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NIH SBIR/STTR

NIH's SBIR/STTR program funds biomedical and life-sciences small businesses through Phase I/II grants plus institute-specific award tracks like the Commercialization Readiness Pilot.

Open checked 2026-08-14 against the official page

What you getPhase I guideline $323,090 (6 months–2 years); Phase II guideline $2,153,927 (1–3 years); limits vary by institute; Commercialization Readiness Pilot (CRP) up to $4,191,495 (institute-dependent, some capped lower)
Sectorsbiotech, life sciences, medtech
Wherenational
Cadencecyclical

About this programme

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are federal set-aside programs that fund early-stage research and development at small businesses. At NIH, the programs are run by the Small Business Education and Entrepreneurial Development (SEED) office, which coordinates SBIR/STTR funding across all of NIH's 24 Institutes and Centers rather than acting as a single grant-making body itself.

Both programs exist to meet the same federal goals: stimulate technological innovation in the private sector, strengthen small business participation in federal R&D, increase the commercial application of federally funded research, and encourage participation by socially and economically disadvantaged and women-owned small businesses. NIH SEED states it earmarks more than $1.2 billion annually across the SBIR and STTR programs to support early-stage biomedical and health-related research.

SBIR and STTR are separate programs with the same broad purpose but different eligibility mechanics. SBIR is open to a small business acting alone (it may still subcontract work). STTR requires the small business to formally partner with a US-based nonprofit research institution — a university, federally funded R&D center, or nonprofit research organization — for a defined share of the project's research effort.

Unlike SBIR/STTR at some other federal agencies (for example the Department of Defense, which often runs the program as a contract vehicle), NIH issues SBIR/STTR awards as research grants, following NIH's standard grants process (peer review by a scientific review group, followed by an Institute/Center funding decision) rather than a contracting officer's award.

How it works

The programs run in phases. Phase I supports a feasibility study or proof-of-concept for the proposed technology. Phase II supports continued research and development of a concept that showed feasibility in Phase I; typically only a company that held the corresponding Phase I award is eligible to apply for Phase II, and NIH generally expects the Phase II application within the first several standard due dates after the Phase I budget period ends.

Some NIH Institutes and Centers additionally offer Phase IIB awards (also called Competing Renewal or Bridge awards) that extend or supplement a Phase II project for further development toward commercialization; these are Institute-specific funding opportunities, not a program-wide guarantee, and are typically announced through the same funding-opportunity channels as regular Phase I/II solicitations.

The two programs differ in who has to do the work. For SBIR, a minimum of two-thirds of the research effort in Phase I and one-half in Phase II must be performed by the small business itself (the rest may be subcontracted, including to a research institution). For STTR, the split is fixed by statute: not less than 40% of the effort must be performed by the small business and not less than 30% by the partnering research institution, with the remainder allocated between them or other subcontractors.

The Principal Investigator requirement also differs by program. Under SBIR, the PI's primary employment must be with the small business during the project (they cannot be primarily employed full-time elsewhere). Under STTR, the PI may be primarily employed by either the small business or the partnering research institution.

Award budgets follow guideline levels published by the Small Business Administration (SBA), which NIH and other federal agencies apply unless a topic carries an SBA-approved waiver for a higher amount, or an individual NIH Institute sets its own budget guidance for a specific funding opportunity. Applicants should check the specific funding opportunity announcement (FOA) and the current SBA guideline levels on seed.nih.gov rather than assume a single fixed dollar figure applies to every topic.

Who can apply

Applicants must be a for-profit, US-organized and operated small business concern, majority-owned and controlled by individuals who are US citizens or permanent residents (or, under program rules, by other qualifying entities such as venture capital operating companies within defined limits), and meet the SBA's small-business size standard.

For STTR, the small business must have a formal, written cooperative research agreement with a single partnering research institution for the project — that institution acts as a subcontractor, not as a co-applicant, and cannot itself apply for the award.

NIH also applies performance-based eligibility rules for high-volume applicants: companies that have received more than a set number of Phase I awards across the prior five fiscal years and fall below NIH's minimum benchmark Transition Rate (the rate at which their Phase I awards proceed to Phase II or to non-SBIR follow-on funding) can be restricted from receiving further Phase I/Phase II awards for a period. This rule targets high-volume, low-transition applicants and does not apply to most first-time or lower-volume applicants.

Eligibility and the current small-business size/ownership thresholds should always be confirmed against the specific funding opportunity announcement and seed.nih.gov's eligibility criteria page, since SBA policy directives are updated periodically.

How to apply

  1. Register the company with SAM.gov (System for Award Management), which issues the Unique Entity ID (UEI) needed for every other federal registration — this step alone can take several weeks and should be started first.
  2. Register the company in the SBA Company Registry at SBIR.gov (using the EIN, UEI, and active SAM.gov registration); this issues an SBC Control ID that must be entered in the application's SBIR/STTR Information form.
  3. Register with Grants.gov once the SAM.gov registration is active.
  4. Register the organization and the Principal Investigator with NIH eRA Commons; a Signing Official account is typically created first, followed by the PI account under it.
  5. Identify a matching NIH funding opportunity (a specific Funding Opportunity Announcement or Notice of Funding Opportunity) via seed.nih.gov's funding-opportunity listings, since NIH publishes topic- and Institute-specific solicitations rather than one single generic SBIR/STTR call.
  6. Prepare and submit the application package through ASSIST (NIH's online application system, accessed with eRA Commons credentials) or an equivalent Grants.gov Workspace / institutional system-to-system route, before the FOA's submission deadline.
  7. The application goes through NIH's standard peer review (scientific review group) and is then considered for funding by the relevant NIH Institute or Center, which makes the final award decision.

Frequently asked

What is the difference between SBIR and STTR at NIH?

SBIR funds a small business alone, which can subcontract work but must itself perform at least two-thirds of the Phase I effort and half of the Phase II effort. STTR requires the small business to formally partner with a US nonprofit research institution, which must perform at least 30% of the effort while the small business performs at least 40%. The Principal Investigator can be based at the small business under SBIR, but can be based at either the small business or the research institution under STTR.

Can our company apply to both SBIR and STTR for the same idea?

SBIR and STTR are separate application tracks with different partnership and effort-split requirements, so the same research idea would need to be structured to meet whichever program's eligibility rules apply — a company should read the applicable FOA and eligibility criteria on seed.nih.gov before choosing a track.

Do we need a Phase I award before applying for Phase II?

Generally yes. NIH's Phase II program is built to continue work that showed feasibility under a Phase I award, and Phase II eligibility is typically limited to companies that held the corresponding Phase I award, with an expected submission window after the Phase I budget period ends.

Does NIH award SBIR/STTR funding as a grant or a contract?

NIH issues SBIR/STTR awards as research grants through its standard grants process, unlike some other federal agencies that run the program primarily through contracts. Applications go through NIH's peer review process before an Institute or Center makes a funding decision.

Is there a fixed dollar cap on Phase I and Phase II awards?

Award budgets follow guideline levels set by the Small Business Administration and adopted by NIH, but individual NIH Institutes and Centers can publish different budget guidance for specific funding opportunities, and some topics carry an SBA-approved waiver allowing higher amounts. The applicable cap should always be checked against the specific FOA rather than assumed.

What registrations does a first-time applicant need before submitting?

At minimum: a SAM.gov registration (which issues the company's Unique Entity ID), registration in the SBA Company Registry at SBIR.gov (which issues an SBC Control ID required on the application), a Grants.gov registration, and NIH eRA Commons accounts for both the organization's Signing Official and the Principal Investigator. SAM.gov registration is the longest step and should be started well ahead of any submission deadline.

Can a company lose eligibility for future Phase I/II awards?

NIH applies a performance benchmark to high-volume applicants: companies that have received a large number of Phase I awards over the prior five fiscal years and fall below NIH's minimum Transition Rate benchmark can be restricted from receiving further Phase I and Phase II awards for a period. This applies to high-volume applicants, not typical first-time or low-volume applicants.

Reviewed 2026-08-16. Programmes change — confirm current eligibility, amounts and deadlines on the official page before you apply. CapEasy is a private consultancy and is not affiliated with any government authority.

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