About FDA
SMG 1114.82
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF THE COMMISSIONER
OFFICE OF THE CHIEF SCIENTIST
OFFICE OF REGULATORY SCIENCE AND INNOVATION
DIVISION OF SCIENTIFIC COMPUTING AND MEDICAL INFORMATION
Effective Date: 07/08/2011
1. DIVISION OF SCIENTIFIC COMPUTING AND MEDICAL INFORMATION (DAEIB)
A. Provides leadership, direction, policy development and coordination to the Office of Chief Scientist on statistical and mathematical aspects to support the scientific computational and health information needs of the Agency as related to FDA-regulated products
B. Interacts with Food and Drug Administration (FDA) staff, Advisory Committees and, nationally and internationally, with academia and the regulated industry to develop the scientific computational and health information infrastructure needed to support and improve efficient, effective review of FDA-regulated products
C. Supports core scientific capacity, scientific infrastructure and bioinformatics computation
D. Facilitates and coordinates the development and implementation of tools and systems for access to and analysis of data used to support regulatory decisions
E. Supports cross-center advanced scientific informatics activities, including advancing activities related to data management and analysis and safety surveillance of FDA-regulated products
2. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Division were approved by the Secretary of Health and Human Services, effective July 8, 2011.
| STATUS (I, R, C) | DATE APPROVED | LOCATION OF CHANGE HISTORY | CONTACT | APPROVING OFFICIAL |
|---|---|---|---|---|
| Initial | 07/08/2011 | N/a | OO/OM | Secretary of the Department of Health and Human Services |
