Draft Agenda

FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

July 17 & 18, 2003

Holiday Inn Select

8120 Wisconsin Avenue

Bethesda, MD 20814

(revised 7/8/03)

First Day, Thursday, July 17, 2003

8:00 a.m. Administrative Remarks

8:10 Opening Remarks

Dr. Suzette Priola, Chairperson

8:20 Topic # 1 - Safety of Bovine Bone Gelatin in Oral and Topical Drugs, Food and Cosmetics

Background and Introduction

Dr. Morrie Potter, CFSAN, FDA (15’)

Questions to the Committee

Dr. Yuan-yuan Chiu, CDER, FDA (10’)

Market Trend in United States

Mr. George Masson, President GMIA (20’)

Manufacturing Process for Bone Gelatin – Industry Practices in United States

Dr. Michael Dunn, Vice President, Chairman of the Regulatory Committee, GMIA (20’)

Manufacturing Process for Bone Gelatin – Industry Practices in Europe

Mr. Reinhard Schrieber, Chief Manufacturing Officer, Deutsche Gelatine-Fabriken Stoess AG, Gelita Group (20’)

9:45 Break

10:00 Reports of Three GME Validation Studies on Bone Gelatin

Dr. Robert Sommerville, IAH Edinburgh, UK (60’)

Risk Analysis of Infectivity

Dr. Robert Hills, Health Canada, Ottawa (15’)

USDA Gelatin Policy

Dr. Terry Morris, APHIS (20’)

11:35 Open Public Hearing (20’)

11:55 Committee Discussion and Voting (30’)

12:25 p.m. Lunch

TSEAC AGENDA

First Day, Thursday, July 17, 2003 (continued)

1:25 p.m. Topic # 2 - BSE in Canada

Review of Bovine Spongiform Encephalopathy in Canada (15’)

Dr. Robert Hills, Health Canada, Ottawa

Potential Exposure of Blood Donors in North America to BSE Agent

Dr. Steven Anderson or Dr. Sonja Sandberg, OBE, CBER, FDA (15’)

1:55 Open Public Hearing (30’)

2:25 Committee Discussion (30’)

Topics # 3 and # 4: General Introduction

TSEs and Decontamination of Medical Equipment and Facilities

2:55 TSEs, Decontamination and FDA Regulated Products

Dr. David M. Asher, OBRR, CBER, FDA (10’)

3:05 Invited Speakers

Principles of TSE Inactivation: Validation and Use of Infectivity Assays and Assays for Abnormal Prion Proteins,

Dr. Robert Rohwer, Director Molecular Neurovirology Unit, VA Medical Center, Baltimore (20’)

Review of Effective Decontamination of TSE Agents: Basis for WHO Recommendations,

Dr. David Taylor, SEDECON 2000, UK (30’)

Reducing the Risk of CJD Transmission through Surgical Procedures: Experience in UK,

Dr. Philippa Edwards, Principal Scientist, CJD Policy Team, UK (30’)

TSE Agents and Infection Control in Hospitals: Experience in USA

Dr. William Rutala, UNC (20’)

4:45 Break

5:00 Preliminary Results: Infectivity of Air Emissions and Residues from Simulated Incineration of Scrapie Tissues

Capt. Edward Rau, Environmental Health Officer, NIH (30’)

TSE Infectivity: Experience with Models for Validating Decontamination of Surfaces and Effects of Decontamination on Materials (30’)

Drs. David M. Asher, CBER and Stanley Brown, CDRH

6:00 p.m. Adjourn

TSEAC DRAFT AGENDA

Second Day, Friday, July 18, 2003

8:00 a.m. Administrative Remarks

8:10 TSEs and Decontamination: Introduction (continued)

A Model for Evaluating TSE Decontamination of Metal Objects: Recent

Progress

Dr. Charles Weissmann, MRC Prion Unit, Imperial Coll., Lond (30’)

TSE Decontamination: Validation Studies Relevant to Manufacturing Facilities and Equipment Cleaning

Dr. Cristoph Kempf, ZLB, Plasma Protein Therapeutics Association (PPTA) and U. of Bern, Switzerland (15’)

9:10 Topic # 3 – Reprocessing of Medical Devices, Contaminated or Potentially Contaminated with TSE agents

Introduction (10’)

Ms. Lillian Gill, CDRH, Senior Associate Director for Science

Background: Validating Sterilization of Medical Devices (20’)

CDR Martha O’Lone, Infection Control Devices Branch, CDRH

9:40 Open Public Hearing (40’)

10:20 BREAK (15)

Presentation of Topic 3 Questions (5’)

Dr. Charles Durfor, CDRH, FDA

Committee Discussion and Voting on Topic 3 Questions (70’)

11:50 Lunch

12:50 Topic # 4 - Methods to Decontaminate Facilities and Equipment Used to Prepare Human Cellular and Tissue Products (HCTP), and Human Blood Products, Including Plasma Derivatives, to Reduce the Theoretical Risk of Transmitting TSE Agents.

Methods used in Human Cells, Tissues & Cellular and Tissue-Based Product (HCT/P) Establishments

Dr. Ruth Solomon (10’)

Methods used in Eye Banks

Ms. Ellen Heck, UT Southwestern Medical Center (10’)

Methods used in Plasma Derivative Manufacturing

Dr. Dorothy Scott, OBRR, CBER, FDA (10’)

Proposed Industry-Sponsored Collaborative Validation Study for TSE Clearance Methods Relevant to Facility and Equipment Cleaning for Plasma Derivatives

Dr. Andrew Bailey, Baxter Healthcare and PPTA (10’)

1:30 Open Public Hearing (30’)

2:00 Presentation of Topic 4 Questions (5’)

Committee Discussion and Voting on Topic 4 Questions (70’)

4:15 p.m. Adjourn