Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to PAR-18-303 Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (R43/R44 Clinical Trial Not Allowed)

Notice Number: NOT-CA-19-002

Key Dates
Release Date:October 15, 2018

Related Announcements
PAR-18-303

Issued by
National Cancer Institute (
NCI)

Purpose

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 reinstated 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-18-303 Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (R43/R44 Clinical Trial Not Allowed) to allow eligible applicants to submit SBIR Direct-to-Phase II applications.

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 NCI.

The following sections of PAR-18-303 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 (Phase II - Direct 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-18-303 remain unchanged.

Inquiries

Please direct all inquiries to:

Jonathan Franca-Koh, Ph.D.
NCI SBIR Development Center

Telephone: 240-276-7622
Email: francakohjc@mail.nih.gov