Notice Number: NOT-AG-18-043
Key Dates
Release Date: November 8, 2018
PAS-18-187
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 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.
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 PAS-18-187, "Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)," to allow for the submission of Direct-to-Phase II applications.
The following sections of PAS-18-187 are changed as follows:
Part 2, Section II. Award Information
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.
Award Budget
According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% as a hard cap ($225,000 for Phase I and $1,500,000 for Phase II). However, NIH has received a waiver from SBA, as authorized by statute, to exceed the hard cap of $225,000 for Phase I or $1,500,000 for Phase II for specific topics. The current list of approved topics can be found at https://sbir.nih.gov/funding#omni-sbir. Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.
Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.
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.
Award Budget
Phase I budgets up to $450,000 and Phase II and Direct-to-Phase-II budgets up to $2,500,000 in total costs may be requested.
Applicants are strongly encouraged to contact NIA program officials prior to submitting applications and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the small business research and development.
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
and Human Services (HHS)
