[Federal Register: August 25, 2003 (Volume 68, Number 164)]
[Page 51023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0200]

Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Export of Medical Devices--Foreign Letters of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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: Submit written comments on the collection of information by 
September 24, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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.

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.
    The respondents to this collection of information are companies 
that seek to export medical devices.
    In the Federal Register of June 3, 2003 (68 FR 33161), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the reporting burden of this collection of 
information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
  Section of the         No. of        Annual Frequency     Total Annual        Hours per
       Act            Respondents        per Response        Responses           Response         Total Hours
801(e)(2)                         20                  1                 20                2.5                 50
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: August 18, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-21625 Filed 8-22-03; 8:45 am]