DRAFT AGENDA (revised 10/22/01)

FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

Holiday Inn

Kennedy Grand Ballroom (Fourth Floor)

8777 Georgia Avenue, Silver Spring, MD

October 25 & 26, 2001

FIRST DAY, Thursday, October 25, 2001, OPEN SESSION

8:00 a.m. Administrative Remarks,

William Freas, Ph.D., Executive Secretary

8:10 Opening Remarks

David Bolton, Ph. D., Committee Chairman

TOPIC 1. FDAís Draft Guidance on Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (published in the Federal Register on August 29, 2001, http://www.fda.gov/cber/gdlns/cjdvcjd.htm )

8:15 a.m. Topic Overview

Dr. Dorothy Scott, M.D., OBRR, FDA

8: 35 Update: Current State of the Blood Monitoring Project and Plans to Extend Monitoring to the Supply of Plasma Derivatives and their Recombinant Analogs

Stephen D. Nightingale, M.D.

Executive Secretary, DHHS Advisory Committee on

Blood Safety and Availability

8:45 Update: DHHS Meeting held on September 24, 2001

Stephen D. Nightingale, M.D.

Executive Secretary, DHHS Advisory Committee on

Blood Safety and Availability

 

 

 

 

TSEAC AGENDA. Thursday, October 25, 2001, OPEN SESSION (continued)

8:55 a.m. Update: Anticipated Implementation of New Donor Deferral Policies

Celso Bianco, M.D.

Executive Vice President

America's Blood Centers

Ms. Jacquelyn Fredrick

Senior Vice President

Biomedical Services and COO Donor Enterprise Unit

American Red Cross

Robert Jones, M.D.

President

New York Blood Center

G. Michael Fitzpatrick, Ph.D.

Col, MS, USA

Director

Armed Services Blood Program Office

9: 20 Open Public Hearing

9:50 Committee Discussion

10:20 a.m. Break

 

TOPIC 2. Discussion of Amino Acid Sourcing and Production, and the Theoretical Risk of Transmission of the BSE Agent Through Their Use in Biopharmaceutical Products

10:30 a.m. Topic Introduction and Overview

Dr. Gerald Feldman, OTRR, CBER

10:50 Degussa-Reximís Amino Acid Production Process

Mr. Gerard Richet

R&D Director, Deputy Plant Manager

Degussa-Rexim, France

11:20 Ajinomotoís Amino Acid Production Process

Mr. Mike McLean

Quality Assurance Director, NC Plant

11:35 Closed Session

TSEAC AGENDA. Thursday, October 25, 2001, OPEN SESSION (continued)

 

12:00 p.m. Lunch

1:00 Open Session - Open Public Hearing

1:30 Committee Discussion and Votes

3:00 Adjourn for the day

 

 

FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

 

SECOND DAY, Friday, October 26, 2001

TOPIC 3: Bovine Brain, Spinal Cord, and Other Neurological Tissue in Foods, Drugs, and Cosmetics for Human Use

8:00 a.m. Overview and Background

Dr. Robert Brackett, CFSAN, FDA

8:10 Opportunities for Contamination of Edible Products in a Slaughter Plant with the BSE Agent

William James, D.V.M.

Director, Food Animal Sciences Division

Office of Public Health & Science

FSIS , USDA

8:50 Presentation of Questions to the Committee

Dr. Robert Brackett, CFSAN, FDA

9:00 Committee Discussion

10:05 Break

10:20 Open Public Hearing

10:50 Committee Discussion and Votes

12:50 Open Public Hearing

1:00 p.m. Adjourn for the day