OMB memo March 13 and 16 2009

From: Matsuoka, Karen Y.
Sent: Monday, March 16, 2009 3:41 PM
To: 'Berbakos, Elizabeth G'
Subject: RE: Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic
Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

Thanks, Liz. In the future, please ensure that the guidance documents are submitted through ICRAS/ROCIS (with the
“associated with other documents” box checked to prevent public disclosure).
The guidance is dated “January 2009.” Does this mean the paperwork requirements are already in effect?
Also, can you send me a list of comments that FDA received regarding this guidance document?
Thanks.
Karen
From: Berbakos, Elizabeth G
Sent: Monday, March 16, 2009 2:46 PM
To: Matsuoka, Karen Y.
Subject: RE: Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic
Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

Karen, here is the guidance....
From: Matsuoka, Karen Y.
Sent: Friday, March 13, 2009 7:24 PM
To: Berbakos, Elizabeth G; Capezzuto, JonnaLynn; Presley, Denver
Subject: Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic
Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

Hi everyone. I don’t see the guidance that this ICR is associated with. Did you upload it into ICRAS/ROCIS? Can you
email it to me? Thanks. – Karen