DEPARTMENT OF HEALTH HUMAN SERVICESÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Public Health Service
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EMPLOYEE/OFFICER LIST MEMO
To: Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â The File
Date:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â April 15, 2014
BLA:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â STN 125478/0Â Â Â Â Â Â Â Â Â Â Â
Sponsor: Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Merck Sharp Dohme Corp.
Product: Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â RAGWITEK, Short Ragweed Pollen Allergen Extract, Tablet for Sublingual Use
From:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â CDR Elizabeth Valenti, MPH, REH/RS, RAC (U.S.)
Signature:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â
Section 916 of the Food and Drug Administration Amendments Act (FDAAA) requires that the identity of each employee or officer who participated in the decision to approve an original application be listed and filed as part of the Action Package for that file.
The following employees and officers have consented to have their names published publicly as being a participant in the approval decision for this file.
Jennifer Bridgewater, M.P.H.                       Regulatory Coordinator
Dennis T. Cato, CSOÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Bioresearch Monitoring Reviewer
Cherry Geronimo, B.S.                      CMC/Lot Release Reviewer
Patricia Holobaugh, Ph.D.                 Chief, Bioresearch Monitoring Branch
Amelia (Dale) Horne, Ph.D.              Chief, Vaccine Evaluation Branch
Cheryl Hulme, CSOÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â CMC/Lot Release Reviewer
CDR James Kenney, D.Sc.                Supervisory Regulatory Management Officer, CMC
Taruna Khurana, Ph.D.                      Product Reviewer
David Martin, M.D. Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Deputy Director, Office of Biostatistics and Epidemiology
Tammy Massie, Ph.D.                                   Statistical Reviewer
Ronald Rabin, M.D.                          Clinical Reviewer
Daphne Stewart                                 Carton and Container Labeling Reviewer
Ching-Long (Joe) Sun, Ph.D.            Toxicology Reviewer
Deborah Trout, CSOÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â CMC/Facility Reviewer
Claire Wernly, Ph.D.                         CMC/Lot Release Reviewer
Lihan Yan, Ph.D.                               Statistical Team Leader