AGENDA

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

ALLERGENIC PRODUCTS ADVISORY COMMITTEE MEETING

 March 15, 2002

 Versailles I and II
Bethesda Holiday Inn
Bethesda, Maryland 20814

8:00 a.m.    Administrative Remarks

8:10            Opening Remarks
                        Samuel Lehrer, Ph.D., Committee Chair

COMMITTEE UPDATES (Open Session)

8:15               Overview of the Division of Bacterial, Parasitic & Allergenic Products (DBPAP)
                     Richard Walker, Ph.D., Division Director

8:30                Overview of the Laboratory of Immunobiochemistry:
                      Personnel, organizational, and lot release activities
                     Jay E. Slater, M.D., DBPAP, Laboratory Chief

8:45               Discussion

8:50               Research Updates
                     Jay E. Slater, M.D
                    Ronald Rabin, M.D., DBPAP, FDA

 9:35               Discussion

 9:50               Break

10:05             Particulates in Allergen Extracts and Compliance Overview
                     Jay E. Slater, M.D
                     Teddi Lopez, OCBQ, FDA

10:35               Discussion

10:50               Reduction of Possible Exposure to TSE Agents in Allergen Extracts
                      Jay E. Slater, M.D

11:05               Discussion

11:15              Open Public Hearing

11:45              Lunch

REGULATORY DISCUSSION TOPICS (Open Session)

12:45 p.m.   Considerations for the Regulation of Recombinant Allergens for the
                   Diagnosis and Treatment of Allergic Disease
                  Jay E. Slater, M.D

1:15           Discussion

1:30           Glycerol in Allergen Extracts
                  Jay E. Slater, M.D

1:45           Discussion

2:00           Open Public Hearing

 CLOSED SESSION

2:30         Presentation and Discussion of Site Visit Report

3:30 p.m.      Adjourn