NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

Open Posted

Opportunity number
PA-27-101
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Grant
Category
  • Health
Eligible applicants
  • Small Businesses
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health is forecasting a Notice of Funding Opportunity inviting eligible United States small business concerns to submit Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough grant applications with an application due date of September 5, 2026. This opportunity is restricted to domestic small businesses that have previously received an NIH SBIR or STTR Phase II award and requires 100 percent cost-sharing through new private capital, new government funding (excluding prior SBIR/STTR Phase awards), or combinations thereof. Only one Phase IIB Strategic Breakthrough award is allowed per project, and applications must be submitted within the first six due dates following the Phase II budget period expiration.

Participating NIH components include the National Eye Institute, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of General Medical Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Minority Health and Health Disparities, National Cancer Institute, National Center for Advancing Translational Sciences, and the Office of Research on Women's Health. Award budgets vary by institute, with the National Cancer Institute allowing up to $15 million and most others limiting awards to $3 million to $4.5 million. The total Phase IIB award period cannot exceed four years.

The Phase IIB program bridges the "Valley of Death" funding gap between Phase II completion and commercialization for projects requiring extraordinary time and effort, including those requiring regulatory approval or developing complex instrumentation, clinical research tools, or behavioral interventions. Applications require submission of a two-page maximum regulatory plan describing the regulatory pathway and milestones, a commercialization plan addressing market opportunity, customer needs, competition, and financial projections, and proof of matching fund commitments. The Program Director/Principal Investigator must be employed primarily with the small business at time of award and during project conduct. Clinical trials are optional, though certain components (NCATS, ORIP) do not accept clinical trial applications.

Applications undergo dual scientific peer review followed by advisory council review considering scientific merit, commercial potential, demonstrated matching funds, and technology effectiveness. Foreign subawards or subcontracts are not eligible; unfunded international collaborations are permitted. Subsequent due dates include January 5, 2027; April 5, 2027; September 5, 2027; January 5, 2028; April 5, 2028; and September 5, 2028, with the final expiration date of April 6, 2029.

Synopsis

The NIH Phase IIB Strategic Breakthrough award bridges the funding gap between the end of a Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II award and commercialization. The Phase IIB Strategic Breakthrough provides previously funded NIH SBIR or STTR projects additional support for later-stage research and development (R & D).

Eligibility

Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to submit applications for this opportunity. Only one NIH Phase IIB Strategic Breakthrough award is allowed per project. This NOFO supports Renewal/Resubmission "Type 2" Applications from recipients with NIH Phase II SBIR/STTR awards that are submitted within the first six due dates following the expiration of their budget period. Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Files

File Type Posted
PA-27-101-Revised-Full-Announcement.html HTML file
PKG00292977.pdf PDF
PA-27-101-Full-Announcement.html HTML file

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