Guidance for Industry: Submitting a Notice of Claimed Investigational Exemption211 in Electronic Format to the Center for Veterinary Medicine via E-Mail

摘要

This guidance document is intended to instruct those participating in the Center211u001efor Veterinary Medicine's submission of Notices of Claimed Investigational 211u001eExemption (NCIEs) in electronic format via e-mail. This guidance represents the 211u001eCenters current thinking on submitting a NCIEs in electronic format via e-mail 211u001eand updates the Guidance for Industry No. 59 dated June 16, 1997. It does not 211u001ecreate or confer any rights for or on any person and does not bind FDA or the 211u001epublic. An alternative approach may be used if such approach satisfies the 211u001erequirements of the applicable statute, regulation, or both.