[Federal Register: August 20, 2003 (Volume 68, Number 161)]
[Notices]
[Page 50153-50155]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au03-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0187]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Postmarket Surveillence of Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management
[[Page 50154]]
and Budget (OMB) for review and clearance under the Paperwork Reduction
Act of 1995.
DATES: Submit written comments on the collection of information by
September 19, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 FDA to require manufacturers to
conduct postmarket surveillance (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.
In the Federal Register of May 15, 2003 (68 FR 26307), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR Section No. of Respondents No. of Responses Total Annual Responses Hours per Response Total Hours
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822.9 and 822.10 5 1 5 120 600
822.21 2 1 2 40 80
822.26 1 1 1 8 8
822.27 1 1 1 40 40
822.28 1 1 1 40 40
822.29 1 1 1 120 120
822.30 1 1 1 40 40
822.34 1 1 1 20 20
822.38 23 2 46 80 3,680
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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Annual Frequency per
21 CFR Section No. of Recordkeepers Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours
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822.31 23 1 23 20 460
822.32 69 1 69 10 690
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,
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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: August 13, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-21226 Filed 8-19-03; 8:45 am]
BILLING CODE 4160-01-S