[Federal Register Volume 66, Number 130 (Friday, July 6, 2001)]
[Notices]
[Pages 35644-35645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0277]


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 September 4, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. Submit written comments on the 
collection of information to the Dockets Management Branch (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 Schlosburg, Office of 
Information Resources Management (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: (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 
No. 0910-0359)--Extension

    Section 519(f) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360i(f)) directs FDA to issue regulations to require 
device manufacturers and importers to report promptly to FDA, any 
correction or removal of a device undertaken by such manufacturers and 
importers, if the correction or removal was undertaken 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. Under 21 CFR 
806.10 and 806.20(a), FDA requires that each device manufacturer and 
importer 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. In addition, each manufacturer and importer of a 
device who initiates a correction or removal of a device that is not 
required to be reported to FDA, 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

[[Page 35645]]

devices that have serious problems and to ensure that dangerous and 
defective devices are removed from the market, assuring that FDA has 
current and complete information regarding these corrections and 
removals and whether recall action is adequate. Failure to collect this 
information prevents FDA from receiving timely information about 
devices that may have a serious effect on the health of the users of 
the devices.
    Respondents to this information collection are businesses or other 
for-profit manufacturers or importers of medical devices who must 
remove or correct medical devices that cause public health risk to the 
general public.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                               Annual Frequency   Total Annual
     21 CFR Section       No. of Respondents     per Response       Responses   Hours per Response   Total Hours
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806.10                          880                   1              880               10            8,800
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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   Total Annual       Hours per
     21 CFR Section          Recordkeepers     per Recordkeeping     Records       Recordkeeper      Total Hours
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806.20(a)                       440                   1              440               10            4,400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The following is an explanation of the burden estimate:

Reporting Burden

    FDA estimates that it would take 10 staff hours to prepare and 
assemble a written report. For the estimated 880 reports, FDA estimates 
that respondents will spend 8,800 hours to prepare, assemble, and send 
the reports.

Recordkeeping Burden

    FDA estimates that it would take 10 staff hours to prepare a 
written record. For the estimated 440 records, the total recordkeeping 
burden is estimated at 4,400 hours per recordkeeper.

    Dated: June 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16989 Filed 7-5-01; 8:45 am]
BILLING CODE 4160-01-C