SMG 1211.11

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR BIOLOGICS, EVALUATION AND RESEARCH

OFFICE OF MANAGMENT

DIVISION OF BUDGET AND RESOURCE MANAGEMENT

Effective Date: 07/08/2011

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1. DIVISION OF BUDGET AND RESOURCE MANAGEMENT (DKKBBA).

A. Coordinates Center activities regarding formulation and implementation of programs concerning budget and resource requests and utilization of biotechnology and biomedical issues.

B. Prepares the Center’s annual budget estimates. This includes all phases of budget analysis, formulation, presentations and briefing materials.

C. Provides administration of the Prescription Drug User Fee Act (PDUFA), Medical Device User Fee and Modernization Act (MDUFMA), and the Export Reform and Enhancement Act (EREA). Manages and tracks Congressional requirements.

D. Directs Center financial and budget activities.

E. Coordinates procurement activities with designated Program Managers in each Center Office which includes iProcurement, P-card, contracts, Inter-Agency Agreements (IAAs), Cooperative Research and Development Agreements (CRADAs) and Royalties.

F. Coordinates as liaison with Agency Ethics Office on employee confidential filers and outside activity requests.

G. Coordinates as liaison with the Office of Management Programs at the Agency on all CBER Reorganizations.

2. AUTHORITY AND EFFECTIVE DATE.

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

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/06/2010	N/A	OC/OA/OM/OMP	Acting Director, Center for Biologics Evaluation and Research
Revised	07/08/2011	N/A	OMPT/CBER/OM	Secretary of Health and Human Services