[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Notices]
[Pages 17282-17283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1072]


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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 reporting and recordkeeping 
requirements imposed on entities that have had products detained during 
an establishment inspection that are believed to be adulterated or 
misbranded, or have had products banned.

DATES: Submit written comments on the collection of information by May 
30, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under the PRA (44 U.S.C. 3501-3520), 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: (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--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 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 17283]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
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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               1               1              25              25
895.21(d) and 895.22(a) and (c)        26               1              26              16             416
TOTALS                                                                                               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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                                                      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: March 24, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-7932 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F