[Federal Register: January 14, 2002 (Volume 67, Number 9)]
[Notices]
[Page 1770-1771]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja02-74]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0402]
Agency Information Collection Activities; Submission for OMB
Review; 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.
-----------------------------------------------------------------------
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
February 13, 2002.
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:
Stuart Shapiro, Desk Officer for FDA.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Devices; Third-Party Premarket Submission Review and
Quality System Inspections Under United States/European Community
Mutual Recognition Agreement (OMB Control No. 0910-0378)--Extension
The third-party program under the United States/European (U.S./EC)
Community/Mutual Recognition Agreement (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. 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
[[Page 1771]]
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.
In the Federal Register of October 5, 2001 (66 FR 51050), the
agency requested comments on the proposed collection of information. No
comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Total
Item No. of Respondents perResponse Responses Hours per Response Hours
----------------------------------------------------------------------------------------------------------------
Premarket Reports by EC 11 5 55 40 2,200
CABs
Quality System Reports by 11 15 165 32 5,280
EC Cabs
------
Total 7,480
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Item Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Reports by EC CABs 11 5 55 10 550
Quality System Reports by EC Cabs 11 15 165 10 1,650
-------------------
Total 2,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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: January 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-854 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-02-S