[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Pages 36241-36242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17602]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0453]


Agency Emergency Processing Under OMB Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns 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 U.S./
European Community (EC) Mutual Recognition Agreement (MRA) to assess 
medical devices produced for the EC market. This collection of 
information also concerns the submission of third-party evaluation 
reports by EC CAB's under the program. FDA is requesting OMB approval 
within 15 days of receipt of this submission.

DATES: Submit written comments on the collection of information by July 
13, 1998.

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: 
Desk Officer for FDA. 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:

I. Background

    FDA has requested emergency processing of this proposed collection 
of information under section 3507(j) of the PRA and 5 CFR 1320.13. The 
information is needed immediately in order for potential CAB's to be 
designated in time to participate in training for premarket and quality 
systems evaluations scheduled for October 14 through 23, 1998. The use 
of normal clearance procedures would be likely to result in the 
prevention or disruption of this collection of information and would 
delay the implementation of the confidence building activities 
authorized by the U.S./EC MRA.
     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.
    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 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. 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 the 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 the EC CAB's to FDA. The EC 
CAB's would also be required to maintain copies of their evaluation 
reports.
    FDA estimates the burden of this collection as follows:

[[Page 36242]]



                                  Table  1.--Estimated Annual Reporting Burden1                                 
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
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       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


                                 Table 2.--Estimated Annual Recordkeeping Burden1                               
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
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       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    The burdens are explained as follows:

II. 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 the 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 to FDA reports of 
their evaluations. Based upon information gathered during the 
negotiation of the 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 to FDA reports of their evaluations. Based 
upon information gathered during the negotiation of the 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.

III. 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 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; therefore, 
the total number of hours per recordkeeper is 10.

    Dated: June 24, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17602 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F