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This notice of opportunity announcement (NOFO) is issued by the National Institute of Neurological Disorders and Stroke to enable submission of program project grant applications that propose to conduct innovative, interactive research to answer significant scientific questions that are important for the mission of NINDS, via a synergistic collaboration between outstanding scientists who might not otherwise collaborate. The program project grant is designed to support research in which the funding of several interdependent highly meritorious projects as a group offers significant scientific advantages over support of these same projects as individual research grants.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this National Insitute of Neurological Disorders and Stroke R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs.To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences, designed to foster the development of physicians as research scientists in areas relevant to the NINDS mission. The research experiences will prepare clinicians to successfully compete for individual NIH mentored career development awards, or where appropriate, independent research awards. This FOA will also support educational activities such that participants of the R25 are expected to attend and participate in an annual workshop specific to this FOA to present their work, discuss progress and plans towards transitioning to the next career stage and to network with other researchers and leaders in their fields. Such success will facilitate their transition from resident/fellow to physician-scientist, and will thus foster retention of a cadre of physician-scientists who will conduct research into the mechanisms of, etiology, and treatment of neurological diseases.

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

(Reissue of PAR-21-266) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.

(Reissue of PAR-18-617) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only STTR Phase II and Fast-Track applications are supported under this program. STTR Phase I applications are only accepted as part of a Fast-track application.

This funding opportunity announcement (FOA) encourages applications for multi-center clinical trials focused on neurological emergencies. Successful applicants will collaborate and conduct the trial within the NIH SIREN Network. The NIH SIREN Clinical Coordinating Center (CCC) will work with the successful applicants to implement the proposed trial efficiently and the SIREN Data Coordinating Center (DCC) will provide statistical and data management support. The NIH SIREN hubs and their affiliated clinical sites will provide on-site implementation of the clinical protocols.The NIH SIREN Network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for neurological emergencies. Multi-center clinical trials in stroke treatment, recovery, or prevention supported by NINDS will be conducted in the NIH StrokeNet, and not within SIREN. Applicants do not need to be part of the existing SIREN infrastructure to apply under this FOA.

The purpose of this Notice is to announce that the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Center for Complementary and Integrative Health (NCCIH) encourage new applications to advance research activities relevant to the five strategic priorities identified in the recently released NIH Strategic Plan for Tickborne Disease Research:

*Note to ICs: Please do not join this announcement. Shared Interest must be completed systematically but the Type 4 submission is for NS R37 applications only. The National Institute of Neurological Disorders and Stroke (NINDS) Javits Neuroscience Investigator Award (R37) provides extended grant support to investigators with a history of exceptional performance and outstanding productivity. The objective of the NINDS Javits Award is to allow Javits awardees to obtain up to seven years of support in two segments: The initial phase of up to four years, and a second phase, providing an additional three years of support. This funding opportunity announcement is specifically for currently funded NINDS Javits recipients to request the second phase of the R37 award.

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. For a drug, biologic or device that has successfully completed the Phase 1/Early Feasibility trial(s), do not use this FOA. Instead use the Companion FOA XXX. For genetic studies, do not use this FOA. Instead, use FOA XXX.

The purpose of this Funding Opportunity Announcement (FOA) 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.