FDA SBIR Program
Status not published
Omnibus/Parent SBIR and STTR grant applications have three standard receipt dates a year, customarily 5 January, 5 April and 5 September. Some institutes also issue targeted contract solicitations (PHS SBIR/STTR contract solicitation) once a year.
NIH SBIR Phase I awards are guided by the HHS/NIH budget ceiling (roughly $0.3m total costs for Phase I and $2.0m for Phase II in FY2026, inflation-adjusted annually). NIH routinely grants waivers above the ceiling for topics on its published waiver list. Awards are grants, not contracts, under the Omnibus/Parent solicitation.
U.S. Food and Drug Administration
public · national
Deadline: Fixed cut-off dates — Omnibus/Parent SBIR and STTR grant applications have three standard receipt dates a year, customarily 5 January, 5 April and 5 September. Some institutes also issue targeted contract solicitations (PHS SBIR/STTR contract solicitation) once a year.
This funder does not publish a success rate. We rank it using the rate observed across similar programmes and label it as an estimate rather than implying we know.
Major bid — written case, budget, possibly partners.
Who can apply
- Up to 500 employees
- small enterprises
- Sectors: health
- Stage: idea stage, pre-seed and seed
- R&D activity required
- Locally registered entity required
FDA participates in the HHS SBIR programme, focused on regulatory science, product evaluation methods and analytical tools. US for-profit small business, 500 or fewer employees, majority US-owned; PI primarily employed by the company for SBIR. NIH permits majority ownership by multiple venture capital, hedge fund or private equity firms under a specific certification route.
How to apply
- Register the company in SAM.gov, eRA Commons and Grants.gov
- Contact the institute's SBIR/STTR programme officer to confirm topic fit
- Prepare the research strategy, specific aims and budget
- Submit through Grants.gov / ASSIST against the NIH Omnibus SBIR or STTR funding opportunity by a standard receipt date
- Respond to summary statement; resubmit or proceed to award negotiation
What you will need
- Specific aims and research strategy
- Detailed budget and justification
- Biosketches for PI and key personnel
- SBC registration in the SBA Company Registry
- eRA Commons registration
Related reading: How grant deadlines actually work · The EU SME definition (Recommendation 2003/361) · SBIR vs STTR: what actually differs
Source. https://www.fda.gov/science-research/
Not yet re-checked against the official page — this record was extracted on 14 August 2026 and may be out of date. Check the source before you rely on it.
Source: www.fda.gov
Report an error Something wrong or out of date? Tell us.
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