NOT-MH-18-070: Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH FOA PA-17-147

Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH FOA PA-17-147

Notice Number: NOT-MH-18-070

Key Dates
Release Date: November 7, 2018

Related Announcements
PA-17-147

Issued by
National Institute of Mental Health (NIMH)

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.

NIH is therefore amending:

1. PA-17-147 Development of Highly Innovative Tools and Technology for Analysis of Single Cells (SBIR) (R43/R44)

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 the FOA are changed as follows:

Part 2, Section I. Funding Opportunity Description

PA-17-147

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

National Center for Complementary and Integrative Health (NCCIH)

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)
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 FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Margaret Grabb, Ph.D.
Telephone: 301-443-3563
Email: [email protected]
Website: http://sbir.nih.gov