[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35874-35875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15790]


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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.

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SUMMARY: The Food and Drug Administration (FDA or we) 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.

[[Page 35875]]


DATES: Fax written comments on the collection of information by August 
26, 2019.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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 (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.
    In the Federal Register of March 11, 2019 (84 FR 8727), 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\
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                                                                                    Number of                                                  Total
                                                                      Number of     responses   Total annual     Average                   operating and
                     Activity/FD&C Act section                       respondents       per        responses    burden per    Total hours    maintenance
                                                                                   respondent                   response                       costs
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Foreign letter of approval--801(e)(2).............................           33             1            33             3            99          $8,250
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\1\ There are no capital costs associated with this collection of information.

    We have adjusted our burden estimate by decreasing the number of 
respondents by 5, which has resulted in a corresponding decrease of 15 
hours to the currently approved hour burden and $1,250 to the total 
operating and maintenance costs. This adjustment is based on a decrease 
in the number of submissions we received over the last few years.

    Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15790 Filed 7-24-19; 8:45 am]
 BILLING CODE 4164-01-P


