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The National Institutes of Health (NIH) announces the continuation of the U.S. entity of the U.S.-Japan Brain Research Cooperative Program (BRCP). This administrative supplement program will provide funds to research projects that are currently supported by the participating NIH Institutes and Centers. The purpose of the BRCP is to promote scientist exchange, training, and collaborations in basic, translational and clinical research between neuroscientists from the U.S. and Japan. The U.S. entity of the BRCP supports the following activities: 1) Visit of U.S. scientists to conduct collaborative research and/or to acquire advanced research skills in Japanese institutions. 2) Joint workshops to exchange scientific information and to foster collaborations.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage epidemiological, clinical and translational research that will increase our understanding of the natural history, prevalence, biological mechanisms, psychological variables, and clinical risk factors responsible for the presence of multiple chronic pain conditions in people with pain. Recent clinical findings suggest that substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the prevalence of overlapping pain conditions, the underlying etiologies, the progression of these conditions, the evolution of these overlaps, and the therapeutic approaches best suited for treating subjects with these conditions. The main objective of this FOA is the formation of research groups with interests bridging expertise in pain mechanisms with translational and clinical expertise to address important unresolved questions about overlapping pain conditions. Applicants are encouraged to leverage existing and develop new resources pertinent to the study of these conditions. Applicants are encouraged to include researchers with complementary expertise from outside the pain field in their research teams who will enhance the breadth of research and understanding of comorbid chronic pain conditions.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage epidemiological, clinical and translational research that will increase our understanding of the natural history, prevalence, biological mechanisms, psychological variables, and clinical risk factors responsible for the presence of multiple chronic pain conditions in people with pain. Recent clinical findings suggest that substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the prevalence of overlapping pain conditions, the underlying etiologies, the progression of these conditions, the evolution of these overlaps, and the therapeutic approaches best suited for treating subjects with these conditions. The main objective of this FOA is the formation of research groups with interests bridging expertise in pain mechanisms with translational and clinical expertise to address important unresolved questions about overlapping pain conditions. Applicants are encouraged to leverage existing and develop new resources pertinent to the study of these conditions. Applicants are encouraged to include researchers with complementary expertise from outside the pain field in their research teams who will enhance the breadth of research and understanding of comorbid chronic pain conditions.

Parkinson's disease (PD) is a chronic, progressive movement disorder that affects at least half a million people in the United States, as well as having significant impact on the relatives and friends who care for them. The average age of onset is during the sixth decade, although earlier onset is also possible, and the incidence of PD is expected to increase as the population ages. While significant research advances continue, the full complexity of PD etiology is not yet evident. Moreover, currently available treatments are primarily symptomatic, and neither slow nor halt disease progression. Challenges posed by the inherent complexity of PD are often best addressed by multidisciplinary research teams working in tandem to surmount obstacles and seize opportunities to advance knowledge and improve treatment. However, development of an effective team, identification of an optimal strategy and collection of preliminary data to address a particular challenge in PD research require dedicated time and resources. Therefore, this Funding Opportunity Announcement (FOA) solicits Exploratory Grant (P20) applications proposing planning and initiation of synergistic research activities to advance Parkinson's Disease (PD) research and treatment. The goal of this program is to formalize collaborative structures and establish a foundation of research discovery necessary to address emergent issues in PD research. Successful exploratory studies should lead to a subsequent application for support of a collaborative, multidisciplinary NINDS Morris K. Udall Center of Excellence (P50). To foster the development of innovative research collaborations, this FOA will provide support for new projects, not continuation of projects that have already been initiated.

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants may be given access to the NIH StrokeNet infrastructure. Following peer review, NINDS will prioritize trials among the highest scoring to be given access to the StrokeNet infrastructure. The StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently. The StrokeNet National Data Management Center (NDMC) will provide statistical and data management support. The Regional Coordinating Centers (RCCs) of the StrokeNet and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012 to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-210, and PAR-14-211; applicants must read all of the companion FOAs.The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 application under this FOA or a UH3 under PAR-14-211 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication. The UH2/UH3 is a two stage application. 1. The UH2 (Stage 1) may be used to support milestone-driven preclinical studies to verify target engagement in a disease model and/or Phase 1b clinical trials using the selected Agent in its existing formulation/route of administration to identify the dose or exposure of the Agent in the proposed patient group, and inform patient selection. Support for the UH2 may be requested for a period that may vary from six months up to one year.UH2 projects that have met the scientific milestones and feasibility requirements will be eligible for rapid transition to the second UH3 stage after NIH administrative review. 2. The UH3 (Stage 2) will support milestone-driven Phase 2a trials to demonstrate that the Agent, made available for this program by the pharmaceutical partners, modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population.The project period for the UH3 stage is up to two years.

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012, to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-210, PAR-14-211; applicants must read all of the companion FOAs.The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 application under this FOA or PAR-14-212, or a UH3 application under PAR-14-211. The UH2/UH3 is a two stage application. 1. The UH2 (Stage 1) for this FOA may be used to support milestone-driven preclinical studies to perform juvenile toxicity testing and verify target engagement in a disease model and Phase 1a and 1b trials for a period that may vary from one to two years.UH2 projects that have met the scientific milestones and feasibility requirements will be eligible for rapid transition to the second UH3 stage after NIH administrative review. 2. The UH3 (Stage 2) will support milestone-driven Phase 2a trials to demonstrate that the Agent, made available for this program by the pharmaceutical partners, modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population.The project period for the UH3 stage is up to two years.

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012, to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-211 and PAR-14-210; applicants must read all of the companion FOAs. The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 under PAR-14-212 or a UH3 application under PAR-14-211 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication.

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012, to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-210, and PAR-14-211; applicants must read all of the companion FOAs.The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH3 application under this FOA or a UH2/UH3 under PAR-14-212 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication. The UH3 will support milestone-driven Phase 2a trials to demonstrate that the Agent, made available for this program by the pharmaceutical partners, modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population.

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support the next stage of development for projects requiring approval from a Federal regulatory agency or for those projects developing complex research tools. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II projects to the commercialization stage by promoting partnerships between NIHs SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.