[Federal Register: October 5, 2001 (Volume 66, Number 194)]
[Notices]
[Page 51050-51052]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc01-110]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0402]
Agency Information Collection Activities; Proposed Collection;
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 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 information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for medical devices; third-party premarket submission
review and quality system inspections under United States/European
Community (U.S./EC) Mutual Recognition Agreement (MRA).
DATES: Submit written or electronic comments on the collection of
information by December 4, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
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: Peggy 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 proposed 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 in this document.
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 Premarket Submission Review and
Quality System Inspections Under U.S./EC Mutual Recognition
Agreement (OMB Control No. 0910-0378)--Extension
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
[[Page 51051]]
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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual
ITEM Respondents per Response Responses Hours per Response Total Hours
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Premarket Reports by EC CABs 11 5 55 40 2,200
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Quality System Reports by EC CABs 11 15 165 32 5,280
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Totals 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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Annual Frequency
ITEM No. of per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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Premarket Reports by EC CABs 11 5 55 10 550
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Quality System Reports by EC CABs 11 15 165 10 1,650
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Totals 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
[[Page 51052]]
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: September 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24998 Filed 10-4-01; 8:45 am]
BILLING CODE 4160-01-S