SMG 1410.111

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - HUMAN DRUGS

PERMIT OR DENY USE OF AN INVESTIGATIONAL DRUG FOR TREATMENT USE

Effective Date: 04/27/2007

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

A. The following officials are authorized to permit or deny the use of an investigational drug for treatment use under a treatment protocol or treatment investigative new drug application ( IND ) submitted under 21 CFR, Part 312, Section 312.34:

1. The Director and Deputy Director, Center for Drug Evaluation and Research (CDER), the Director, Office of New Drugs (OND), 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.