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Vaccines, Blood & Biologics

Report of Telephone Conversation, September 7, 2012 - EVARREST

Report of Telephone Conversation


Date/Time of Call:                 September 7, 2012



Representative:                      Randa Melhem, Ph.D., OCBQ/DMPQ, HFM-676



Representative:                      Jessica Chung, Associate Director, Regulatory Affairs


Organization:                         Ethicon Inc.


Telephone:                             ---b(6)----------------


Subject:                                  Information Request – Follow up on the August 2, 2012 Telecon


STNs:                                     125392/0





During the August 2, 2012 Telecon, Ethicon clarified in response to comment 6 regarding the      clean and sterile/sanitized hold time for equipment at FPPF, that they have initiated an SPR to perform studies to support 24 hour CEHT and SEHT which will be completed during this month (August) and sent to FDA.



I called Ms. Jessica Chung and requested that Ethicon submit the results of the CEHT and SEHT studies referred to in the August 2, 2012 telecon. She said they have the data and would submit to FDA within few days.



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