[Federal Register Volume 65, Number 119 (Tuesday, June 20, 2000)]
[Notices]
[Pages 38288-38289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1311]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on collection of information 
requirements for reporting requirements for firms that intend to export 
certain unapproved medical devices.

DATES: Submit written comments on the collection of information by 
August 21, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the

[[Page 38289]]

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be 
identified with the docket number found in brackets in the heading of 
this document.

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: Under the PRA (44 U.S.C. 3501-3520) Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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.
    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: June 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-15433 Filed 6-19-00; 8:45 am]
BILLING CODE 4160-01-F