CLARIFICATION OF INNOVATION REVIEW CRITERIA FOR PROGRAM ANNOUNCEMENTS PAR-03-042 AND PAR-03-043 RELEASE DATE: July 6, 2004 NOTICE: NOT-DE-04-006 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) The NIDCR is revising the definition for innovation used as one of the review criteria in the NIDCR CLINICAL TRIAL PLANNING GRANT (PAR-03-042) to the following: In general, planning grants leading to a Phase III clinical trial are not expected to be innovative. For clinical trial planning grants, innovation will be evaluated on the basis of whether the Phase III clinical trial tests new paradigms of public health policy or standards of clinical practice. The NIDCR is revising the definition for innovation used as one of the review criteria in the NIDCR CLINICAL PILOT DATA GRANT (PAR-03-043) to the following: In general, pilot data grants leading to a Phase III clinical trial are not expected to be innovative. For pilot data grants, innovation will be evaluated on the basis of whether the pilot data grant tests new paradigms of public health policy or standards of clinical practice. INQUIRIES We encourage inquiries concerning this Notice and the two Program Announcements and welcome the opportunity to answer questions from potential applicants. Please direct inquiries to: Dr. Bruce L. Pihlstrom, Acting Director Division of Clinical Research and Health Promotion NIDCR National Institutes of Health 45 Center Drive, MSC 6401, Room 4AS43H Bethesda, MD 20892-6401 Telephone: (301) 594-4830 Fax: (301) 480-8322 e-mail: bruce.Pihlstrom@nih.gov Or Dr. Richard L. Mowery, Chief Clinical Research Branch Division of Clinical Research and Health Promotion NIDCR National Institutes of Health 45 Center Drive, MSC 6401, Room 4AS43F Bethesda, MD 20892-6401 Telephone: (301) 594-4841 Fax: (301) 480-8322 e-mail: rm33a@nih.gov


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