Document ID: FDA-2010-N-0554-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reports of Corrections and Removals
Posted Date: 2010-11-23T05:00Z

[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Pages 71446-71447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29520]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 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 the information collection 
requirements for reports of corrections and removal.

DATES: Submit either electronic or written comments on the collection 
of information by January 24, 2011.

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, e-mail: 
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.

Reports of Corrections and Removals--21 CFR Part 806 (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 (FDAMA) 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.

[[Page 71447]]

    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
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                                                                                           Annual
                           21 CFR section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
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806.10.............................................................             666                1              666               10            6,660
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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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                                                                                           Annual
                           21 CFR Section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                      recordkeepers    recordkeeping       records           record
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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.

    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 this section. The 
estimates of time needed to collect part 806 information have not 
changed.

    Dated: November 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29520 Filed 11-22-10; 8:45 am]
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