Document ID: FDA-2010-N-0554-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Reports of Corrections and Removals
Posted Date: 2011-03-15T04:00Z

[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14022-14023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0554]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Reports of Corrections and Removals

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 April 
14, 2011.

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 0910-0359. 
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, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 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.

Medical Devices; Reports of Corrections and Removals--(OMB Control 
Number 0910-0359)--(Extension)

    The collection of information required under the reports of 
corrections and removals, part 806 (21 CFR part 806), implements 
section 519(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 360i(g)), as amended by the Food and Drug 
Administration Modernization Act of 1997 (21 U.S.C. 301) (Pub. L. 105-
115). Each device manufacturer or importer under Sec.  806.10 shall 
submit a written report to FDA of any action initiated to correct or 
remove a device to reduce a risk to health posed by the device, or to 
remedy a violation of the FD&C Act caused by the device that may 
present a risk to health, within 10 working days of initiating such 
correction or removal. Each device manufacturer or importer of a device 
who initiates a correction or removal of a device that is not required 
to be reported to FDA under Sec.  806.20 shall keep a record of such 
correction or removal.
    The information collected in the reports of corrections and 
removals will be used by FDA to identify marketed devices that have 
serious problems and to ensure that defective devices are removed from 
the market. This will assure that FDA has current and complete 
information regarding these corrections and removals and to determine 
whether recall action is adequate.
    Respondents to this collection of information are manufacturers and 
importers of medical devices. FDA reviewed reports of device 
corrections and removals submitted to the Agency for the previous 3 
years as part of responding to the current request for approval of the 
information collection requirements for Sec. Sec.  806.10 and 806.20. 
This information was obtained through the Agency's voluntary recall 
provisions (i.e., 21 CFR part 7). The specific information requested 
was the total number of class I, II, and III recalls for the last 3 
years. This information was obtained from the Agency's Recall 
Enterprise System--a database of all recalls submitted to the Agency.
    This information is relevant since a Sec.  806.10 report is 
required for all class I and II recalls. Although class III recalls are 
not required to be submitted to FDA (by Sec.  806.10), a record must be 
kept in the firm's Sec.  806.20 file. Therefore, the number of class I 
and II recalls can be used to estimate the maximum number of reports 
that are required to be submitted under Sec.  806.10. Also, the 
recordkeeping burden can be estimated based upon the number of class 
III recalls, which are not required to be reported, but must be 
retained in a Sec.  806.20 file.
    FDA has determined that estimates of the reporting burden for Sec.  
806.10 should be revised to reflect a projected 7.3 percent increase 
(from the last PRA numbers) in reports submitted to FDA as class I and 
II. FDA also estimates the recordkeeping burden in Sec.  806.20 should 
be revised to reflect a reduction of 6.8 percent (from the last PRA 
numbers) in records filed and maintained under Sec.  806.20. The 
estimates of time needed to collect part 806 information have not 
changed.
    In the Federal Register of November 23, 2010 (75 FR 71446), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 14023]]

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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                                                              Number of                    Average burden
               CFR section                    Number of     responses per   Total annual    per response   Total
                                             respondents     respondent       responses      (in hours)    hours
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806.10...................................             666               1             666              10  6660
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 2--Estimated Average Annual Recordkeeping Burden \1\
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                                                                                           Average burden
                                              Number of       Number of     Total annual         per       Total
               CFR section                  recordkeepers    records per       records      recordkeeping  hours
                                                            recordkeeper                     (in hours)
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806.20...................................              90               1              90              10  900
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5916 Filed 3-14-11; 8:45 am]
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