Clarification for the NIH-Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules PAR-12-203 (X02) Pre-Application, and Limited Competition RFA-TR-12-004 (UH2/UH3) and RFA-TR-12-005 (UH3)

Notice Number: NOT-TR-12-008

Release Date:  July 20, 2012

National Center for Advancing Translational Sciences (NCATS)

The purpose of this notice is to provide clarification regarding application requirements.

Agents or targets/mechanisms of action:

X02 pre-applications that are not proposing studies investigating one of the Agents or targets/mechanisms of action listed on the NCATS website http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/directory.html will not be responsive and will not be accepted for review.  Compounds must be used in their current formulation.  New formulations will not be responsive.

Clarification on use of term “Expedited IRB”:

The announcements (PAR-12-203, RFA-TR-12-004, and RFA-TR-12-005) make reference to “expedited Institutional Review Board (IRB) approval.”  Applicants should be advised that “expedited” for the purposes of these announcements is intended to mean expedient, and does not relate to the requirements outlined by the DHHS Office of Human Research Protections for expedited review http://www.hhs.gov/ohrp/policy/expedited98.html .

Please direct all inquiries to:

Christine Colvis, Ph.D.
Therapeutics Discovery Program
National Center for Advancing Translational Sciences, NIH
6701 Democracy Blvd., Democracy I, Rm. 924
Bethesda MD 20892-4874 (Regular mail)
Bethesda MD 20817 (FedEx)
Phone: 301-451-3903
E-mail: ccolvis@mail.nih.gov