Small Business Application Types

This phase aims to establish the technical merit, feasibility, and commercial potential of the proposed research and development (R&D) efforts and to determine the quality of performance of the small business awardee organization.

• Funding Range: Normally does not exceed $150,000 in total costs
• Funding Timeframe: 6 months (SBIR) or 12 months (STTR)
• Small Business Innovation Research (SBIR) Phase I: The small business typically performs a minimum of 67% of the work supported by the award.
• Small Business Technology Transfer (STTR) Phase I:
  • The small business must perform at least 40% of the work.
  • The research institution must perform at least 30% of the work.
  • The remaining 30% may be done by the small business concern, the nonprofit research institution partner, or an additional third party.

Phase II continues the R&D efforts initiated in Phase I to develop the project's commercial viability. In general, only Phase I awardees are eligible for Phase II awards. Phase II awards are viewed as renewals and not new applications.

• Funding Range: Normally does not exceed $1,000,000 in total costs
• Funding Timeframe: Up to 2 years
• SBIR Phase II: The small business typically performs a minimum of 50% of the work supported by the award.
• STTR Phase II:
  • The small business must perform at least 40% of the work.
  • The research institution must perform at least 30% of the work.
  • The remaining 30% may be done by the small business concern, the nonprofit research institution partner, or an additional third party.

Fast-track incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application.

Because both phases undergo review at the same time, the NIH Fast-Track mechanism can reduce or eliminate the funding gap between phases.

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 an SBIR Phase II award even if they have not previously received a Phase I award for the R/R&D of their technology.

The congressional authority for SBIR Direct Phase II is reinstated until FY2022. To be eligible for the SBIR Direct-to-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., U.S. Food and Drug Administration [FDA], Federal Communications Commission). Such products include, but are not limited to: medical implants, pediatric devices, drugs, vaccines, and new treatment or diagnostic tools that require FDA approval.

Applicants who received NICHD SBIR Phase I or Phase II support and who are currently Phase II awardees are eligible (NICHD SBIR only and only competing renewals of NICHD-supported Phase II awards).

The purpose of this mechanism is to provide additional support for later stage research and development necessary to move closer to commercialization. Funding priority will be given to those small business concerns that show the ability to develop innovative products and demonstrate growth toward independence from the SBIR/STTR programs.

• Funding Range: Up to $1,000,000 per year
• Funding Timeframe: Up to 3 years

You are strongly encouraged to contact Dr. Toyin Ajisafe or the branch program officer before beginning the process of putting a Phase IIB competing renewal application together.

Prospective applicants are strongly encouraged to submit to the program officer a letter of intent that includes the following information:

• Descriptive title of the proposed research
• Name, address, and telephone number of the Principal Investigator (PI)
• 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 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 Phase IIB (NICHD does not accept Phase IIB for STTR).
• Phase II SBIR awardees may apply for NIH SBIR or STTR Phase IIB.