
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
TREAS NYC
33 Liberty Street
New York, NY 10045

FDA Deposit Account Number:  75060099
US Department of Treasury routing/transit number:  021030004
SWIFT Number: FRNYUS33

 

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.)