Animal & Veterinary
FDA Announces A Pilot Project For NCIE Submission
May 22, 1997
The Food and Drug Administration (FDA) is announcing the Notice of Claimed Investigational Exemption (NCIE) Electronic Submissions Pilot Project developed by the Center for Veterinary Medicine (CVM). This project is intended to increase the efficiency of the review process of the investigational new animal drug file (INAD), the new animal drug application (NADA), the investigational food additive petition (IFAP), and the food additive petition (FAP) by providing for the electronic submission of NCIEs, commonly known as drug shipment notices. 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 pilot, anticipated to begin September 8, 1997, and run for six months (March 9, 1998), is limited in scope in order to apply metrics to a defined set of variables to be evaluated at the conclusion of the project. The sponsors who participate in the pilot must anticipate at least one drug shipment within the six-month pilot and must also agree to submit all NCIEs in an electronic format for the duration of the pilot. Submissions may be to any of the CVM Divisions -- HFV-110, HFV-120, HFV-130, and/or HFV-220. CVM is requesting that interested sponsors submit, on a voluntary basis, electronic copies of NCIE, via e-mail, for review in a portable document format (PDF), in lieu of the paper submission. A copy of the draft guidance document for this pilot project may be obtained from the CVM Home Page or by calling CVM's Communications Staff at 301-594-1755. Prospective participants must notify CVM by June 16, 1997. For further information about participation in 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 (301-594-2604) or e-mail email@example.com.