From: Ian DeVeau [ifd@usp.org]
Sent: Friday, June 14, 2002 11:01 AM
To: FDADockets@oc.fda.gov
Cc: Eric Sheinin; Ian DeVeau; Joseph Valentino; Roger Dabbah; sally.seaver@verizon.net
Subject: Notice of participation - Docket number: 02N-0169
To: FDA Dockets Management Branch (HFA-305)
From: The United States Pharmacopeia
 
Gentlemen,
 
Please be advised that the United States Pharmacopeia (USP) wishes to formally participate in the public hearing on Monday, June 24, 2002 concerning combination products containing live cellular components.
 
The USP is the publisher of the USP and NF, the official compendia under the FD&C Act.  The primary purpose of our testimony will be to inform the Agency of our experience in developing public standards for these articles in order to assist the Agency in formulating its regulatory policies.
 
The USP will be represented by Dr. Sally Seaver, Chair of USP Expert Committee on Gene Therapy, Cell Therapy and Tissue Engineering.  She will be accompanied by a USP staff member.  Approximately 10 - 15 minutes are requested for the presentation.  Please address any comments to:
 
Dr. Sally Seaver
Seaver Associates
174 Hawthorne Lane
Concord, MA 01742
1-978-369-9000
Sally.Seaver@verizon.net
 
Thank you for this opportunity to participate.
 
Sincerely,
 
Joseph G. Valentino
The United States Pharmacopeia
Sr. Vice President, Secretary & General Counsel