Notice Number: NOT-DC-08-004

Key Dates
Release Date:  May 23, 2008

Issued by
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)

This notice informs potential applicants of changes in NIDCD’s clinical trials program that will occur in July 2008.  Funding Opportunity Announcements (FOAs) will be published in the NIH Guide to Grants and Contracts.  More information on the changes to the clinical trials program are described on the NIDCD’s homepage at http://www.nidcd.nih.gov/research/clinicaltrials/ct_changes.htm.
NIDCD plans to support all phases of investigator-initiated clinical trials from Phase I/II Preliminary Clinical Trials grants through Phase III Definitive Clinical Trials grants.  In addition, NIDCD will support NIDCD-specific Clinical Trial Planning grants.  NIDCD will soon publish the following three FOAs in the NIH Guide to Grants and Contracts:

• NIDCD Clinical Trial Planning Grant (R34):  will provide funding to develop the organizational structure to perform a Phase III Definitive Clinical Trial and prepare a detailed Manual of Procedures for the conduct of the trial;
• Phase I/II Preliminary Clinical Trials in Communication Disorders (R01):  provides support to obtain preliminary data that are necessary to address core scientific, design, and clinical issues prior conducting a Phase III Definitive Clinical Trial; and,
• Phase III Definitive Clinical Trials in Communication Disorders (R01):  provides support for well-designed Phase III Definitive Clinical Trials aimed at establishing safe and effective treatments or behavioral interventions for communication disorders.

Effective with the publication of the NIDCD R34 Clinical Trial Planning Grant FOA, the NIDCD will no longer accept applications submitted under PA-06-363 NIH Clinical Trial Planning Grant (R34) (http://grants.nih.gov/grants/guide/pa-files/PA-06-363.html). 

Inquiries

Inquiries concerning investigator-initiated clinical trials should be directed to:

Judith A. Cooper, Ph.D.
Director, Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders, NIH
6210 Executive Blvd., EPS-400C MSC 7180
Bethesda MD 20892-7180
Phone: 301 496 5061
FAX 301 402 6251
Email: Cooperj@nidcd.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.