Opportunity Information: Apply for PA 27 101
The NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent R44, Clinical Trial Optional) is a later-stage NIH funding opportunity designed to help small businesses move promising, previously NIH-funded technologies from the end of SBIR/STTR Phase II toward real-world commercialization. Its core purpose is to bridge the common financing gap that happens after Phase II ends, when a project may still need additional research and development work to reduce risk, complete key validation steps, and become attractive for customers, partners, or follow-on investors. In practical terms, this award is meant to support more advanced R&D that builds directly on an existing NIH Phase II SBIR or STTR project, keeping momentum going so that a product, platform, or service can reach the market rather than stalling after early proof-of-concept work.
Eligibility is tightly focused. Only United States small business concerns (SBCs) that have already received an NIH SBIR or STTR Phase II award can apply. This is not an entry-point program for new applicants or companies without prior NIH Phase II support; it is specifically a continuation-style mechanism for projects with an established NIH-funded foundation. Another important limitation is that only one Phase IIB Strategic Breakthrough award is permitted per project, so it functions as a single, targeted extension to push the original Phase II effort across a major translational hurdle.
This notice of funding opportunity (NOFO) supports renewal/resubmission Type 2 applications tied to prior NIH Phase II SBIR/STTR awards, with a defined timing window for submission. Applications must be submitted within the first six due dates following the expiration of the prior Phase II budget period. That timing requirement matters because it effectively sets a clock for when a company can seek Phase IIB Strategic Breakthrough support after the Phase II period ends, and applicants need to plan their regulatory, technical, and commercialization milestones accordingly so they can propose a coherent next-stage R&D plan within the allowed submission window.
The award is listed as “Clinical Trial Optional,” which signals that proposed projects may include a clinical trial if scientifically appropriate and allowed under the broader NIH and institute/center policies, but a clinical trial is not required for all applicants. This makes the opportunity relevant to a wide range of health-related innovations, from therapeutics and diagnostics to devices, digital health tools, and research technologies, depending on the topic fit and the needs of the next-stage development plan.
On the restrictions for foreign involvement, the program is clear that non-U.S. entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to be included as part of the funded project. However, the NOFO leaves room for certain limited international connections: unfunded international collaborations or unfunded foreign components may be allowed if they meet NIH Grants Policy Statement definitions and requirements. In other words, the applicant organization must be a U.S. small business, and the funded work generally needs to be domestic, but some collaboration that does not involve NIH funds flowing to a foreign site may be permissible.
Administratively, this is a discretionary grant opportunity run by the National Institutes of Health (NIH) under Funding Opportunity Number PA-27-101, with an original closing date listed as 2029-04-05. The opportunity sits within the health funding activity category and references multiple CFDA (Assistance Listing) numbers that correspond to NIH programs and institutes. The listing does not specify an award ceiling or the expected number of awards in the provided source data, so applicants typically need to consult the full NOFO text for budget guidance, institute-specific considerations, and any constraints tied to particular NIH components.
Overall, the Phase IIB Strategic Breakthrough Award is best understood as NIH’s mechanism for giving strong Phase II projects a focused, later-stage push to complete the R&D needed for commercialization. It is aimed at companies that can clearly show continuity from the prior Phase II work, justify why additional R&D is necessary to reach the market, and fit within NIH’s eligibility and timing rules, with clinical trial work permitted when it makes sense but not mandatory.Apply for PA 27 101
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.242, 93.273, 93.307, 93.313, 93.350, 93.351, 93.393, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2026-05-28.
- Applicants must submit their applications by 2029-04-05.
- Eligible applicants include: Small businesses.
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FAQs: NIH SBIR Phase IIB Strategic Breakthrough Award (Parent R44, Clinical Trial Optional) - PA-27-101
What is the NIH SBIR Phase IIB Strategic Breakthrough Award?
It is a later-stage NIH funding opportunity intended to help U.S. small businesses advance promising technologies that were previously supported under an NIH SBIR or STTR Phase II award. The goal is to provide a targeted push beyond Phase II so the technology can move closer to real-world commercialization.
What problem is this award designed to solve?
It is designed to bridge the common financing and development gap that can occur after an SBIR/STTR Phase II ends, when additional R&D may still be needed to reduce risk, complete validation steps, and make the project more attractive to customers, partners, or follow-on investors.
Who is eligible to apply?
Only United States small business concerns (SBCs) that have already received an NIH SBIR or STTR Phase II award are eligible. This opportunity is not intended for first-time NIH SBIR/STTR applicants or companies without prior NIH Phase II support.
Is prior NIH Phase II funding required?
Yes. The program is specifically structured to build directly on an existing NIH-funded Phase II SBIR or STTR project. Without a prior NIH Phase II award, a company is not eligible under the criteria described.
Is this award meant to be a continuation of an existing project?
Yes. It functions as a continuation-style mechanism tied to prior NIH Phase II SBIR/STTR work, supporting advanced R&D that extends the Phase II foundation toward commercialization.
How many Phase IIB Strategic Breakthrough awards can a single project receive?
Only one Phase IIB Strategic Breakthrough award is permitted per project. It is intended as a single, focused extension to push the original Phase II effort across a major translational hurdle.
What application type does this NOFO support?
The NOFO supports renewal/resubmission Type 2 applications tied to prior NIH Phase II SBIR/STTR awards, as described in the opportunity summary.
When can a company submit an application after Phase II ends?
Applications must be submitted within the first six due dates following the expiration of the prior Phase II budget period. This creates a defined submission window that applicants need to plan around.
Why does the submission window matter?
Because it effectively sets a clock after the Phase II budget period ends. Applicants need to align their technical, regulatory, validation, and commercialization milestones so they can propose a coherent next-stage R&D plan within the allowed window.
Are clinical trials required?
No. The opportunity is listed as "Clinical Trial Optional," meaning a clinical trial may be included if scientifically appropriate and consistent with applicable NIH and institute/center policies, but a trial is not required for every project.
Can a proposed project include a clinical trial?
Yes. Since the NOFO is "Clinical Trial Optional," applicants may propose a clinical trial when it makes scientific sense and is permitted under relevant NIH and institute/center policies.
What kinds of technologies or products might fit this opportunity?
The description indicates it can be relevant to a wide range of health-related innovations, including (as examples) therapeutics, diagnostics, devices, digital health tools, and research technologies, depending on the fit and what is needed in the next-stage development plan.
What is the main purpose of the funded work in Phase IIB?
To support more advanced R&D that directly builds on the prior NIH Phase II project and helps complete the remaining development needed to reduce risk and move toward commercialization, rather than stalling after early proof-of-concept.
Are non-U.S. entities eligible to apply?
No. Non-U.S. entities are not eligible to apply under the restrictions described.
Can a U.S. applicant include a non-U.S. component as part of the funded project?
No. Non-U.S. components of U.S. organizations are also not eligible to be included as part of the funded project, based on the restrictions provided.
Are any international collaborations allowed at all?
The description allows for certain limited international connections: unfunded international collaborations or unfunded foreign components may be allowed if they meet NIH Grants Policy Statement definitions and requirements. In practical terms, the applicant must be a U.S. small business and funded work is generally domestic, but some unfunded collaboration may be permissible.
What does "unfunded foreign component" mean in this context?
Based on the provided summary, it refers to a foreign involvement that does not receive NIH grant funds, and is only permissible if it fits NIH Grants Policy Statement definitions and requirements. The NOFO indicates this can be allowed in limited cases.
Which agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (NIH) as a discretionary grant program.
What is the funding opportunity number?
PA-27-101.
What is the original closing date listed for this opportunity?
The original closing date listed in the provided information is 2029-04-05.
Does the provided listing specify the award ceiling or number of awards?
No. The provided source data does not specify an award ceiling or the expected number of awards. Applicants are directed (implicitly by the summary) to consult the full NOFO text for budget guidance and institute-specific considerations.
Are there institute- or program-specific considerations?
The summary notes that multiple CFDA (Assistance Listing) numbers are referenced and that applicants typically need to consult the full NOFO text for institute-specific considerations and constraints tied to particular NIH components.
What should an applicant be prepared to demonstrate in their proposal?
Based on the program purpose described, applicants should be able to show continuity from the prior Phase II work, explain why additional R&D is still needed to reach commercialization, and ensure the proposal fits NIH eligibility rules and the timing window. If proposing a clinical trial, it should be scientifically justified and consistent with applicable NIH policies.
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