[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66315-66318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25323]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4465]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is

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announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection for 
administrative detention and banned medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by January 21, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 21, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 21, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-4465 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Administrative Detention and 
Banned Medical Devices.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

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administrative detention, includes among other things certain reporting 
requirements (Sec.  800.55(g)(1) and (g)(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.
    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 (g)(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.


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    Dated: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25323 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P


