[Federal Register Volume 69, Number 198 (Thursday, October 14, 2004)]
[Notices]
[Pages 61021-61023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23103]


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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://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]
BILLING CODE 4160-01-S