DR. FREAS: Good morning. I would like to go around and introduce to the audience the members seated at the table who are temporary voting members, standing Committee members, and our guests. I'll be starting on the right-hand side of the room.

In the first seat is Dr. Lawrence Schonberger, Assistant Director for Public Health, Division of Viral and Rickettsial Diseases, Centers for Disease Control.

Next is Dr. William Hueston. And if the members would raise their hands so that the people in the audience can identify them? Dr. William Hueston, Associate Dean, Virginia-Maryland Regional College of Veterinary Medicine.

Next is Dr. Susan Leitman, Chief of Blood Services, Department of Transfusion Medicine, NIH.

Next is Dr. Stan Prusiner, Professor of Neurology at University of California's School of Medicine.

Next is Dr. Raymond Roos, Chairman, Department of Neurology, University of Chicago.

Next is one of our new Advisory Committee members: Dr. Ermias Belay, Medical Epidemiologist, Centers for Disease Control and Prevention.

Next is a new Advisory Committee member who is familiar to the table. He has been here many times as a temporary voting member: Dr. Peter Lurie, Public Citizen's Health Research Group, Washington, D.C.

Next, a standing Committee member, Dr. David Hoel, Professor and Chairman, Department of Biometry and Epidemiology, Medical University of South Carolina.

Around the corner of the table is a new member: Dr. David Bolton, head, Laboratory of Molecular Structure and Function, New York State Institute for Basic Research.

Next is a member of the Blood Products Advisory Committee, who will be serving as a temporary voting member at today's meeting. That's Dr. Kenrad Nelson, Professor at Johns Hopkins University.

Next is another new member: Dr. Jeffrey McCullough, Professor, Department of Laboratory Medicine and Pathology, University of Minnesota Hospital.

Next is the Chairman of this Committee, whom you heard from, Dr. Paul Brown, Medical Director, Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke.

Next to me is Dr. Bruce Ewenstein, Clinical Director, Hematology Division, Brigham and Women's Hospital, another new member.

Next, at the corner, is Dr. Linda Detwiler, Senior Staff Veterinarian, U.S. Department of Agriculture.

Next is Dr. Pedro Piccardo, Assistant Professor, Indiana University Hospital.

Next is Dr. Elizabeth Williams, Professor, Department of Veterinary Sciences, University of Wyoming.

Next is the Chairman of FDA's Blood Products Advisory Committee, who will be serving as a temporary voting member at today's Committee discussions, Dr. Blaine Hollinger, Professor of Medicine, Virology and Epidemiology, Baylor College of Medicine.

Next is our consumer representative: Barbara Harrell from Montgomery, Alabama.

Next is a standing Committee member, Dr. Donald Burke, Director, Center for Immunization Research, Johns Hopkins University.

Next is Dr. Dean Cliver, Professor, School of Veterinary Medicine, University of California.

Then was Dr. Donald Burke, Director, Center for Immunization Research, Johns Hopkins.

Next is Dr. Edmund Tramont, Professor of Medicine, University of Maryland.

At the end of the table is Dr. Robert Rohwer, who is a consultant to this Committee. He is Director of Molecular and Neuro-virology Unit, VA Medical Center, Baltimore.

We also have three guests that, unfortunately, we could not fit at the table because it is rather crowded up here. The three guests are sitting off to the right-hand side of the room. They are: Ronald Gilcher, President and CEO, Oklahoma Blood Institute.

Next is Dr. Merlin Sayers, Director of the Blood Bank, Carter Blood Care in Bedford, Texas.

And next is Dr. Louis Katz, Vice President for Medical Affairs and Medical Director for Mississippi Valley Regional Blood Center in Iowa.

Welcome to all of you this morning.

Now I would like to read into the public record the conflict of interest statement which is prepared for this meeting. "The following announcement is made part of the public record to preclude even the appearance of conflict of interest at this meeting.

"Pursuant to the authority granted under the Committee charter, the Director, Center for Biologics Evaluation and Research has appointed Drs. Blaine Hollinger, William Hueston, Susan Leitman, Kenrad Nelson, Lawrence Schonberger, and Edmund Tramont as temporary voting members.

"Based on the agenda made available, it has been determined that the agenda addresses general matters only. General matters waivers have been approved by the agency for all of the TSE Advisory Committee members as well as Dr. Tramont, a consultant.

"In addition, a waiver has been approved for Dr. Robert Rohwer to participate as a nonvoting consultant. The general nature of the matters to be discussed by the Committee will not have a unique and distinct effect on any member's personal or imputed financial interests.

"In regards to FDA's invited guests, the agency has determined that the services of these guests are essential. There are reported interests which are being made in the public record to allow our many participants to be objectively evaluated.

"These statements to be added to the public record are: Dr. Jeffrey Almond is employed by Pasteur Merieux Connaught. Dr. Ronald Gilcher is employed by the Oklahoma Blood Institute. Dr. Louis Katz is employed part-time by the Mississippi Valley Regional Blood Center. Dr. Merlin Sayers is employed by the Carter Blood Care Community Blood Center.

"Dr. Alan Williams is employed by the American Red Cross, Holland Labs, and is Scientific Adviser for the Florida Blood Services and Canadian Blood Services. In addition, he has financial interests in firms that could be affected by the general discussions.

"Dr. Richard Race has financial interests in firms that could be affected by the general discussions and is a public health science researcher.

"In the event that the discussions involve specific products or specific firms for which FDA participants have a financial interest, the participants are aware of the need to exclude themselves from such involvement. And their exclusion will be noted for the public record. A copy of the waivers is available by written request under the Freedom of Information Act.

"With respect to all other meeting participants, we ask in the interest of fairness that they address any current or previous financial involvement with any firm whose product they may wish to comment upon."

So ends the reading of the conflict of interest statement. Dr. Brown, I turn the meeting over to you.

CHAIRMAN BROWN: We'll pass directly to Dr. Randolph Wykoff, the Associate Commissioner for Operations in the FDA, for some introductory remarks. Dr. Wykoff?

Introduction