February 18, 1999
UPDATED NCIE ELECTRONIC SUBMISSION GUIDANCE AVAILABLE
The FDA's Center for Veterinary Medicine (CVM) has released updated guidance for submission of Notices of Claimed Investigational Exemption (NCIEs) in electronic format via e-mail.
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 updated version of "Guidance for Industry, Submitting a Notice of Claimed Investigational Exemption in Electronic Format to the Center for Veterinary Medicine via E-Mail," is available on the our web site.
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
Copies of this guidance document and form may also be obtained by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Send one self-addressed adhesive label to assist in processing your requests.
In the next few weeks, CVM expects to have an interactive fill-out word processing version of the NCIE form available on the CVM Home Page. The availability of this interactive form will be announced in the "What's New" section of the CVM Home Page.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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