[Federal Register Volume 65, Number 177 (Tuesday, September 12, 2000)]
[Notices]
[Pages 55027-55028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1311]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
October 12, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA 250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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.

[[Page 55028]]

Export of Medical Devices--Foreign Letters of Approval--Federal 
Food, Drug, and Cosmetic Act--21 U.S.C. 381(e)(2) (OMB Control No. 
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. FDA uses 
the written authorization from the foreign country to determine whether 
the foreign country has any objection to the importation of the device 
into their country.
    The respondents to this collection of information are companies 
that seek to export medical devices.
    In the Federal Register of June 20, 2000 (65 FR 38288), the agency 
requested comments 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\
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                                                      Annual
             Statute                  No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Section 801(e)(2) of the Federal       20               1              20               2.5            50
 Food, Drug, and Cosmetic Act
Total                                                                                                 50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    These estimates are based on the experience of FDA's medical device 
program personnel, who estimate that completion of the requirements of 
this collection of information should take approximately 2.5 hours to 
complete. Prior to the enactment of the Food and Drug Export Reform and 
Enhancement Act of 1996, FDA received approximately 800 requests from 
U.S. firms to export medical devices under section 801(e)(2) of the 
act. The enactment of the Food and Drug Export Reform and Enhancement 
Act of 1996 has greatly reduced the number of export permit requests 
made to the present estimated 20 per year.

    Dated: September 5, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-23326 Filed 9-11-00; 8:45 am]
BILLING CODE 4160-01-F