SBIR and STTR Grants

Requirements for Applying

Credentials

One of the most challenging parts of the SBIR applications is the extensive credentialing process required before submission of an application . The following credentials must be obtained in order (Figure 2):

Figure 2: Steps Involved in Preparing a Small Business for Filling SBIR/STTR Grant Applications

It is important to retain the PDF generated by the SBA registration as it must be uploaded with the grant application.

This portion of the application process can take several months. It is best practice to start obtaining credentials even if the academic entrepreneur is still just considering applying; this way the application can be expedited once the decision is made. At a minimum, credentials should be obtained two months before submitting an application. The applicant should also be prepared to answer verification phone calls from Dun and Bradstreet and from the System for Award Management (SAM). In addition, the NIH has specific guidelines about the criteria for qualifying as an eligible small business concern (these are reviewed in the chapter "SBIR/STTR Grants: Introduction and Overview"), including percent of effort devoted to the small business by the principal investigator; these should be carefully reviewed on the NIH website at https://sbir.nih.gov/about/eligibility-criteria. Much like the FDA, the NIH encourages informal emails and calls regarding SBIR/STTR submissions.

Proposal

Investigators may solicit pre-submission feedback at the seedfund.nsf.gov website. A pre-submission may help an investigator determine if their project meets the requirements and goals of the SBIR/STTR program before applying. However, a pre-submission is not required and does not directly improve the chances of receiving an award.

There are two routes to making a proposal for an SBIR/STTR grant. The first is to identify an NIH institute that already has an objective in line with the research or technology enterprise of the principal investigator. The other - much more common - route is simply to apply during a request for proposals period as determined by the NIH. All submissions are electronic, and the SBIR/STTR program uses the "SF 424 Research and Related" document form.

A proposal for a Phase I award must demonstrate proof of concept and feasibility. Phase I should be outlined sufficiently to lead to a Phase II award, even if the investigator does not intend on submitting a Phase II application. The review committee prefers to see applications with future objectives in mind. This requires having milestones to measure successful completion of Phase I; these milestones should have very specific outcomes and measurable, numeric thresholds for success/failure. Investigators are often reluctant to do this because they worry this will limit their ability to apply for a Phase II grant in the future, but the review committee members are asked to search for these criteria, thus they need to be included. It is crucial that a proposed technology be novel and that funds not be purposed for marketing or minor improvements to existing products.

It is also imperative that the proposed budget and study plan be within the time and financial limits of Phase I and Phase II. The five axes upon which a proposal will be judged include "significance, approach, innovation, instigators (team), and environment" . The submission of a proposal does not formally constitute a public disclosure. This consideration is especially salient if the investigator has not yet made a public disclosure and intends to obtain intellectual property protection in the future. However, the abstract of the grant application will be made public, so any information in the abstract should not be privileged. Applicants can also request that elements of the grant application be kept confidential for a limited period of time. However, the grant may be requested under the Freedom of Information Act, with some information redacted.

Readers should refer to the NIH guidelines for a crucial list of elements that should and should not be included in the proposal. If a proposal is successful, the investigator must enter into a funding agreement with the federal government to receive funding.

The project summary is critically important because it will determine which study section will review the SBIR application; however, the applicant may request a particular study section on the cover page of the proposal. The summary should be interpretable by a reader outside the pertinent field, so it should be the most scrutinized and heavily edited part of the application. A poorly written project summary is often grounds for dismissal of the whole application. A cover letter may also be submitted with the application that requests a specific study section; this can be helpful to ensure that the application is reviewed in a timely manner by a section with sufficient expertise. Study sections have assigned Scientific Review Officers (SROs), who are often able to provide guidance prior to submission; after the review, however, it is best for the principal investigator to communicate with the NIH Program Officer (PO).

While preliminary data are required for a Phase II application, they are not required for a Phase I application; however, they can vastly improve the competitiveness of a Phase I proposal. If preliminary data are included, then they must be presented as if they were in a peer-reviewed journal article: they must contain statistical analysis that can be replicated, and be presented in a cogent, unbiased fashion. However, as noted earlier, excessive preliminary data in a Phase I application may lead to rejection, as the reviewers may feel that a Phase II application is warranted instead, or that the project was already completed as evidenced by the preliminary data.