Notice Number: NOT-TR-19-004
Key Dates
Release Date:October 15, 2018
None
Issued by
National Center for Advancing Translational Sciences (NCATS)
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.
NCATS is therefore amendingthe following SBIR FOA to allow SBIR Direct-to-Phase II submissions per below:
PAR-17-035 Platform Delivery Technologies for Nucleic Acid Therapeutics (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:
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:
NCATS SBIR/STTR Program
Telephone: 301-827-7170
Email: NCATS-SBIRSTTR@mail.nih.gov
and Human Services (HHS)
