[Federal Register: March 4, 2005 (Volume 70, Number 42)]
[Notices]               
[Page 10647-10648]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr05-69]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0525]

 
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 April 
4, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 Administration 
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 14, 2004 (69 FR 74527), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents to this collection of information are manufacturers and 
importers of medical devices.
    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 per    Total Annual      Hours per
     21 CFR Section        Respondents           Response            Responses      Respondent      Total Hours
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806.10                              482                        1             482              10           4,820
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Totals                   ..............  .......................  ..............  ..............           4,820
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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 per    Total Annual      Hours per
     21 CFR Section       Recordkeepers           Record              Records      Recordkeeper     Total Hours
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806.20                              143                        1             143              10           1,430
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Totals                   ..............  .......................  ..............  ..............           1,430
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 10648]]

    In 2001, when preparing the earlier package for approval of the 
information collection requirements in part 806, FDA reviewed the 
reports of corrections and removals submitted in 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. Sec.  806.10 
and 806.20 should be revised to reflect a reduction of 29 percent for 
reports and records submitted under part 7 due to a decrease in recall 
actions. The time needed to collect information has been reduced by 4 
hours per record due to the implementation of a computerized program 
for information collection requirements in part 806.

    Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4159 Filed 3-3-05; 8:45 am]

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