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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Report of Telephone Conversation, September 7, 2012 - EVARREST

Report of Telephone Conversation

 

Date/Time of Call:                 September 7, 2012

 

CBER                                    

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

                                               

Organization                         

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

 

 

 

Background:

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.

 

Telecon

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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