Inspections, Compliance, Enforcement, and Criminal Investigations
1-7 - CENTER FOR VETERINARY MEDICINE (CVM)
1-7 - CENTER FOR VETERINARY MEDICINE (CVM)
1-7-1 - Office of Surveillance and Compliance (HFV-200)
1-7-2 - Division of Surveillance (HFV-210)
1-7-3 - Division of Animal Feeds (HFV-220)
1-7-4 - Division of Compliance (HFV-230)
1-7-5 - Division of Veterinary Product Safety (HFV-240)
The functional statements for the Office of Surveillance and Compliance are:
- Advises the Center Director on surveillance and compliance policy concerning FDA regulatory responsibility with respect to animal drugs, food for animals, food additives, veterinary medical devices, and other veterinary medical products;
- Develops and evaluates surveillance and monitoring programs to ensure the safety and effectiveness of animal drugs and food for animals;
- 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, food for animals, food additives, veterinary medical devices, and other veterinary medical products;
- Directs and coordinates the development of scientific evidence supporting Formal Evidentiary Hearings requested by the Center;
- Recommends to the Center Director the amendment or withdrawal of approved new animal drug applications;
- 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; and,
- Provides scientific and regulatory expertise to the center as needed.
The four Divisions in this office are:
- Division of Surveillance;
- Division of Animal Feeds;
- Division of Compliance, and
- Division of Veterinary Product Safety.
Note: The Division of Epidemiology (HFV-250) no longer exists. Its functions have been distributed throughout CVM. For information contact: 240-453-6830.
The functional statements for the Division of Surveillance are:
- 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;
- 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;
- Reviews marketed product labeling to make 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;
- Monitors and evaluates promotion of marketed veterinary drugs to ensure promoted claims are consistent with approved claims;
- Manages compliance programs covering regulated industries in animal drugs, veterinary medical devices, and other veterinary medical products to ensure the effectiveness of the programs. Review 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.
- Evaluates the safety and effectiveness of marketed unapproved animal drugs, special dietary feeds, veterinary medical devices, and other veterinary medical products to establish medical risk as related to animal and public health. Coordinates with the Division of Compliance and other CVM Divisions to determine enforcement priorities and risk mitigation strategies.
There are three Teams in this Division:
- Marketed Product Information Team;
- Post-Approval Review Team; and
- Medical Review Team.
The functional statements for the Division of Animal Feeds are:
- 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;
- 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;
- 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;
- 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;
- Coordinates scientific reviews and develops policy recommendations for animal food issues (e.g., contaminants, biotech plants, unapproved feed ingredients);
- 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 Office of Surveillance and Compliance (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;
- Approves feed mill licenses after being assured that the licensee can manufacture and label medicated feed in compliance with agency regulations;
- Maintains inventory of distributors of veterinary feed directives drugs;
- 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;
- Provides consulting reviews to Office of New Animal Drug Evaluation (ONADE) for medicated feed labels, including medicated pet food labels;
- 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;
- Provides scientific support for regulatory actions for food for animals and medicated animal feeds; and,
- 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.
There are four Teams within this Division:
- Animal Feed Safety Team;
- Ingredient Safety Team;
- Medicated Feeds Team; and,
- Nutrition and Labeling Team.
The functional statements for the Division of Compliance are:
- 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;
- Develops, monitors, and evaluates the Center's Bioresearch Monitoring Programs and their investigative and regulatory follow-up. Manages the application integrity policy;
- Develops, monitors, and evaluates the Center's compliance and surveillance programs pertaining to tissue residues and National Drug Residue Milk Monitoring;
- Collaborates with CORE, monitors and handles many emerging issues involving animal food, drugs, and zoonotic diseases that require immediate CVM response and coordination;
- 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 FDA/CVM by the USDA/FSIS and developing strategies designed to prevent food safety problems associated with pathogens and residues;
- Coordinates and prepares compliance and enforcement oriented replies to inquiries from consumers, State and Federal governments, Congress, industry, etc.;
- Advises on regulatory and administrative policy issues and develops enforcement strategies involving animal drugs, food for animals, food additives, veterinary medical devices, and other veterinary medical products; prepares and issues guidance to the field offices; and,
- 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.
There are five Teams within this Division:
- Imports/Complaint/Emergency/Recall Team;
- Post-Market Compliance Team;
- Drug Residue Compliance Team;
- Pre-Market Compliance and Administrative Actions Team; and
- Programs and Operations Support Team.
The functional statements for the Division of Veterinary Product Safety are:
- Monitors adverse drug event database to identify safety signals and effectiveness issues of concern;
- Evaluates adverse event reports to ensure labeling contains a current accurate safety profile, identifies unsafe products, and unsafe product uses;
- Maintains liaison with other agencies and organizations engaged in similar activities to identify product interactions and coordinate activities;
- Provides surveillance for adverse events involving consumption of pet food. Performs scientific and epidemiologic assessment of data as part of the pet food early warning system to assist the Division of Compliance in recognizing potential safety issues and establishing the need for product recalls;
- Coordinates with FDA District Offices to receive and evaluate product defect reports for the identification of product safety issues. Interacts with other FDA centers to ensure appropriate investigatory and risk mitigation measures are taken by the Agency. Analyzes data and relevant information to assess the need for product recall(s);
- Provides pre-market and post-market surveillance of drug product medication errors to CVM review Divisions; and,
- Participates in outreach programs to encourage veterinarians to participate in the pharmacovigilance program and to educate veterinarians, animal owners, and the public regarding the medical risks and benefits of veterinary products.
There are three Teams in this Division:
- Adverse Drug Event Review Team
- Adverse Event Review Team; and,
- Data Management and Analysis Team.