[Federal Register: October 2, 2006 (Volume 71, Number 190)]
[Notices]
[Page 57973-57975]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc06-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0382]
Agency Information Collection Activities; Proposed Collection;
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 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 under 21 CFR part 822.
DATES: Submit written or electronic comments on the collection of
information by December 1, 2006.
[[Page 57974]]
ADDRESSES: Submit electronic comments on the collection of information
to http://www.fda.gov/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: Denver Presley, Office of Management
Programs (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 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.
Postmarket Surveillance--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. 360(l)) authorizes FDA to require manufacturers to conduct
postmarket surveillance of any device that meets the criteria set forth
in the statute.
The postmarket surveillance (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 postmarket surveillance
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 plan could result in the collection of useful data which 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 postmarket surveillance of their products.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Response Total Hours
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822.9, 822.10 5 1 5 120 600
822.21 3 1 3 40 120
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 10 2 20 120 2,400
Total .................... .................... ................. ................. 3,338
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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 Total Annual
21 CFR Section No. of Recordkeepers Recordkeeping Records Hours per Record Total Hours
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822.31 10 1 10 20 200
822.32 30 1 30 10 300
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 postmarket surveillance 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
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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 Devices 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 (three 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: September 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16231 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S