NIAID SBIR-Technology Transfer Direct Phase II (R44) | Apply Online

Frequently Asked Questions (FAQs)

What is the NIAID SBIR-Technology Transfer Direct Phase II (R44) opportunity?

This is a Small Business Innovation Research (SBIR) grant opportunity run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services (HHS). It is designed to move specific technologies developed inside NIAID intramural (government) laboratories into commercial development so they can become real-world products.

What is the official Funding Opportunity Number (FOA) for this program?

The Funding Opportunity Number is RFA-AI-16-009.

What SBIR mechanism does this opportunity use?

It uses the Direct-to-Phase II SBIR mechanism under the R44 activity code (also described as a Technology Transfer Direct Phase II approach).

What does "Direct-to-Phase II" mean in practice?

Direct-to-Phase II means the project is expected to be beyond the earliest proof-of-concept stage and ready to start Phase II-level R&D without first completing a traditional Phase I. Applicants are generally expected to already have sufficient preliminary evidence, feasibility data, or prior development groundwork to justify moving straight into advanced development activities.

What is the main purpose of this grant?

The core purpose is technology transfer: taking inventions that originated in NIAID intramural research laboratories and funding the next steps needed to turn those inventions into commercially viable products, especially vaccines or other products that prevent or treat diseases aligned with NIAID mission areas.

What kinds of products or technologies is the program trying to advance?

The opportunity is focused on NIAID-developed technologies that can become commercially viable vaccines or products that prevent or treat diseases within NIAID mission areas, generally including infectious diseases, immunology, and allergy-related conditions.

Who is eligible to apply?

Applications are specifically solicited from eligible U.S. small business concerns. The applicant organization must qualify as a small business under SBIR rules and must be prepared to serve as the primary driver of the development effort.

Does the small business have to lead the project?

Yes. The small business is expected to be the primary driver of the development effort, consistent with the SBIR program structure described in the opportunity summary.

Are collaborations allowed, and who can be involved?

Yes. The scientific and product-development work can include the small business team plus collaborators from NIAID intramural laboratories and/or external partners. These relationships may be organized through collaborations or consortium arrangements.

What type of work is NIAID looking to fund under this FOA?

The program is aimed at closing the gap between lab-stage discoveries and development work needed to move a product toward commercialization. This can include work that supports marketplace readiness, clinical testing preparation, regulatory readiness, manufacturing scale-up planning, and eventual adoption.

Is this program intended for basic research or product development?

The emphasis is on development-oriented, milestone-driven work aimed at commercialization. The opportunity highlights assembling the right expertise and capabilities to advance a defined technology toward commercial use, rather than conducting purely academic research.

What kinds of outcomes is this program trying to produce?

It is structured to generate outcomes that position a technology for entry into the marketplace. This typically includes de-risking a product, refining the technology, demonstrating performance in relevant models, and producing deliverables that support partnering, licensing, regulatory planning, and downstream investment.

What agency and institute are sponsoring this opportunity?

The sponsoring agency is the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH). The mission-aligned institute for this opportunity is the National Institute of Allergy and Infectious Diseases (NIAID).

What is the funding instrument type?

The funding instrument is a grant.

What is the funding activity area?

The opportunity is categorized under the health funding activity area.

What CFDA numbers are associated with this opportunity?

The associated CFDA numbers are 93.855 and 93.856.

When was this FOA posted, and what is the closing date?

The FOA was posted/created on February 18, 2016. The original and current closing date listed is June 23, 2016.

Does the provided information specify an award ceiling or the expected number of awards?

No. The source details provided do not list an award ceiling or the expected number of awards.

How should applicants interpret funding limits if they are not listed here?

Because an award ceiling and expected number of awards are not provided in the supplied summary, prospective applicants would typically need to consult the full announcement and applicable NIH SBIR budget guidelines to understand funding limits, project period expectations, and any institute-specific constraints.

What makes this opportunity different from a typical SBIR solicitation?

Two defining features are emphasized: (1) it is specifically focused on technology transfer of NIAID intramural innovations (government lab inventions) into commercial development, and (2) it uses a Direct-to-Phase II approach intended to accelerate progress for projects that are already beyond the earliest feasibility stage.

Is the program focused on licensing or adopting government lab innovations?

Yes. The opportunity is framed as a commercialization-focused SBIR pathway for small businesses to license or otherwise adopt NIAID intramural innovations and complete later-stage applied R&D needed to turn them into deployable vaccines or therapeutics/preventatives.

What kind of project approach is implied by the FOA summary?

The summary points toward projects that move quickly, are grounded in strong development planning, rely on appropriate partnerships and expertise, and are designed to achieve commercialization-relevant deliverables rather than remaining in the research domain.