[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Pages 36241-36242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17602]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0453]
Agency Emergency Processing Under OMB Review
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information concerns the submission of applications to recognized
accreditation bodies that will assess potential U.S. Conformity
Assessment Bodies (CAB's) seeking to be designated under the U.S./
European Community (EC) Mutual Recognition Agreement (MRA) to assess
medical devices produced for the EC market. This collection of
information also concerns the submission of third-party evaluation
reports by EC CAB's under the program. FDA is requesting OMB approval
within 15 days of receipt of this submission.
DATES: Submit written comments on the collection of information by July
13, 1998.
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. All comments should be identified with the docket
number found in brackets in the heading of this document.
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:
I. Background
FDA has requested emergency processing of this proposed collection
of information under section 3507(j) of the PRA and 5 CFR 1320.13. The
information is needed immediately in order for potential CAB's to be
designated in time to participate in training for premarket and quality
systems evaluations scheduled for October 14 through 23, 1998. The use
of normal clearance procedures would be likely to result in the
prevention or disruption of this collection of information and would
delay the implementation of the confidence building activities
authorized by the U.S./EC MRA.
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.
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 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. 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 the 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 the EC CAB's to FDA. The EC
CAB's would also be required to maintain copies of their evaluation
reports.
FDA estimates the burden of this collection as follows:
[[Page 36242]]
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:
II. 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 the 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 a paperwork 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, 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 to FDA reports of
their evaluations. Based upon information gathered during the
negotiation of the 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 to FDA reports of their evaluations. Based
upon information gathered during the negotiation of the 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.
III. 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 5 reviews per respondent; therefore,
the total number of hours per recordkeeper is 10.
Dated: June 24, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17602 Filed 7-1-98; 8:45 am]
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