[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]


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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.

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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 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 Burden<SUP>1                                  
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                                                     Number of                                                  
              Item                    No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
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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       
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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<SUP>1                                
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                                                      Annual                                                    
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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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       
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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 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