The National Institutes of Health (NIH) is the major medical research agency in the United States with a budget of over $30 billion. NIH funds almost 50,000 grant applications per year through its 27 Centers and Institutes. While about 80% of these funds go towards medical research at universities, medical schools, and other research institutions, almost $1 billion of these funds is allocated for small businesses through the SBIR and STTR programs. NIH will fund most concepts that have the potential to improve life and reduce illness. Applications that propose new therapies, diagnostics, or preventatives addressing almost any disease or health issue can be submitted to NIH. Tools that enable further knowledge of diseases also interest NIH.
NIH is broken into 27 Centers and Institutes that each have their own mission. Proposals are submitted, reviewed, and funded by the particular Center or Institute that fits best with the proposed effort.
NIH CentersCenter for Information Technology (CIT)Center for Scientific Review (CSR)Fogarty International Center (FIC)National Center for Advancing Translational Sciences (NCATS)National Center for Complementary and Integrative Health (NCCIH)NIH Clinical Center (CC)
NIH InstitutesNational Cancer Institute (NCI)National Eye Institute (NEI)National Heart, Lung, and Blood Institute (NHLBI)National Human Genome Research Institute (NHGRI)National Institute on Aging (NIA)National Institute on Alcohol Abuse and Alcoholism (NIAAA)National Institute of Allergy and Infectious Diseases (NIAID)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)National Institute of Biomedical Imaging and Bioengineering (NIBIB)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)National Institute on Deafness and Other Communication Disorders (NIDCD)National Institute of Dental and Craniofacial Research (NIDCR)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)National Institute on Drug Abuse (NIDA)National Institute of Environmental Health Sciences (NIEHS)National Institute of General Medical Sciences (NIGMS)National Institute of Mental Health (NIMH)National Institute on Minority Health and Health Disparities (NIMHD)National Institute of Neurological Disorders and Stroke (NINDS)National Institute of Nursing Research (NINR)National Library of Medicine (NLM)
For details on the mission of each Center and Institute, please check out the NIH website here.
As with all other SBIR agencies, NIH SBIR and STTR efforts are composed of a Phase I feasibility study, followed by a Phase II period funding further research and development. Phase I awards are normally funded at up to $150,000 for 6-12 months and Phase II awards are for up to $1,000,000 for up to 2 years of effort. With justification, applications can request up to 50% more funding for Phase I and Phase II, resulting in budgets of $225,000 for Phase I and $1,500,000 for Phase II.
While these funding levels are typically hard ceilings, one difference with the NIH SBIR program compared to other agencies is the ability to request even more funding. Every year, NIH publishes a list of topics where the funding ceiling can be waived. If you plan to submit a budget greater than $225,000 for Phase I and greater than $1,500,000 for Phase II, then it’s best to contact the topic Program Manager prior to submission. Here is the list of current topic waivers at NIH.
Besides the ability to request larger than normal funds for SBIRs and STTRs, NIH has other key differences over other SBIR agencies. One difference is the ability to apply for a Phase I and Phase II at the same time. This is what NIH terms a Fast Track application. A Fast Track proposal reduces the delay between Phase I and Phase II funding by having NIH review both Phase I and Phase II applications simultaneously. The Fast Track application is submitted as a single, contiguous proposal with research strategies and associated budgets clearly split between the Phase I and Phase II periods. Fast Tracks are quite competitive but can be the best approach to take if you have a coherent plan showing how you will prove feasibility in Phase I and transition to Phase II and beyond.
Another key difference between NIH STTRs and other STTRs is the allowance of having academic Principal Investigators (PIs). For SBIRs and most STTRs, the PI has to be majority employed by the applicant business. However, NIH allows companies that are submitting STTRs to have a PI with an academic appointment and allows for that academic PI to maintain their appointment. Essentially, the PI can remain at the academic institution and is not required to be employed by the company upon time of award, as with all SBIRs and most STTRs. This arrangement can be quite helpful to those companies who are transferring technology from a university or medical research institution.
Finally, another difference between NIH and other SBIR agencies is submitting proposals. Similar to the DOD, NIH has broad topics open three times per year – January, April, and September. This is for their Omnibus Solicitation, which covers most of the topics of interest at NIH. However, NIH also has an R&D Contract Solicitation that opens once a year with a due date, typically in October. The contracts are much more specific than the topics listed in the Omnibus Solicitation. The budgets for contracts are also more defined with hard ceilings. However, many contract topics allow for budgets that are greater than your typical SBIR or STTR application. Besides the Contract Solicitation and Omnibus Solicitation, NIH also releases target solicitations throughout the year that call for proposals that address specific needs. With these solicitations, NIH provides the greatest number of opportunities for medical funding. You can learn more about NIH SBIR/STTR funding opportunities here on the NIH website.