Document ID: FDA-2012-N-0306-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Administrative Detention and Banned Medical Devices
Posted Date: 2012-04-10T04:00Z

[Federal Register Volume 77, Number 69 (Tuesday, April 10, 2012)]
[Notices]
[Pages 21564-21565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8507]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0306]

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 for 
administrative detention and banned medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by June 11, 2012.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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 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 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 and recordkeeping requirements. 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 
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. 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 21565]]

                                                     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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800.55(g).....................................................                 1                 1                 1                25                25
895.21(d) and 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 Burden \1\
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                                                               Number of      Number of records     Total annual      Average burden
                      21 CFR Section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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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.

    Dated: April 3, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8507 Filed 4-9-12; 8:45 am]
BILLING CODE 4160-01-P