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SMG 1410.22

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

EMERGENCY FUNCTIONS

Effective Date: 04/04/2011

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1.  AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A.  Each Regional Food and Drug Director, Office of Regulatory Affairs, ORA is authorized, during any period when normal channels of direction are disrupted between the Food and Drug Administration (FDA) Headquarters and his or her region to:

1.  fully represent FDA 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 FDA 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 FDA 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 Commissioner of Food and Drugs approved this delegation on April 4, 2011.

STATUS (I, R, C) DATE APPROVED LOCATION OF CHANGE HISTORY CONTACT APPROVING OFFICIAL
Initial 04/04/2011 N/a ORA/ORM Margaret A. Hamburg, M.D., Commissioner of Food and Drugs