SMG 1410.102

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - HUMAN DRUGS

TERMINATION OF EXEMPTIONS FOR NEW DRUGS FOR INVESTIGATIONAL USE IN HUMAN BEINGS

Effective Date: 04/27/2007

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A. The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of the Commissioner of Food and Drugs on the termination of exemptions for new drugs (including those that are biological products which are subject to the licensing provisions of the Public Health Service Act) for investigational use in human beings under 21 CFR, Part, 300, Section 312.44 and in animals under 21 CFR, Part 300, Section 312.160:

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

2. The Director, the Deputy Director, and the Directors, Office of New Drugs and Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

3. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH).

B. The following officials, for drugs under their jurisdiction, are authorized to terminate exemptions for new drugs for investigational use when sponsors fail to submit an annual progress report under 21 CFR, Part 300, Section 312.44(b)(1)(viii):

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

2. The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER.

3. The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), OVRR, and Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER.

4. The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OCTGT, CBER.

5. The Director and Deputy Directors, Office of Device Evaluation (ODE), and the Director and Deputy Director, Office of In Vitro Diagnostics (OIVD), CDRH.

C. The following officials, for drugs under their jurisdiction, are authorized to make the findings set forth in Sec. 312.44(b) of 21 CFR and to notify sponsors and invite correction before termination action on such exemptions:

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

2. The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER.

3. The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER.

4. The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OCTGT, CBER.

5. The Director and Deputy Directors, ODE, and the Director and Deputy Director, OIVD, CDRH.

2. REDELEGATION.

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

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