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Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices-Foreign Letters of Approval

Action

Notice.

Summary

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

Fax written comments on the collection of information by May 17, 2010.

ADDRESSES: Back to Top

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0264. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Back to Top

Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Back to Top

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Export of Medical Devices-Foreign Letters of Approval (OMB Control Number 0910-0264)—Extension Back to Top

Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(e)(2)) provides for the exportation of an unapproved device under certain circumstances if the exportation is not contrary to the public health and safety and it has the approval of the foreign country to which it is intended for export. 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 must be obtained from the appropriate office within the foreign government approving the importation of the medical device. An alternative to obtaining written authorization from the foreign government is to accept a notarized certification from a responsible company official in the United States 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 U.S.C. 1001. This statutory provision 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 department or agency of the United States. The respondents to this collection of information are companies that seek to export medical devices. FDA's estimate of the reporting burden is based on the experience of FDA's medical device program personnel.

In the Federal Register of January 26, 2010 (75 FR 4086), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden 1 Back to Top
Section of the Federal Food, Drug, and Cosmetic Act No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Total Operating and Maintenance Costs2
1There are no capital costs or operating and maintenance costs associated with this collection of information.
2Due to a clerical error, the operating and maintenance costs that appeared in the notice issued in the Federal Register of January 26, 2010, were reported as zero. The correct figure is in Table 1 of this document.
801(e)(2) 38 1 38 3 114 $6,250

Dated: April 9, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-8572 Filed 4-14-10; 8:45 am]

BILLING CODE 4160-01-S

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