NCIE Pilot Project Extended

March 25, 1998

CVM's Notice of Claimed Investigational Exemption (NCIE) Electronic Submissions Pilot Project has been extended until March 8, 1999. The purpose of the pilot project is to determine the practicality and feasibility of electronic submission and review as an alternative to the current paper-based processes.

The CVM standardized NCIE form, Form FDA 3458 (1/98), may be submitted via either electronic transmission or hard copy. The form is available on the CVM Home Page or by calling CVM's Communications Staff at (301)827-3797.

For further information about the pilot project, please contact Charles J. Andres, Ph.D., Center for Veterinary Medicine (HFV 128), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855 by telephone (301-827-7561) or e-mail candres@cvm.fda.gov.