On the Road to Grant Success – Preparing an Effective NIH SBIR Grant Resubmission Application
September 29. 2020
You’ve submitted an NIH SBIR grant proposal and patiently waited, and then finally the impact score is posted on eRA Commons and shortly followed by the Summary Statement. Once the impact scores are released, it can be another 3-5 months to be notified about a funding decision. Adding to the suspense, the relationship between impact scores and funding probability (referred to as the ‘payline’) is not entirely transparent for all NIH Institutes. In general, if your application is fortunate to have a favorable impact score of <20, your chances of funding are reasonably high. Unfortunately, with the recent overall success rates for SBIR/STTR applications of 19%/20% for Phase 1 and 33%/40% for Phase 2 applications in 2019, not everyone can be in a position to celebrate. If your application was either unscored (ranked in the lower half of the applicant pool) or given an impact score that makes funding improbable (>40), a resubmission is worth consideration. Resubmitting the application with changes costs only your time and gives your application the advantage of supplying what reviewers are looking for. The Program Officer (contact information is on the Summary Statement) may be able to provide some guidance about funding probabilities and whether to resubmit grants with an Impact Score between 20 and 40.
Timing is Everything
As the Omnibus/Parent NIH SBIR and STTR Funding Opportunity Announcement only has three submission dates (January 5, April 5 and September 5), if you choose to resubmit, it is important to move quickly. From the receipt of the Summary Statement, there may only be a few weeks until the next submission deadline. Depending on the impact score, your company likely can’t afford to skip a deadline and risk not getting funded on the current application. Deadlines for targeted Program Announcements and Request for Applications (RFA) may vary; check that applications are still being accepted if the original grant application was made under a special RFA.
Organize a Response Strategy
Distribute the Summary Statement document to all key personnel, and arrange a time to discuss whether to resubmit and if so, outline a response strategy. Carefully read through the comments from individual reviewers on the Significance, Investigators, Innovation, Approach and Environment and the summary statement paragraph that reflects the discussion among all reviewers in the Scientific Review Group (SRG). Pick out common themes about aspects of the grant that scored well and what did not. The more favorable parts can be left alone, and the problematic areas will need closer attention. The Principal Investigator (PI) ideally should manage the process to rewrite sections that need to be changed, and prepare an Introduction, a document that summarizes the responses to reviewers’ comments in the resubmitted application. Lastly, if more than one reviewer seemed to have trouble understanding the proposal, it is worth contacting your Program Officer to discuss if resubmitting to a different SRG would result in a more appropriate review.
How do I Prepare an Introduction?
An Introduction is a summary of responses (limited to 1 page) to reviewers’ comments and appears just before the Specific Aims in the resubmission application. It is a critical document as reviewers will be required to consider how well the revised application addresses the previous review, and this will contribute to the new overall impact score. With limited space, the Introduction document requires clear thinking and focus. A good starting point is to briefly thank the reviewers for a careful examination of the proposal and state how changes in response their comments, insights, and suggestions will strengthen the application. The Introduction should then address all comments point by point and cite specific sections of the application that have been changed. This is not the place to have a defensive or sarcastic tone; just stick with facts backed up with data or literature references. If a reviewer misunderstood or misinterpreted something, provide a more clear description or graphic of your technology, methods or strategy. You may need to acknowledge that there is some controversy around a belief or conclusion, or even the basis for your proposal, but then explain how your proposal will help lead to clarity. Briefly mention any new data that helps to address reviewers’ concerns, and include the updated details in the Research Strategy section. Cite any new published data that can strengthen the premise or rationale for your proposal.
Several aspects of the application may have changed since your original submission; many sections of the grant are interdependent, so make sure everything is consistent. Review this checklist of documents that may need to be updated:
- Biosketches for key personnel- addition of new publications; changes to patent applications
- Budgets- change start/end dates, review costs and salaries for any changes, request new quotes for significant purchases, make sure the budget justification text agrees with any changes to the research strategy
- Commercialization Plan (Phase 2 applications)- update with any changes to the competitive landscape, key personnel/advisors/management team, and patents
- Letters of Support- update letters as needed
- Research Strategy- add new preliminary data and published research in the field
- References- add recent publications
There is almost no downside to resubmitting an NIH SBIR grant application with a less than optimal score. Reviewers cycle in and out of SRGs, and there is no guarantee the same reviewers will have a second look at the application. There is the possibility that new reviewers may bring up additional criticisms. However, if reviewers’ comments are carefully addressed your application should be more competitive and more likely to result in an award.
NIH SBIR Grant Receipt Dates and Review Schedule
NIH SBIR Grant Scoring System
NIH SBIR Grant Award Data
NIH/AHRQ Application Submission/Resubmission Policy
Examples of Successful Resubmissions