Document ID: FDA-2013-N-0370-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Export of Medical
Devices; Foreign Letters of Approval
Posted Date: 2016-08-19T04:00Z

[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55462-55463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19807]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0370]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Export of Medical 
Devices; Foreign Letters of Approval

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: Fax written comments on the collection of information by 
September 19, 2016.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0264. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

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 
FD&C Act)

[[Page 55463]]

(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.
    In the Federal Register of April 22, 2016 (81 FR 23720), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                               Number of       Number of     Total annual       Average                    operating and
               Activity/Section of FD&C Act                   respondents    responses per     responses      burden per     Total hours    maintenance
                                                                              respondent                       response                        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign letter of approval--section 801(e)(2).............             38               1              38               3           114          $9,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    Dated: August 15, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19807 Filed 8-18-16; 8:45 am]
 BILLING CODE 4164-01-P