[Federal Register: February 5, 2010 (Volume 75, Number 24)]
[Notices]
[Page 6036-6037]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe10-85]
[[Page 6036]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0033]
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 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 Postmarket Surveillance.
DATES: Submit written or electronic comments on the collection of
information by April 6, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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: Daniel Gittleson, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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. 360l) 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 instructions to
manufacturers so they know what information is required in a PS plan
submission. FDA reviews PS plan submissions in accordance with part 822
(21 CFR part 822) in Sec. Sec. 822.15 to 822.19 of the regulation,
which describe the grounds for approving or disapproving a PS plan. In
addition, the PS regulation provides instructions to manufacturers to
submit interim and final reports in accordance with Sec. 822.38.
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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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822.9, 21 1 21 120 2,520
822.10
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822.21 (supplements) 5 1 5 40 200
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822.28 (stop marketing) 5 1 5 8 40
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822.29 (request waiver) 1 1 1 40 40
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822.30 (request exemption) 1 1 1 40 40
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822.38 (reports) 40 1 40 40 1,600
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Total 4,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Record Records Total Hours
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822.31 21 1 21 20 420
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822.32 63 1 63 10 630
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Total 1,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Reporting Burden Estimate
The burden captured in table 1 for this document for each of these
responses is based on the data available in FDA's internal tracking
system for 2009. There was not an internal tracking system prior to
2009.
Sections 822.26, 822.27, and 822.34 do not constitute information
collection subject to review under the PRA because ``it entails 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)).
Explanation of Recordkeeping Burden Estimate
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 under the Safe Medical Devices Act. Therefore, FDA would
expect that the recordkeeping requirements would apply to a maximum of
21 manufacturers (3 to 4 added each year) and 30 investigators (3 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: January 27, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2458 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S
SOURCE