[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Annual
Item No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
Annual
Item No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-F
