OMB memo May 27 2009

From: Neyland, Kevin F.
Sent: Wednesday, May 27, 2009 6:21 PM
To: 'Lutter, Randall'
Subject: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility Testing Devices

Randy,
Following up on our phone call and emails, I asked staff to show me comments on guidance that
were essentially comments on an ICR.
They skimmed 6 of 10 comments related to the draft guidance "Updating Labeling for
Susceptibility Test Information in Systemic Antibacterial Drug Products and
Antimicrobial Susceptibility Testing Devices," located on Regulations.gov, and found at least
one reference related to the ICR in each of the comments. The comments seem to be along the
following themes: a) the guidance is unclear as to what info is required for the annual report, b)
the timeframe is too short to justify label changes, and c) the timeline for FR submission is too
long to allow those interested to disseminate findings.
For your convenience, the 6 skimmed letters are attached w/ marginalia. Do you agree that the
noted comments are related to the ICR? Let's talk soon so that we can move forward.
Best!
Kevin