Winning NIH SBIR/STTR Grants in 2026

NIH’s SBIR/STTR solicitations, released in June 2026, are no longer “omnibus” solicitations. They have been replaced by Parent Announcements. Applicants can now access these opportunities through Grants.gov.  

Upcoming submission deadlines are: 

• • September 8, 2026 
  • January 5, 2027 
  • April 5, 2027 

Applicants should also note that late submissions will no longer be accepted, including exceptions that were previously available under certain circumstances. Applications are due by 5:00 p.m. local submitter time on the deadline date. 

Both SBIR and STTR Parent Announcements are now clinical trial optional, eliminating the need to select between separate ‘clinical trial required’ and ‘clinical trial not allowed’ solicitations. 

There are some exceptions. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), National Center for Advancing Translational Sciences (NCATS), Office of Research Infrastructure Programs (ORIP), and the Food and Drug Administration (FDA) will not accept clinical trials through the Parent Announcements.  

Applications proposing an NIH-designated clinical trial must also include a new two-page Regulatory Plan outlining the regulatory pathway, anticipated approval timeline, and interactions with regulatory authorities.

The new Phase IIB Strategic Breakthrough Award provides an additional funding pathway for eligible SBIR applicants that have completed Phase II and are working toward commercialization. The award budget ranges from $3,000,000 to $15,000,000 in total costs, depending on the participating Institute or Center, as specified in PA-27-101, and requires a minimum of 51% of the budget to be allocated to the Small Business Concern (SBC). In addition, the award requires a 100% non-federal cost match.  

The Commercialization Readiness Pilot (CRP), unlike the Strategic Breakthrough Award, does not require a cost match, allows greater flexibility in how work is performed (no minimum budget allocation to the SBC), and can run concurrently with an active Phase II award. The CRP award budget ranges from $500,000 to $4,191,495, depending on the participating Institute or Center, as specified in PAR-27-098. 

Another important change for 2026 is that STTR applicants can now apply Direct to Phase II, an option previously available only to SBIR applicants.

NIH has introduced new limits on the number of applications a company and an individual Principal Investigator (PI) can submit: 

• • Company-level cap: Up to nine new or resubmitted applications across the Department of Health and Human Services (HHS) SBIR/STTR activity codes per fiscal year. Renewals and revisions are excluded. 
  • Program Director (PD)/PI-level cap: Each PD/PI can be listed on no more than six proposals per fiscal year. 

These limits make strategic planning, careful selection of funding opportunities, and timing of application submission increasingly important.

The NIH has issued updated guidance on the use of AI in proposal development. Applications either developed substantially by AI, or containing sections developed substantially by AI, will not be considered the original ideas of applicants by NIH, and are therefore not eligible for funding. If the NIH detects the use of AI post-award, it may elect to refer the award to the Office of Research Integrity to determine whether research misconduct may have occurred and may simultaneously take enforcement actions. Applicants should consider this guidance carefully before using AI tools in proposal preparation.

The NIH has updated its baseline SBIR/STTR budget limits for total project costs, per the Small Business Administration (SBA)’s statutory budget guidelines:

• • Phase I: $323,090 
  • Phase II: $2,153,927 
  • CRP: $4,191,495

The NIH Grants & Funding page lists approved topics for awards over statutory budget guidelines (i.e., budget waiver topics) specific to each participating Institute or Center (IC). For a project that is well-aligned with a qualifying budget waiver topic, applicants may request up to $400,000 or $700,000 in total costs in Phase I, and up to $2,500,000 or $3,000,000 in total costs, depending on the participating IC. This information can be found in the Parent SBIR/STTR solicitations.  

NIH guidance on indirect cost rates for SBCs remains unchanged from past SBIR/STTR solicitations (refer to the SBIR/STTR Form I Application Guide and the NIH Grants Policy Statement). Briefly, for SBIR/STTR Phase I applicants whose SBC does not have a currently effective negotiated indirect cost rate with a federal agency, a rate not exceeding 40% of the total direct costs may be proposed. The NIH will not negotiate indirect cost rates for Phase I awards. For SBIR/STTR Phase II and CRP applicants, a currently effective federally negotiated indirect cost rate may be utilized. If this is unavailable, a proposed indirect cost rate of 40% or less may be awarded without further justification required from NIH. If the proposed rate is greater than 40%, this must be negotiated with the NIH prior to award. 

All NIH biographical sketches must now be generated through SciENcv, which requires linked ORCID and eRA Commons accounts and produces a digitally certified PDF for submission. Applicants should allow time to create and link these accounts before initiating their application on the ASSIST portal in eRA Commons.

NIH has also simplified eRA Commons access by allowing Signing Official (SO) and PI roles to be managed through a single login.gov account.

NIH’s updated SBIR/STTR foreign-risk framework, implemented under the 2026 Small Business Innovation and Economic Security Act, expands and formalizes pre-award and post-award security due diligence for all competing applications and active awards. Applicants must disclose funded and unfunded foreign relationships for all owners and “covered individuals,” a definition that now encompasses both senior key personnel and anyone contributing substantively to the project. HHS will assess cybersecurity practices, patent filing history, malign foreign talent-program involvement, foreign ownership and financial obligations, foreign affiliations, investment and business relationships, and technology licensing or joint ventures involving foreign countries of concern. The policy also establishes mandatory bases for denial, including affiliations with foreign country-of-concern entities, or links to specified U.S. restricted-party lists. Note that the policy does not provide a pre-award opportunity to remediate an identified risk. SBIR/STTR applicants should therefore carefully review the NIH’s Foreign Disclosure and Risk Management webpage, which contains the foreign risk review areas and case studies, and resolve any foreign security risks. 

Applicants should also be aware of new research security training (RST) requirements. All senior/key personnel listed on an NIH grant application must certify that they have completed RST within 12 months of the date of application submission. To satisfy this requirement, applicants are encouraged to complete the condensed Research Security Training module, developed by NIH in partnership with the National Science Foundation, prior to award negotiations.

TABA funding now offers greater flexibility. TABA funds could previously be accessed by either (1) budgeting for these funds during application preparation, or (2) participating in a TABA Needs Assessment post-award. Awardees can now consider a third option, which is to request for TABA funds post-award through an administrative supplement.  While TABA provision was previously restricted strictly to vendors external to the SBC, TABA can now also be provided by existing company staff, new staff hires, or collaborators and consultants named on the application. Note that TABA funds can only be used for technical and business activities towards facilitating the commercialization of the product proposed in the application, and cannot be used for any research and development (R&D) activities proposed in the application. Refer to the NIH SEED Office’s TABA page and TABA FAQs for more information.  

TABA limits remain $6,500 for Phase I and $50,000 across Phase II and Phase IIB. TABA is not available for CRP awards. 

The Data Management and Sharing Plan is no longer required for NIH SBIR/STTR applications.

NIH Institutes and Centers will no longer rely on traditional paylines as the sole basis for funding decisions. Instead, funding recommendations will consider application scores and reviewer feedback alongside portfolio priorities and available funding. With this change, it is vital for applicants to clearly communicate the significance of their technology and its alignment with the mission and priorities of the specific NIH IC being targeted for SBIR/STTR funding.