SMG 1118.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF COMMISSIONER

OFFICE OF POLICY AND PLANNING

Effective Date: 07/08/2011

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1. OFFICE OF POLICY AND PLANNING (DAQ)

A. Advises the Commissioner and other key agency officials on matters relating to agency policy, regulations development, legislative issues, budget formulation, risk communication, and planning and evaluation activities

B. Provides strategic policy direction, planning, and data-driven analysis for FDA to more effectively and efficiently protect and promote public health

C. Develops significant and cross-cutting policy and engages in strategic problem solving

D. Serves as FDA’s focal point for the development, coordination, oversight, and processing of regulations, guidance and other policy documents

E. Conducts economic analyses, program evaluations, and special studies

F. Leads overall FDA strategic, performance and business process planning, including the development of performance measures

G. Leads and coordinates agency-wide efforts to plan, evaluate and improve FDA risk communication

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office were approved by the Secretary of the Health and Human Services on July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/23/2007	N/a	OC/OO/ OM/OMP	Secretary of the Department of Health and Human Services
Revision	08/07/2009	N/a	OC/OA/OM/ OBOHCP/OMP	Secretary of the Department of Health and Human Services
Revision	02/11/2011	N/a	OC/OA/OEO	Commissioner of Food and Drugs
Revision	07/08/2011	N/a	OO/OM	Secretary of the Health and Human Services