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U.S. Department of Health and Human Services

Animal & Veterinary

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Introduction and Purpose of Meeting

by Dr. Linda Youngman

(9:10 a.m.)

DR. YOUNGMAN: Good morning. We are just about ready to start. So, if I could ask that you take your seats, please.

(Pause.)

DR. YOUNGMAN: Good morning. I apologize for the delay in getting started this morning, but everything is here now, except for the booklets that we will be providing. The booklets will have the slides that people are presenting today. Those will be arriving shortly. I apologize that they are not here yet.

Anyway, we are very grateful that you all are here, and I want to do an introduction. My name is Linda Youngman, and on behalf of the Food and Drug Administration’s Center for Veterinary Medicine, I would like to welcome you to this NARMS Meeting.

I know that some of you have traveled quite a distance to be here, and we really appreciate you taking the time out of your busy schedules to be with us today. We look forward to your comments and advice about our NARMS program.

Rear Admiral Tollefson is not here today. I am filling in for her. She sends her regrets. She was called away by the Secretary of Health and Human Services for a bioterrorism exercise. We were looking forward to having her here, and we are a bit lost without her, but we will struggle through nevertheless.

We have asked each of you here today and tomorrow because you possess individual expertise that we believe will be critical and invaluable in helping us to prepare a review of our NARMS program. Today representatives from FDA, USDA and CDC will provide you with factual background and information on the NARMS program, and then we will ask for your individual comments once you have heard some of the background about NARMS.

For many of you this will be a repeat. You already know a lot of this. For some of you it will be completely new. But for everyone we are hoping to provide an update.

The representatives who will be speaking today can provide clarification to the questions that we are asking you to consider, but they cannot actually engage in any discussion about any particular aspect of the NARMS program. This meeting is not an advisory committee meeting, and we are asking you for your individual thoughts, rather than a consensus opinion, and there is not going to be any time allotted for you to prepare a consensus opinion. So, please. If we could ask for your individual thoughts, we would be grateful.

The meeting will be transcribed so that we can use it in drafting an internal assessment of the NARMS program, and we will draft this report to give to the Science Board, which is an external advisory board that has responsibilities to the FDA. They will advise us on the direction of our science, and the Science Board will also be doing a review of our NARMS program.

We will draft an internal assessment of the NARMS program using the transcription of today’s meeting as one piece of information that we will be providing to the FDA’s Science Board. We will wait for the Science Board review to be completed and then we are planning a follow up with either a public meeting or a publication of the Science Board’s review of the program, and possibly, also including pieces of this internal assessment. A Federal Register notice of availability with requests for comments will be put in the public docket.

Now for some housekeeping details. Most of you know Aleta Sindelar. Is she here? I guess she is trying to get the booklets for you. If you need something, Aleta can help you. I know there were some questions about getting some copies made while we are here today. She will help you with those kinds of issues.

The bathrooms are down the hall. So, if you take a left and then a right where the TV screens are, the mens and ladies rooms and telephones are back there.

You should each have an agenda now. Again, we apologize for the delay in starting, but we are going to try to stick closely to the agenda and try to make up for lost time this morning. So, we are very grateful that you are here. Thank you for coming. Especially those of you who came from a long distance. We appreciate it; flying through thunderstorms.

So, without further ado, I would like to turn this over to the first speaker, Dr. David White, who is going to be giving you an introduction to our NARMS program.

DR. VOGEL: Linda, can I ask a question?

DR. YOUNGMAN: Sure.

DR. VOGEL: You mentioned that the speakers can provide clarification, but cannot enter into discussion. Can you expand on that? What do you really mean?

DR. YOUNGMAN: We are looking for individual opinions, not a consensus; from the representatives who are here to give us their individual advice today. So we don’t want to push people toward a certain conclusion. We want to hear from each of you individually.

DR. VOGEL: But we are free to question the presenters?

DR. YOUNGMAN: Yes. Yes. Oh, I’m sorry. I also forgot one other thing. That is, parking. If you parked in the garage today, the normal cost is $8.50 a day. If you punch in this code, it will be free, and I think it is the same code tomorrow, but I will let you know tomorrow for sure. If you punch in #1470, you will be able to park for free. It is covered by your attending this conference.

DR. McEWEN: I have one question as well. Are you expecting our opinions as we go? Or are we to consider things and prepare written notes to submit after we convene?

DR. YOUNGMAN: No. We are asking for your comments today. But if you look at the agenda, we are providing questions and asking for answers after several of the presenters have presented. We scheduled in time for the meeting for questions and answers after the talks.

I am sure some questions are going to come up during the talks, however, but again, the reason for this is that we don’t want a consensus and we don’t want you to ask you to draft a consensus opinion. We are asking for your individual advice.

All right. I will turn it over to Dr. Dave White. Thank you.