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U.S. Department of Health and Human Services

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SMG 1270.223

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PLANNING AND INFORMATICS

OFFICE OF BUSINESS INFORMATICS

DIVISION OF REGULATORY REVIEW SUPPORT

Effective Date: 03/02/2010

[PDF Version]

1. DIVISION OF REGULATORY REVIEW SUPPORT (DBNTBC).

A. Develops and conducts training programs for review and support personnel targeting the electronic submission and review process.

B. Provides business-related training for IT systems.

C. Interacts with applicants, sponsors and Center for Drug Evaluation and Research (CDER) personnel to provide accurate and timely guidance on electronic submission issues.

D. Works with organizational units within the Center to help identify and address local computing requirements.

E. Supports development of guidance and regulations associated with information management issues.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this office were approved by the Commissioner of Food and Drugs on March 2, 2010.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial03/02/2010N/aOC/OA/OM/OMPCommissioner of Food and Drugs

 

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