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The goal of this initiative is to study the role of epigenetic mechanisms regulating HIV CNS (central nervous system) latency and neuropathogenesis in brain derived cells such as macrophages, microglia and astrocytes using novel single cell technologies. Thus this FOA will encourage studies of the role of epigenetic mechanisms regulating HIV CNS latency and neuropathogenesis in brain derived cells such as macrophages and microglia using novel single cell technologies.

This funding opportunity announcement (FOA) seeks applicants experienced in the isolation and sequencing of RNA from brain-derived extracellular vesicles to develop a research resource for the Accelerating Medicines Partnership in Parkinson's Disease (AMP PD). Approximately 2400 blood samples will be provided for this project from existing Parkinson's disease and normal control cohorts that already have longitudinal clinical and sequencing data that is publicly available to interested researchers. It is intended that this resource will become a part of the AMP PD Knowledge Platform, where it will be broadly shared with the research community.

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seek highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications will be required to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans.

The purpose of the initiative is to utilize the cohort study design to address key population research gaps in the health of Asian Americans (AsA), Native Hawaiians, and Pacific Islanders (NHPI). This FOA is for clinical/community field centers (CCFCs), and a companion one will solicit for the coordinating center (CC).

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator- initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE. Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.

The purpose of the initiative is to utilize the cohort study design to address key population research gaps in the health of Asian Americans (AsA), Native Hawaiians, and Pacific Islanders (NHPI). This FOA is for the coordinating center (CC), and a companion one will solicit for clinical/community field centers (CCFCs).

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA) support the Regenerative Medicine Innovation Project (RMIP), which aims to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. Before a research team undertakes a clinical trial, it is critical to have clear delineation and documentation of the trials rationale, design, analytic techniques, protocols, and procedures in a Manual of Procedures (MOP). Additionally, there are other elements essential to the launching of a trial, such as obtaining regulatory authorizations or approvals and establishing agreements with requisite partners including cell manufacturing and production facilities, assay or cell analysis centers, and data coordinating centers. These activities are often costly and time-consuming, and they may involve collection of preliminary data to assess feasibility. Applicants may use the RMIP Clinical Trial Planning Grant to support the preparation of a clinical trial MOP and procedures necessary for implementing a clinical trial to evaluate interventions (or new treatments) that explore and enable the evaluation of the safety and/or efficacy of RM interventions using adult stem cells that are not of embryonic or fetal origin. Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.

This Funding Opportunity Announcement (FOA) solicits applications for the early-stage development of therapeutics to mitigate the adverse health effects resulting from toxic chemical exposure. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include specific chemical warfare agents, toxic industrial chemicals, pesticides, and pharmaceutical-based agents. The overall scope of this solicitation includes validation of therapeutic targets and preclinical characterization of lead compounds. The UG3 phase of this FOA supports target validation and characterization of initial lead compound(s); UH3 phase activities include candidate optimization and in vivo demonstration of activity and efficacy in relevant post-exposure models. At the conclusion of the overall UG3/UH3 funding period, projects are expected to deliver at least one well-characterized therapeutic candidate.

This Funding Opportunity Announcement (FOA) invites applications for basic and translational research on the impact of the microbiome on Alzheimers Disease and Alzheimers Disease Related Dementias (AD/ADRD). While there is growing evidence that the microbiome is an important factor that contributes to overall health and a variety of diseases and disorders, the role of the alimentary canal and other sources of endogenous microbiota in specific AD/ADRDs has not been adequately addressed. This FOA will support mechanistic research focused on a more rigorous in-depth examination of the potential interactions between the microbiome and genetic and non-genetic molecular targets that influence AD/ADRD. It is expected that these studies will address the clinical relevance of the microbiome on disease initiation, progression, or modification, and will lead ultimately to better therapeutic interventions.

The purpose of this initiative is to solicit applications for Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers. These Centers promote collaborative basic, translational, and clinical research, and provide important resources that can be used by the national muscular dystrophy research community. The Centers also provide outstanding environments for the training of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Furthermore, Center investigators participate in community outreach efforts to increase awareness and convey the importance and implications of their research activities to the patient and advocacy communities.