[Federal Register: May 15, 2003 (Volume 68, Number 94)]
[Notices]
[Page 26307-26308]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my03-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0187]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarket Surveillance of Medical Devices
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 information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for postmarket surveillance (PS) of medical devices.
DATES: Submit written or electronic comments on the collection of
information by July 14, 2003.
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.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
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 Robbins, 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.
Postmarket Surveillance of Medical Devices--21 CFR Part 822 (OMB
Control Number 0910-0449)--Extension
Section 522(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360l(a)) authorizes the FDA to require manufacturers to
conduct PS of any device that meets the criteria set forth in the
statute.
The PS regulation in part 822 (21 CFR part 822) establishes
procedures that FDA uses to approve and disapprove PS plans. The
regulation provides specific, clear, and flexible instructions to
manufacturers so they know what information is required in a PS plan
submission. FDA reviews submissions in accordance with Sec. Sec.
822.15 through 822.18 (which describe the grounds for approving or
disapproving a PS plan). If this information is not collected, FDA
cannot ensure that the PS will result in the collection of useful data
that can reveal unforeseen adverse events or other information
necessary to protect the public health.
Respondents to this collection of information are those
manufacturers who require PS of their products. As previously stated,
the collection of data and information under these regulations is
conducted on a very infrequent basis and only as necessary.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Total Annual
21 CFR Section No. of Respondents Responses No. of Responses Hours per Response Total Hours
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822.9 and 822.10 5 1 5 120 600
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822.21 2 1 2 40 80
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822.26 1 1 1 8 8
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822.27 1 1 1 40 40
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822.28 1 1 1 40 40
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822.29 1 1 1 120 120
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822.30 1 1 1 40 40
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822.34 1 1 1 20 20
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822.38 23 2 46 80 3,680
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Totals .................... .................... .................... .................... 4,628
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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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21 CFR Total Annual
Section No. of Recordkeepers Records No. of Records Hours per Record Total Hours
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822.31 23 1 23 20 460
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822.32 69 1 69 10 690
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Totals .................... .................. .................. .................. 1,150
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates, based on current staffing and resources, only one
actual PS action and manufacturers' aversion to the stigma of PS over
the past year. One PS action will be issued for generic devices
comprising of approximately five manufacturers. Each manufacturer will
be required to submit a PS plan (Sec. Sec. 822.9 and 822.10) and
interim and final reports on the progress of the surveillance (Sec.
822.38). FDA anticipates that, on a case-by-case basis, requests for
additional information may be made from a manufacturer. FDA expects
that a small number of respondents will propose changes to their PS
plans (Sec. 822.21), request a waiver of a specific requirement of
this regulation (Sec. 822.29), or request exemption from the
requirement to conduct PS of their device (Sec. 822.30). FDA's
experience has shown that a few respondents will go out of business
(Sec. 822.26) or cease marketing the device subject to PS (Sec.
822.28) each year. In addition, manufacturers must certify transfer of
records when ownership changes (Sec. 822.34).
Section 822.25 does not constitute information collections subject
to review under the PRA because ``* * * they entail no burden other
than that necessary to identify the respondent, the date, the
respondent's address, and the nature of the instrument * * *'' (5 CFR
1320.3(h)(1)).
FDA expects that at least some of the manufacturers will be able to
satisfy the PS requirement using information or data they already have.
For purposes of calculating burden, however, FDA has assumed that each
PS order can only be satisfied by a 3-year clinically-based
surveillance plan, using three investigators. These estimates are based
on FDA's knowledge and experience with limited implementation of
section 522 of the act under the Safe Medical Devices Act of 1990.
Therefore, FDA would expect that the recordkeeping requirements would
apply to a maximum of 23 manufacturers (6 added each year) and 69
investigators (3 years per surveillance plan). After 3 years, FDA would
expect these numbers to remain level as the surveillance plans
conducted under the earliest orders reach completion and new orders are
issued.
Dated: May 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12192 Filed 5-14-03; 8:45 am]
BILLING CODE 4160-01-S