As part of the SBIR and STTR Reauthorization of 2011, NIH issued a pilot SBIR Direct to Phase II solicitation, which permits small businesses to receive a Phase II award even if they have not previously received a Phase I award for the research/research and development of their technology.
In order to be eligible for the Pilot SBIR Direct Phase II award, the small business must have performed the Phase I stage-type of research through other funding sources.
NICHD will accept Phase IIB SBIR Competing Renewal grant applications to continue the process of developing products that require approval of a Federal regulatory agency (e.g., FDA, FCC). Such products include, but are not limited to: medical implants, pediatric devices, drugs, vaccines, and new treatment or diagnostic tools that require FDA approval. This renewal grant should allow small businesses to get to a stage where interest and investment by third parties is more likely.
Applicants who received NICHD SBIR Phase I or Phase II support and who are currently Phase II awardees are eligible. Budgets for Phase IIB renewals should not exceed $3 million total costs for 3 years. Depending on the research proposed the amounts may vary each year for the time requested.
Prospective applicants are strongly encouraged to submit to the program contact a letter of intent that includes the following information:
- Descriptive title of the proposed research
- Name, address, and telephone number of the Principal Investigator
- Names of other key personnel
- Participating institutions
- Funding Opportunity Announcement Number (e.g., PA-12-XXX)
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. It is expected that only a portion of NICHD SBIR/STTR Phase II awards will be eligible for a Phase IIB Competing Renewal grant.
NIH SBIR and STTR applicants may now switch programs at Phase II or Phase IIB to any active and open NIH SBIR or STTR solicitation, including SBIR and STTR Omnibus Solicitations and any SBIR or STTR targeted funding opportunity. Applicants must follow all the rules and policies for the program and solicitation for which they are applying. The employment status of the PI, sub-contracting rules, etc., must be adhered to for the Phase II or IIB application to the opposite program. Applicants are also strongly advised to discuss this option with their Program Officer well in advance of any due date.
This means that:
- Phase I STTR Awardees may apply for NIH SBIR or STTR Phase II.
- Phase I SBIR Awardees may apply for NIH SBIR or STTR Phase II.
- Phase II STTR Awardees may apply for NIH SBIR or STTR Phase IIB.
- Phase II SBIR Awardees may apply for NIH SBIR or STTR Phase I