[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Notices]
[Page 33161-33162]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn03-84]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
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801(e)(2) 20 1 20 2.5 50
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.
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