SMG 1410.103

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - HUMAN DRUGS

AUTHORITY TO APPROVE AND TO WITHDRAW APPROVAL OF A CHARGE FOR INVESTIGATIONAL NEW DRUGS

Effective Date: 04/27/2007

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of the Commissioner of Food and Drugs to approve a charge and to withdraw approval to charge for investigational drugs in a clinical trial under an investigational new drug application under 21 CFR, Part 300, Section 312.7(d)(1):

1. The Director and the Deputy Director, Center for Drug Evaluation and Research (CDER), and the Directors, Office of New Drugs (OND) and Office of Pharmaceutical Science, CDER, and the Directors, Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), OND, CDER.

2. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors, Offices of Blood Research and Review, Vaccines Research and Review, and Cellular, Tissue and Gene Therapies, CBER.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on April 27, 2007.