[Federal Register: October 14, 2004 (Volume 69, Number 198)]
[Notices]
[Page 61021-61023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc04-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0437]
Agency Information Collection Activities; Proposed Collection;
Comment Request;Medical Devices; Third-Party Review Under the Food and
Drug Administration Modernization Act, Third-Party Premarket Submission
Review, and Quality System Inspections Under the 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 review under the Food and
Drug Administration Modernization Act (FDAMA), third-party premarket
submission review, and quality system inspections under the United
States/European Community (U.S./E.C.) Mutual Recognition Agreement
(MRA).
DATES: Submit written and electronic comments on the collection of
information by December 13, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(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 Robbins, Office of Management
Programs (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 these topics: (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 Under FDAMA, Third-Party
Premarket Submission Review, and Quality System Inspections Under U.S./
E.C. Mutual Recognition Agreement (OMB Control Number 0910-0378)--
Extension
[[Page 61022]]
Section 210 of FDAMA established section 523 of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to
accredit persons in the private sector to review certain premarket
applications and notifications. Participation in this third party
review program by accredited persons is entirely voluntary. A third
party wishing to participate will submit a request for accreditation to
FDA. Accredited third-party reviewers have the ability to review a
manufacturer's submission under section 510(k) of the act (21 U.S.C.
360(k)) for selected devices. After reviewing a submission, the
reviewer will forward a copy of the 510(k) submission, along with the
reviewer's documented review and recommendation to FDA. Third-party
reviews should maintain records of their 510(k) reviews and a copy of
the 510(k) for a reasonable period of time, usually a period of 3
years. This information collection will allow FDA to continue to
implement the accredited person review program established by FDAMA and
improve the efficiency of 510(k) review for low-to-moderate risk
devices.
The third-party program under the U.S/E.C. MRA is intended to
implement that part of the U.S./E.C. 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 evaluations and verifications for selected devices based
on European Union (EU) requirements under the voluntary third-party
program authorized by MRA. Firms designated as EU CABs could conduct
quality system evaluations for all classes of devices and premarket
510(k) evaluations for selected devices based on FDA's 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 for a period of
no less than 3 years.
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 Hours per
Item Respondents per Response Responses Response Total Hours
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Requests for accreditation 15 1 15 24 360
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510(k) reviews conducted by accredited third parties 15 14 210 40 8,400
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Premarket reports by EU CABs 9 5 45 40 1,800
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Quality system reports by EU CABs 9 4 36 32 1,152
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Totals 11,712
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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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No. of Record- Annual Frequency Total Annual Hours per Record-
Item keepers per Recordkeeper Records keeper Total Hours
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510(k) reviews 15 14 210 10 2,100
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Premarket reports by EU CABs 9 5 45 10 450
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Quality system reports by EU CABs 9 4 36 10 360
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Totals 2,910
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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:
I. Reporting
A. Requests for Accreditation
Under the agency's third-party review pilot program, the agency
received 37 applications for recognition as third-party reviewers, of
which the agency recognized 7. In the past 3 years, however, the agency
has averaged receipt of 15 applications for recognition of third-party
review accredited persons, and 9 EU CABS. The agency has accredited 15
of the applicants to conduct third-party reviews, and 9 EU CABs.
B. 510(k) Reviews Conducted by Accredited Third Parties
In the 18 months under the third-party review pilot program, FDA
received only 22 total 510(k)s that requested and were eligible for
review by third parties. Because the third-party review program is not
as limited in time as the pilot program, and is expanded in scope, the
agency anticipates that the number of 510(k)s submitted for third-party
review will remain the same as they were during the last OMB approval
in 2001. The agency has experienced that the number of 510(k)s
submitted by accredited persons for third-party review since the last
OMB approval in 2001 has been approximately 210 annually, which is 14
annual reviews per each of the estimated 15 accredited reviewers.
1. Premarket Reports
Under this program, EU CABs will be able to perform third-party
evaluations for certain products produced in Europe for export to the
United States. EU CABs would be required to submit to FDA reports of
their evaluations. Based upon
[[Page 61023]]
information gathered since this collection was last reviewed in 2001,
the agency has experienced that nine European manufacturers have not
received any third-party requests for review annually. The agency
estimates, based on dialog with EU officials and actual experience,
nine firms will be designated to act as EU CABs.
2. Quality System Reports
Under this program, EU CABs 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. EU CABs
would be required to submit to FDA reports of their evaluations. Based
upon information gathered during the negotiation of the U.S./E.C. MRA
and actual experience since the collection was last approved by OMB in
2001, the agency anticipates that European manufacturers will request
third-party audits for approximately 36 medical device products
annually. The agency estimates that 9 EU CABs will perform these
evaluations.
II. Recordkeeping
Third-party reviewers are required to keep records of their review
of each submission. The agency anticipates approximately 210 annual
submissions of 510(k)s for third-party review.
As stated previously, firms designated as EU CABs 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 review 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 review.
The agency anticipates that 45 premarket reports and 36 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: October 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-23103 Filed 10-13-04; 8:45 am]
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