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

Notice Number: NOT-NS-19-024

Key Dates
Release Date: November 21, 2018

Related Announcements

PAR-18-618

PAR-18-628

PAR-18-563

RFA-NS-18-022

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

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.

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

1. PAR-18-618NINDS Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)

2. PAR-18-628 NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

3. PAR-18-563 NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trial Optional

4. RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)

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 II. Award Information

For each of these FOAs: PAR-18-618 ,PAR-18-628 , PAR-18-563 , RFA-NS-18-022

Currently Reads:

Application Types Allowed

New (Phase I, Fast-Track)
Renewal (Phase II* Direct Phase II notallowed)
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 Read:

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:

Stephanie Fertig, MBA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:301-496-1779
Email:fertigs@ninds.nih.gov