[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28853-28854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11697]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0557]
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 of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by July 15, 2013.
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, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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
[[Page 28854]]
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 of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
360l) authorizes the FDA to require a 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 through 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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Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Postmarket surveillance 131 1 131 120 15,720
submission (Sec. Sec. 822.9
and 822.10)....................
Changes to PS plan after 15 1 15 40 600
approval (Sec. 822.21).......
Changes to PS plan for a device 80 1 80 8 640
that is no longer marketed
(Sec. 822.28)................
Waiver (Sec. 822.29).......... 1 1 1 40 40
Exemption request (Sec. 16 1 16 40 640
822.30)........................
Periodic reports (Sec. 822.38) 131 3 393 40 15,720
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Total....................... .............. .............. .............. .............. 33,360
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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 of this document is based on the data available in FDA's
internal tracking system. 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)).
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Manufacturer records (Sec. 131 1 131 20 2,620
822.31)........................
Investigator records (Sec. 393 1 393 5 1,965
822.32)........................
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Total....................... .............. .............. .............. .............. 4,585
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 postmarket surveillance.
Dated: May 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11697 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P