From: PETERS, JENNY L [R&D/0200] [jenny.l.peters@pharmacia.com] Sent: Friday, September 20, 2002 11:27 AM To: 'fdadockets@oc.fda.gov' Subject: Docket 00N-1663 Docket No. 00N-1663; Proposed Rule, Investigational New Drugs: Export Requirements for Unapproved New Drug Products; 67 Federal Register 41642 (June 19, 2002) We have reviewed and agree with the comments submitted by PhRMA on 17 September 2002. We congratulate FDA for taking the initiative to propose amending its regulations for exporting investigational new drugs so that they include mechanisms which are simpler while still taking into account public health concerns. Jenny L. Peters Pharmacia Director, Global Regulatory Affairs 616.833.8141 phone 616.833.0512 fax jenny.l.peters@pharmacia.com