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Vaccines, Blood & Biologics

Information Request, September 3, 2010 - Kedbumin

From: Allard, Crystal
Sent: Friday, September 03, 2010 9:15 AM
To: 'Urs Aeberli'
Cc: -----------------------(b)(4)--------------------------------
Subject: Information Request - 125384/0
HI Urs, 

We have a request and also a few comments for you regarding 125384/0. 

Please submit a data dictionary for the data files submitted in 125384/0. If you do not have a data dictionary available, a define.pdf file will be acceptable also. You can send this to me via email and I will have it routed through DCC as an amendment to 125384/0.

Also, I have two electronic submissions-related comments: 

  1. In the future, please do not include empty folders in the electronic copy of your submission, especially ifthe submission is submitted entirely electronically. Empty folders make us worry that perhaps you intended to submit something which was inadvertently left out. It also forces reviewers to spend unnecessary time clicking on folders to find nothing there. This is also an eCTD validation error.
  2. Please submit all sas files in .xpt format rather than .sas7bdat. The review tools we use require .xpt format. Our statisticians can convert the files to .xpt so there is no need to resubmit the files originally sent in .sas7bdat, but just keep this in mind for next time. This is also an eCTD validation error.

If you have electronic submission-type questions, we encourage you to include them in questions sent as part of a Pre-submission meeting.


Crystal Allard, RAC
Regulatory Project Manager
U.S. Food & Drug Administration
WOC1; RM480N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Ph# 301.827.3927
Fax# 301.827.2857
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