[Federal Register Volume 67, Number 9 (Monday, January 14, 2002)]
[Notices]
[Pages 1770-1771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0402]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
February 13, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Devices; Third-Party Premarket Submission Review and 
Quality System Inspections Under United States/European Community 
Mutual Recognition Agreement (OMB Control No. 0910-0378)--Extension

    The third-party program under the United States/European (U.S./EC) 
Community/Mutual Recognition Agreement (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 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

[[Page 1771]]

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.
    In the Federal Register of October 5, 2001 (66 FR 51050), the 
agency requested comments on the proposed collection of information. No 
comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                Annual Frequency      Total Annual                         Total
           Item            No. of Respondents      perResponse          Responses      Hours per Response  Hours
----------------------------------------------------------------------------------------------------------------
Premarket Reports by EC           11                   5                  55                  40           2,200
 CABs
Quality System Reports by         11                  15                 165                  32           5,280
 EC Cabs
                                                                                                          ------
Total                                                                                                      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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                                                            No. of         Annual Frequency      Total Annual          Hours per
                        Item                             Recordkeepers     per Recordkeeping        Records          Recordkeeper         Total Hours
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Premarket Reports by EC CABs                                 11                   5                  55                  10                 550
Quality System Reports by EC Cabs                            11                  15                 165                  10               1,650
                                                                                                                                     -------------------
Total                                                                                                                                     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 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: January 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-854 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-02-S