2005N-0190 Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
FDA Comment Number : EC2
Submitter : Mr. Michael Sevigny Date & Time: 07/15/2005 05:07:44
Organization : Bio-Tek Instruments, Inc
Category : Device Industry
Issue Areas/Comments
I am submitting two comments on the "Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products - Export Certificates" Docket No. 2005N-0190 which appeared in the Federal Register on June 21, 2005 page 35678-9. Bio-Tek Instruments is a manufacturer of General Purpose laboratory devices which are also Class I IVDs.

Comment 1. Financial burden. Some of our international dealers must have current "Certificate to Foreign Government" documents on file with their regulatory agencies. (Thailand being one example.) They have informed us that a two year expiration date causes them problems with keeping their registration to import current. They suggest that a longer period be applied to the documents such as the 5 years used by the UK. Our opinion is any extension of the date to three, four or five years would reduce Bio-Tek and the dealer's financial burden. This burden is based on the $175. for the initial document (which averages down if several are ordered at the same time) plus all the other expenses to prepare the submission and have the documents legalized. Here is the process: First we prepare and send our submission to FDA, we then receive the Certificate, and next send it to the Maryland Courthouse to have certification that the FDA Notary is in good standing attached ($1 per document plus Express outgoing and return mail). After we receive the Certificate back then we must sent it the Maryland Secretary of State for certification that the Clerk of the Court that certified the Notary was authorized to do so ($5 per document plus Express Mail both ways). Next the Document package must be sent to the Thailand Embassy in Washington for legalization (cost $15 per document plus Express Mail both ways.) We must next send the document to the dealer who must submit it to their governmental agency. All this must be done before the previous "Certificate to Foreign Government" expires thus further reducing the two year life of the Certificate. We thus request that the expiration date for "Certificate to Foreign Government" documents be extended to five years if possible, or to three or four years if five is not feasible.

Comment 2. The wording that you allow in the "Foreign Country Certification Statement" that says "A Photocopy of the Certificate to Foreign Government may be used as long as this original statement is attached." would be more official if reworded and placed on the "Certificate to Foreign Government". This is the case as a document that I originate saying that photocopies are acceptable does not bear the credence of an FDA issued document.

Thank you in advance for your consideration of these comments.

Mike Sevigny
Director QA &RA
Bio-Tek Instruments, Inc
Winooski, Vermont 05404 USA
TEL: - in USA 888-451-5171 ext. 336
International 802-655-4040 ext. 336
FAX: 802-655-3849

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