From:	Gareth Griffiths [beacons.crc@ntlworld.com]
Sent:	Friday, September 06, 2002 10:18 AM
To:	fdadockets@oc.fda.gov
Subject:	Comment to Proposed Amendment to 21 CFR Part 312
Dear Sirs,

I refer to the proposed amendment to Code of Federal Regulations 21 Part 312 entitled 'Investigational New Drug: Export Requirements for Unapproved New Drug Products', Document No. 00N-1663.  Under this proposed amendment, Section 312.110(b)(2) would allow export of investigational product that is not approved for use in the US but has valid marketing authorisation in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or in any country in the EU or EEA 'to any country provided that the export complies with all applicable requirements pertaining to exports.'.  There is disagreement amongst my colleagues whether the term 'any country' means 'any listed country' or 'any country worldwide'.

Clarification of the intended interpretation via the e-mail address below would be gratefully received.
Thank you in anticipation.
Kind regards

Gareth Griffiths
Director,
Beacons Clinical Research Consultants Ltd.
19 New Road
Twyford
Berks  RG10 9PS
UNITED KINGDOM
Tel. +44 (0) 118 9340662
Fax. +44 (0) 118 9321527
E-Mail: beacons.crc@ntlworld.com