Document ID: FDA-2013-N-0557-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
Posted Date: 2013-05-16T04:00Z

[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28853-28854]
From the Federal Register Online via the Government Printing 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, 
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

[[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