women that act prior to fertilization. This NOFO aims to position innovative and validated methods for future clinical development.

Notice NOT-NR-24-001 from the NIH Guide for Grants and Contracts

Notice NOT-AI-23-075 from the NIH Guide for Grants and Contracts

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

Notice NOT-MD-23-021 from the NIH Guide for Grants and Contracts

Notice NOT-AG-23-069 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-CA-23-043 from the NIH Guide for Grants and Contracts. Through this non-competitive single source cooperative agreement Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits an application from (-----institute name-----) with the intent of funding a single award to continue to support the AIDS and Cancer Specimen Resource (ACSR). This is a reissue of RFA-CA-18-012. The ACSRs mission is to address the specimen needs of clinician and basic researchers in HIV and HIV-associated malignancy research. The ACSR is an international repository with specimens that reflect different eras of the epidemic (notably pre-cART and post-cART), different regions of the world, and people of diverse genetic backgrounds with different environmental exposures. Specimens have been obtained from people with HIV (PWH), people at risk for acquiring HIV, and HIV-uninfected controls. Specimens have been obtained from participants in clinical trials, observational cohort studies, or other research studies conducted by HIV investigators and consortium. The ACSR uses informed approaches to prospectively curate specimens in the USA, sub-Saharan Africa and Latin America that will be most valuable for the research community. Specimens and associated data are made available to the research community-at-large at NO COST. A second key role of the ACSR, is to serve as the AMC Biorepository for the AIDS Malignancy Consortium (AMC). The AMC is an NCI funded, multicenter clinical trials cooperative group that performs clinical trials research in the treatment and prevention of HIV-associated malignancies. The ACSR is currently providing support for domestic (two), sub-Saharan African, and Latin American biorepositories for the AMC.

Funding Opportunity PAR-24-043 from the NIH Guide for Grants and Contracts. Reissue of PAR-18-546. The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

Notice NOT-HL-23-116 from the NIH Guide for Grants and Contracts

Notice NOT-HS-24-003 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-RM-24-001 from the NIH Guide for Grants and Contracts. The purpose of this NOFO is to provide support for applications for IND-enabling studies for the development of a novel in vivo genome editing therapeutic platform (genome editor plus delivery system) for two or more disease indications, using the same genome editor, route of administration, and delivery system. Through this initiative, NIH aims to explore the extent to which the use of a therapeutic genome editing platform can streamline the regulatory path for multiple disease indications and to disseminate this regulatory information (and supporting documentation) to the scientific community.

Funding Opportunity RFA-NR-24-002 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 R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on: (1) Courses for Skills Development; and (2) Develop and implement a program to prepare nurse scientists, and scientists in aligned fields, to conduct research on the social determinants of health in alignment with the NINR Strategic Plan.

Funding Opportunity RFA-DA-25-022 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to develop technologies to improve the delivery of pharmacological, gene editing, or other cargoes for HIV and SUD or mechanistic or therapeutic research

Funding Opportunity RFA-DA-25-058 from the NIH Guide for Grants and Contracts. Psychedelic treatments are currently in clinical development for a range of mental disorders. Therapeutic areas undergoing active clinical research include alcohol and substance use disorders (ASUD). The exploration of the beneficial clinical and functional outcomes require our urgent attention to the refinement and optimization of the psychedelic treatment administration paradigms, and an exploration of novel clinical trial designs, which are of high nascent interest for the ASUD field in general. This Concept supports clinical studies applications to study psychedelic treatment administration paradigms, assess the role of psychotherapy in its administration, and describe and assess the range of clinical outcomes, including downstream functional effects, that are evidenced as the result of this treatment

Notice NOT-NS-24-021 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-23-314 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity PAR-23-313 from the NIH Guide for Grants and Contracts. 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 FOA 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 the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this NOFO supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer clinical 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 collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientist.