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.

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

1. PAR-18-269 Products to Support Applied Research Towards Zero Suicide Healthcare Systems (R43/R44 Clinical Trial Optional)

2. PA-18-819 Lab to Marketplace: Tools for Brain and Behavioral Research (R43/R44 - Clinical Trial Optional)

3. PA-18-566 Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R43/R44 Clinical Trial Optional)

4.PA-18-871 BRAIN Initiative: Development Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (SBIR) (R43/R44 - Clinical Trial Not Allowed)

5. PA-18-708 Novel Tools for Investigating Brain-derived GPCRs in Mental Health Research (R43/R44 Clinical Trial Not Allowed)

6. PA-18-928 I nnovative Technologies for HIV Behavioral and Social Science Research (R43/R44 Clinical Trial Optional)

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:

For each of these FOAs: PAR-18-269, PA-18-819, PA-18-566, PA-18-871, PA-18-708, PA-18-928

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:

Margaret C. Grabb
NIMH SBIR/STTR Program Coordinator
Telephone: 301-443-3563
Email: mgrabb@mail.nih.gov
Website: https://www.nimh.nih.gov/funding/sbir/index.shtml