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Information Collections on Medical Devices, Export Controls, Imported Seed Under Review

Tuesday, July 09, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting written comments through Aug. 8 on an information collection entitled “Export of Medical Devices; Foreign Letters of Approval.” The Federal Food, Drug and Cosmetic Act provides for the exportation of unapproved medical devices under certain circumstances if the exportation is not contrary to public health and safety and has the approval of the foreign country to which it is intended. Requesters communicate (either directly or through a business associate in the foreign country) with a representative of the foreign government to which they seek exportation, and written authorization for the importation must be obtained from the appropriate office within that government. An alternative is to accept a notarized certification from a responsible company official in the U.S. that the product is not in conflict with the foreign country’s laws. This certification must include a statement acknowledging that the responsible company official making the certification is subject to the provisions of 18 USC 1001, which makes it a criminal offense to knowingly and willingly make a false or fraudulent statement, or make or use a false document, in any manner within the jurisdiction of a federal department or agency.

TheBureau of Industry and Security is inviting written comments through Sept. 9 on an information collection regarding foreign availability procedures. Exporters are urged to voluntarily submit data to support the contention that items controlled for export for national security reasons are in fact available from a non-U.S. source in sufficient quantity and of comparable quality so as to render the control ineffective.

BIS is also accepting through Sept. 9 comments on the application for special comprehensive license (forms BIS-752A and 752-P), which authorizes multiple shipments of items from the U.S. or from consignees abroad who are approved in advance by BIS to conduct the following activities: servicing, support services, stocking spare parts, maintenance, capital expansion, manufacturing, support scientific data acquisition, reselling and reexporting in the form received, and other activities as approved on a case-by-case basis. An application for an SCL requires the submission of additional supporting documentation such as the company’s internal control program.

The Department of Agriculture’s Animal and Plant Health Inspection Service is accepting public comments through Aug. 8 on the proposed extension of forms PPQ 925, Seed Analysis Certificate, and PPQ 519, Compliance Agreement. These information collections are associated with APHIS’ seed analysis program with Canada that allows U.S. companies that import seed for cleaning or processing to enter into compliance agreements with APHIS that eliminate the need for sampling shipments of Canadian-origin seed at the border and allow certain seed importers to clean seed without the direct supervision of an APHIS inspector.

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