NIH Releases FY2026 SBIR/STTR Solicitations

NIH Releases FY2026 SBIR/STTR Solicitations

The National Institutes of Health (NIH) has released its FY2026 Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding opportunities. These programs support small businesses developing innovative health-related technologies, from early feasibility through later-stage commercialization.

For many applicants, NIH funding is not a single-step process. It is a long-term commercialization journey that may include Phase I, Phase II, follow-on commercialization support, strategic partnerships, and private investment.

Standard Application Due Dates

Standard NIH SBIR/STTR application due dates are September 5, January 5, and April 5. When a due date falls on a weekend or federal holiday, the deadline moves to the next business day.

The next upcoming standard due date is September 8, 2026.

FY2026 NIH SBIR/STTR Opportunities

What’s New in FY2026?

• HHS now limits SBIR/STTR submissions to 9 per small business per fiscal year.
  This applies across HHS, including affiliates, for all SBIR/STTR activity codes.
• Foreign disclosure and risk management requirements have expanded.
  HHS due diligence now includes cybersecurity practices, patent analysis, employee analysis, foreign ownership, foreign affiliations, investment relationships, licensing agreements, joint ventures, and certain business relationships with foreign countries of concern.
• Small business applications are no longer eligible for NIH late submission.
  NIH’s updated late application policy states that Small Business applications, including R41, R42, R43, R44, SB1, UT1, and U44, will not be accepted late.
• New Phase IIB Strategic Breakthrough Award: NIH has introduced a new later-stage SBIR award designed to help previously funded NIH SBIR/STTR projects bridge the gap between Phase II and commercialization.
• ORCID iDs are now required: All Senior/Key Personnel listed on an NIH application must have an ORCID iD linked to their eRA Commons profile.
• Institute Funding Considerations are now online: NIH has replaced the former Program Descriptions PDF with an online Small Business Funding Considerations and Contacts resource.
• Direct to Phase II and Fast-Track pathways continue: Eligible applicants may be able to pursue these options when appropriate for the project and funding opportunity.
• Commercialization support remains available: NIH continues to support later-stage commercialization activities through the Commercialization Readiness Pilot Program.

SBIR: From Idea to Feasibility

The NIH SBIR program supports small businesses developing innovative technologies that address health-related challenges. Through Phase I and Phase II funding, companies can establish technical feasibility, continue research and development, and advance toward commercialization.

This opportunity may be a fit if you are:

• New to federal R&D funding and exploring your first application
• Developing an innovative technology with commercial potential
• Seeking funding to establish technical feasibility
• Looking to validate your concept before pursuing larger investments or partnerships

STTR: Turning Research into Innovation

The NIH STTR program supports small businesses that partner with nonprofit research institutions, such as universities. STTR requires a formal collaboration between the small business and the research institution and is often a strong fit for technologies emerging from academic research.

This opportunity may be a fit if you are:

• Commercializing technology emerging from a university or research institution
• Building a startup around licensed intellectual property
• Seeking to formalize a collaboration between a small business and a research organization
• Exploring pathways to move promising research toward real-world impact

Budget Guidelines

The budget guidelines are the same for both the SBIR and STTR programs, but individual NIH Institutes and Centers may set their own budget limits. Some Institutes may support budgets above the standard SBA guidelines for approved waiver topics, while others may set lower practical limits. Applicants should review Institute-specific funding considerations and speak with Program Officials early.

*The Phase IIB Strategic Breakthrough Award has a substantially higher ceiling, but applicants should not assume this represents a typical award size. Budget expectations may vary by participating NIH Institute or Center, and applicants must provide not less than 100 percent matching funds.

Commercialization Readiness Pilot: Preparing for Market Entry

The Commercialization Readiness Pilot (CRP) Program supports companies that have completed significant technical development and are preparing for commercialization activities. CRP funding can help companies address commercialization barriers such as regulatory planning, manufacturing readiness, market-entry preparation, and other activities needed to reduce commercialization risk.

This opportunity may be a fit if you are:

• Managing an active or recently completed NIH Phase II project
• Preparing for regulatory, manufacturing, or market-entry activities
• Seeking resources to reduce commercialization risk
• Looking to strengthen your path toward customers, partners, or investors

New: Phase IIB Strategic Breakthrough Award

One of the most significant additions in the FY2026 NIH release is the new Phase IIB Strategic Breakthrough Award.

The program is designed to bridge the funding gap between the end of an NIH SBIR or STTR Phase II award and commercialization. It provides previously funded NIH SBIR/STTR projects additional support for later-stage research and development.

Total funding support may not exceed $30,000,000, including direct costs, indirect costs, and fee. However, budget guidelines may vary by participating NIH Institute or Center. Applicants must also show not less than 100 percent matching funds.

This opportunity may be a fit if you are:

• Advancing beyond Phase II and preparing for significant commercialization milestones
• Developing a technology that requires substantial additional development before market entry
• Building relationships with investors, strategic partners, or other sources of matching capital
• Navigating the transition from federally funded research to sustainable commercial growth

Required Registrations

NIH applicants must complete several registrations before submitting an application. Registration can take six weeks or longer, so applicants should begin the process as early as possible. Failure to complete registrations before the due date is not a valid reason for a late submission.

Required registrations include:

• System for Award Management (SAM)
• Unique Entity Identifier (UEI)
• SBA Company Registry
• eRA Commons
• Grants.gov

Greater flexibility for Technical and Business Assistance (TABA)

NIH now allows small businesses to use either qualified third-party providers or in-house personnel to perform eligible commercialization and business assistance activities. TABA funding is requested as part of the proposed project budget rather than as a separate supplement, with up to $6,500 available in Phase I and up to $50,000 available in Phase II.

New for FY2026: ORCID IDs Required for Senior/Key Personnel

NIH now requires all Senior/Key Personnel listed on an application to have an ORCID iD linked to their eRA Commons profile. ORCID is a free, persistent digital identifier that helps distinguish researchers and supports NIH’s Common Forms and research security requirements.

ORCID information is required when preparing Biographical Sketch and Current and Pending Support documents through SciENcv. Applicants should ensure all Senior/Key Personnel obtain and link their ORCID iD well before submission.

A missing ORCID iD for any Senior/Key Personnel can prevent a compliant NIH submission.

Finding the Right NIH Institute or Center

NIH is made up of multiple Institutes, Centers, and Offices, each with its own mission, funding priorities, and program interests. Applicants should use NIH’s Small Business Funding Considerations and Contacts resource to identify potential fit, review Institute-specific considerations, and find appropriate contacts.

This resource replaces the former Program Descriptions PDF and should be reviewed early in the planning process. Because participation, budget expectations, clinical trial acceptance, and funding priorities may vary, applicants are strongly encouraged to contact NIH Program Officials before preparing an application.

A Long-Term Commercialization Journey

NIH SBIR/STTR funding is often part of a multi-year commercialization pathway. A company may begin with Phase I feasibility work, continue through Phase II development, and later pursue commercialization-focused opportunities such as CRP, the Phase IIB Strategic Breakthrough Award, strategic partnerships, private investment, licensing, or other market-entry pathways.

Most successful companies begin preparing for the next phase before the current phase is complete. Commercialization planning, customer discovery, regulatory strategy, manufacturing readiness, and partnership development should begin early and continue throughout the SBIR/STTR journey.

MNSBIR Recommendation

Companies considering NIH SBIR/STTR funding should begin preparation early. Required registrations, ORCID requirements, agency fit discussions, commercialization planning, and proposal development can take months before an application is submitted.

MNSBIR encourages Minnesota small businesses to explore fit, understand the full commercialization pathway, and seek guidance well in advance of the next NIH due date.