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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter November/December 2001 Volume XVI, No VI

by Ballard H. Graham

The FDA/ORA/CVM Field Committee met on August 20-22, 2001, at the Hilton Hotel, Gaithersburg, MD. Current members of the committee are: Ballard H. Graham, Atlanta District Director, Chair; Brenda Holman, Pacific Regional Food and Drug Director, Advisor; Thomas (Tom) Gardine, Philadelphia District Director, Vice Chair; James (Jim) Rahto, Minneapolis District Director, Jerome (Jerry) Woyshner, New York District Director, Gayle Lancette, Director, Southeast Regional Lab., Austin (Rick) Long, Director, Pacific Regional Lab., Northwest, and Darrell Lee, Director of Compliance, San Francisco District.

There are five FDA/ORA Program Field Committees, including the Drug, Device, Food, Biologics, and CVM Committees. Their purpose is to assist in managing the Office of Regulatory Affairs (ORA) organization and its implementation of Agency programs. This includes, but is not limited to, serving as the principal contact for ORA (Field and Headquarters) and Centers on matters relating to the specific program area. Field Committees are the primary liaison between ORA and the Centers on general program matters. As such, they seek input from ORA components on Center proposals, programs, and initiatives in order to formulate an "institutional" ORA position. Similarly, they also seek input from Centers on ORA initiatives.

The Field Committee reviews and clears, with appropriate ORA input, assignments, compliance programs, circulars, and changes issued by the Center to the Field, consistent with current Field Management Directives. They also coordinate and participate with the Center in developing program implementation goals, strategies, procedures, strategic enforcement initiatives, problem solving, and evaluation measures necessary to ensure effective execution of the Agency's responsibilities.

CVM management participants in the meeting included: Dr. Stephen Sundlof, Director, CVM; Dr. Linda Tollefson, Deputy Director, CVM, Dr. Daniel McChesney, Acting Director, Division of Surveillance and Compliance; and Glo Dunnavan, Director, Division of Compliance.

Others present at the meeting included staff members from the Office of Enforcement (OE), Office of Regional Operations (ORO), Division of Federal State Relations (DFSR), Division of Emergency Investigational Operations (DEIO), Division of Field Science (DFS), Office of Resource Management (ORM), Division of Planning Evaluation Management (DPEM); and the President of the Association of American Feed Control Officials. (John Breitsman)

This two-and-a-half-day meeting focused on the Agency's Bovine Spongiform Encephalopathy (BSE) surveillance and enforcement policy activities. Dr. Mac Lumpkin, Senior Medical Advisor to the Acting Commissioner, provided an Agency overview of the HHS and FDA BSE and TSE (Transmissible Spongiform Encephalopathies) Action Plans.

Dr. Steven Solomon, Deputy Director, Office of Regional Operations (ORO), provided an ORA perspective with respect to BSE accomplishments and enforcement activities.

Glo Dunnavan, Director, Division of Compliance, provided a CVM perspective with respect to BSE resources that have been and will continue to be made available to maintain surveillance and, as needed, enforcement in an effort to maintain full oversight. Dr. Sundlof provided a presentation on the "FDA Leadership Council" concerning its mission with respect to ORA/Center(s) working together to achieve maximum efficiency regarding the utilization of Agency resources.

Other pertinent topics and presentations made during the meeting included: The New BSE Checklist and Database Form, the Voluntary Self Inspection Program (VSIP), Tissue Residue Surveillance and Enforcement Strategies, Vet Drug Pharmacy Compounding, and Cloned Milk and Meat. In addition, a presentation on "Procedures for Reporting and Responding to Congressional Inquiries" was provided by ORA's Executive Secretariat, Marie Urban.

A couple of celebrations were in order as the Committee congratulated Dr. Linda Tollefson on her promotion to Rear Admiral, and Jerry Woyshner on his recent appointment as New York District Director.

The meeting generated several action items for the committee as well as CVM, DFSR, ORO, DPEM, et al. The action items from this meeting will be revisited by the committee during subsequent committee conference calls and at the next committee meeting, tentatively planned for early 2002.

Ballard Graham is the Director of FDA's Atlanta District Office, and Chairman of the CVM Veterinary Field Committee