SBIR Proposal Writing Basics: Submission Rules on NIH Fast Track Proposals

Gail & Jim Greenwood, Greenwood Consulting Group, Inc.  

Copyright © 2011 by Greenwood Consulting Group, Inc.

 

An Alerting Service reader recently asked us to comment on two issues regarding submission of Fast Track Proposals at the National Institutes of Health (NIH). We took both questions to Dr. Matt Portnoy, Acting SBIR/STTR Program Coordinator for NIH, for his response. We appreciate Dr. Portnoy’s clarifications on these questions, and thought we would share them with you in this proposal writing tip.  

Let us start with a brief description of the NIH Fast Track Program, which differs from SBIR/STTR Fast Track Programs in other agencies like the Department of Defense. In an NIH Fast Track proposal, a small firm will present both the Phase 1 feasibility study and Phase 2 prototype development/testing effort in a single proposal. This proposal must adhere to NIH’s downsized page limits for Phase 2 proposals; i.e., the Research Plan cannot exceed 12 pages (since many SBIR/STTR companies find it tough to squeeze a Phase 2 proposal into that limit, you can imagine the challenge of doing a proposal for both Phase 1 and 2 within the 12 pages!). If the NIH reviewers like the project, and if it is awarded, then the company can conduct Phase 1 and, upon successful completion thereof and approval by NIH staff, continue into Phase 2 without having to submit a Phase 2 proposal for peer review.   NIH cautions that the Fast Track program is not for all SBIR/STTR projects and applicants, but we have found it is not unusual for NIH staff to encourage Fast Track submissions from even first-time applicants.

Now, for those two issues:  

1.       The reader said that she had been told that if she submitted a Fast Track proposal to NIH, and if it was not funded, then if she wanted to resubmit the proposal it would have to be sent in as a Fast Track proposal.  This would presumably be a concern if the NIH reviewers’ comments, and perhaps the SBIR/STTR applicant’s conversation with NIH staff after seeing those comments, suggested that the proposed project was not suitable for the Fast Track program.  However, Dr. Portnoy indicated that the company could submit just the Phase 1 portion of the rejected Fast Track proposal if they wanted to. This would be treated as a new application, which has the additional advantage of giving the applicant an additional chance of getting the Phase 1 funded (NIH grant proposals can be resubmitted one time if they are rejected on their initial submission; therefore, a resubmitted Fast Track proposal has only one additional chance of being funded. But if the Phase 1 portion of a rejected Fast Track proposal is revised and submitted by itself, then it is considered a new application and could receive yet another consideration if it has to be resubmitted).  

2.      The reader also had been told that she could resubmit a rejected Fast Track proposal, and simultaneously submit the Phase 1 portion of that Fast Track as a separate proposal, thus having two concurrent chances of getting funding to start the project. Dr. Portnoy clarified that an SBIR/STTR applicant cannot submit the same project simultaneously in two different proposals to NIH. Even if the proposals are being submitted in response to different NIH solicitations/funding opportunity announcements, this is not allowed. The two proposals would have to be for different projects, or one of the proposals would have to be submitted to a different SBIR/STTR agency for consideration (and, if both NIH and the other agency want to fund the project, the applicant would have to choose one agency or the other—if the applicant takes funds from both agencies to do the work and thus get double payment, then they likely will be writing the Phase 2 proposal from the confines of a Federal penitentiary).  

The broader lesson here is that, even though NIH is an extremely flexible agency in its SBIR/STTR programs, it does have rules and restrictions that must be followed. In other words, “flexibility” should not be misinterpreted to mean that you can do whatever the heck you want to do when submitting SBIR/STTR projects to NIH. Further, if you are not sure whether or not something is allowed at NIH (or at any other SBIR/STTR agency, for that matter), then seek out guidance far in advance of the proposal submission deadline. We recommend you ask your question (and hopefully get an answer) via email so that you have clear documentation on what you were told, on what date, and by whom. At a minimum, if guidance is sought or received via phone or in person conversations, be sure to make a note for your files regarding who told you what and on what date. To ensure that there was no mistake in your understanding of that verbal guidance, you may want to send the advice giver an email confirming what you understood to be their guidance and asking them to respond to you within 10 business days if you are mistaken.