Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIGMS SBIR FOAs

Notice Number: NOT-GM-19-003

Key Dates
Release Date: October 22, 2018

Related Announcements
PA-18-815
PAR-18-402
PA-16-186
PA-16-157

Issued by
National Institute of General Medical Sciences (
NIGMS)

Purpose

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 flexbility' is called a ‘Direct-to-Phase II’ SBIR award. The original authority for this provision had expired on 9/30/2017.  Recent legislation P.L. 115-232 re-instated this SBIR Direct Phase II provision through Fiscal Year 2022.  

The SBIR Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACL SBIR progams.

As such, 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.

As a result of this, 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.

NIGMS is therefore amending its targeted SBIR FOAs to allow SBIR Direct-to-Phase II submissions per below:

PA-18-815 "Better Defining Growth Medium to Improve Reproducibility of Cell Culture (SBIR) (R43/R44 - Clinical Trial Not Allowed)"

PA-18-402 "Interactive Digital Media STEM Resources for Pre-College and Informal Science Education Audiences (SBIR) (R43/R44 Clinical Trial Not Allowed)"

PA-16-186 "Tools for Cell Line Identification (SBIR [R43/R44])"

PA-16-157 "New Technologies  for the Glycosciences (R43/R44)"

 An updated SBIR/STTR Application Guide with additional instructions for SBIR Direct Phase II application preparation and submission will be posted by November 26, 2018.

The following sections of each FOA are changed as follows:

Part 2, Section II. Award Information

Application Types Allowed

Language regarding New and Renewal applications currently reads:

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

Language regarding New and Renewal applications is modified to read:

New (Phase I, Fast-Track)

New (Phase II - Direct Phase II)

Renewal (Phase II)

All other aspects of these FOAs remain unchanged.

Inquiries

Please direct all inquiries to:

Please direct all inquiries to the relevant NIH staff indicated in Part 2. Section VII Agency Contracts of the FOA.