[Federal Register: December 14, 2004 (Volume 69, Number 239)]
[Notices]               
[Page 74527-74528]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de04-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0525]

 
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 information collection 
requirements for reports of corrections and removals.

DATES: Submit written or electronic comments on the collection of 
information by February 14, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/


[[Page 74528]]

dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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(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.
    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     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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806.10                           482                  1                482                 10              4,820
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Total                                                                                                      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
                   21 CFR Section                      Recordkeepers         Recordkeeping            Records       Hours per  Record     Total Hours
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806.20                                                             143                        1                143                 10              1,430
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Total                                                                                                                                              1,430
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    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: December 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-27293 Filed 12-13-04; 8:45 am]

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