Notice Number: NOT-HL-18-633

Key Dates
Release Date: July 30, 2018

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

On May 16th, 2018, NHLBI issued RFA-HL-19-017 NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional). The purpose of this Notice is to clarify the Criteria for Complete, Compliant and Responsive Applications.

Section I. Funding Opportunity Description

Criteria for Complete, Compliant and Responsive Applications

Current Language:

Criteria for Complete, Compliant, and Responsive Applications

Applications deemed to be non-responsive will not proceed to review. The following are considered non-responsive to this FOA:

• Applications that do not propose a budget amount and project period that conform to the limits described under Section II ("Award Budget" and "Award Project Period")
• Applications that do not propose R&D that represents the continuation of work conducted under a previously-funded SBIR or STTR Phase II award (grant or contract)
• Applications that do not propose R&D that falls within the technical scope of this FOA as described under Section I (Specific Objectives for SBIR Phase IIB Bridge Award Applications)
• Applications that do not contain a Commercialization Plan that includes all sections (a-l) and the required elements for each section, as described under Section IV ("SBIR/STTR Information: Commercialization Plan")
• Does the application include letters of support from third-party investors in the Letters of Support section ("PHS 398 Research Plan"), and/or documentation of support from third-party investors in the Other Project Information section ("Other Attachments")

Revised Language:

Applications deemed to be non-responsive will not proceed to review. The following are considered non-responsive to this FOA:

• Applications that do not propose R&D that represents the continuation of work conducted under a previously-funded SBIR or STTR Phase II award (grant or contract)
• Applications that do not propose R&D that falls within the technical scope of this FOA as described under Section I (Specific Objectives for SBIR Phase IIB Bridge Award Applications)
• Applications that do not contain a Commercialization Plan that includes all sections (a-l) and the required elements for each section, as described under Section IV ("SBIR/STTR Information: Commercialization Plan")
• Does the application include letters of support from third-party investors in the Letters of Support section ("PHS 398 Research Plan"), and/or documentation of support from third-party investors in the Other Project Information section ("Other Attachments")

Applications deemed to be non-compliant will not proceed to review. This includes the following, which is detailed in Section II.

• Applications that do not propose a budget amount and project period that conform to the limits described under Section II ("Award Budget" and "Award Project Period")

Applications deemed to be incomplete will not proceed to review. This includes the following, which is detailed in Section IV.2

• Applications that do not include letters of support from third-party investors in the Letters of Support section ("PHS 398 Research Plan"), and/or documentation of support from third-party investors in the Other Project Information section ("Other Attachments")

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Gary Robinson, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-2149
Email: [email protected]