Food and Drug Administration

Center for Biologics Evaluation and Research

SUMMARY MINUTES

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

Meeting # 99: May 6, 2004

Teleconference

Committee Members FDA Participants

Dr. Gary Overturf, Chair Dr. Kathryn Carbone

Dr. Walter Royal III Dr. William Egan

Dr. Peter Palese Dr. Norman Baylor

Dr. Ruth A. Karron Dr. Andrew Lewis

Dr. David Markovitz

Dr. Monica M. Farley

Dr. Bonnie M. Word

Dr. Richard Whitley

Dr. Philip S. LaRussa

Dr. Steven Self

Dr. Michael Decker**+

Cindy Province, R.N., M.S.N.*

Executive Secretary Committee Management Specialist

Christine Walsh, R.N. Denise Royster

These summary minutes for the May 6, 2004 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on ___________________.

I certify that I participated in the May 6, 2004 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.

________________________ ______________________

Christine Walsh, R.N. Gary D. Overturf, M.D.

Executive Secretary Chair

*Consumer Representative **Industry Representative +Present for Open Session Only

The Chair, Dr. Gary D. Overturf, called the ninety-ninth Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 1:40 p.m. EST on May 6, 2004. The meeting addressed the site visit of the intramural research program of the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review (OVRR), Center for Biologics and Research (CBER), completed on March 4, 2004.

The meeting was held by telephone conference call. The public was welcome to attend the open session of the meeting at the Food and Drug Administration, Bldg. 29B, Conference Room C, Bethesda, MD. A speakerphone was provided at the specified location for public participation.

An Open Public Hearing was announced. No public comment was offered.

Following is a summary of the discussion. Additional information and specific details may be obtained from the transcript of the meeting. The transcript may be viewed on the World Wide Web at: http://www.fda.gov/ohrms/dockets/ac/cber04.htm#VaccinesandRelatedBiological

Proceedings were adjourned at approximately 2:50 p.m. EST on May 6, 2004.

Open Session

The telephone conference meeting focused on the intramural research program of the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review (OVRR). The Committee heard a presentation from Dr. Andrew Lewis, FDA to include an overview of the Unit on Cell Substrate and Adventitious Agents, Unit of Viral Latency, Unit of Viral Gene Expression, and Unit on Poxvirus Biology.

Closed Session

After discussion, the Committee members voted unanimously to accept the Laboratory of DNA Viruses Site Visit Report as written.