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U.S. Department of Health and Human Services

Animal & Veterinary

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UPDATED NCIE ELECTRONIC SUBMISSION GUIDANCE AVAILABLE

FDA Veterinarian Newsletter March/April 1999 Volume XIV, No II

This guidance, entitled "Guidance for Industry: Submitting a Notice of Claimed Investigational Exemption in Electronic Format to the Center for Veterinary Medicine via E-Mail," (guidance #59) updates an earlier guidance dated June 16, 1997. Starting September 8, 1997, CVM conducted a pilot program to determine the practicality of electronic submission and review as an alternative to the paper-based processes used in the past. The pilot project was conducted for six months and then extended until March 10, 1999, to allow for finalization of procedures. The current guidance document is based on the Center's and participating animal drug industry's experiences in the pilot project and incorporates those procedures into NCIEs electronic submission. It presents the procedures necessary for electronic NCIEs submitted to the Center to be accepted as the official original document.

The CVM standardized NCIE form, Form FDA 3458 (1/98), may be submitted via either electronic transmission or hard copy.

Copies of this guidance document and form may also be obtained by calling or writing the FDA Veterinarian.