SMG 1410.205

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - BIOLOGICS

NOTIFICATION OF RELEASE FOR DISTRIBUTION OF BIOLOGICAL PRODUCTS

Effective Date: 06/27/2003

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials are authorized to issue written notices of release for distribution of licensed biological products under 21 CFR subchapter F (parts 600 through 680.31):

1. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).

2. The Director and Deputy Directors, Office of Compliance and Biologics Quality (OCBQ), CBER.

3. The Director and Deputy Director, Division of Manufacturing and Product Quality, OCBQ, CBER.

4. The Director and Deputy Director, CDER.

5. The Director and Deputy Director, Office of Compliance, CDER.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

This delegation was signed by the Commissioner on June 27, 2003.