Notice2022-18326
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 164 (Thursday, August 25, 2022)</title>
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[Federal Register Volume 87, Number 164 (Thursday, August 25, 2022)]
[Notices]
[Pages 52388-52389]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#26767467755247404066404247084e4e5508414950"><span class="__cf_email__" data-cfemail="de8e8c9f8daabfb8b89eb8babff0b6b6adf0b9b1a8">[email protected]</span></a>.
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
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