From: Dr.Donna Gultom [donna@deptan.go.id] Sent: Wednesday, December 24, 2003 4:07 AM To: fdadockets@oc.fda.gov Subject: Comment on Section 305 and 307, BTA Jakarta, 23 December 2003 To. Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 Docket Number: 2002D-0276 2002N-0278 Dear Sir/Madam, We do appreciate the United States Food and Drugs Administration (FDA) and the US Bureau of Customs and Border Protection (CBP) for issuing the transition policy of the Bio-terrorism Act for 8 months (until August. 12, 2004). We hope that during the transition period, FDA will have time to make necessary improvement to the Act so that it would not create unnecessary problems in its future implementation. In this opportunity, we would once again like to raise the issue of US Agent that foreign facilities must have. From your explanation during the Training Seminar on the Bio-terrorism Act in November 6-7, 2003 in Washington D.C, we understand as the role of US Agent is mainly an agent for communication to your country. We feel that the burden on us is too heavy, especially for the SME of the developing countries. As we understand that international communication is not a problem anymore in the current situation. We, therefore earnestly, request FDA to reconsider the elimination of this unnecessary requirement. Furthermore, in regard to Prior Notice (PN), we feel that there is an area need to be clarified, this is related to food articles sent as gifts or personal consumption to persons in US. The clarification is needed due to the different explanation you gave to us; the written instruction is different with the oral presentation you gave during Training Seminar. It was mentioned that PN is a must if the food articles will be distributed or traded in US. Thank you for kind attention, Sincerely, Director General, Directorate General of Agricultural Product Processing and Marketing Development Ministry of Agriculture of the Republic of Indonesia