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This funding opportunity is intended to provide support through an administrative supplement to existing Rare Diseases Clinical Research Network (RDCRN) awardees whose projects encompass the implementation of clinical trials. Through this supplement, NCATS intends to provide support for phase 1 and/or 2 clinical trial sites that will test the potential use of an existing molecule for the treatment of a rare disease as part of a multi-site international E-Rare-3 trial.

This funding opportunity announcement invites research grant applications focused on: identifying HIV-1-infected cells in the central nervous system (CNS) compartment that are latently infected; developing strategies for targeting these latently infected cells; and aiming to achieve viral silencing leading to inhibition of viral production, without the need for pro-viral reactivation.

This funding opportunity announcement invites research grant applications focused on: identifying HIV-1-infected cells in the central nervous system (CNS) compartment that are latently infected; developing strategies for targeting these latently infected cells; and aiming to achieve viral silencing leading to inhibition of viral production, without the need for pro-viral reactivation.

This Funding Opportunity Announcement (FOA) announces the availability of a one-time administrative supplement for clinical research awards from limited NIH Institutes and Centers and for specific types of awards, listed above in 'Activity Codes', to support research on sleep disturbance and chronic pain. The proposed activities may include the addition of: sleep assessment to clinical studies of pain; pain assessment to clinical studies of sleep; measures of sleep and/or pain for clinical studies already incorporating sleep and/or pain measures; additional data collection time points for clinical studies already incorporating sleep and/or pain measures; or secondary data analysis of clinical studies to explore contributions of sleep disturbances to chronic pain as long as the research objectives are within the original scope of the peer reviewed and approved project and can be completed within the remaining funding period. The final goal of the supplement should be a contribution to methods or understanding needed for future larger scale studies that directly investigate the interactions between sleep disturbances and chronic pain.

The NIH Small Research Grant Program supports small research projects that can be carried out in a short period of time with limited resources. This program supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

The NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

The National Institutes of Health (NIH) will award Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) to eligible, domestic institutions to enhance predoctoral and postdoctoral research training, including short-term research training, and help ensure that a diverse and highly trained workforce is available to meet the needs of the Nations biomedical, behavioral, and clinical research agenda. Research training programs will incorporate didactic, research, and career development elements to prepare individuals for careers that will have a significant impact on the health-related research needs of the Nation. Programs proposing only short-term research training should not apply to this announcement, but rather to the Kirschstein-NRSA Short-Term Institutional Research Training Grant Program (T35) exclusively reserved for predoctoral, short-term research training (see PA-16-151).

The mission of the NIH Countermeasures Against Chemical Threats (CounterACT) program is to develop new and improved therapeutics to treat and/or prevent injuries resulting from exposure to chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents and toxic industrial chemicals and materials. This Funding Opportunity Announcement (FOA) requests research applications seeking support for research on the optimization of small molecule or biologic compounds that are excellent candidates for therapeutic development. A previously identified lead compound is required to be eligible for this funding opportunity. In this regard, lead compounds are defined as biologically active compounds or hits where affinity, potency, target selectivity, and preliminary safety have been established. The scope of research supported by this FOA includes development of appropriate human-relevant animal models and generation of in vivo efficacy data consistent with the intended use of the product in humans.It also includes bioanalytical assay development and validation, laboratory-scale and scale-up manufacturing of the product, and non-GLP toxicity and pharmacology studies. The scope of this FOA encompasses Technical Readiness Levels (TRLs) 4-5 - see TRLs. Each project must include annual milestones that create discrete go or no-go decision points in a progressive translational study plan.