65FR38288 Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices--Foreign Letters of Approval
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Posting-number: Volume 65, Issue 119, Page 38288
[Federal Register: June 20, 2000 (Volume 65, Number 119)]
[Notices]
[Page 38288-38289]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn00-77]
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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