From: Randi Basian [torontobaskets@on.aibn.com] Sent: Thursday, July 08, 2004 3:49 PM To: fdadockets@oc.fda.gov Cc: jodi.robinson@dfait-maeci.gc.ca; godfrey@on.aibn.com; godfrj@parl.gc.ca; peterj@parl.gc.ca; spellb@parl.gc.ca; ottawacomments@state.gov Subject: Docket No. 2002N-0278 July 8, 2004 Baskets By Geri's Eatin' Centre 1875 Leslie Street Unit 5 Toronto, ON M3B 2M5 Canada To Whom It May Concern, Baskets By Geri's Eatin' Centre would like to submit formal comments on the US Food and Drug Administration Prior Notice Interim Final Rule that appeared in the Federal Register of October 10, 2003 (68 FR 58974). My name is Elaine Levison. My daughter and I own Baskets by Geri's Eatin' Centre - a gift basket store in Toronto, Ontario. We have been in this business since 1979 - 25 years. We package gift baskets using sealed, pre-packaged, non-perishable foods and confections, manufactured in Canada, USA and Europe. We ship locally and across Canada and the USA. In a basket of ten items, at least five items may be originally from the USA. We have been dealing with our suppliers for 25 years and sell their products in our store as well as packaging them in our gift baskets. We are definitely NOT in the "TERRORISM GIFT BASKET BUSINESS". If this were the case, I would not be here to-day, alive and well, corresponding with you. We are in a NO-RISK business, as we know and trust our suppliers. Since the USFDA Prior Notice regulations have come into effect, my staff and I have experienced nothing but utter frustration. For 3 full days this week, we have been on the internet collecting date from the USFDA, and on the phone calling long-distance to their offices in Maryland, AT OUR EXPENSE, since there was no toll-free number to access. We downloaded 55 pages of a tutorial on how to create a Prior Notice, and 143 pages of products and codes to identify the products we use for shipping. However in our extreme frustration, those we contacted in the FDA were unable to provide us with product codes which were not on their website. We had a shipment to New York waiting for our Prior Notice preparation, and were told that the only person in the FDA who could be of assistance was unavailable for one week and we would have to call back. At the end of day 3 of attempting to comply, we were able to complete prior notices for only 2 of the 10 products we had included in the basket. Each item requires so much information, that it takes l to 1 1/2 hours to complete information PER GIFT BASKET! One option, as suggested to us, is to hire a data company or broker to do this work for us. The cost for the service was from $750.00 annual fee and up to $20.00 PER PRIOR NOTICE SHEET per basket. In a 10 item basket, where those 10 products could total $50.00 in value, it would cost us (after registration fee of $750.00) up to $200.00 to ship ONE basket across the US border. THIS IS LUDICROUS- as a small business owner I cannot stay in business under these conditions. Certain categories are, by nature, no-to-low risk,. Our business category falls into the NO RISK category, We deal with reputable, TRACEABLE suppliers, and furthermore, I have so many family members whom I LOVE who live across the USA , the last thing I would ever do would be to bring harm to any of them. I feel that, since we are in this no-risk category, we should be exempt from these regulations so we can carry on our business and pay our bills. Looking forward to an easy resolution to this situation, and a reply. I remain Elaine M. Levison Proud and Frustrated Owner Baskets by Geri's Eatin' Centre 1875 Leslie Street, Unit 5 Toronto, Ontario, Canada M3B 2M5 416-445-5504 (phone) 416-445-3424 (fax) mail@torontobaskets,com