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Eradicating latent reservoirs of HIV-1 within the body and achieving a sterilizing or functional cure have become priority areas in the AIDS field and NIH AIDS programs across many Institutes and Centers, including NIMH. In addition understanding the mechanisms of HIV- associated co-morbidities in the setting of effective anti-retroviral therapy (ART) is a major topic of interest in the field. HIV Associated CNS (central nervous system) co-morbidities continue to exist despite excellent virologic control in this compartment. HIV persistence and neuroinflammation also continues to observed in the CNS in the setting of ART. HIV targets the CNS early in infection, and HIV-infected individuals suffer from mild forms of neurological impairments even under antiretroviral therapy (ART). CD4+ T cells and monocytes mediate HIV entry into the brain and constitute a source for HIV persistence and neuronal damage. CD8+ T cells are also massively recruited in the CNS in acute infection to control viral replication.

Eradicating latent reservoirs of HIV-1 within the body and achieving a sterilizing or functional cure have become priority areas in the AIDS field and NIH AIDS programs across many Institutes and Centers, including NIMH. In addition understanding the mechanisms of HIV- associated co-morbidities in the setting of effective anti-retroviral therapy (ART) is a major topic of interest in the field. HIV Associated CNS (central nervous system) co-morbidities continue to exist despite excellent virologic control in this compartment. HIV persistence and neuroinflammation also continues to observed in the CNS in the setting of ART. HIV targets the CNS early in infection, and HIV-infected individuals suffer from mild forms of neurological impairments even under antiretroviral therapy (ART). CD4+ T cells and monocytes mediate HIV entry into the brain and constitute a source for HIV persistence and neuronal damage. CD8+ T cells are also massively recruited in the CNS in acute infection to control viral replication.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones.

Through this I-Corps at NIH program Notice of Funding Opportunity (NOFO), NIH and CDC provide administrative supplement awards to active SBIR (NIH and CDC) and STTR Phase I (NIH only) grantees/awardees. The I-Corps at NIH mission is to empower entrepreneurs in developing and validating a strategic business model through diverse customer discovery in order to meet unmet clinical needs. I-Corps enables and accelerates the transformation of invention to impact SBIR and STTR Phase I awardees in a no-cost extension are eligible as long as, if selected, their no cost extension covers the entire duration of I-Corps at NIH cohort. The program provides three-member project teams with access to instruction and mentoring to accelerate the translation of technologies currently being developed with NIH and CDC SBIR and STTR funding. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies. Prospective applicants are strongly encouraged to contact Scientific/Research staff for more information about the program before applying.

The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support: 1) research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity.

This Notice of Funding Opportunity (NOFO) supports translational exploratory/developmental research that directly advances the discovery of novel treatment strategies, i.e., medical countermeasures (MCMs), that address serious morbidity and mortality after acute exposure to highly toxic chemical threats. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pesticides, and ultra-potent synthetic (UPS) opioids. This NOFO supports translational research that includes, but is not limited to, preliminary efficacy and/or early preclinical development studies towards discovery and validation of novel molecular entities or biologics as candidate MCMs. In addition to novel agents, new treatment strategies may involve repurposing already FDA-approved products or combinations of interventions based on established mechanisms of action. Projects supported by this NOFO are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement program and/or other related initiatives.

To develop a national, interdisciplinary, patient-centered research consortium to advance Temporomandibular Disorders (TMDs) basic and clinical research, research training, and translation to evidence-based treatments and improved clinical care.

The NIH Blueprint for neuroscience is soliciting applications to pilot the establishment of an integrated resource for users to explore, analyze and download processed deidentified human brain single-cell transcriptomics and epigenomics data that is harmonized across reference and disease datasets. The resource will generate a unified cell type taxonomy, provide users with a draft annotatable cell-type nomenclature, and the ability to map community generated single cell omics data to the taxonomy. This pilot will lay the groundwork for an expanded and sustained effort to increase utility and accessibility of human cell-type classification data across multiple NIH consortia. BD

This notice of funding opportunity (NOFO) seeks to support research aimed at holistic understanding of inter-individual or between-person differences in human pain conditions, focusing on Whole Person Health and enhancing pain treatment and management strategies towards personalized pain medicine. The goal of this NOFO is to support studies that focus on the collection of clinical and/or preclinical data to enable evidence-based modeling and understanding of inter-individual differences and/or heterogeneity of pain occurring with use of pain therapy/management, or with conditions such as a second pain condition, a comorbid health condition, a comorbid mental health condition, or conditions of use / misuse of opioids, alcohol or other substances. Applicants are encouraged to develop and implement novel, multidisciplinary research approaches, and include investigators with complementary expertise to fulfill the project and program goals. Input from patients and caregivers on the goals of the project is highly encouraged. Rigorous data-driven and evidence-based research approaches supported under this NOFO are expected to provide better understanding of biological and/or biopsychosocial underpinnings of inter-individual differences, heterogeneity, and stratification of persons with lived pain experience, which would accelerate the development of evidence-based solutions toward precision pain medicine.

The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical trials for the diagnosis, mitigation, treatment, or cure of ALS ("intermediate EA protocol for ALS"). Providing the investigational drug or biological product under an intermediate EA protocol for ALS must not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval, or otherwise compromise the potential development of medical products for the diagnosis, mitigation, treatment, or cure of ALS. Eligible applicants are clinical trial sites that participate in a phase 3 clinical trial supported by a United States (U.S.) small business concern (as defined in section 3(a) of the Small Business Act (15 U.S. C. 623(a)) that is also the U.S. Food and Drug Administration (FDA) designated sponsor of a drug or biological product for ALS that is the subject of an Investigational New Drug Application (IND). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in May 2022 with an expected application due date in June 2022. This FOA will utilize the U01 activity code.