[Federal Register Volume 68, Number 94 (Thursday, May 15, 2003)]
[Notices]
[Pages 26307-26308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12192]



[[Page 26307]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0187]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Postmarket Surveillance of Medical Devices

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 (PS) of medical devices.

DATES: Submit written or electronic comments on the collection of 
information by July 14, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

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: (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 of Medical Devices--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(a)) authorizes the FDA to require manufacturers to 
conduct PS of any device that meets the criteria set forth in the 
statute.
    The PS regulation in part 822 (21 CFR part 822) 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 Sec. Sec.  
822.15 through 822.18 (which describe the grounds for approving or 
disapproving a PS plan). If this information is not collected, FDA 
cannot ensure that the PS will result in the collection of useful data 
that can 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. As previously stated, 
the collection of data and information under these regulations is 
conducted on a very infrequent basis and only as necessary.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                      Total Annual
              21 CFR Section                 No. of Respondents         Responses         No. of Responses     Hours per Response        Total Hours
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822.9 and 822.10                                     5                     1                     5                   120                   600
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822.21                                               2                     1                     2                    40                    80
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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                                              23                     2                    46                    80                 3,680
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Totals                                      ....................  ....................  ....................  ....................       4,628
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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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  21 CFR                             Total Annual
  Section   No. of Recordkeepers        Records         No. of Records     Hours per Record       Total Hours
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822.31              23                    1                  23                  20                 460
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822.32              69                    1                  69                  10                 690
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Totals      ....................  ..................  ..................  ..................      1,150
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates, based on current staffing and resources, only one 
actual PS action and manufacturers' aversion to the stigma of PS over 
the past year. One PS action will be issued for generic devices 
comprising 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 surveillance (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).
    Section 822.25 does not constitute information collections subject 
to review under the PRA because ``* * * they entail 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)).
    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 of the act under the Safe Medical Devices Act of 1990. 
Therefore, FDA would expect that the recordkeeping requirements would 
apply to a maximum of 23 manufacturers (6 added each year) and 69 
investigators (3 years 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: May 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12192 Filed 5-14-03; 8:45 am]
BILLING CODE 4160-01-S