Document ID: FDA-2009-N-0475-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
Posted Date: 2010-01-19T05:00Z

[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2871-2872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-795]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 
February 18, 2010.

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 e-mailed to oira_submission@omb.eop.gov. 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:  Daniel Gittleson, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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--(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.

[[Page 2872]]

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 
permits 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 (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.
    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.
    In the Federal Register of October 16, 2009 (74 FR 53257), 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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                                                              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 895.22(a)                                                26                     1                 26                 16                416
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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.

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-795 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S