[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Notices]
[Pages 41679-41680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17021]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1072]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Administrative Detention and Banned Medical 
Devices; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995. This document also corrects 
several errors that appeared in Table 1 of a notice published in the 
Federal Register of March 31, 2000 (65 FR 17282).

DATES: Submit written comments on the collection of information by 
August 7, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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), 800.55(k), 895.21, and 895.22 (OMB No. 0910-0114)--
Extension

    FDA has the statutory authority under section 304(g) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 334(g)), to detain 
during establishment inspections devices that are believed to be 
adulterated or misbranded. On March 9, 1979, FDA issued a final 
regulation on administrative detention procedures, which includes, 
among other things, certain reporting requirements (Sec. 800.55(g) (21 
CFR 800.55(g))) and recordkeeping requirements (Sec. 800.55(k)). Under 
Sec. 800.55(g), an applicant 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, as well as records of distribution of 
the detained devices. These recordkeeping requirements for 
administrative detentions allow FDA to trace devices for which the 
detention period expired

[[Page 41680]]

before a seizure is accomplished or injunctive relief is obtained.
    FDA also has the statutory authority under section 516 of the act 
(21 U.S.C. 360f) to ban devices that present substantial deception or 
an unreasonable and substantial risk of illness or injury. The final 
regulation for banned devices contains certain reporting requirements 
(Secs. 895.21(d) and 895.22(a) (21 CFR 895.21(d) and 895.22(a))). 
Section 895.21(d) states that if the Commissioner of Food and Drugs 
(the Commissioner) decides to initiate a proceeding to make a device a 
banned device, a notice of proposed rulemaking will be published in the 
Federal Register, and this notice will contain the finding that the 
device presents a substantial deception or an unreasonable and 
substantial risk of illness or injury. The notice will also contain the 
reasons why the proceeding was initiated, an evaluation of data and 
information obtained under other provisions of the act, any 
consultations with the panel, and a determination as to whether the 
device could be corrected by labeling or change of labeling, or change 
of advertising, and if that labeling or change of advertising has been 
made. Under Sec. 895.21(d), any interested person may request an 
informal hearing and submit written comments. Under Sec. 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.
    Respondents to this collection of information are those 
manufacturers, distributors, or importers whose products FDA seeks to 
detain or ban.
    In the Federal Register of March 31, 2000 (65 FR 17282), the agency 
requested comments on the proposed collection of information. No 
significant comments were received. Also, in the notice published in 
the Federal Register of March 31, 2000 (65 FR 17282 at 17283), Table 1 
contained several errors. Table 1 of this document corrects those 
errors.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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800.55(g)(1) and (g)(2)                 1               1               1               1               1
895.22(a)                              26               1              26              16             416
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 Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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800.55(k)                               1               1               1              20             20
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Over the past 3 years, there has been an average of one new 
administrative detention action per year. Each administrative detention 
will have varying amounts of data and information that must be 
maintained. Historically, FDA's Center for Devices and Radiological 
Health (CDRH) has had very few or no annual responses for this 
information collection and normally reports one response per year. CDRH 
is anticipating a banning action in fiscal year 2000 that will involve 
26 firms.

    Dated: June 28, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-17021 Filed 7-5-00; 8:45 am]
BILLING CODE 4160-01-F