Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH SBIR Omnibus Solicitations

Notice Number: NOT-OD-19-019

Key Dates
Release Date:October 15, 2018

Related Announcements
NOT-DK-19-003

PA-18-573

PA-18-574

Issued by
National Institutes of Health (NIH)

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 flexibility' 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 programs.

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. SBIR Direct-to-Phase II application are 'New' submissions and are not Renewals.

NIH is therefore amending its two SBIR Omnibus FOAs to allow SBIR Direct-to-Phase II submissions per below:

1. PA-18-573 PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

2. PA-18-574 PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

Other targeted SBIR FOAs issued by NIH Institutes and Centers may be modified in the future to also allow SBIR Direct-to-Phase II submissions on a FOA by FOA basis at the issuing Institute's/Center's discretion.

NIH  strongly encourages small businesses to contact the appropriate Institute or Center early in their application planning process to ensure their technology is of priority to the Institute/Center.

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 I. Funding Opportunity Description

The following text is added at the bottom of this Section for each FOA:

PA-18-573

The following Components will NOT accept a SBIR Direct-to-Phase II submission:

National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)

PA-18-574

The following Components will  NOT accept a SBIR Direct-to-Phase II submission:

National Institute of Environmental Health Sciences (NIEHS )

National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Centers for Disease Control and Prevention (CDC) (All Components of CDC)
U.S. Food and Drug Administration (FDA) (All Components of FDA)

 
Part 2, Section II. Award Information

For both PA-18-573 and PA-18-574:

Currently reads:

Application Types Allowed

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

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 Phase II)
Renewal (Phase II)
Resubmission (all phases)
Phase IIB Competing Renewal (Phase IIB)
Revision

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

All other aspects of these FOAs remain unchanged.

Inquiries

Please direct all inquiries to:

NIH SBIR/STTR Program Office
Telephone: 301-435-2688
Email: sbir@od.nih.gov
Website: http://sbir.nih.gov