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
DIVISION OF COMPLIANCE
Effective: October 1, 2012
DIVISION OF COMPLIANCE (DJJVDC).
A. Coordinates the preparation of evidence concerning withdrawal/refusal to approve animal drugs and the documentation for a formal evidentiary hearing; coordinates the preparation of administrative and evidentiary records for a hearing.
B. Develops, monitors, and evaluates the Center’s Bioresearch Monitoring Programs and their investigative and regulatory follow-up. Manages the application integrity policy.
C. Develops, monitors, and evaluates the Center’s compliance and surveillance programs pertaining to tissue residue and National Drug Residue Milk Monitoring.
D. Evaluates regulatory approaches to human food safety concerns including monitoring the prevalence of violative levels of harmful drugs and chemicals in meat and poultry based on findings reported to the Food and Drug Administration/Center for Veterinary Medicine (FDA/CVM) by the United States Department of Agriculture/Food Safety Inspection Service (USDA/FSIS) and developing strategies designed to prevent food safety problems associated with pathogens and residues.
E. Coordinates and prepares compliance and enforcement oriented replies to inquiries from consumers, State and Federal governments, Congress, industry, etc.
F. Advises on regulatory and administrative policy issues and develops enforcement strategies involving animal drugs, feeds, feed additives, veterinary medical devices, and other veterinary medical products; prepares and issues guidance to the field offices.
G. Preliminarily reviews Establishment Inspection Reports, investigations, complaints and other information on regulated products. Coordinates investigative and regulatory follow-up through consultation with management, legal and scientific advisors. Reviews proposed regulatory actions submitted by the field offices and recommends whether such actions should be pursued further by the Agency.
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.