[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Notices]
[Page 74926-74927]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0382]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarket
Surveillance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
12, 2007.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974.
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: 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--21 CFR Part 822 (OMB No. 0910-0449)--Extension
Section 522(a) of the Federal Food, Drug and Cosmetic Act (the act)
(21 U.S.C. 360(l)) 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 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 part 822 (21 CFR part 822) in Sec. Sec. 822.15 to 822.18 of the
regulation, which describe the grounds for approving or disapproving a
PS plan. If this information is not collected, FDA would not be able to
ensure that the PS will result in the collection of useful data that
could 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.
In the Federal Register of October 2, 2006 (71 FR 57973), 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 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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822.9, 822.10 5 1 5 120 600
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822.21 3 1 3 40 120
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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 10 2 20 120 2,400
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Total 3,338
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 74927]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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822.31 10 1 10 20 200
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822.32 30 1 30 10 300
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Total 500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that, based on current staffing and resources and
experience with five actual PS actions over the past 3 years, five PS
actions will be issued for generic devices, comprised 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 PS (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).
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 PS plan,
using three investigators. These estimates are based on FDA's knowledge
and experience with limited implementation of section 522 under the
Safe Medical Device Act of 1990. Therefore, FDA would expect that the
recordkeeping requirements would apply to a maximum of 10 manufacturers
(3 to 4 added each year) and 30 investigators (3 per PS plan). After 3
years, FDA would expect these numbers to remain level as the PS plans
conducted under the earliest orders reach completion and new orders are
issued.
Dated: December 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21167 Filed 12-12-06; 8:45 am]
BILLING CODE 4160-01-S