NIH SBIR Phase IIB Strategic Breakthrough Award (PA-27-101): Full Guide for Startups
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Quick Answer
The NIH SBIR Phase IIB Strategic Breakthrough Award (PA-27-101) provides up to $30,000,000 in follow-on funding to small businesses that have already completed an NIH SBIR or STTR Phase II award and need additional capital to bridge the gap to commercialization, often called the Valley of Death. The award requires companies to secure 100 percent matching funds from a new private investor or another government agency before applying. Standard due dates are September 5, January 5, and April 5 each year, with the next deadline on September 5, 2026. Only prior NIH Phase II recipients are eligible. There is no Phase I step for this award.
What This Funding Opportunity Is
The Phase IIB Strategic Breakthrough Award is a reissue of two earlier NIH funding opportunities, PA-24-245 and PA-24-246, and it exists to solve one specific problem. Many biomedical, MedTech, and life sciences companies finish a strong Phase II award and still face years of additional work before they can commercialize, particularly if their product needs FDA clearance, involves a complex manufacturing process, or targets a small patient population. NIH calls this gap the Valley of Death, and this award is designed to bridge it with a second, larger Phase II style grant.
This is not a new company's first NIH grant. It is a continuation award available only to businesses that already hold or previously held an NIH SBIR or STTR Phase II grant, cooperative agreement, or contract. A company cannot apply for a Phase IIB award without that Phase II history, and the Phase IIB award can only begin after the original Phase II project has ended.
Nineteen NIH institutes, centers, and offices participate in this funding opportunity, including the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, and others. Each participating component reviews applications aligned with its own mission and health research priorities.
Who Should Apply
This opportunity is a strong fit for a company if it can check most or all of the following boxes.
The company is a United States small business concern with 500 or fewer employees, including affiliates, and it already completed or is completing an NIH SBIR or STTR Phase II award.
The company has a product, therapeutic, device, or platform that needs a defined regulatory pathway, such as FDA clearance or approval, and that pathway requires more capital and more time than a standard Phase II budget allows.
The company can demonstrate, or is close to securing, a dollar-for-dollar match of the requested federal funds, drawn from new private capital such as venture investment, or from a non-SBIR federal or state award.
The company is within its first six standard due dates following the end of its Phase II budget period. Waiting longer than that risks losing eligibility for this specific mechanism.
If a company has Phase II results but does not yet have committed matching funds, or needs a smaller amount of technical assistance rather than a full second Phase II award, NIH recommends looking instead at the Commercialization Readiness Pilot Program (CRP) under PAR-27-098, which does not require a third-party match.
Funding Allowance and Budget Limits
Total funding support, meaning direct costs, indirect costs, and fee combined, cannot exceed $30,000,000 for a single Phase IIB Strategic Breakthrough award. Beyond that ceiling, each participating institute or center sets its own budget guideline, and applicants must stay within the guideline for whichever component will review their application. Representative examples include the National Cancer Institute at up to $15,000,000, the National Heart, Lung, and Blood Institute at up to $4,500,000, the National Institute on Alcohol Abuse and Alcoholism at up to $4,500,000, and most other participating institutes and centers at up to $3,000,000. A handful of components, including the National Eye Institute, the National Institute on Minority Health and Health Disparities, and the Office of Research on Women's Health, follow the standard SBA guideline rather than a fixed dollar figure.
The award period cannot exceed four years. Applicants should propose a project length that realistically matches the scope of the remaining development and commercialization work, not simply the maximum allowed.
Every dollar of federal funding requested must be matched by an equal dollar of third-party funding. This 100 percent match is a hard requirement under the Small Business Innovation and Economic Security Act, and it is one of the most heavily weighted factors in review. Matching funds must come from new private capital, such as another company, a venture capital firm, or another private investor, from a new government award other than a Phase I or Phase II SBIR or STTR grant, or from a combination of the two. Letters documenting committed matching funds should be included with the application's letters of support, and additional proof may be requested later during Just in Time review.
Key Dates and Timeline
The opportunity was posted on May 28, 2026, and the earliest applications can be submitted is August 5, 2026.
Applications are accepted on the standard NIH cycle three times per year, and every submission must be a Renewal, Resubmission, or Revision application type, except in the specific case of a Phase IIB tied to an underlying Phase II contract rather than a grant, which is submitted as New.
The upcoming due dates and their associated review timelines are as follows.
September 5, 2026 due date leads to scientific merit review in November 2026, advisory council review in January 2027, and an earliest possible start date of April 2027.
January 5, 2027 due date leads to scientific merit review in March 2027, advisory council review in May 2027, and an earliest possible start date of July 2027.
April 5, 2027 due date leads to scientific merit review in July 2027, advisory council review in August 2027, and an earliest possible start date of December 2027.
This same September, January, April cycle repeats through the expiration date of April 6, 2029. All applications are due by 5:00 PM local time at the applicant organization, and no late applications are accepted under this opportunity. If a due date falls on a weekend or federal holiday, it automatically moves to the next business day.
How to Apply
Applications are submitted electronically through one of three paths: the NIH ASSIST system, an institutional system to system solution, or Grants.gov Workspace, with application status then tracked in eRA Commons. Paper applications are not accepted.
Before submitting, a company must have several registrations active and current, and these can take six weeks or more to complete, so early preparation matters. The company needs an active registration in the System for Award Management (SAM.gov), which also issues a Unique Entity Identifier and a CAGE code. It needs an SBA Company Registry registration, which requires the UEI first. It needs an eRA Commons organizational account with at least one Signing Official and one Program Director or Principal Investigator listed, and every Program Director or Principal Investigator needs both a personal eRA Commons account and a linked ORCID iD. Finally, the company needs an active Grants.gov registration, which itself requires an active SAM.gov registration to complete.
The primary employment of the Program Director or Principal Investigator must be with the small business at the time of award and throughout the project, with limited exceptions for multi-PI teams.
Required application components include a Regulatory Plan of no more than two pages describing the regulatory pathway and milestone timeline, a Commercialization Plan addressing market opportunity, target customers, competitive landscape, and the source and evidence of 100 percent matching funds, and, where applicable, a VCOC Certification for companies majority owned by venture capital operating companies, hedge funds, or private equity firms. A Data Management and Sharing Plan is not required for this specific opportunity.
What NIH Reviewers Are Looking For
Reviewers score applications on the standard NIH criteria of Significance, Investigators, Innovation, Approach, and Environment, with extra weight placed on commercial trajectory given the Phase IIB context. For this award specifically, reviewers pay close attention to the progress made during the original Phase II project, whether market research supports the technology as an effective solution, and whether the applicant has provided compelling, documented evidence of its 100 percent match. Applications are also evaluated against Strategic Breakthrough criteria, including the technology's potential to advance national security capabilities, whether it offers new alternatives to existing approaches, whether a federal agency customer has expressed intent to adopt the technology, and whether the technology area is currently undercapitalized by private investors.
Funding decisions also weigh scientific merit alongside fund availability, demonstrated availability of the required match, and results of an HHS security risk assessment. Companies with certain ties to foreign countries of concern, or that appear on specified federal restricted entity lists, cannot receive an award under this opportunity, and all applicants under consideration for funding must submit an SBA Disclosure of Foreign Affiliations form during Just in Time review.
Common Reasons Applications Are Rejected Before Review
Applications are screened for completeness and responsiveness before they ever reach a review panel. The most common disqualifiers under this opportunity are applying without a completed NIH Phase II award as the foundation, applying for a clinical trial through an institute that does not accept clinical trials under this NOFO, such as NCATS or ORIP, missing or incomplete SAM.gov, UEI, or eRA Commons registrations at the time of submission, and failing to document credible progress toward the required 100 percent match.
Frequently Asked Questions
Does my company need a Phase I award to apply for Phase IIB? No. This opportunity is only for companies that already completed a Phase II award. There is no standalone Phase I component to this NOFO.
Can we apply if our matching funds are not fully secured yet? You should have strong, documented progress toward the full 100 percent match, ideally with signed or near final commitment letters, since this is one of the most heavily weighted review factors. If your match is not yet in place, the Commercialization Readiness Pilot Program under PAR-27-098 may be a better near-term fit.
How long do we have to apply after our Phase II award ends? You should submit within the first six standard NIH due dates following the end of your Phase II budget period to maintain eligibility for this mechanism.
What is the maximum award amount? Total funding support cannot exceed $30,000,000, though most participating institutes and centers set lower internal guidelines, commonly in the $3,000,000 to $4,500,000 range, with a few components following standard SBA guidelines instead.
Can foreign owned companies apply? No. Non-domestic entities and non-domestic components of United States organizations are not eligible. Companies with certain ownership ties, research affiliations, or listed relationships connected to countries of concern, including the People's Republic of China, are barred from receiving an award.
Is a clinical trial required? No. Clinical trials are optional under this opportunity, but applicants proposing a clinical trial should confirm their target institute or center accepts clinical trials, since NCATS and ORIP do not.
Can we submit more than one Phase IIB application? Yes, provided each application is scientifically distinct from any other pending or funded application, including any Commercialization Readiness Pilot application tied to the same underlying Phase II project.
What is the difference between Phase IIB and the Commercialization Readiness Pilot (CRP)? Phase IIB requires a full 100 percent third party match and functions as a second, larger Phase II award. CRP, under PAR-27-098, is designed for companies that need additional technical assistance or later stage research and development but do not yet have matching funds secured or need significant outsourced work. The two can run concurrently on the same underlying Phase II project if they are scientifically distinct.
Do we need a Data Management and Sharing Plan? No. This NOFO explicitly states a Data Management and Sharing Plan is not applicable.
What registrations do we need before we can submit? An active SAM.gov registration with an assigned UEI, an SBA Company Registry registration, an eRA Commons account for the organization and for each Program Director or Principal Investigator, an ORCID iD linked to each PD or PI's eRA Commons profile, and an active Grants.gov registration. Start this process early, since it can take six weeks or more from start to finish.
