Notice Number: NOT-HL-12-157

Key Dates
Release Date: September 21, 2012

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

Purpose

On May 17, 2012, the NHLBI issued a Funding Opportunity Announcement (FOA): RFA-HL-13-008 "The NIH Centers for Accelerated Innovations (U54)". The purpose of this Notice is three-fold:

(1) Additional Information and Clarifications Regarding NOT-HL-12-156
For detailed additional information and clarifications concerning the recent (September 17, 2012) NIH Guide Notice (NOT-HL-12-156) about the NIH Centers for Accelerated Innovations (NCAI), please visit the Centers NOT-HL-12-156 website.

(2) Change in Scope for RFA-HL-13-008
The FOA will no longer prescribe the number, type (i.e., therapeutics/preventatives, devices, diagnostics), or mix of technologies in a center’s portfolio at any given time. The new modified conditions are described below.

Changes to Part II. Section I. Specific Requirements
Current Language:
Each Center must demonstrate access to adequate numbers of technologies within the NHLBI priorities described above such that approximately three new technologies are accepted into the Center for development per year. It is expected that at least 6 technologies (3 new) will be under some form of development each year from years 2 through 6 of the award and that appropriate negotiated agreements will be in place between the Center Partners for both the technology development and for access to the research investigators.

Modified Language:
Each Center must demonstrate access to an adequate number of technologies within the NHLBI priorities described above such that the Center maximizes the generation of innovative commercially viable technologies. It is expected that appropriate negotiated agreements will be in place between the Center partners for both the technology development and for access to the research investigators.
Changes to Section IV.6. Research Strategy

C. Investigator engagement, technology solicitation, and technology selection

Current Language:
Each Center must demonstrate access to an adequate number of technologies within the NHLBI priority areas described in Section I under Research Scope such that approximately three new technologies are accepted into the Center for development per year. It is anticipated that at least 6 technologies (3 new) will be in some form of development each year from years 2 through year 6 of the award and that appropriate negotiated agreements will be in place with the source institutions for technology development and access to research investigators.

Modified Language:
Each Center must demonstrate access to an adequate number of technologies within the NHLBI priority areas described in Section I under Research Scope such that the Center maximizes the generation of innovative commercially viable technologies. It is anticipated that appropriate negotiated agreements will be in place with the source institutions for technology development and access to research investigators.

Current Language:
Describe the breadth and diversity of the accessible portfolio of early stage technologies within the NHLBI mission available from the Center (terms of the cooperative agreement require that each Center has at least one therapeutic/preventative, one device and one diagnostic concurrently under development).

Modified Language:
Describe the breadth and diversity of the accessible portfolio of early stage technologies within the NHLBI mission available from the Center.

Updated Technology Table:
The Technology Table in this section has been revised to reflect the removal of prescriptions for technology types. The updated Technology Table is found at http://www.nhlbi.nih.gov/about/dera/otac/caip/technology_table.xlsx.

(3) Facilitated Conference Call
The NHLBI invites interested parties to participate in a facilitated conference call regarding the recent changes to RFA-HL-13-008 on October 3, 2012 at 1:00 pm EST. The NHLBI Director and staff will be available to discuss the changes and answer questions. Please visit the Centers FAQs website for answers to commonly asked questions about the changes to the RFA-HL-13-008. Submit additional questions to be addressed during the conference call in advance of the event at NHLBICentersRFA@mail.nih.gov. Questions and answers will be posted on the Centers FAQs website after the call. Additional information about the event is available at the Centers NOT-HL-12-156 website.

Inquiries

Please direct all inquiries to:

Kathleen Rousche, PhD
Program Director
Office of Translational Alliances and Coordination
Division of Extramural Research Activities
National Heart, Lung and Blood Institute
6701 Rockledge Drive, MSC 7924, Room 7215
Bethesda, MD 20892
Phone: 301-496-2149
Direct: 301-594-5507
Email: rouschek@mail.nih.gov