Key Dates

Related Announcements

• April 18, 2023 - Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed. See NOFO PAR-23-268.

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is to extend the expiration date by one receipt date and change application instructions for PAR-23-268 “Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed”. Note, the change in application instructions is applicable to applications submitted for the January 05, 2026 application due date.

Extension of Expiration Date for PAR-23-268 “Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed”:

PAR-23-268 will now expire on October 07, 2025.

Due to the extension, the following dates will be added:

New application due date: October 06, 2025
Renewal/Resubmission/Revision (as allowed): October 06, 2025
Scientific Merit Review: March 2026
Advisory Council: May 2026
Earliest Start Date: July 2026

The following sections of the NOFO have been changed:
Part 1. Overview Information/Key Dates

Currently reads:

Expiration date: June 07, 2025.

Revised to read (changes shown in bold and italics):

Expiration date: October 07, 2025.

Change in application instructions for PAR-23-268 “Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed”: Changes in application instructions to PAR-23-268 are only applicable to the October, 06, 2025 due date.

Part 2. Full Text of Announcement/Section IV. Application and Submission Information

Currently Reads:

SBIR/STTR Information

Commercialization plan. All applications are expected to describe a realistic strategy that outlines how and when full commercialization can be accomplished. The full commercialization plan for the platform should extend beyond the period of SBIR funding.

The instructions for the Commercialization Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.

The following considerations should be included in the Commercialization plan:

- Applicants must indicate how the proposed platform for the production, manufacturing, and use, of extracellular vesicles as therapeutics has significant commercial potential.

- Applicants must address their intellectual property (IP) portfolio/position (pertinent to the proposed project) and any strategic collaborations and partnerships to further the adoption and commercialization of their IP.

- Applicants must address how the proposed technology platform will enable a FDA IND application.

Modified to Read (in bold italics):

SBIR/STTR Information

Commercialization plan. Phase II applications are expected to describe a realistic strategy that outlines how and when full commercialization can be accomplished. The full commercialization plan for the platform should extend beyond the period of SBIR funding. Phase I applications should not include a Commercialization plan.

The instructions for the Commercialization Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.

The following considerations should be included in the Commercialization plan:

- Applicants must indicate how the proposed platform for the production, manufacturing, and use, of extracellular vesicles as therapeutics has significant commercial potential.

- Applicants must address their intellectual property (IP) portfolio/position (pertinent to the proposed project) and any strategic collaborations and partnerships to further the adoption and commercialization of their IP.

- Applicants must address how the proposed technology platform will enable a FDA IND application.

All other aspects of the NOFO remain unchanged. 

Inquiries

Please direct all inquiries to:

Christine Happel, Ph.D.
Program Officer, Office of Special Initiatives
National Center for Advancing Translational Sciences (NCATS))
Telephone: 301-827-9444
Email: [email protected]

Meena Rajagopal, Ph.D.
Program Officer, NCATS SBIR/STTR Program
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-827-1921
Email: [email protected]