Notice Number: NOT-OD-06-004

Key Dates
Release Date: October 13, 2005

Issued by
National Institutes of Health (NIH), (http://www.nih.gov/)

The purpose of this notice is to announce two major changes in the submission and review of Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Fast-Track grant applications.

Submission. In the past, applicant small business concerns submitting SBIR and STTR Fast-Track grant applications to NIH were required to complete two separate and complete applications one for Phase I and another for Phase II. Beginning with the December 1, 2005, submission date, you need only prepare one grant application package consisting of both Phase I and Phase II activities.

Review. Previously, failure to provide clear, measurable goals might have been sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review and evaluate the Phase I application only. Beginning with the December 1, 2005 , submission date, the option for reviewers of NIH SBIR and STTR Fast-Track applications to decouple the Phase I/Phase II applications at the time of review will be eliminated. Consequently, a Fast-Track application will receive a single rating for the entire proposed project (i.e., it will receive a numerical score or it will receive an unscored designation). Thus, the entire proposed project is linked to its Phase I and Phase II components, without benefit of potential separation.

Rationale. The change to submission of a single Fast-Track application will enable applicants to tell a more complete, cogent story from feasibility to the commercialization plan. This new policy will also reduce the burden on small business applicants and reviewers by eliminating the redundant information in separate Phase I and Phase II applications. Further, t he changes preserve the original intent of the Fast-Track review option, namely to expedite the decision and award of SBIR and STTR Phase II funding for scientifically meritorious applications that have a high potential for commercialization.

The Phase I portion of a Fast-Track must still specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II work. In addition, as is required for all Phase II applications, the Phase II portion of a Fast-Track application must present a Commercialization Plan (maximum 15 pages) that addresses specific points. Applicants are reminded that failure to meet their milestones will be grounds for the project not continuing into Phase II.

All grant applicants must submit competing SBIR and STTR Fast Track applications online to the NIH through Grants.gov (http://www.grants.gov/) using the SF424 Research and Research Related (R&R) form as of the December 1, 2005, submission date (as announced in http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html. Specific instructions for preparing SBIR or STTR applications, including NIH Fast-Track applications will be included in the SF424 (R&R) Application Guide. This Application Guide will accompany the Funding Opportunity Announcements for SBIR and STTR Grant Applications, scheduled to be posted on October 17, 2005 in Grants.Gov.

Inquiries

Questions concerning this notice should be directed to

Ms. Kathleen Shino
NIH SBIR/STTR Program office
Phone: 301-435-2689
Email : ks48e@nih.gov