APPLICATIONS TO THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL 
RESEARCH FOR SUPPORT OF CLINICAL TRIALS

RELEASE DATE:  April 15, 2004

NOTICE:  NOT-DE-04-004 (Rescinded per Notice NOT-DE-08-002)

National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/) 

The purpose of this notice is to clarify when the NIDCR will accept 
investigator-initiated applications for clinical trials.   Effective 
with the publication of this Notice, the NIDCR will accept 
investigator-initiated applications proposing to conduct a clinical 
trial only under one of the following three approaches:

o When submitted as described on the NIDCR’s Clinical Trials Program 
website 
(http://www.nidcr.nih.gov/ClinicalTrials/).

o When submitted as a Phase I or Phase II clinical trial as an integral 
and scientifically justified aim, but not the sole aim, of a basic 
science application that fits the mission and goals of the NIDCR.

o When submitted as a Phase I or Phase II clinical trial as part of an 
SBIR or STTR application.

Investigator-initiated clinical trial applications submitted to the 
National Institutes of Health and assigned to the NIDCR that do not 
follow one of the three methods described above will be returned to the 
applicant without undergoing peer review.

INQUIRIES

We encourage inquiries concerning this Notice and welcome the 
opportunity to answer questions from potential applicants.  Please 
direct inquiries to:

For applications to be submitted through the NIDCR’s Clinical Trials 
Program contact Dr. Jane C. Atkinson, (301) 435-7908(jatkinso@mail.nih.gov)

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