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The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and limited-size clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and effectivenesting, design verification and validation activities leading to submission of an Investigational Device Exemption (IDE) to the FDA or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities. For more information see: https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medte…

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical feasibility studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities. For more information see BP MedTech website.

The purpose of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support a cohort of early career, independent investigators from diverse backgrounds conducting research in NIH mission areas. The long-term goal of this program is to enhance diversity in the basic biomedical sciences research workforce. The MOSAIC K99/R00 program is designed to facilitate a timely transition of outstanding postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions at research-intensive institutions. The MOSAIC K99/R00 program will provide independent NIH research support during this transition to help awardees launch competitive, independent research careers. Additionally, MOSAIC K99/R00 scholars will be part of organized scientific cohorts that will be expected to participate in mentoring, networking, and professional development activities coordinated by MOSAIC Institutionally-Focused Research Education Award to Promote Diversity (UE5) grantees.

The purpose of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support a cohort of early career, independent investigators from diverse backgrounds conducting research in NIH mission areas. The long-term goal of this program is to enhance diversity in the basic biomedical sciences research workforce. The MOSAIC K99/R00 program is designed to facilitate a timely transition of outstanding postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions at research-intensive institutions. The MOSAIC K99/R00 program will provide independent NIH research support during this transition to help awardees launch competitive, independent research careers. Additionally, MOSAIC K99/R00 scholars will be part of organized scientific cohorts that will be expected to participate in mentoring, networking, and professional development activities coordinated by MOSAIC Institutionally-Focused Research Education Award to Promote Diversity (UE5) grantees.

The purpose of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support a cohort of early career, independent investigators from diverse backgrounds conducting research in NIH mission areas. The long-term goal of this program is to enhance diversity in the basic biomedical sciences research workforce. The MOSAIC K99/R00 program is designed to facilitate a timely transition of outstanding postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions at research-intensive institutions. The MOSAIC K99/R00 program will provide independent NIH research support during this transition to help awardees launch competitive, independent research careers. Additionally, MOSAIC K99/R00 scholars will be part of organized scientific cohorts that will be expected to participate in mentoring, networking, and professional development activities coordinated by MOSAIC Institutionally-Focused Research Education Award to Promote Diversity (UE5) grantees.

(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.

(Reissue of PAR-18-665) This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIH's 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.

(Reissue of PAR-18-618) 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.

The National Institutes of Health (NIH) hereby notify recipient organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of recipient organization may be submitted to this FOA. This assumes such a change is programmatically permitted for the particular grant. Applications for change of recipient organization are considered prior approval requests (as described in Section 8.1.2.7 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although requests for change of recipient organization may be submitted through this FOA, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students, and enhancing the research environment at these applicant institutions. Eligible institutions must award baccalaureate science degrees, and have received less than 6 million dollars per year of NIH support (total costs) in 4 of the last 7 fiscal years.