NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed) | PAR 21 114

Opportunity Information: Apply for PAR 21 114

The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), is offering a funding opportunity called "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-21-114). It is a discretionary grant program in the health area (CFDA 93.853) that supports small businesses that have already completed an NINDS-funded SBIR or STTR Phase II project and now need additional runway to reach the next major development milestones on the path to commercialization. The focus here is strictly pre-clinical work; clinical trials are not allowed under this specific R44 announcement.

The main purpose of the award is to help promising neuroscience and neurology-related technologies overcome the well-known funding gap often called the "Valley of Death." This is the period after Phase II funding ends but before a product is mature enough to attract sufficient private capital or generate revenue, especially for medical biotechnology products that typically require expensive validation, advanced preclinical development, and preparation for federal regulatory pathways. NINDS is essentially trying to keep high-potential SBIR/STTR projects from stalling at the point where the science is encouraging but the remaining development work is too costly or too risky for many investors to fund without additional de-risking.

This Phase IIB competing renewal mechanism is designed to push a project toward commercialization by funding the next appropriate, concrete milestone(s). In practical terms, that can include work needed to advance a candidate or device toward eventual federal regulatory approval, or to bring a complex research tool to market. The opportunity also places a strong emphasis on commercialization readiness and market transition, not just additional research for its own sake. In other words, the funded work should be the kind of work that clearly increases the value of the technology, reduces technical and regulatory risk, and makes it more likely that the product can move into later-stage development, partnering, or sales.

A central feature of this opportunity is its encouragement of partnerships between NINDS SBIR/STTR awardees and third-party investors and/or strategic partners. NINDS is looking for applicants who are not operating in isolation and who can demonstrate real-world commercial engagement, whether that comes from private investment, industry partnerships, or other forms of external support that signal the technology has a credible path to market. Applicants are strongly encouraged to secure independent third-party funding throughout the Phase IIB project period, reflecting NIH’s preference to see shared commitment and validation from outside stakeholders as the project matures.

Eligibility is limited to small businesses, consistent with the SBIR program. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, may be allowed in certain circumstances, which typically means specific, justified parts of the work might be performed outside the U.S. if they are essential and properly approved, but the applicant organization itself must be a U.S. small business.

Key administrative details included in the source information are that the opportunity was created on January 25, 2021, and listed an original closing date of April 5, 2024. The listing does not specify an award ceiling or the expected number of awards in the provided fields, so applicants would typically need to consult the full FOA text for budget limits, project period expectations, review criteria, required components, and any NINDS-specific program priorities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2021-01-25.
• Applicants must submit their applications by 2024-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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