(System Info - 215193 DAVIDSON MARK 10/04/2012 12:31:58 DAVIDSONM)
From: Davidson, Mark
Sent: Thursday, October 04, 2012 10:53 AM
To: CBER-OCOD-Action Packages
Cc: Burk, Suzann
Subject: FDAAA Section 916 (Action Packages), Officer/Employee List for STN 125407
Hi OCOD Staff,
According to Section 916 of the Food and Drug Administration Amendments Act (FDAAA) includes a new requirement to identify by name each officer or employee who participated in the decision to approve an application for which an “Action Package” is prepared (i.e., NDA/BLA original application). This provision also requires that the employee’s consent must be obtained to list his/her name. To implement this provision, an Officer/Employee List memo will be prepared and included as part of the Action Package. Approval documents to follow this afternoon.
The following officers or employees of FDA participated in the decision to approve this application and consented to be identified on this list.
Yao Yao Zhu
Atm Shamsul Hoque
Mark L. Davidson, RHIA
Regulatory Project Manager
"THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone."