US for-profit small business ( 50% US-owned; PI primary employment with the SBC for SBIR (STTR PI may be at partner institution). STTR requires formal partnership with a US nonprofit research institution (min. 30% work at RI).

What burden and restrictions apply?

NIH grants require progress, financial, human/animal research and invention reporting; commercialization plans and TABA requests are phase-dependent. Funds are restricted to the approved work plan, budget, eligible cost categories and award period; unrelated, unsupported, double-funded and noncompliant expenditure is excluded.

NIH SBIR/STTR (Small Business Programs / SEED)

Phase I guideline up to USD 400,000 and Phase II up to USD 2.15 million; approved waiver topics may reach about USD 700,000 Phase I and USD 3 million Phase II. · National Institutes of Health (NIH) — HHS · deadline 2026-09-08

The National Institutes of Health SBIR/STTR is the largest source of early-stage, non-dilutive life-science funding — grants (and some contracts) for biotech, diagnostics, devices, digital health, and therapeutics. Administered via NIH's SEED office. Higher-than-standard budget caps for many topics. Current lifecycle: upcoming; next verified deadline 2026-09-08. Real economics: Phase I guideline up to USD 400,000 and Phase II up to USD 2.15 million; approved waiver topics may reach about USD 700,000 Phase I and USD 3 million Phase II..

Tier 1sbirsttrlife-sciencesbiotech

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Key facts

Funder	National Institutes of Health (NIH) — HHS
Amount	Phase I guideline up to USD 400,000 and Phase II up to USD 2.15 million; approved waiver topics may reach about USD 700,000 Phase I and USD 3 million Phase II.
Deadline	2026-09-08
Decision time	Registration, NOFO selection, scientific and commercialization application, peer review, advisory council and institute award decision typically take roughly 8-9 months.
Eligibility	US for-profit small business (<500 employees), >50% US-owned; PI primary employment with the SBC for SBIR (STTR PI may be at partner institution). STTR requires formal partnership with a US nonprofit research institution (min. 30% work at RI).
Restrictions	NIH grants require progress, financial, human/animal research and invention reporting; commercialization plans and TABA requests are phase-dependent. Funds are restricted to the approved work plan, budget, eligible cost categories and award period; unrelated, unsupported, double-funded and noncompliant expenditure is excluded.
Status	upcoming

Always confirm on the official page before applying — dates and terms change.

Application process

Obtain SAM.gov UEI + registration, register in eRA Commons, and register/verify SBC in SBIR.gov
Identify a Funding Opportunity (omnibus PA-27-100/PA-27-102 or targeted IC NOFO) and contact a program officer
Prepare application (Specific Aims, Research Strategy, commercialization plan) and submit via Grants.gov/ASSIST
Standard due dates: Jan 5 / Apr 5 / Sep 5 (next: Sep 8, 2026)
Peer review by study section (scored for significance, innovation, approach, commercialization)
Advisory council recommendation and IC funding decision → Notice of Award

Background

National Institutes of Health (NIH) — HHS operates NIH SBIR/STTR (Small Business Programs / SEED). This pass separates direct cash, repayable finance, credits, incentives and umbrella programs so later ranking does not compare unlike instruments. NIH SEED is a major source of non-dilutive life-science startup funding. Applicants receive peer-review scores and may discuss next steps with a program official. NIH offers TABA and commercialization resources after application.

How the application really works

Obtain SAM.gov UEI + registration, register in eRA Commons, and register/verify SBC in SBIR.gov → Identify a Funding Opportunity (omnibus PA-27-100/PA-27-102 or targeted IC NOFO) and contact a program officer → Prepare application (Specific Aims, Research Strategy, commercialization plan) and submit via Grants.gov/ASSIST → Standard due dates: Jan 5 / Apr 5 / Sep 5 (next: Sep 8, 2026) → Peer review by study section (scored for significance, innovation, approach, commercialization) → Advisory council recommendation and IC funding decision → Notice of Award

Tips

Show direct fit with biotechnology.
Show direct fit with diagnostics.
Show direct fit with medical devices.
Show direct fit with digital health.
Show direct fit with therapeutics.

Watch out for

Current lifecycle is upcoming.
NIH grants require progress, financial, human/animal research and invention reporting; commercialization plans and TABA requests are phase-dependent.
Funds are restricted to the approved work plan, budget, eligible cost categories and award period; unrelated, unsupported, double-funded and noncompliant expenditure is excluded.

Track record

NIH SEED is a major source of non-dilutive life-science startup funding.
Applicants receive peer-review scores and may discuss next steps with a program official.
NIH offers TABA and commercialization resources after application.

The reviewed official corpus does not publish a comparable applicant denominator and selection rate.

Frequently asked questions

Is this actionable now?: upcoming. Next verified deadline: 2026-09-08.
What is the real economic value?: Phase I guideline up to USD 400,000 and Phase II up to USD 2.15 million; approved waiver topics may reach about USD 700,000 Phase I and USD 3 million Phase II.
Who is eligible?: US for-profit small business (<500 employees), >50% US-owned; PI primary employment with the SBC for SBIR (STTR PI may be at partner institution). STTR requires formal partnership with a US nonprofit research institution (min. 30% work at RI).
How does selection work?: Obtain SAM.gov UEI + registration, register in eRA Commons, and register/verify SBC in SBIR.gov; Identify a Funding Opportunity (omnibus PA-27-100/PA-27-102 or targeted IC NOFO) and contact a program officer; Prepare application (Specific Aims, Research Strategy, commercialization plan) and submit via Grants.gov/ASSIST; Standard due dates: Jan 5 / Apr 5 / Sep 5 (next: Sep 8, 2026); Peer review by study section (scored for significance, innovation, approach, commercialization); Advisory council recommendation and IC funding decision → Notice of Award. Registration, NOFO selection, scientific and commercialization application, peer review, advisory council and institute award decision typically take roughly 8-9 months.
What burden and restrictions apply?: NIH grants require progress, financial, human/animal research and invention reporting; commercialization plans and TABA requests are phase-dependent. Funds are restricted to the approved work plan, budget, eligible cost categories and award period; unrelated, unsupported, double-funded and noncompliant expenditure is excluded.
What evidence exists?: NIH SEED is a major source of non-dilutive life-science startup funding. Applicants receive peer-review scores and may discuss next steps with a program official. NIH offers TABA and commercialization resources after application. The reviewed official corpus does not publish a comparable applicant denominator and selection rate.

Sources

seed.nih.gov/small-business-funding — Official current program, phase routes and public contact (checked 2026-08-10)
seed.nih.gov/small-business-funding/how-to-apply — Official registration and full application process (checked 2026-08-10)
seed.nih.gov/small-business-funding/how-to-apply/after-you-apply — Official peer-review, program-official and post-application route (checked 2026-08-10)