Notice2022-09455
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
May 3, 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 85 (Tuesday, May 3, 2022)</title>
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[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Notices]
[Pages 26208-26209]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09455]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4465]
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: Fax written comments on the collection of information by June 2,
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. All comments should be
identified with the OMB control number 0910-0114. 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-45, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#144446554760757272547270753a7c7c673a737b62"><span class="__cf_email__" data-cfemail="88d8dac9dbfce9eeeec8eeece9a6e0e0fba6efe7fe">[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
OMB Control Number 0910-0114--Extension
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), on
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 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), on 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.
[[Page 26209]]
In the Federal Register of November 22, 2021 (86 FR 66315), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received communicating
general support for the information collection. Although the comment
suggested the Agency's burden estimate may be too low, no figures were
provided.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Administrative detention 1 1 1 25 25
reporting requirements--
800.55(g) and (h)..............
Banned devices reporting 26 1 26 16 416
requirements--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 hours
recordkeepers recordkeeper records recordkeeping
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Records regarding device adulteration or misbranding and records of 1 1 1 20 20
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.
Administrative Detention Reporting--Sec. 800.55(g)(1) and (2): A
person who would be entitled to claim the devices, if seized, may
appeal a detention order by submitting a written request to the FDA
District Director in whose district the devices are located. This
written appeal could include a request for an informal hearing as
defined in section 201(y) of the FD&C Act (21 U.S.C. 321(y)). In some
cases, the appellant must include documents showing that that person
has the legal right to appeal this order.
Movement of Detained Devices--Sec. 800.55(h)(2): If detained
devices are not in final form for shipment, the manufacturer may move
them within the establishment where they are detained to complete the
work needed to put them in final form. As soon as the devices are moved
for this purpose, the individual responsible for their movement shall
orally notify the FDA representative who issued the detention order, or
another responsible district office official, of the movement of the
devices. As soon as the devices are put in final form, they shall be
segregated from other devices, and the individual responsible for their
movement shall orally notify the FDA representative who issued the
detention order, or another responsible district office official, of
their new location. The devices put in final form shall not be moved
further without FDA approval.
Administrative Detention Recordkeeping--Sec. 800.55(k): The firm
shall have, or establish, and maintain records relating to how the
detained devices may have become adulterated or misbranded, records on
any distribution of the devices before and after the detention period,
records on the correlation of any in-process detained devices that are
put in final form, records of any changes in, or process of, the
devices permitted under the detention order, and records of any
movement of the detained devices.
Procedures for Banned Devices Informal Hearing Request--Sec.
895.21(d)(8): Section 895.21(d) describes the procedures for banning a
device when the Commissioner decides to initiate such a proceeding.
Under Sec. 895.21(d), the Commissioner may decide to initiate a
proceeding to make a device a banned device. In that event, any
interested persons may submit written comments and request an informal
hearing within 30 days after the date of the publication of the
proposed regulation.
Banned Devices Reporting--Sec. 895.22(a): 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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: April 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09455 Filed 5-2-22; 8:45 am]
BILLING CODE 4164-01-P
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