Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to PAR-18-801 Cancer Prevention, Diagnosis, and Treatment Technologies for Low-Resource Settings (R43/R44 - Clinical Trial Optional)

Notice Number: NOT-CA-19-003

Key Dates
Release Date:October 15, 2018

Related Announcements

Issued by
National Cancer Institute (NCI)


Section 5106 of the SBIR/STTR Reauthorization Act of 2011 authorized that the National Institutes of Health (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" Small Business Innovation Research (SBIR) award.  The original authority for this provision had expired on September 30, 2017.  Recent legislation P.L. 115-232 re-instated this SBIR Direct Phase II provision through Fiscal Year 2022.

The NIH is re-implementing the SBIR Direct-to-Phase II program.  The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs).  The transition to FORMS-E earlier this year now allows NIH to track SBIR Direct-to-Phase II applications at the application level, as there is a new check-box on the SBIR/STTR Information Form for Direct Phase II.

The NIH does not need to issue separate SBIR Direct-to-Phase II FOAs as before, but can offer Direct-to-Phase II as an allowable Application Type on any SBIR FOA.

Accordingly, the NCI hereby amends PAR-18-801 Cancer Prevention, Diagnosis, and Treatment Technologies for Low-Resource Settings (R43/R44 - Clinical Trial Optional) to allow eligible applicants to submit SBIR Direct-to-Phase II application.

NCI  strongly encourages small businesses to contact the NCI SBIR Development Center in their application planning process to ensure their technology is of priority to the Institute/Center.

The following sections of PAR-18-801 are changed as follows:

Part 2, Section II. Award Information

Currently reads:

Application Types Allowed

New (Phase I, Fast-Track)
Renewal (Phase II* Direct Phase II  not allowed)
Resubmission (all phases)

The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

Modified to:

Application Types Allowed

New (Phase I, Fast-Track)

New (Direct-to-Phase II)
Renewal (Phase II)
Resubmission (all phases)

The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

All other aspects of PAR-18-801 remain unchanged.


Please direct all inquiries to:

Ming Zhao, Ph.D.
NCI SBIR Development Center 
Telephone: 240-276-5225