Division of Compliance

The Division of Compliance is committed to preventing violations and enforcing the Federal Food, Drug and Cosmetic Act and related laws through guidance, education and regulatory actions.  It is comprised of three (3) teams - Bioresearch Monitoring and Administrative Actions; Compliance Information Management; Enforcement and Regulatory Policy

Division of Compliance (HFV-230)
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
MPN IV Bldg., Room 146
7519 Standish Place
Rockville, MD 20855-2773
Telephone: (240) 276-9200
FAX: (240) 276-9241

Bioresearch Monitoring and Administrative Actions Team (BIMO and AA) - HFV-234 - ensures data integrity in premarket approval applications, develops regulatory and enforcement policy related to premarket inquiries, and manages administrative actions.

• Monitors and manages the three Bioresearch Compliance Programs (Sponsor Monitor, Good Laboratory Practice and Clinical Investigator) and all surveillance and compliance activities (e.g., withdrawal of eligibility to receive investigational-use new animal drugs and termination of exemptions) resulting from the administration of these programs.
• Handles administrative actions of the Center, such as application withdrawal or feed mill license revocation.
• Primary contact with the Office of New Animal Drug Evaluation on regulatory and enforcement policy issues associated with pre-marketing; such as Mutual Recognition Agreements and the Application Integrity Policy.
• Provides general and specific (as resources allow) assistance to firms on product development, as well as assisting them in obtaining outside consultation as appropriate.
• Responsible for recalls

Compliance Information Management Team (CIMT) - HFV-235 - develops, provides and manages compliance related training programs, information, and systems that meet the needs of our internal and external customers.

• Responsible for providing, maintaining and managing compliance data and information for the internal and external customers.
• Works closely with the premarket and regulatory teams to plan compliance activities and field resources.
• Responsible for developing or overseeing the development of training, education and guidance materials. Represents or assures appropriate Compliance representation at all internal or external education and training events which address the concerns or activities of the Division.
• Coordinates and oversees the Center’s compliance programs to assure they are current and revised as necessary and manages and monitors their assigned programs.
• Writes, coordinates and oversees the writing of compliance policy documents.
• Maintains division assignments and assures that significant actions and documents are on track.
• Responsible for export certificates

Enforcement and Regulatory Policy Team (EARP) - HFV-232 - develops and implements appropriate enforcement strategies and regulatory decisions to ensure the compliance of marketed products.

• Responsible for developing appropriate enforcement strategies for regional, nationwide or import violations (such as Bovine Spongiform Encephalopathy (BSE)), for emerging or expanding compliance problems, and for new regulations related to compliance initiatives.
• Responsible for keeping up to date on violative activities through contacts with other Center and FDA offices, state regulatory officials and other federal agencies.
• Responsible for evaluating the evidence, quality, significance and appropriateness of regulatory and judicial actions.
• Coordinates scientific reviews and policy issues for enforcement actions and prepares necessary decision documents.
• Supports legal counsel by providing timely and reliable information and supports field compliance activities by managing and monitoring their assigned compliance programs.
• Coordinates emergency operations for the Center, such as feed contamination, and directs unusual compliance investigations to assure suitable outcomes.
• Develops and coordinates Center enforcement policies or provides input on those which have an enforcement component.