[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Notices]
[Pages 26208-26209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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)......................
                                 -------------------------------------------------------------------------------
    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]
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