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SMG 1244.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF FOODS AND VETERINARY MEDICINE

CENTER FOR VETERINARY MEDICINE

OFFICE OF SURVEILLANCE AND COMPLIANCE

Effective: October 1, 2012

[PDF Version]

1. OFFICE OF SURVEILLANCE AND COMPLIANCE (DJJVD).

A. Advises the Center Director on surveillance and compliance policy concerning Food and Drug Administration (FDA) regulatory responsibility with respect to animal drugs, feeds, food additives, veterinary medical devices, and other veterinary medical products.

B. Develops and evaluates surveillance and monitoring programs to ensure the safety and effectiveness of animal drugs and animal feeds.

C. Plans, develops, monitors, and evaluates Center surveillance and compliance programs and coordinates their field implementation to ensure the safety and effectiveness of marketed animal drugs, feeds, food additives, veterinary medical devices, and other veterinary medical products.

D. Directs and coordinates the development of scientific evidence supporting Formal Evidentiary Hearings requested by the Center.

E. Recommends to the Center Director the amendment or withdrawal of approved new animal drug applications.

F. Develops, coordinates, and directs the Center’s Bioresearch Monitoring Program to ensure reliability of information on which to base new animal drug application and food additive petition.

G. Provides scientific and regulatory expertise to the Center as needed.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Secretary for Health and Human Services, effective October 1, 2012.

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