generate results that are purchased by NIH, unlike the procurement-oriented programs at DoD and NASA.
The NIH program has a number of defining characteristics, some of which are addressed in more detail in the remainder of this chapter.
Investigator-initiated research. NIH is the only agency where the topics areas in the program solicitation (request for applications) are guidelines, not mandatory limitations on research topics.
Larger awards. NIH now consistently exceeds the SBA awards size guidelines for Phase I and Phase II, utilizing a blanket SBA waiver to do so.
Peer-driven selection procedures. NIH appears to depend more than most other SBIR programs on external peer review for advice on award selection, although final decisions remain the responsibility of NIH staff.
Regulatory concerns. NIH is the only agency whose research often requires approval from the FDA before it can reach the market. This creates an important barrier to commercialization.
Multiple awarding components. Twenty-three Institutes and Centers (ICs) at NIH award fund their own SBIR awards, using a range of procedures and with different degrees of integration with other programs.
Together, these characteristics give the NIH program a unique character, and have informed management of the program in a number of important ways.
Outreach activities at NIH are extensive, compared to some other agencies, and have received significant attention from the NIH SBIR/STTR Program Office in recent years.
The activities appear in general to have had three primary objectives:
To ensure that SBIR attracts the most qualified applicants;
To reach geographical areas often perceived to be underserved; and
To reach specific demographic groups that are perceived to be underserved (e.g., businesses owned by women and minorities).
Mechanisms for achieving these objectives include:
National SBIR conferences, which twice a year bring together representatives from all of the agencies with SBIR programs, usually at locations far from the biggest R&D hubs (e.g., the spring 2005 national conference was in Omaha, Nebraska).
The National NIH SBIR conference held annually, in Bethesda, MD.