Notice of Change and Informational Webinar for RFA-HL-16-009 "NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44)"

Notice Number: NOT-HL-16-317

Key Dates
Release Date:   April 19, 2016

Related Announcements
 RFA-HL-16-009

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

Purpose

This Notice informs potential applicants that the National Heart, Lung, and Blood Institute (NHLBI) is correcting and updating sections of RFA-HL-16-009 "NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44)" to clarify eligibility requirements and third-party funding expectations, and update the allowed post-submission materials to include regulatory agency communications.

Part 2. Section III. Eligibility Information

3. Additional Information on Eligibility

The following section is added:

Eligibility Requirements for Phase IIB Bridge Award

The SBIR Phase IIB Bridge Award application must represent a continuation of the R&D efforts performed under a previously funded SBIR or STTR Phase II award. Applications must be predicated on a previously funded SBIR or STTR Phase II grant or contract award. Qualifying "parent" SBIR or STTR Phase II projects may be renewed only once. Following the Phase IIB Bridge Award period (i.e., up to 3 years), recipient SBCs are expected to pursue the full commercialization of these SBIR-funded projects using non-SBIR funds.

NOTE: Applicants who intend to submit a Phase IIB Bridge Award application that is predicated on an SBIR Phase II contract or a Phase II award from a non-NIH Federal agency MUST contact the NHLBI prior to submission (see Section VII. Agency Contacts) so that the NHLBI can properly arrange for such applications to be accepted. See NIH FAQs for more information about submitting a Phase IIB application based on a Phase II contract or Phase II award from a non-NIH Federal agency:
https://sbir.nih.gov/faqs#app-prep-sub26

To qualify for renewal under the Phase IIB Bridge Award, the prior Phase II award could have been funded in response to any Federal SBIR or STTR solicitation and could have been funded by the NHLBI, by another NIH Institute/Center, or by another Federal agency. However, the proposed objectives for the Phase IIB application must fall within the technical scope required for this FOA as defined in Section I (under “Specific Objectives for SBIR Phase IIB Bridge Award Applications”). In addition, the development activities completed under the previous Phase II award must provide the appropriate technical foundation to justify continued development of the technology for an NHLBI mission-related indication/use. Platform technologies that were initially developed for a non-NHLBI mission-related indication/use (i.e., certain Phase II projects funded by another NIH Institute/Center or another Federal agency) may be eligible for continued support under this FOA only if the earlier data demonstrate technical proof-of-concept that is scientifically relevant to the NHLBI mission-related indication/use. For all projects supported under this FOA, the aims of the project should focus on an NHLBI mission-relevant indication/use as the primary product or service. SBIR Phase IIB Bridge awards are non-renewable.

The NHLBI will only accept one new Phase IIB Competing Renewal application and one Phase IIB Resubmission application for a particular project. For Resubmissions, the NIH policy described in NOT-OD-14-082 applies.

In all cases, the Phase II project period must end before a Phase IIB Bridge Award can be issued.

Part 2. Section IV. Application and Submission Information

2. Content and Form of Application Submission

SBIR/STTR Information, Commercialization Plan, e) Finance Plan

Current Language:
Third-party investors generally should not include owners of the applicant SBC, their family members, and/or “affiliates” of the applicant SBC.

Revised Language:
Third-party investors generally should not include owners of the applicant SBC, their family members, and/or “affiliates” of the applicant SBC, or other Federal sources of funding.

6. Other Submission Requirements and Information

Current Language:
Criteria for Complete, Compliant, and Responsive FOAs

Revised Language:
Criteria for Complete, Compliant, and Responsive Applications

Post Submission Materials

Current Language:
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.  In addition, updated documentation regarding third-party funding is allowed as Post Submission Materials (within the page limits defined in NOT-OD-13-030).

Revised Language:
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030. In addition, updated documentation regarding third-party funding and regulatory agency communications are allowed as Post Submission Materials to be submitted no later than 30 days prior to the scheduled review meeting, and within the page limits defined in NOT-OD-13-030.

Webinar
There will be an informational webinar on the NHLBI SBIR Phase IIB programs on Wednesday, May 4 at 2 pm ET. Please register at http://bit.ly/Ph2Bwebinar2016.  Participation in this webinar, although encouraged, is optional and is not required for the submission of an application in response to this FOA.

Inquiries

Please direct all inquiries to:

Jennifer Shieh, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-2149
Email: jennifer.shieh@nih.gov