Notice of Claimed Investigational Exemption (NCIE)

1. Notice of Claimed Investigational Exemption (NCIE) Informational Tidbits

2. The Form FDA 3458 (revision date 10/2008) is a notice of drug shipment. It is a written notification to FDA of a sponsor’s intent to ship an unapproved new animal drug or animal feed containing or bearing a new animal drug for use in an investigation intended to be conducted to support approval of new animal drugs or animal feeds. What is a NCIE?

3. Notice of Claimed Investigational Exemption (Form FDA 3458)

4. Continued… • The NCIE is submitted under a (J)INAD file • Investigational new animal drug regulations 21 CFR 511.1 (b)(4) describes the requirements for submitting an NCIE.

5. For all clinical studies including laboratory studies conducted to evaluate bioequivalence. e.g. Bioequivalence, Palatability, and Dissolution studies When does FDA require NCIEs?

6. When does FDA require NCIEs? Continued.. • This includes: - shipment of unapproved new animal drugs directly to researchers responsible for use in clinical investigations - conducting a nonclinical laboratory study(ies) for the purpose of evaluating residues in food-producing animals. In such cases, a food-use authorization is required.

7. When should CVM receive an NCIE? • Under 21 CFR 511.1(b)(4), INAD regulations require that sponsors submit the NCIE prior to (not concurrent or after) shipment of the new animal drug.

8. Ways to submit a NCIE? • Guidance 59, “How to Submit a Notice of Claimed Investigational Exemption in Electronic Format to CVM,” provides instructions on how to submit NCIEs in electronic format to CVM. • 21 CFR 511.1(b)(4) states “prior to shipment of the new animal drug for clinical tests in animals, the sponsor shall submit in triplicate to FDA a NCIE, including a signed statement of information”.

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10. Questions?