SMG 1130.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE COUNSELOR TO THE COMMISSIONER

Effective Date: 08/07/2009

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1. OFFICE OF THE COUNSELOR TO THE COMMISSIONER (DAR).

A. Formulates and renders advice to the Commissioner related to policy development, interpretation and integration that cuts across program lines or which is not well defined.

B. Provides a leadership role in advocating for and advancing the Commissioner's priorities.

C. Reviews recommendations for actions and reviews other materials to ensure that all points of view and program interests are developed for consideration and fully analyzed.

D. Provides top level leadership for the development of, and management of emergency and crisis management policies and programs for FDA to ensure that a structure exists for FDA to respond rapidly to an emergency or crisis situation in which FDA-regulated products need to be utilized or deployed.

E. Provides strategic oversight of FDA’s participation in internal and external counter-terrorism and emergency exercises.

F. Oversees the coordination of the Agency’s evaluation of emergency and crisis situations to determine appropriate internal and external referrals for further action.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Secretary of Health and Human Services on August 7, 2009.

NOTE: The SMG does not meet the requirements for the size of an office but the office is requested by the Commissioner.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/07/2009	N/a	OC/OA/OM/OBOHCP/OMP	Secretary of the Department of Health and Human Services