E7-2489. Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices-Foreign Letters of Approval

AGENCY:

Food and Drug Administration, HHS.

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.

DATES:

Fax written comments on the collection of information by March 16, 2007.

ADDRESSES:

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: [phone].

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:

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

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.

FDA uses the written authorization from the foreign country or the certification from a responsible company official in the United States to determine whether the foreign country has any objection to the importation of the device into their country.

In the Federal Register of September 22, 2006 (71 FR 55487), FDA published a 60-day notice soliciting public comments on the proposed information collection provisions for this requirement. In response to this notice, no comments were received. The agency is also correcting an error. The operating and maintenance cost, which was inadvertently omitted in the burden table for the 60-day notice, has been added as a column to the burden table for this notice.

The respondents to this collection of information are companies that seek to export medical devices.

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

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency Per Response	Total Annual Responses	Hours per Response	Total Hours	Total Operating & Maintenance Costs
801(e)2	25	1	25	2.5	62.5	$6,250
1 There are no capital costs associated with this collection of information.

These estimates are based on the experience of FDA's medical device program personnel. There are no capital costs associated with this collection of information. In addition, the respondent's costs of submission of a request to the foreign country for approval to import into that country, and subsequent submission of such approval to FDA, vary and are considered operating and maintenance costs. On average, it appears that it can cost a requester approximately $125 per page of translation. From review of our records, it appears that foreign approval letters average two pages. Therefore, the “other” estimated cost to requestors for processing a foreign approval letter is approximately $6,250 (25 submissions per year x 2 pages = 50 pages x $125 per page = $6,250).

Dated: February 7, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.