SMG 1410.22

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

EMERGENCY FUNCTIONS

Effective Date: 04/02/2001

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A. Each Regional Food and Drug Director is authorized, during any period when normal channels of direction are disrupted between the Food and Drug Administration headquarters and his or her region to:

1. Fully represent the Food and Drug Administration within his or her region in cooperation with the Department of Health and Human Services regional emergency plans, and

2. Exercise the authority of the Commissioner of Food and Drugs for supervision of and direction to all Food and Drug Administration activities and use of resources within his or her region for continuity and for Federal Emergency Health Service operations.

B. These same officials are authorized to provide in Regional Emergency Plans for the delegation of Food and Drug Administration regional authorities to heads of field activities when such activities are cut off from national and regional headquarters.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Acting Principal Deputy Commissioner approved this delegation on April 2, 2001 (Via Memorandum from the Acting Senior Associate Commissioner for Management and Services to the Acting Principal Deputy Commissioner, Subject: Comprehensive Update to 21 CFR Part 5, Delegations of Authority and Organization - ACTION, dated April 2, 2001, and Tab C - Delegations of Authority Statement signed by the Acting Principal Deputy Commissioner, dated April 2, 2001). This information was previously published in the June 8, 2001, Final Rule, 66 Federal Register 30992-31025.