NIDDK Targeted SBIR Funding Opportunity Announcements Modified to Allow SBIR Direct-to-Phase II Applications

Notice Number: NOT-DK-19-003

Key Dates
Release Date: October 24, 2018

Related Announcements
PAR-18-108

PA-17-130

PA-16-452

NOT-OD-19-019

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

NIDDK is amending three targeted SBIR funding opportunity announcements (FOAs) to allow SBIR Direct-to-Phase II submissions per below:

1. PAR-18-108 NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)

2. PA-17-130 Lead Optimization and Preclinical Development of Therapeutic Candidates for Diseases of Interest to the NIDDK (R43/R44)

3. PA-16-452 Kidney Precision Medicine Project - Technology Development and Validation (R43/R44)

NIDDK will also accept SBIR Direct-to-Phase II submissions to 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). Please see NOT-OD-19-019.

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 PAR-18-108:

Currently reads:

Application Types Allowed

New (Fast-Track)
Renewal (Phase II* Direct Phase II not allowed)
Resubmission (Fast-Track or Phase II)
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 (Fast-Track)
New (Phase II - Direct Phase II)
Renewal (Phase II)
Resubmission (Fast-Track, Phase II, Phase IIB, or Phase II - Direct Phase II)
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.

For both PA-17-130 and PA-16-452:

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 (Phase II - 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:

Daniel Gossett, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7723
Email: daniel.gossett@nih.gov