Small Business

The NEI Small Business Innovative Research (SBIR) (R43/R44) and Small Business Technology Transfer Research (STTR) (R41/R42) programs provide early-stage capital for innovative small U.S. companies for the purpose of engaging in federal Research & Development (R&D) that has a strong potential for commercialization. Both the SBIR and STTR programs are divided into three phases, however, only the first two received federal funds. Phase I is the Feasibility and Proof of Concept stage, which establishes the technical merit, feasibility, and commercial potential of the proposed Research and Development (R&D) project and also determines the quality of performance of the small business. Phase II is the Research and Development stage, which continues the R&D work initiated in Phase I and brings the project to an advanced level, approaching commercialization. Phase III is the Commercialization stage, where the small business pursues commercialization objectives to bring the product to market with non SBIR/STTR funds.

Key elements of the SBIR and STTR programs are as follows:

• Allows for a wide range of topics and innovative projects with strong science/technology, and high commercialization potential
• Provides funding for three phases depending on performance:
  • Phase I Feasibility grant: 6 months to 2 years and $295,924 (total costs)
  • Phase II R&D grant: 2 years and $1,972,828 (total costs)
  • Phase IIB Competing Renewal R&D grant for projects that need extraordinary time & effort in the R&D stage to develop such projects: 2 years and $1,972,828 (total costs)
• Offers distinct technical assistance programs to SBIR Phase I and Phase II awardees which include a Niche Assessment Program and a Commercialization Acceleration Program
• Gives access to the NIH Regulatory Assistance Program, which aids in the procurement of consultants knowledgeable in the federal regulatory process necessary for the approval of new drugs and devices and helps grantees bring innovative vision and eye care products to the marketplace more efficiently