Notice2025-10888
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
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
June 16, 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 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25323-25324]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10888]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4731]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Administrative
Detention and Banned Medical Devices
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 July 16, 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 0910-0114. 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#643436253710050202240200054a0c0c174a030b12"><span class="__cf_email__" data-cfemail="58080a190b2c393e3e183e3c397630302b763f372e">[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.
Administrative Detention and Banned Medical Devices--21 CFR 800.55,
895.21, and 895.22
OMB Control Number 0910-0114--Extension
This information collection supports FDA regulations. FDA has the
statutory authority under section 304(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 334(g)) to detain during established
inspections devices that are believed to be adulterated or misbranded.
Section 800.55 (21 CFR 800.55), regarding administrative detention,
includes among other things certain reporting requirements (Sec.
800.55(g)(1) and (2)) and recordkeeping requirements (Sec. 800.55(k)).
Under Sec. 800.55(g), an appellant of a detention order must show
documentation of ownership if devices are detained at a place other
than that of the appellant. Under Sec. 800.55(k), the owner or other
responsible person must supply records about how the devices may have
become adulterated or misbranded, in addition to records of
distribution of the detained devices. These recordkeeping requirements
for administrative detentions permit FDA to trace devices
[[Page 25324]]
for which the detention period expired before a seizure is accomplished
or injunctive relief is obtained.
FDA also has the statutory authority under section 516 of the FD&C
Act (21 U.S.C. 360f) to ban devices that present substantial deception
or an unreasonable and substantial risk of illness or injury. Section
895.21 (21 CFR 895.21), regarding banned devices, contains certain
reporting requirements. Section 895.21(d) describes the procedures for
banning a device when the Commissioner of Food and Drugs (the
Commissioner) decides to initiate such a proceeding. Under 21 CFR
895.22, a manufacturer, distributor, or importer of a device may be
required to submit to FDA all relevant and available data and
information to enable the Commissioner to determine whether the device
presents substantial deception, unreasonable and substantial risk of
illness or injury, or unreasonable, direct, and substantial danger to
the health of individuals.
In the Federal Register of November 29, 2024 (89 FR 94734), 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 Average
21 CFR section Number of responses per annual burden per Total
respondents respondent responses response hours
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Administrative detention reporting 1 1 1 25 25
requirements--800.55(g) & (h)................
Banned devices reporting requirements-- 26 1 26 16 416
895.21(d)(8) and 895.22(a)...................
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Total..................................... ............ ............... ........... ........... 441
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR section Number of records per Total annual per Total
recordkeepers recordkeeper records recordkeeping hours
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Records regarding device 1 1 1 20 20
adulteration or misbranding
and records of distribution of
detained devices--800.55(k)...
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
During the past several years, there has been an average of less
than one new administrative detention action per year. Each
administrative detention will have varying amounts of data and
information that must be maintained. FDA's estimate of the burden under
the administrative detention provision is based on FDA's discussion
with one of the firms whose devices had been detained.
Based on our evaluation of the information collection we have made
no adjustment to our current estimates.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10888 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P
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