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U.S. Department of Health and Human Services

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SMG 1219.2

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 COMMUNICATION, OUTREACH AND DEVELOPMENT

DIVISION OF DISCLOSURE AND OVERSIGHT MANAGEMENT

Effective Date: 07/08/2011

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1. DIVISION OF DISCLOSURE AND OVERSIGHT MANAGEMENT (DKKBHA).

A. Tracks, directs and controls development and coordination of important and sensitive Center responses to Congressional requests, including proposed legislation. Serves as Center liaison with the Office of Legislative Affairs.

B. Prepares, develops and coordinates Center and Agency responses to inquiries on AIDS and biological products under the Freedom of Information (FOI) Act, the Privacy Act, and other statutes.

C. Responsible for litigation under the Tort Claims Act and responding to third party subpoenas.

D. Prepares, develops and coordinates Center and Agency responses to requests under the Freedom of Information (FOI) Act, the Privacy Act, and other statutes.

E. Serves as Center liaison for General Accounting Office and Inspector General investigations.

F. Provides direction and support in the management of the Center’s Document Control contract.

2. AUTHORITY AND EFFECTIVE DATE.

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

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