[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Notices]
[Pages 41573-41575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20702]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0453]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 collection and
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on 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
United States (U.S.)/European Community (EC) Mutual Recognition
Agreement (MRA) to assess medical devices produced for the EC market.
Elsewhere in this issue of the Federal Register, FDA is publishing a
notice announcing OMB's approval of this collection of information (OMB
control number 0910-0378). Since this was an emergency approval that
expires on January 31, 1999, FDA is following the normal PRA clearance
procedures by issuing this notice.
DATES: Submit written comments on the collection of information by
October 5, 1998.
ADDRESSES: 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: 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: 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 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 below.
[[Page 41574]]
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 Review Program Under U.S./EC MRA (OMB
Control Number 0910-0378--Extension)
The third-party program under 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. 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.
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Number of
Item No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent 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 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 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
[[Page 41575]]
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 and a total of 10 hours per recordkeeper.
Dated: July 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20702 Filed 8-3-98; 8:45 am]
BILLING CODE 4160-01-F