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Vaccines, Blood & Biologics

Telecon Memo, November 21, 2011 - Flucelvax


Date: November 21, 2011
From: Carla Vincent, CBER RIMS User Fees
Through: David Dickerson, CSO DVRPA
John Barry, Head of Regulatory Affairs North America, Novartis
Summary: I contacted Mr. Barry to indicate that a user fee had not been received from Novartis for BLA STN# 125408, Influenza Vaccine (MDCK Cells). Mr. Barry said this was an inadvertent mistake and would see that payment was wired immediately. I provided the following wire payment information.
Wire Transfer Payment
US Department of Treasury
33 Liberty Street
New York, NY 10045
FDA Deposit Account Number:  75060099
US Department of Treasury routing/transit number:  021030004
Mr. Barry thanked me for calling and the call ended pleasantly. (Note: Because the payment was received on 11/22/2011, an Unacceptable for Filing letter was not issued to Novartis. DVRPA decided to convey the new action due date via the acknowledgment letter.)

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