SMG 1211.10

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

Effective Date: 07/08/2011

[PDF Version]

1. OFFICE OF MANAGEMENT (DKKBB).

A. . Monitors the development and operation of strategic planning systems for Center activities and resource allocations and advises the Center Director on Center administrative policies and guidelines.

B. Provides leadership and direction for the management and administrative interface with the Agency, the Department and other Federal Agencies.

C. Plans and directs Center operations related to financial, personnel, administrative, and safety management services.

D. Directs Center programs involving use of scientific advisors, consultants and committees.

E. Manages studies designed to improve processes and resource allocations in the Center.

F. Advises the Center and coordinates with the Agency on contract and grant proposals.

G. Provides direction and expertise on all veterinary services provided to the Center.

2. REGULATORY INFORMATION MANAGEMENT STAFF (DKKBB1).

A. Performs quality control functions to ensure accuracy of review and tracking of application data collected and reported by Center for Biologics Evaluation and Research (CBER).

B. Monitors the quality assurance and consistency of data collected and reported on CBER review activities.

3. PLANNING AND PERFORMANCE MANAGEMENT STAFF (DKKBB2).

A. Coordinates strategic planning and development for the Center. Provides Center input and direction for the agency planning activities.

B. Directs Center performance measurement development and reporting for the Agency performance management initiatives. Develops, tracks and analyzes CBER performance measures. Briefs senior leadership on progress.

C. Coordinates the development and reporting of CBER performance related requirements.

4. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office 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	09/22/2005	N/A	OC/OO/OM/OMP	Director, Center for Biologics Evaluation and Research
Revision	08/06/2010	N/A	OC/OA/OM/OMP	Acting Director, Center for Biologics Evaluation and Research
Revision	07/08/2011	N/A	OMPT/CBER/OM	Secretary of Health and Human Services