[Federal Register Volume 63, Number 239 (Monday, December 14, 1998)]
[Notices]
[Pages 68773-68774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33054]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0453]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Medical Devices: Third-Party Review Program 
Under U.S./EC MRA

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 
January 13, 1999.

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: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. 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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Medical Devices: Third-Party Review Program Under U.S./EC MRA (OMB 
Control Number 0910-0378--Extension)

    The third-party program under the United States/European Community 
Mutual Recognition Agreement (U.S./EC MRA) is intended to implement 
that part of 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 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 EC CAB's could, in turn, 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 EC CAB's to 
FDA. EC CAB's would also be required to maintain copies of their 
evaluation reports.
    In the Federal Register of August 4, 1998 (63 FR 41573), the agency 
requested comments on the proposed collection of information. The 
agency received two comments.
    One comment questioned why FDA chose 12 as the number of U.S. 
CAB's, when Europe already has 20. The agency's estimate is based on 
discussions with the National Institute of Science and Technology of 
the U.S. Department of Commerce and officials of other standards 
organizations as well as firms who have expressed interest directly to 
FDA. FDA still believes that 12 is the appropriate number.
    The other comment questioned why FDA did not include all eligible 
class I and class II devices in the program. FDA did not include in the 
program three class I devices that are regulated by the Center for 
Biologics Evaluation and Research (CBER), because FDA determined that 
it would not be cost effective to train CBER employees in the program 
for only three devices. FDA included in the program the 97 class II 
devices for which guidance and/or

[[Page 68774]]

recognized standards exist and which represent 60 percent of the 
510(k)s we receive each year. If the program is successful, FDA will 
add additional devices, as appropriate.
    FDA estimates the burden of this collection as follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Requests for designation as U.S.
 CAB                                   12               1              12              24             288
Premarket reports by EC CAB's          20               5             100              40           4,000
Quality system reports by EC
 CAB's                                 20               5             100              32           3,200
Total                                                                                               7,488
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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 Burden1
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                                                      Annual
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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Records of evaluation of
 premarket submissions by EC
 CAB's                                 20               5             100              10           1,000
Records of evaluation of quality
 systems                               20               5             100              10           1,000
Total                                                                                               2,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burdens are explained as follows:

I. Reporting

A. Requests for Designation as U.S. CAB

    Under this program, U.S. firms may apply for designation as a U.S. 
CAB. Such designation will enable that firm to perform third-party 
evaluations of U.S. products for export to EC. Likewise, European firms 
may apply to be designated as EC CAB's, which will enable them to 
perform third-party evaluations of products to be exported to the 
United States. The application for nomination as an EC CAB does not 
represent an information collection burden subject to the PRA because 
the designation procedure is an internal process which 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. 
The agency anticipates, based on discussions with the National 
Institute of Science and Technology of the U.S. Department of Commerce 
and officials of other standards organizations, as well as firms who 
have expressed interest directly to FDA, that approximately 12 
applications for designation as U.S. CAB's will be received.

B. Premarket Reports

    Under this program, EC CAB's will be able to perform third-party 
evaluations for certain products produced in Europe for export to the 
United States. EC CAB's would be required to submit reports of their 
evaluations to FDA. Based upon information gathered during the 
negotiation of U.S./EC MRA, the agency anticipates that European 
manufacturers will request third-party evaluation for approximately 100 
medical device products annually. The agency further estimates, based 
on dialogue with EC officials, that 20 firms will be designated to act 
as EC CAB's.

C. Quality System Reports

    Under this program, EC CAB's will be able to perform third-party 
evaluations of the quality systems established by manufacturers of 
European products produced for export to the United States. EC CAB's 
would be required to submit reports of their evaluations to FDA. Based 
upon information gathered during the negotiation of U.S./EC MRA, the 
agency anticipates that European manufacturers will request third-party 
evaluations for approximately 100 medical device products annually. The 
agency estimates that 20 EC CAB's will perform these evaluations.

II. Recordkeeping

    As stated previously, firms designated as EC CAB's will be able to 
perform third-party evaluations of quality systems and premarket 
submissions for certain products produced for export to the United 
States. Such evaluation will be conducted consistent with FDA's 
regulatory requirements, and FDA will require the reviewers to keep, in 
their records, a copy of the report that they submit to FDA for each 
evaluation. The agency anticipates that 100 premarket reports and 100 
quality system reports will be generated and required to be maintained 
by EC CAB's annually. Thus, the agency estimates that 100 records of 
evaluations of quality systems and premarket submissions will be 
retained by the designated EC CAB's. Based on experience with the 
Third-Party Review Pilot Program, which was announced in the Federal 
Register of April 3, 1996 (61 FR 14789), the agency anticipates that 
each recordkeeper will require no more than 2 hours of recordkeeping 
per review. The agency is estimating five reviews per respondent and a 
total of 10 hours per recordkeeper.

    Dated: December 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-33054 Filed 12-11-98; 8:45 am]
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