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The purpose of this NOFO is to establish the NIH Blueprint for Neuroscience Research Coordination Center for Interoception Research (BPCCIR). Interoception, for the purpose of this NOFO, encompasses the processes by which an organism or a person senses, interprets, integrates, and regulates signals that represent the internal states. The goals of the NBCCIR are to: 1) promote a multidisciplinary approach for interoception research, and 2) bridge the gap between brain and body studies through a cooperative agreement funding mechanism, U24. This NOFO aims to foster interactions within the broad community of interoception researchers, rather than focusing on disease-specific subdisciplines. Specifically, the NOFO will support efforts to: 1) establish and maintain a multidisciplinary team of interoception researchers to oversee and guide NBCCIR activities; 2) create and support digital communication platforms to facilitate networking, collaborations, and information dissemination; 3) plan, organize, and host at least one scientific meeting per year that will include NIH-funded interoception researchers, trainees, and other stakeholders; 4) identify challenges and future technological and scientific opportunities for the field of interoception and develop common terminology, data standards, and common data elements; and 5) generate metrics of success and plans to ensure the sustainability of the interoception research community.

The objective of this Notice of Funding Opportunity (NOFO) is to invite new and renewal applications for the Rare Diseases Clinical Research Consortia (RDCRC) that comprise the Rare Diseases Clinical Research Network (RDCRN). The RDCRCs are intended to advance and improve diagnosis, management, and treatment of numerous, diverse rare diseases through highly collaborative, multi-site, patient-centric, translational and clinical research. Special emphasis will be placed on the early and timely identification of individuals with rare diseases and clinical trial readiness.

The purpose of this announcement is to encourage grant applications for investigator-initiated prospective observational comparative effectiveness research (CER) to the National Institute of Neurological Disorders and Stroke (NINDS). The study must address questions within the mission and research interests of the NINDS and may evaluate preventive strategies, diagnostic approaches, or interventions including drugs, biologics, and devices, or surgical, behavioral, and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (https://www.ninds.nih.gov/). Studies proposed should provide a cost-effective means of collecting data with a meaningful bearing on current clinical practice. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a observational study phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase for observational studies will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of data collection, storage, and planned analyses. Operational planning activities include, at a minimum, development of recruitment and retention strategies, case report forms, data management system and other tools for data and quality management. The UH3 phase of the award will support the conduct of investigator-initiated observational study.

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 initiative are to accelerate research leading to improved understanding and treatments for Guillain Barre Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Responsive applications would propose studies of immunological mechanisms of nerve damage/dysfunction, contributing genetic/epigenetic factors, novel animal/cellular model systems, discovery of novel diagnostic or treatment response biomarkers, novel treatments or mechanisms of action of existing treatments.

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.

This Notice of Funding Opportunity (NOFO) aims to support the establishment of programs to enhance research rigor and transparency practices within academic and research institutions to promote a culture of high-quality neuroscience research. Attention to principles of rigorous study design and transparent reporting are essential to enable the neuroscientific community, as well as the biomedical community at large, to design and perform valid experiments and to assess the value of scientific findings. Awards are intended to support the implementation of innovative programs, strategies, and approaches at the departmental, inter-departmental, or equivalent intra-institutional entity level.

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.