Division Of Surveillance (HFV-210)

1. The functional statements for the Division of Surveillance are:
   1. Evaluates the safety and effectiveness of marketed animal drugs, special dietary feeds, veterinary medical devices, and other veterinary medical products and recommends action to correct deficiencies resulting from inadequate directions for use, warnings, and cautionary information;
   2. Evaluates drug product labels and other information to determine new animal drug status, regulatory priority, acceptable conditions of use, and need for regulatory activity; maintains and makes available inventory listing of all marketed animal drugs to ensure adequate information is available for regulatory activity and customer support; coordinates with field to develop enforcement activity, obtains expert witnesses and performs other scientific and regulatory case development activities;
   3. Reviews marketed product labeling and makes recommendations concerning label revisions, regulatory supplements, suspension of manufacturing, and withdrawal of approval of new animal drugs to ensure marketed products are safe and effective;
   4. Monitors and evaluates promotion of marketed veterinary drugs to ensure promoted claims are consistent with approved claims;
   5. Evaluates reports of product adverse experiences to ensure labeling contains a current accurate safety profile, identify unsafe products, and unsafe product uses; maintains liaison with other agencies and organizations engaged in similar activities to identify product interactions and coordinate activities; participates in outreach programs to encourage veterinarians to participate in the pharmacovigilance program; and,
   6. Manages compliance programs covering regulated industries in animal drugs, veterinary medical devices, and other veterinary medical products to ensure the effectiveness of the programs.  Reviews establishment inspection reports, labeling, and other findings to determine whether regulated products are being marketed in accordance with the act and agency regulations and policy.
2. There are three teams in this division:
   1. Marketed Product Information;
   2. Scientific and Regulatory Review-Specified Products I; and,
   3. Scientific and Regulatory Review-Specified Products II.

1. The functional statements for the Division of Animal Feeds are:
   1. Evaluates food additive petitions, generally recognized as safe petitions and investigational food additive applications for adequacy of : (1) data on animal safety, utility, and stability; (2) labeling; and; (3) manufacturing facilities and controls; coordinates the review of the human food  safety and environmental impact information; recommends approval of food additives and GRAS substances to the center director; 
   2. Evaluates the safety of complete feeds, feed supplements, and feed ingredients for animals, including pets, and provides risk assessments on hazardous contaminants in animal feeds;
   3. Evaluates safety data, manufacturing and use information, and labeling for complete animal feeds and for non-drug substances added to animal feeds to determine their legal status;
   4. Provides technical and scientific evaluations of new feed ingredients defined in the Official Publication of the Association of American Feed Control Officials (AAFCO), coordinates feed regulatory activities with state feed control offices, and participates in the activities of AAFCO committees and task forces and the AAFCO Board of Directors;
   5. Coordinates scientific reviews and develops policy recommendations for animal feed issues (e.g., contaminants, biotech plants, unapproved feed ingredients);
   6. Evaluates Biotech Plant Notifications for adequacy of the composition and animal safety data; collaborates on Note to Files with the Center for Food Safety and Applied Nutrition (CFSAN), and recommends sign-off by the OSC Director on letters to the firms concluding FDA consultations relating to feed issues; develops policy recommendations on feed issues involving biotech plants, and participates in developing policy recommendations on general issues involving biotech plants with CFSAN, other centers and offices in FDA, and other federal agencies;
   7. Approves feed mill licenses after being assured that the licensee can manufacture and label medicated feed in compliance with agency regulations;
   8. Maintains inventory of distributors of veterinary feed directives drugs;
   9. Ensures that licensed facilities comply with the medicated feed license regulations by implementing and evaluating the results of an inspectional compliance program for these facilities;
   10. Provides consulting reviews to ONADE for medicated feed labels, including medicated pet food labels;
   11. Develops, monitors and evaluates CVM compliance programs or field assignments for medicated feeds, Type A medicated articles, and feed contaminants (e.g., BSE, microbial pathogens, mycotoxins, pesticides, heavy metals, industrial chemicals); reports the findings from the programs to the states, FDA field, and other interested parties;
   12. Provides scientific support for regulatory actions for animal feeds and medicated animal feeds; and,
   13. Recommends and may participate in intramural and extramural research projects conducted or coordinated by the Office of Research to gain further information on contaminants, drugs, and food additives. 
2. There are three teams within this division:
   1. Animal Feed Safety Team;
   2. Medicated Feeds Team; and,
   3. Nutrition and Labeling Team.

1. The functional statements for the Division of Compliance are:
   1. 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;
   2. Develops, monitors, and evaluates the center’s bioresearch monitoring programs and their investigative and regulatory follow-up; manages the application integrity policy;
   3. Develops, monitors, and evaluates the center’s compliance and surveillance programs pertaining to tissue residues and national drug residue milk monitoring;
   4. 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 FDA/CVM by USDA/FSIS and developing strategies designed to prevent food safety problems associated with pathogens and residues;
   5. Coordinates and prepares compliance and enforcement oriented replies to inquiries from consumers, state and federal governments, Congress, industry, etc.;
   6. 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; and,
   7. 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. There are three teams within this division:
   1. Enforcement and Regulatory Policy Team;
   2. BIMO and Administrative Actions Team; and,
   3. Compliance Information Management Team.