[Federal Register Volume 84, Number 82 (Monday, April 29, 2019)]
[Notices]
[Pages 18057-18058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08558]


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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 May 29, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. 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: 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, 
[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--21 CFR 
800.55(g)(1), (g)(2), and (k), 895.21(d), and 895.229(a)

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.  [thinsp]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.  [thinsp]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.
    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.
    In the Federal Register of December 21, 2018 (83 FR 65683), 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
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Documentation of ownership--                   1               1               1              25              25
 800.55(g)......................
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                       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.


[[Page 18058]]

    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 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08558 Filed 4-26-19; 8:45 am]
 BILLING CODE 4164-01-P


