[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7046-7047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2489]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0380]


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.

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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: 202-395-6974.

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 Burden\1\
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                                                                     Annual Frequency     Total Annual       Hours per                 Total Operating &
               21 CFR Section                  No. of Respondents      Per Response        Responses         Response     Total Hours  Maintenance Costs
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801(e)2                                                         25                  1                 25             2.5         62.5             $6,250
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\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

[[Page 7047]]

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.
[FR Doc. E7-2489 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S