[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70327-70328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23962]



[[Page 70327]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0460]


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 written or electronic comments on the collection of 
information by February 11, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or 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: 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from 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 for 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                           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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                         No. of        Annual Frequency     Total Annual
  21 CFR Section     Recordkeepers     of Recordkeeping       Records       Hours per  Record     Total Hours
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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.


[[Page 70328]]

    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 21 CFR 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 21 CFR part 7 due to a 
decrease in class III recall actions. The time needed to collect 
information has not been changed.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

    Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23962 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S