[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20660-20661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07915]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0370]
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 reporting requirements for
firms that intend to export certain unapproved medical devices.
DATES: Submit either electronic or written comments on the collection
of information by June 4, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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 these topics: (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 Control
Number 0910-0264)--Extension
Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the
FD&C 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. The
respondents to this collection of information are companies that seek
to export medical devices. FDA's estimate of the reporting burden is
based on the experience of FDA's medical device program personnel.
FDA estimates the burden of this collection of information as
follows:
[[Page 20661]]
Table 1--Estimated Annual Reporting Burden \1\
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No. of Total operating
Activity/section of FD&C Act No. of responses per Total annual Average burden Total hours & maintenance
respondents respondent responses per response costs
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Foreign letter of approval--Sec. 801(e)(2)...... 38 1 38 3 114 $9,500
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\1\ There are no capital costs associated with this collection of information.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07915 Filed 4-4-13; 8:45 am]
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