Notice2025-16850
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
September 3, 2025
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 90 Issue 168 (Wednesday, September 3, 2025)</title>
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[Federal Register Volume 90, Number 168 (Wednesday, September 3, 2025)]
[Notices]
[Page 42591]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16850]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0953]
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 October 3, 2025.
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: 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,
<a href="/cdn-cgi/l/email-protection#a9f9fbe8faddc8cfcfe9cfcdc887c1c1da87cec6df"><span class="__cf_email__" data-cfemail="623230233116030404220406034c0a0a114c050d14">[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 (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 must 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
stating 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 make a false or fraudulent statement knowingly and
willingly, 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 June 16, 2025 (90 FR 25339), 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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Total
Number of Number of Total Average Total operating and
Activity respondents responses per annual burden per hours maintenance
respondent responses response costs
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Foreign letter of approval-- 801(e)(2)............................ 36 1 36 2 72 $10,080
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\1\ There are no capital costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16850 Filed 9-2-25; 8:45 am]
BILLING CODE 4164-01-P
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