1. Laboratory of Immunobiochemistry Ronald L. Rabin, MD Allergenic Products Advisory Committee 12 May 2011

2. 2/12 Laboratory of Immunobiochemistry Ronald L. Rabin, MD - Lab Chief Jay E. Slater, MD – Supervisory Medical Officer Ashraf El Fiky, MD, PhD – Visiting Associate Tarunah Khurana, PhD – Visiting Associate Philippa Hillyer, PhD – Visiting Associate (July 2011) Sandra Menzies, MS, Consumer Safety Officer Katya Dobrovolskaia – Biologist Mona Febus – Microbiologist Cherry Valerio – Biologist Aaron Chen – Biologist Giulia Fabozzi, PhD Lynnsie Schramm Kevin Kirschman Roger Perreault Danielle Dougherty Maggie Collison Susan Huynh

3. 3/12 Division of Bacterial, Parasitic, and Allergenic Products Jay E. Slater, MD Director Drusilla Burns, PhD Deputy Director (Acting) Jennifer Bridgewater, MPH Associate Director for Regulatory Policy Tina Roecklein, MS Regulatory Coordinator

4. 4/12 Division of Vaccines and Related Products Applications (DVRPA) Wellington Sun, MD Director Paul Richman, PhD Chief, Regulatory Review Branch 1 CAPT Julienne Vaillancourt, RPh, MPH Team Leader CDR Colleen Sweeney, MS Regulatory Health Project Coordinator Nicolette DeVore, PhD Review Scientist LT Elizabeth Valenti, MPH Regulatory Review Officer

5. LIB Staff have dual responsibilities Regulatory/review Research

6. 6/12 “Routine” regulatory activities Lot release 2010: 408 Protocols Reviewed Reference distribution 2010: 4644 vials in 110 shipments sent to manufacturers Reference maintenance Semi-annual checks Reference replacement

7. 7/12 Lot release protocols submitted

8. 8/12 Reference distribution

9. 9/12 References replaced in 2010-2011 Extracts E10-Dp E5-cat pelt C14-Ras Sera S6-Dpf S2-Cat S3-Ber

10. 10/12 Planned replacements in 2011 Human serum S7-Dpf S5-Grass

11. 11/12 How do we manage the inventory? Semi-annual reference checks Estimate replacement dates based on expiry and consumption Monitoring manufacturer requests Limited distribution for research purposes

12. 12/12 Review Responsibilities Investigational New Drug (IND) Sponsor originated (goal is licensure/market) Investigator originated (use of extract for purpose other than licensed) onasal or bronchial challenges omechanistic studies Biological License Applications (BLA) Initial License Supplements Annual Reports Consultations for other centers CDER CDRH