[Federal Register Volume 69, Number 239 (Tuesday, December 14, 2004)]
[Notices]
[Pages 74527-74528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27293]
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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://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]
BILLING CODE 4160-01-S