Lab to Marketplace: Tools for Brain and Behavioral Research (R43/R44 - Clinical Trial Optional | PAR 18 565

FAQs: Lab to Marketplace: Tools for Brain and Behavioral Research (PAR-18-565)

What is PAR-18-565?

PAR-18-565, titled "Lab to Marketplace: Tools for Brain and Behavioral Research," is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding opportunity designed to help translate promising brain and behavioral research tools into commercial products and services.

What is the main purpose of this funding opportunity?

The central goal is commercialization-oriented translation. The program is intended to move an existing research technology from an academic or other non-small-business setting closer to broad adoption by improving practical, real-world features that determine whether a tool is actually used outside the lab.

What kinds of projects are a good fit for this FOA?

Projects that take an existing brain or behavioral research technology and focus on product development steps that reduce barriers to adoption. Examples described include engineering improvements, reliability and reproducibility upgrades, workflow and usability enhancements, software hardening, packaging for distribution, documentation and training materials, interoperability with commonly used systems, and quality control processes.

Is this opportunity intended for early-stage discovery research?

No. The emphasis is on translating an existing research-grade prototype, method, or technology into something more robust, user-friendly, and positioned for dissemination and routine use, rather than supporting early-stage discovery.

What funding mechanism does PAR-18-565 use?

The mechanism is NIH SBIR R43/R44. This generally supports Phase I (R43) feasibility work and Phase II (R44) development and validation work, consistent with a typical SBIR pathway.

Can an applicant propose only Phase I or only Phase II?

Yes. Applicants can propose a Phase I (R43) project to establish feasibility, a Phase II (R44) project to further develop and validate the product, or a combined approach depending on the FOA structure and eligibility.

Are clinical trials required under this FOA?

No. Clinical trials are optional. A clinical study may be included when appropriate for development or validation, but the opportunity is not limited to clinical trial work.

What does NIH mean by improving "practical features" for adoption?

Based on the description, NIH is looking for work that makes tools easier to deploy and support in real settings. That can include improving reliability and reproducibility, enhancing usability and workflows, strengthening software, enabling interoperability, building distribution-ready packaging, and creating documentation, training, and quality control processes.

Does the FOA emphasize dissemination and routine use?

Yes. A key aim is to turn a research-grade tool into a product or service that researchers can reliably purchase, install, learn, and use routinely, with the support and robustness expected of a market-ready offering.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR requirements.

Are foreign institutions or non-U.S. entities eligible to apply?

No. Foreign institutions and other non-U.S. entities are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible to apply.

Can a U.S.-based applicant include any foreign involvement?

Possibly. The opportunity notes that foreign components (as defined in the NIH Grants Policy Statement) may be allowed under certain conditions. This would require that the primary applicant is U.S.-based, that any foreign elements are permitted under NIH policy, and that they are well-justified for the project.

What kind of collaboration does NIH expect for this FOA?

A defining expectation is close partnership between the small business and the original technology developers, who are often at universities, research institutes, or other non-small-business organizations. The intent is to keep the scientific and technical know-how of the original inventors actively involved while the small business drives product development and commercialization.

How can the collaboration between the small business and inventors be structured?

The FOA indicates collaboration can be structured in multiple ways, including the use of multiple program directors/principal investigators (PDs/PIs) when appropriate, and generally encourages arrangements that ensure sustained, hands-on involvement from both the inventors and the commercialization-focused small business.

What is NIH looking for in competitive applications under this FOA?

Based on the description provided, the most competitive projects typically combine a strong technical foundation with a credible product-development plan, a clear route to commercialization, and evidence that the collaboration between the inventors and the small business is real, active, and essential to delivering a tool that can succeed beyond the originating lab.

What agency administers this grant program?

This is administered by the National Institutes of Health (NIH).

What type of grant program is this listing describing?

The posted opportunity data describes it as a discretionary grant program.

What is the CFDA number associated with this opportunity?

The CFDA number listed for this program is 93.242.

What were the dates shown in the posted opportunity data?

The listing includes a creation date of January 9, 2018, and an original closing date of June 6, 2018.

Does the listing provide an award ceiling or expected number of awards?

No. The posted opportunity data referenced does not provide an award ceiling or an expected number of awards.

What gap is this FOA trying to bridge?

It targets the common gap between a useful brain or behavioral research tool created in an academic environment and a market-ready offering that can be reliably deployed, supported, and used broadly beyond the originating laboratory.

Is the program limited to tools used only in research settings?

The focus is on tools for the research community, and the description also notes that clinical or applied settings may be relevant when appropriate for the tool and its development or validation.