Image Guided Cancer Interventions (SBIR R43/R44) | Apply Online

Frequently Asked Questions (FAQs)

What is the Image Guided Cancer Interventions (SBIR R43/R44) funding opportunity?

It is an NIH discretionary grant opportunity (Funding Opportunity Number PA 07 042) under the SBIR program (R43/R44) that supports research and development of image guided interventions (IGIs) for cancer, with a strong focus on integrated systems and clinical validation.

What is the main goal of PA 07 042?

The central aim is to move beyond standalone imaging tools or isolated therapy devices and support the development and real-world testing of fully integrated IGI systems that combine cancer imaging, treatment planning, real-time monitoring, and therapy delivery.

What types of technologies is the FOA seeking?

The FOA is seeking technologies that help clinicians visualize tumors more clearly, target them more accurately, monitor what is happening during the procedure in real time, and deliver therapy in a way that is coordinated with imaging and monitoring components as part of an integrated platform.

Does the opportunity prioritize engineering development or clinical testing?

A major emphasis is clinical validation. The program is interested in projects that build and optimize integrated IGI platforms and then demonstrate that they work through clinical evaluations, rather than projects limited to early engineering work only.

What does "integrated system" mean in the context of this FOA?

In this context, an integrated system is a platform that links imaging, therapy planning, real-time monitoring, and therapy delivery into a coordinated workflow, instead of treating each component as a separate tool or device.

Are clinical evaluations required?

The FOA places strong emphasis on clinical evaluation and validation. It is designed to support credible clinical testing where performance, usability, and potential impact on cancer care can be measured.

Can the grant support development of multiple prototypes?

Yes. The FOA explicitly notes that multiple prototype systems may be needed, particularly for multisite clinical studies where more than one unit must be deployed across participating hospitals or clinical centers.

What kinds of partnerships are encouraged?

The FOA encourages partnerships that help move integrated IGI systems into clinical workflows, including collaborations among small businesses, large businesses, and academic medical centers, as well as small business joint ventures.

What funding mechanism is used for this program?

Funding is provided through the NIH Small Business Innovation Research (SBIR) program using the R43/R44 grant mechanisms.

What application types can applicants submit?

Applicants may submit Phase I, Phase II, or Fast Track applications under the SBIR R43/R44 mechanisms.

What is typically supported in Phase I?

Phase I generally supports feasibility work and early prototyping consistent with SBIR Phase I expectations.

What is typically supported in Phase II?

Phase II generally supports further development and more robust testing, including clinical evaluation when appropriate, aligned with the FOA's emphasis on clinical validation.

What are the Phase I budget and project period limits?

For Phase I, applicants may request up to $150,000 in total costs per year for up to 2 years, within SBIR limits and NIH application guidance.

What are the Phase II budget and project period limits?

For Phase II, applicants may request up to 3 years of support. When Phase II work includes clinical evaluation, the FOA allows up to $1,000,000 in total costs per year. If Phase II work does not include clinical evaluation, the budget cap is up to $750,000 in total costs per year.

How does clinical evaluation affect the Phase II budget cap?

If the Phase II plan includes clinical evaluation, the allowable budget cap is higher (up to $1,000,000 total costs per year) than if the work does not include clinical evaluation (up to $750,000 total costs per year).

Who is eligible to apply?

Eligibility is centered on small businesses, consistent with SBIR rules, with additional eligibility details referenced in the full FOA.

Are foreign institutions eligible to apply?

No. Foreign institutions are explicitly not eligible to apply under this opportunity.

Is cost sharing or matching required?

No cost sharing or matching requirement is stated for this FOA.

Is there a related opportunity for teams that fit STTR better?

Yes. This FOA runs in parallel with a closely related opportunity of the same scientific intent under the STTR program: PA 07 041 (R41/R42). This may be relevant for teams whose formal collaboration structure aligns better with STTR requirements.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA 93.394, Cancer Detection and Diagnosis Research.

What category is this opportunity listed under?

It is categorized under education and health.

Does this FOA have a single deadline or multiple receipt dates?

The announcement had multiple receipt dates rather than a single deadline. The specific receipt schedules and submission details are provided in the NIH Grants Guide entry for PA 07 042.

Where can applicants find the official receipt dates and application instructions?

The FOA indicates that full details, including receipt schedules and application instructions, are provided through the NIH Grants Guide link associated with PA 07 042.

What kind of applicant is this opportunity best suited for?

It is meant for small companies building integrated, clinically relevant cancer intervention systems where imaging and therapy are tightly linked and where the development plan includes credible validation in clinical settings, potentially across multiple sites with strong institutional partnerships.