Document ID: FDA-2009-N-0475-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
Posted Date: 2009-10-16T04:00Z

[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Notices]               
[Page 53257-53259]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc09-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0475]

 
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 information collection 
requirements for administrative detention and banned medical devices.

DATES: Submit written or electronic comments on the collection of 
information by December 15, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793, 
Denver.Presley@fda.hhs.gov.

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

[[Page 53258]]

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 (the act) (21 U.S.C. 334(g)), to detain 
during established inspections, devices that are believed to be 
adulterated or misbranded. FDA issued a final rule that published in a 
March 9, 1979, Federal Register (44 FR 13234) on administrative 
detention procedures, which includes among other things, certain 
reporting requirements and recordkeeping requirements under Sec.  
800.55(g) and (k), (21 CFR 800.55(g) and (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, in addition to records of distribution of the detained 
devices. These recordkeeping requirements for administrative detentions 
pemits 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 
rule for banned devices that published in the May 18, 1979, Federal 
Register (44 FR 29221) contained certain reporting requirements under 
21 CFR 895.21(d) and 895.22(a). Section 895.21(d) states that if the 
Commissioner of Food and Drugs Administration (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 document will contain the finding that the 
device presents a substantial deception or an unreasonable and 
substantial risk of illness or injury. The document 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, change of labeling, 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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800.55(g)                          1                  1                  1                 25                 25
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895.21(d) and                     26                  1                 26                 16                416
 895.22(a)
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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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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers    per Recordkeeping       Records          Recordkeeper       Total Hours
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800.55(k)                          1                  1                  1                 20                 20
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Totals                                                                                                       461
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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. FDA's estimate of the burden under 
the administrative detention provision is based on FDA's discussion 
with one of three firms whose devices had been detained.

[[Page 53259]]

    Dated: October 8, 2009.
David Horowitz,
Assistant Commissioner for Policy.

[FR Doc. E9-24921 Filed 10-15-09; 8:45 am]

BILLING CODE 4160-01-S