[Federal Register Volume 67, Number 190 (Tuesday, October 1, 2002)]
[Notices]
[Pages 61638-61639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24811]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0405]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device Reporting: Manufacturer Reporting, 
Importer Reporting, User Facility Reporting, and Distributor Reporting

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 medical device reporting: Manufacturer reporting, 
importer reporting, user Facility reporting, and distributor reporting.

DATES: Submit written or electronic comments on the collection of 
information by December 2, 2002.

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 Schlosburg, 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

[[Page 61639]]

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.

Medical Device Reporting: Manufacturer Reporting, Importer Reporting, 
User Facility Reporting, and Distributor Reporting (OMB Control Number 
0910-0437)--Extension

    Section 519(a), (b), and (c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360i(a),(b), and (c)) requires user 
facilities, manufacturers, and importers of medical devices to report 
adverse events involving medical devices to FDA. On December 11, 1995 
(60 FR 63597), FDA issued part 803 (21 CFR part 803) that implemented 
section 519 of the act. The regulation was amended to conform with the 
changes reflected in the 1997 FDA Modernization Act.
    Information from these reports will be used to evaluate risks 
associated with medical devices and to enable FDA to take appropriate 
regulatory measures to protect the public health.
    Respondents to this collection of information are businesses or 
other for profit and non-profit organizations including user 
facilities, manufacturers, and importers of medical devices.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                          Annual
         21 CFR Section                No. of        [chyph]Frequency    Total Annual       Hours per      Total
                                 [chyph]Respondents    per Response    [chyph]Responses  [chyph]Response   Hours
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803.19                                     25                   1               25                3          75
803.30                                  1,000                   3            3,000                1       3,000
803.33 FDA Form 3419                    1,000                   1            1,000                1       1,000
803.40                                     50                  10              500                1         500
803.50                                  1,500                  34           51,000                1       51,000
803.55 FDA Form 3417                      700                   5            3,500                1       3,500
TOTALS                           ..................  ................  ................  ...............  59,075
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\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                             Annual
                                             No. of         Frequency    Total Annual       Hours per      Total
            21 CFR Section             [chyph]Respondents      per     [chyph]Responses  [chyph]Response   Hours
                                                            Response
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803.17                                        3,200                1         3,200              3.3       10,560
803.18\2\                                    39,000                1        39,000              1.5       58,500
TOTAL                                  ..................  ..........  ................  ...............  69,060
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\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
  information.
\2\ Include an estimated 35,000 medical device distributors. Although they do not submit MDR reports, they must
  maintain records of complaints.

    The agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the MDR requirements as 
part of their internal quality control system.
    Part 803 requires user facilities to report incidents where a 
medical device caused or contributed to a death or serious injury to 
the device manufacturer and to FDA (in case of death). Manufacturers of 
medical devices are required to report to FDA when they become aware of 
information indicating that one of their devices may have caused or 
contributed to death or serious injury or has malfunctioned in such a 
way that should the malfunction recur, it would be likely to cause or 
contribute to death or serious injury. Device importers report deaths 
and serious injuries to the manufacturers and FDA. Importers report 
malfunctions only to the manufacturers, unless they are unknown. If the 
manufacturer is unknown, the importer sends the reports to FDA.
    The agency has estimated that on average, 1,800 entities annually 
would be required to establish new procedures or revise existing 
procedures in order to comply with medical device report (MDR) 
provisions. For those entities, a one-time burden of 10 hours is 
estimated for establishing written MDR procedures. The remaining 
manufacturers, user facilities, and importers which are not required to 
revise their written procedures to comply with this provision are 
excluded from the burden because the recordkeeping activities needed to 
comply with this provision are considered ``usual and customary'' under 
5 CFR 1320.3(b)(2).

    Dated: September 24, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-24811 Filed 9-30-02; 8:45 am]
BILLING CODE 4160-01-S