[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Notices]
[Page 70327-70328]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de07-48]
[[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