Document ID: FDA-2013-N-0370-0010
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: 2022-08-25T04:00Z

[Federal Register Volume 87, Number 164 (Thursday, August 25, 2022)]
[Notices]
[Pages 52388-52389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18326]

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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) 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: Submit written comments (including recommendations) on the 
collection of information by September 26, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0264. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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

[[Page 52389]]

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. Respondents to this collection of 
information are companies that seek to export medical devices.
    In the Federal Register of January 28, 2022 (87 FR 4609) we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                        Number of                                                        Total operating
           Activity and FD&C Act section               Number of      responses per     Total annual    Average burden    Total hours    and maintenance
                                                      respondents       respondent       responses       per response                         costs
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Foreign letter of approval--801(e)(2).............              36                1               36                2               72           $8,250
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\1\ There are no capital costs associated with this collection of information.

    Our estimate of the reporting burden is based on our experience 
with the information collection and reflects an overall decrease of 27 
hours and a corresponding increase of three responses. We attribute 
this adjustment to an increase in the number of submissions received.

    Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18326 Filed 8-24-22; 8:45 am]
BILLING CODE 4164-01-P