NIH SBIR and STTR Application Types

Phase I awards are intended to establish the technical merit, feasibility, and commercial potential of the proposed research and research and development (R/R&D) efforts. These applications help determine the quality of performance of the small business prior to providing further Federal support in Phase II. Phase I awards normally do not exceed $150,000 total costs for 6 months (SBIR) or 1 year (STTR).

If an applicant receives a Phase I award, they may submit a Phase II application either before or after expiration of the Phase I budget period. To maintain eligibility to seek Phase II support, a Phase I grantee should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period. If the grantee is outside of the six receipt period timeframe, they must contact their Phase I program officer and if the program officer is willing to receive an application, a waiver may be granted. Phase I applications are considered new (Type 1) in the NIH grant numbering system.

Phase II awards are intended to continue the R/R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. Only Phase I awardees are eligible for a Phase II award. SBIR Phase II awards normally do not exceed $1,000,000 total costs for 2 years. Phase II applications are considered renewals (Type 2) in the NIH grant numbering system.

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. Fast-track applications are considered new (Type 1) in the NIH grant numbering system.

Section 5106 of the SBIR/STTR Reauthorization Act of 2011 authorized that NIH may ‘issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development'.  This 'phase flexibility' is called a ‘Direct-to-Phase II’ SBIR award. The SBIR Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACL SBIR programs. See https://sbir.nih.gov/funding#phase2.

Phase IIB awards are intended to provide follow-on funding to small businesses for projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of projects such as drugs, devices, vaccines, therapeutics, and medical implants. Not all ICs offer Phase IIB awards, and depending on the IC, the budget may be requested for up to $1M per year for up to 3 years. For a full listing of those ICs that accept Phase IIBs, see the Omnibus Solicitation Program Descriptions and Research Topics document. Prospective applicants are strongly encouraged to contact NIH program staff prior to submission. Phase IIB applications are considered renewals (Type 2) in the NIH grant numbering system.

The Commercialization Readiness Program (CRP) may provide up to $3 million in additional funding for Phase II SBIR/STTR projects, and is not subject to the same partnering requirements that apply to SBIR or STTR awards. Therefore, the CRP may fund work that is not typically support through SBIR or STTR Phase II or Phase IIB awards, including:

For more information, please refer to the Commercialization Readiness Program (CRP) solicitations. You may also view the materials from the HHS CRP Informational Webinar (December 2, 2015).

• Preparation of documents for a Food and Drug Administration (FDA) submission
• Development of an intellectual property strategy
• Investigational New Drug (IND)-enabling studies
• Clinical studies
• Manufacturing costs
• Regulatory assistance
• Subcontracted work to other institutions, including contract research organizations (CRO)
• A combination of services