Document ID: FDA-2008-N-0213-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals
Posted Date: 2008-04-10T04:00Z

[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]               
[Page 19509-19510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap08-56]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0213] (formerly Docket No. 2007N-0460)

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 May 12, 
2008.

[[Page 19510]]

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: 202-395-6974, or e-mailed to baguilar@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: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

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(f) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360i(f)), as amended by the Food and Drug Modernization Act 
of 1997 (FDAMA) (21 U.S.C. 301) (Public Law 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 act caused by the device which 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.
    In the Federal Register of December 11, 2007 (72 FR 70327), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     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
--------------------------------------------------------------------------------------------------------------------------------------------------------
806.10                                                                   488                  1                488                 10              4,880
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Total                                                                                                                                              4,880
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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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                                                                               Annual Frequency
                      21 CFR Section                             No. of              per            Total Annual    Hours per  Record     Total Hours
                                                             Recordkeepers      Recordkeeping         Records
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806.20                                                                   132                  1                132                 10              1,320
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Total                                                                                                                                              1,320
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    In preparing the previous clearances for approval of the 
information collection requirements under Sec. Sec.  806.10 and 806.20, 
FDA reviewed the reports of corrections and removals submitted for the 
previous 3 years under part 7 (21 CFR part 7), the agency's recall 
provisions. FDA has determined that estimates of the reporting burden 
in Sec.  806.10 should be revised to reflect a 1.2 percent increase for 
reports and records submitted under part 7 due to a decrease in class I 
and class II recall actions. FDA also estimates the reporting burden in 
Sec.  806.20 should be revised to reflect a reduction of 8 percent for 
reports and records submitted under part 7 due to a decrease in class 
III recall actions. The time needed to collect information has not been 
changed.

    Dated: April 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7638 Filed 4-9-08; 8:45 am]

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