(8:30 a.m.)

CHAIRMAN BROWN: My name is Dr. Paul Brown. Welcome to the FDA traveling road show. We are asked yet once more by the FDA to consider a question of theoretical risk in the absence of sufficient knowledge on which to base any firm conclusion.

The issue before us today is that of excluding categories of American blood donors who have either visited or resided for longer periods of time in Great Britain. The issue is sufficiently delicate, as you see that we have been moved outside the Beltway.


CHAIRMAN BROWN: And the program has been very nicely designed and very logically designed. We are after a brief discussion of background for this issue by Dr. Mary Elizabeth Jacobs going to hear detailed presentations, the first of which will be by Alan Williams, Dr. Alan Williams, on the effect of any exclusions on the U.S. blood supply.

That will be followed by two presentations, one by Christl Donnelly from the United Kingdom and the other by Philip Comer from the United Kingdom, in which the question of what exactly would one expect with respect to numbers of new variant cases, new variant of Creutzfeldt Jakob disease cases, in Great Britain because that, of course, is the other term in this risk equation.

Then we're going to hear from Dr. Penny Chan from Health Canada National Blood Safety Council, actually, see what the Canadian response to this issue is, following which we'll have lunch, a public hearing, we'll have extensive committee discussion and a vote at that point. And the end of the afternoon will be devoted to the operational definition of possible cases of new variant CJD as they may occur in this country.

I see that the suggested break for the day is 5:30. I have in mind a substantially earlier termination, if possible before 5:00 o'clock. I think the times allotted to the speakers have been generous, and I would hope that each of them would remain within his or her allotted time.

Now I introduce Dr. William Freas, the Executive Secretary of this Committee.