[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Notices]
[Pages 33161-33162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0200]


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 information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements for 
firms that intend to export certain unapproved medical devices.

DATES: Submit written or electronic comments on the collection of 
information by August 4, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the 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 Robbins, 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 (OMB 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. An 
alternative to obtaining written

[[Page 33162]]

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.
    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
    21 CFR         No. of      Frequency     Total    Hours per   Total
   Section      Respondents       per       Annual     Response   Hours
                               Response    Responses
------------------------------------------------------------------------
801(e)(2)      20             1           20          2.5        50
Total                                                            50
------------------------------------------------------------------------
\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.

    Dated: May 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13755 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S