Document ID: FDA-2013-N-0370-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection Comment Request; Export of Medical Devices; Foreign Letters of Approval
Posted Date: 2013-04-05T04:00Z

[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20660-20661]
From the Federal Register Online via the Government Printing 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, 
daniel.gittleson@fda.hhs.gov.

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]
BILLING CODE 4160-01-P