Department of Health
and Human Services (HHS)
and Human Services (HHS)
January 6, 2020
National Institute of Neurological Disorders and Stroke (NINDS)
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 RFA-NS-18-012 to allow SBIR Direct-to-Phase II submissions
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
The following sections of RFA-NS-18-012 are changed as follows:
Part 2, Section II. Award Information
Currently Reads:
Application Types Allowed
New (Fast-Track)
Resubmission (Fast-Track)
Revision (Fast-Track)
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 (Fast-Track)
New (Phase II - Direct Phase II)
Resubmission (Direct Phase II, Fast-Track)
Revision (Direct Phase II, Fast-Track)
The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.
All other aspects of this FOA remain unchanged.
Emily Caporello, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: Emily.caporello@nih.gov
Nick Langhals, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: nick.langhals@nih.gov