NOT-DC-12-005: Notice of Change to NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders

Notice of Change to NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders

Notice Number: NOT-DC-12-005

Update: The following update relating to this announcement has been issued:

March 23, 2012 - See Notice NOT-DC-12-008. Notice of Replacement of NIDCD Clinical Trial Funding Opportunity Announcements.

Key Dates
Release Date: November 18, 2011

Related Notices
NOT-DC-12-004

Issued by
National Institute on Deafness and Other Communication Disorders (NIDCD)

Purpose

The NIDCD clinical trials program is changing from soliciting applications with the R34 Research Program Grant mechanism to the U34 Cooperative Agreement mechanism. NIDCD has routinely utilized the Cooperative Agreement mechanism to facilitate the management of phase III clinical trial awards in recent years with positive benefits for both NIDCD and clinical trial PIs. NIDCD’s new approach will extend these benefits into the U34 planning grant application stage. A U34 cooperative agreement enables the NIDCD program official to have substantial involvement as Project Collaborator in helping with trial design before award and execution after award, in addition to normal stewardship. The proposed Funding Opportunity Announcement (FOA) will support a cooperative agreement between NIDCD project collaborator and investigator for a planning grant for phase III clinical trials of definitive efficacy. The NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders is used to gather information and prepare a Manual of Procedures.

This change is projected to take effect in the spring 2012 with the anticipated first receipt date in June 2012, and will replace PAR-09-142 NIDCD Definitive Phase III Clinical Trial Planning Grant (R34). NIDCD anticipates that PAR-09-142 will remain active until after the Cycle I receipt dates.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and projects.

Inquiries

Please direct all inquiries to:

Gordon B. Hughes, M.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd.
EPS-400C MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-435-4085
Fax: 301-402-6251
Email: [email protected]