[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Notices]
[Pages 51050-51052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0402]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Third-Party Premarket Submission 
Review and Quality System Inspections Under United States/European 
Community Mutual Recognition Agreement

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 devices; third-party premarket submission 
review and quality system inspections under United States/European 
Community (U.S./EC) Mutual Recognition Agreement (MRA).

DATES: Submit written or electronic comments on the collection of 
information by December 4, 2001.

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 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 Devices; Third-Party Premarket Submission Review and 
Quality System Inspections Under U.S./EC Mutual Recognition 
Agreement (OMB Control No. 0910-0378)--Extension

    The third-party program under the U.S./EC MRA is intended to 
implement that part of the U.S./EC MRA that covers the exchange of 
quality system evaluation reports for all medical

[[Page 51051]]

devices and premarket evaluation reports for selected low-to-moderate 
risk devices. Under the MRA, firms may apply to become designated as a 
U.S. Conformity Assessment Body (CAB). Firms who are designated will be 
qualified to conduct quality system evaluations for all classes of 
devices and product type examinations and verifications for selected 
devices based on EC requirements under the voluntary third-party 
program authorized by MRA. Firms designated as European Union (EU) CABs 
could conduct quality system evaluations for all classes of devices and 
premarket 510(k) evaluations for selected devices based on FDA 
requirements. Under the voluntary third-party program, reports of these 
evaluations would be submitted by the EU CABs to FDA. The EU CABs would 
also be required to maintain copies of their evaluation reports.
    FDA requests approval of the following collection of information:
    Requests for Designation as U.S. CABs--Under this program, U.S. 
companies were allowed to apply for designation as a U.S. CAB. Such 
designation enabled the company to perform third-party reviews of U.S. 
products for export to the EU and third-party audits of quality systems 
established by manufacturers of medical devices manufactured for export 
to the EU. Third-party review of U.S. products for export and third-
party audit of quality systems was elective and at the discretion of 
the manufacturer of the product. At the present time, only eight U.S. 
CABs are active. The agency is not accepting applications for U.S. CAB 
designation at this time and in the foreseeable future.
    Premarket Reports by EU CABs--Under this program, EU CABs will be 
able to perform third-party evaluations for certain products 
manufactured in Europe for export to the United States. Third-party 
evaluation is elective and at the discretion of the manufacturer of the 
product.
    Quality System Reports by EU CABs--Under this program, EU CABs will 
be able to perform third-party audits of the quality systems 
established by EU manufacturers of products manufactured for export to 
the United States. Third-party audit of quality systems is elective and 
at the discretion of the manufacturer of the product.
    EU CABs must maintain records of their third-party evaluations of 
quality systems and premarket submissions for certain products 
manufactured for export to the United States for a period of no less 
than 3 years.
    The program implements that part of the U.S./EC MRA that covers the 
exchange of quality system evaluation reports for all medical devices 
and premarket evaluation reports for selected low-to-moderate risk 
devices.
    Respondents to this information collection are businesses or other 
for-profit organizations.
    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
                         ITEM                             Respondents      per Response         Responses        Hours per Response      Total Hours
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Premarket Reports by EC CABs                                 11                 5                  55                   40                2,200
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Quality System Reports by EC CABs                            11                15                 165                   32                5,280
                                                                                                                                    --------------------
  Totals                                                                                                                                  7,480
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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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                                                                         Annual Frequency
                         ITEM                               No. of              per            Total Annual          Hours per           Total Hours
                                                         Recordkeepers     Recordkeeping         Records            Recordkeeper
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Premarket Reports by EC CABs                                 11                 5                  55                   10                  550
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Quality System Reports by EC CABs                            11                15                 165                   10                1,650
                                                                                                                                    --------------------
  Totals                                                                                                                                  2,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The following is an explanation of the burden estimate.

I. Reporting Burden

A. Requests for Designation as U.S. CAB

    U.S. firms who have applied and have been accepted for designation 
as a U.S. CAB will be able to perform third-party evaluations of U.S. 
products for export to the EU. Likewise, European firms who have 
applied and been designated as EC CABs, will be able to perform third-
party reviews of products to be exported to the United States. The 
application for nomination as an EU CAB does not represent a paperwork 
burden subject to the PRA because the designation procedure is an 
internal process that is required by, and administered by, European 
authorities. Only the application for designation as a U.S. CAB 
represents a paperwork burden under the PRA. However, the agency has 
received 10 applications for designation as U.S. CABs, 8 of whom are 
still active. The agency is not accepting any applications at this 
time, and does .not anticipate accepting any applications in the near 
future. Thus burden for U.S. CAB designation is nonexistent at this 
time.

B. Premarket Reports

    EU CABs are required to submit to FDA reports of their third-party 
evaluations. Based upon information gathered during the negotiation of 
the

[[Page 51052]]

U.S./EC MRA, the agency anticipates that European manufacturers will 
request third-party review for approximately 55 to 100 medical device 
products annually. The agency expects that interest and participation 
in the program will increase with time. The agency further estimates 
based on dialogue with EC officials, that 11 firms will be designated 
to act as EC CABs.

C. Quality System Reports

    EU CABs are required to submit to FDA reports of their third-party 
evaluations. Based upon information gathered during the negotiation of 
the U.S./EC MRA, the agency anticipates that European manufacturers 
will request third-party audits for approximately 165 medical device 
products annually. The agency estimates that 11 EU CABs will perform 
these evaluations.

II. Recordkeeping

    FDA requires the reviewers to keep in their records a copy of the 
report that they submit to FDA for each review. The agency anticipates 
that 55 premarket reports and 165 quality system reports will be 
generated and required to be maintained by EU CABs annually. The agency 
further estimates that each reviewer will require no more than 10 hours 
(2 hours per recordkeeping per report) for each to maintain such 
records annually.

    Dated: September 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24998 Filed 10-4-01; 8:45 am]
BILLING CODE 4160-01-S