What to do if you lose a NIH SBIR grant twice

by Tom Hollon

NIH’s rule of two strikes and you’re out makes winning SBIRs harder than ever. But even if you do strike out, you still may have options for getting your research funded.

There may still be options to win a grant for part or all of your research idea.

Not so long ago NIH allowed you to try three times to win a SBIR grant with the same research idea.

Now you can only try twice. Two strikes and you’re out.

This is one of several big changes NIH has made in the past few years to streamline grant review. With tens of thousands of grant applications to review each year, making grant review easier is a priority at NIH — even if it unintentionally makes winning SBIR grants harder.

If you’re in the situation of having struck out twice, here are some options for winning a grant for part or all of your research idea. But first, here’s what not to do.

These strategies for resubmitting a twice-failed SBIR grant don’t work (NIH won’t be fooled and will refuse to review your grant):

  • don’t merely change the title of your research project
  • don’t change your Specific Aims in just a minor way
  • don’t make minor changes to your research plan based on critiques in your Summary Statement
  • don’t submit your research plan to a different Funding Opportunity Announcement (FOA), different review committee, or different NIH institute

5 options for winning a grant for a twice-failed NIH SBIR research idea

1. If your research plan has such terrible scores for Significance, Innovation, or Approach that fixing it requires major changes to your Specific Aims and Approach, your repaired research plan might actually be a new application not subject to the two strikes rule.

To be sure it qualifies as a new application, talk it over with your institute’s SBIR Program Officer. Prior to speaking with your PO, email an abstract of your repaired SBIR research plan and your old abstract so your PO can compare.

In comparing, your PO will be guided by NIH Notice Number NOT-OD-09-100:

“A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in a resubmitted application. A new application should include substantial changes in all sections of the Research Plan, particularly in the Specific Aims and the Research Strategy sections. There should be fundamental changes in the questions being asked and/or the outcomes examined. Changes to the Research Plan should produce a significant change in direction and approach for the research project.”

If your PO agrees your repair job qualifies as a new application, then you can also discuss submitting it to a new FOA, different review committee, different institute, etc.

2. Decide whether you can develop your product through alternate Specific Aims and an alternate Approach. If you can do this, you may have a new application with no strikes against it.

This is slightly different from repairing a research plan as in option 1. Here you’re asking if there’s an alternate experimental approach to obtain the same or similar goal. This will drastically alter your twice-failed research plan, of course, but you may be able to retain some part of your original Specific Aims and Approach. Just be sure a PO believes it qualifies as a new SBIR application under NOT-OD-09-100 above.

3. Ask your SBIR Program Officer is there’s a RFA (Request for Applications) in your area of interest.

RFAs solicit grant applications (including SBIRs) on topics where NIH wants research encouraged. If there is a RFA in your field, you may be able to resubmit your twice-rejected SBIR research plan as a new application under NIH Notice Number NOT-OD-09-100:

“When a previously unfunded application that was originally submitted as an investigator-initiated application is to be submitted in response to an RFA, it is to be prepared as a new application.”

Naturally, your resubmitted application must meet the RFA’s grant review criteria or it won’t win a dime. Details for the RFA will be posted somewhere on NIH’s website, including the PO to contact to discuss resubmitting your SBIR research plan to compete for RFA funds.

4. If your SBIR research project can be reworked into a R21 or R01 research grant project, it can be submitted as a new application.

The vast majority of NIH R21 and R01 grants are awarded to academic researchers at universities, but a few are awarded to researchers at companies. But understand you’re in for a fight if you try this: winning these grants is even tougher than SBIRs.

To change your grant application from a SBIR to a R21 or R01 is to change its “activity code,” in NIH parlance. Under NIH Notice Number NOT-OD-09-100, such a change can make your application new, no longer subject to two-strikes-and-out:

“When an unfunded application that was reviewed for a particular research grant activity code is to be submitted for a different grant activity code, it is to be prepared as a new application.”

You’re probably familiar with R01s as the mainstay grants for funding basic medical research in academic labs. R01 grants can pay several hundred thousand per year for several years.

R21s are NIH Exploratory/Developmental Research Grant Awards. These are two-year grants worth up to $275,000 in direct costs over the duration of the grant. “The R21 grant mechanism is intended to encourage exploratory / developmental research by providing support for the early and conceptual stages of project development.”

As always, if you’re thinking of going this route, talk it over with a PO.

5. Submit part or all of your NIH SBIR research plan to the SBIR program of a different agency such as NSF, DOD, DOE, FDA, CDC, etc.

Depending upon what you’re doing, NIH may not be the only game in town.

For example, while SBIR grants from the National Science Foundation (NSF) do not fund research on specific diseases, they do sometimes fund research on medical technologies. Development of a drug delivery device or a special DNA microarray are examples of what NSF might be willing to consider.

Similarly, the Dept. of Defense (DOD) has funded SBIR grants for medical devices and research related to infectious diseases.


It’s devastating to lose a SBIR grant twice, but not necessarily the end of the world. You may still have ways to get your research idea funded. Start by looking over these options, then contact Program Officers for advice on what makes sense for your situation.















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