From: Sara Radcliffe []
Sent: Monday, November 08, 2004 1:20 PM
Subject: Question re Docket 2004N-0355 (Considerations for Developing Follow-On Protein Products)

Dear Sir/Madam,


BIO would like to request that FDA extend the deadline for docket 2004N-0355 by approximately two weeks (from November 12 to November 29).  BIO is still hoping to submit our comments on time, but will be able to provide better comments if the deadline is extended; we are also aware of BIO members which may have trouble meeting the deadline.


Please let me know if this is possible.


Thanks and Regards,





Sara Radcliffe, MPH

Managing Director, Scientific and Regulatory Affairs

Biotechnology Industry Organization (BIO)

1225 Eye Street NW, Suite 400

Washington DC 20005-5958


tel 202 962 9239

fax 202 962 9201