The National Institutes of Health (NIH) is offering the "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research," aimed at supporting U.S. small businesses in advancing medical technology and biotechnology projects toward commercialization, particularly in the neurological field. This funding opportunity encourages applications from small business concerns that have previously received NIH SBIR or STTR Phase II awards, focusing on projects that evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral, or rehabilitation therapies. The initiative seeks to bridge the funding gap for clinical trials, promoting partnerships with third-party investors and requiring a detailed Commercialization Plan from applicants. The total funding support for a Phase II award is capped at $2,045,816, with applications due by April 5, 2027. Interested parties can find more information and submit applications through Grants.gov or the NIH ASSIST system, and inquiries can be directed to grantsinfo@nih.gov.

PAR-24-221-Full-Announcement.html

PAR-24-221.html

The Department of Health and Human Services is issuing a Notice of Funding Opportunity (NOFO) titled "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research," aimed at supporting U.S. small businesses in transitioning medical technology and biotechnology projects toward commercialization. This NOFO specifically targets projects in the neurological field previously funded under SBIR or STTR Phase II grants, helping bridge the funding gap often referred to as the "Valley of Death." Applicants are encouraged to establish partnerships with third-party investors and must demonstrate plans for diverse perspectives. Key funding components include support for exploratory clinical trials, regulatory compliance, and plans to recruit diverse populations. The total funding support for a Phase II award is capped at $2,045,816, with specific eligibility requirements focused on small business concerns. Applications should be submitted through Grants.gov or the NIH ASSIST system, with deadlines specified for 2024-2027. The initiative reflects NINDS's commitment to advancing innovative solutions for neurological disorders while fostering a diverse research workforce. Compliance with robust application guidelines is imperative to ensure eligibility and funding approval.

https://grants.nih.gov/grants/guide/pa-files/PAR-24-221.html

(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&apos;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.

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

NIH Grants Information&lt;br/&gt;grantsinfo@nih.gov

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