2005N-0290 Agency Information Collection Activities: Proposed Collection; Comment Request;
FDA Comment Number : EC1
Submitter : Mr. Fred Gorrell Date & Time: 10/04/2005 03:10:09
Organization : Canadian Embassy, Washington
Category : Federal Government
Issue Areas/Comments
October 3, 2005

Comments of the Government of Canada on the Agency Information Collection Activities; Proposed Collection; Comment Request; Importer?s Entry Notice

Docket No: 2005N-0290

RE: Importer's Entry Notice (OMB Control Number 0910-0046) - Extension

The Government of Canada welcomes the opportunity to provide comments on the Extension of the Importer's Entry Notice (OMB Control Number 0910-0046) concerning the cost of the collection of information by the Food and Drug Administration (FDA) as notified under Docket No. 2005N-0290 and published by the FDA, in the Federal Register of August 3, 2005 (Volume 70, Number 148).

The notice indicates that the FDA collects information on foreign-origin FDA-regulated foods, drugs, cosmetics, medical devises and radiological health products electronically via the U.S. Customs Service's Automated Commercial System at the same time the information is filed with the U.S. Custom Service. The methodology used to calculate FDA's estimate of the burden of the proposed collection of information is based on this process.

The Government of Canada is concerned that the methodology used does not take into consideration the additional burden of the FDA Interim Final Prior Notice and Registration Rules which came into effect December 2003.

In order to be comprehensive, we urge the FDA to amend the methodology used to take into consideration the burden associated with all requirements for providing information concerning foreign-origin FDA regulated foods, in particular, the burden resulting from the implementation of the Prior Notice and Registration Rules under the FDA Bio-Terrorism Act of 2002.