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SMG 1268.32

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF TRANSLATIONAL SCIENCE

OFFICE OF BIOSTATISTICS

DIVISION OF BIOMETRICS II

Effective Date: 05/09/2006

[PDF Version]

1. DIVISION OF BIOMETRICS II (DBNGBB).

A. Provides comprehensive statistical and computational services to the Office of Drug Evaluation II (ODEII) (Includes the Division of Metabolism and Endocrinology Products, the Division of Pulmonary and Allergy Products, and the Division of Anesthesia and Rheumatology Products). Performs original statistical analysis. Reviews data and analysis submitted by regulated industries for accuracy and appropriateness.

B. Conducts research and development in statistical, biomathematical, computational and other scientific decision-making methodologies.

C. Develops statistical methodologies for analyzing clinical, preclinical and epidemiological data and collaborates with other Center components on such methodologies.

D. Develops, maintains and operates, in coordination with other Center components, computer software related to these activities.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Division were approved by the Director, Center for Drug Evaluation and Research on May 9, 2006.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial05/09/2006N/aOC/OO/OM/OMPSteven Galson, Director, Center for Drug Evaluation and Research