Addition of SBIR Direct-to-Phase II Program to PAR-18-588, Assistive Technology for Persons with Alzheimer's Disease and Related Dementias and Their Caregivers (R43/R44 Clinical Trial Optional)"

Notice Number: NOT-AG-18-042

Key Dates
Release Date: November 8, 2018

Related Announcements
PAR-18-588

Issued by
National Institute on Aging (NIA)

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 flexibility' 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.  

Note: The SBIR Direct-to-Phase II (DPII) award authority is not available for the STTR program.

The legislative reauthorization of the DPII Program empowers NIH to relaunch the SBIR DPII Program.  Prior NIH SBIR/STTR application forms required NIH to issue stand-alone DPII funding opportunity announcements (FOAs). However, NIH's transition earlier this year to FORMS-E allows NIH to invite and track DPII applications through the FORMS-E, as there is a check-box on the SBIR/STTR Information Form (part of FORMS-E) for the DPII Program.

Consequently, NIH and NIA do not need to issue stand-alone SBIR DPII FOAs but can offer the DPII Program as an allowable Application Type on any SBIR FOA.

NIA is therefore amending PAR-18-588, “Assistive Technology for Persons with Alzheimer’s Disease and Related Dementias and Their Caregivers (R43/R44 Clinical Trial Optional),” to allow for the submission of Direct-to-Phase II applications.

The following sections of PAR-18-588 are changed as follows:

Part 2, Section II. Award Information

Currently reads:

Application Types Allowed

New (Phase I, Fast-Track)
Resubmission (all phases)
Revision

The  OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

Award Budget

Budgets up to $500,000 total costs per year for Phase I and up to $1,000,000 total costs per year for Phase II may be requested.

Modified to:

Application Types Allowed

New (Phase I, Fast-Track)

New (Phase II – SBIR Direct Phase II)
Resubmission (all phases)
Revision

The  OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

Award Budget

Phase I budgets up to $500,000 in total costs per year and Phase II and Direct-to-Phase-II budgets up to $2,500,000 in total costs may be requested.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Michael-David A.R.R. Kerns, M.M., M.S. Ph.D.

National Institute on Aging (NIA)
Telephone: 301-402-7713
Email:  kernsmd@mail.nih.gov