From: Mary Rouleau [MRouleau@uaw.net]
Sent: Monday, April 22, 2002 2:32 PM
To: FDADockets@OC.FDA.GOV
Cc: fitzpatrickc@cder.fda.gov; PDELANEY@OC.FDA.GOV
Subject: Notice of Request to Participate-"Risk management of Rx Drugs
hearing"

Dear Madam or Sir:

On behalf of the Patients and Consumers Coalition, I am requesting that
our coalition be allowed to formally participate in the public hearing
noticed for May 22, 2002 .

The Patient & Consumer Coalition does not anticipate expenses other
than local travel, which each member will pay for itself.  We are
requesting 30 minutes to present comments on the following:
 
1. Our views on the current risk management system, including
provisions expected to be adopted as a part of PDUFA III.

2. Our views on what the FDA should be doing in risk management beyond
current methods and PDUFA III.

Please contact me if you have any questions.

Mary Rouleau
Deputy Legislative Director
International Union, UAW
1757 N Street NW
Washington, DC 20036

202-828-8500
202-861-2938 fax