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APPLICATION INTEGRITY POLICY

List of Application Integrity Policy (AIP) Committee Members and AIP Contact Persons
(Updated June 2004)

[This document had been included in the internet version of Regulatory Procedures Manual (RPM) (August 1997, as updated March 1998), Chapter 10. The list is included in Attachment A of the Application Integrity Policy procedures. The AIP procedures and this contact list will no longer appear in the RPM when it is updated in 2004.]

AIP COMMITTEE MEMBERS/ AIP CONTACT PERSONS
(List updated: June, 2004)

Center for Biologics Evaluation and Research:

Tom Adams, HFM-610, Ph: 301-827-6201, FAX 301-594-0940

Diane Alexander, HFM-610, Ph: 301-827-6201, FAX 301-594-0940

Patricia Holobaugh, HFM-664, Ph: 301-827-6347, FAX: 301-827-6748

Center for Devices and Radiological Health:

Carl T. DeMarco, R.Ph., J.D., HFZ-400, Ph: 301-594-2022, FAX 301-594-2510

Sonali P. Gunawardhana, J.D., HFZ-310, Ph: 301-594-4718, x133, FAX: 301-594-4731

Michael Marcarelli, PharmD., HFZ-310, Ph: 301-594-4720 x129, FAX 301-594-4731

Center for Drug Evaluation and Research:

Brenda Friend, R.Ph., J.D., HFD-47, Ph: 301-827-7391, FAX 301-594-1204

Wayne Mitchell (Regulatory Policy Staff), HFD-007, Ph: 301-594-5639, FAX 301-827-5562

Leah Ripper, HFD-102, Ph: 301-827-5921, FAX 301-480-6644

John Simmons, Ph.D., HFD-810, Ph: 301-594-2570, FAX 301-827-4590

Peter Rickman, HFD-610, Ph: 301-827-5846, FAX 301-827-5911

Randall Woods, HFD-322, Ph: 301-827-9011, FAX: 301-827-8909

Center for Food Safety and Applied Nutrition:

John Welsh, Ph.D., HFS-205, 202-418-3057, FAX 202-418-3126

Andrew Zajac, Ph.D., HFS-265, Ph: 202-418-3095, FAX 202-418-3131

Center for Veterinary Medicine:

George Prager, HFV-234, Ph: 301-827-7791, FAX 301-827-1498

Vernon Toelle; HFV-234, Ph: 301-827-0312, FAX 301-827-1498

Office of Chief Counsel (Legal Advisor):

Erica Keys, Esq., GCF-1, Ph: 301-827-1141, FAX 301-827-3076

Nancy Stade, Esq., GCF-1, Ph: 301-827-6540, FAX: 301-827-7145

Office of Regulatory Affairs (ORA)

Rudaina Alrefai, Ph.D., HFC-240, Ph: 301-827-0413, FAX 301-827-0343

Kim Rice, HFH-550, Ph: 301-902-1516, FAX 301-344-3465

Shari Sheehan, J.D., HFC-230, Ph: 301-827-0412, FAX 301-827-0482 (For ORA and Office of the Commissioner)

Charles Zielinski, HFH-550, Ph: 301-344-0614, FAX: 301-344-0002

Page reformatted: 6-2004