[Federal Register Volume 64, Number 14 (Friday, January 22, 1999)]
[Notices]
[Page 3524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0038]


Agency Emergency Processing Under OMB Review; Survey of 
Biomedical Equipment Manufacturers for Year 2000-Compliant Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 a survey of manufacturers of Year 2000-vulnerable 
biomedical devices in order to obtain a list of their products that 
have been identified as being Year 2000-compliant. The list of the Year 
2000-compliant biomedical devices will be made available to the public 
via the Federal Year 2000 Biomedical Clearinghouse on the World Wide 
Web. FDA is requesting OMB approval within 9 days of receipt of this 
submission.

DATES: Submit written comments on the collection of information by 
February 12, 1999.

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: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. The information is needed 
immediately to allow health care facilities and others to assess their 
vulnerability to Year 2000 problems and to take corrective actions, if 
necessary, well in advance of January 1, 2000. The existence of a Year 
2000 date problem in biomedical equipment, which includes medical 
devices and scientific laboratory equipment, could pose potentially 
serious health and safety consequences. It is vital that there be no 
Year 2000 failures of biomedical equipment. The use of normal clearance 
procedures would be likely to result in the prevention or disruption of 
this 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.

Title: Survey of Biomedical Equipment Manufacturers for Year 2000-
Compliant Products

     Manufacturers of biomedical equipment that may be Year 2000-
vulnerable will be asked to provide a list of their products that have 
been evaluated and found not to be impacted by the Year 2000 date 
issue. The information requested will include the specific 
manufacturer, product type, model and specific serial or version number 
(when applicable) of each product evaluated by the manufacturer and 
determined to be compliant. The request will also ask for a single 
point of contact at the manufacturer to discuss product information, 
including information on testing protocols.
     The manufacturer will be able to provide the information directly 
to a government web site via the Internet or provide electronic or 
paper copy of the information to FDA for inclusion in the web site data 
base. Government agencies, as well as health care facilities and the 
general public, will have access to the web site and will use the 
information to assess currently owned equipment as well as to evaluate 
potential acquisitions. The posting of information on compliant 
products is designed to provide health care facilities with a positive 
statement as to the status of compliant products.
Respondents: Manufacturers of Year 2000-vulnerable medical devices and 
scientific laboratory products.
FDA estimates the burden of this collection as follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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3,500                                                   1           3,500              12          42,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

     FDA mailing lists as well as experience with the data base on 
noncompliant products were used to estimate the number of manufacturers 
who would be subject to this collection. Based on experience with 
submissions to the noncompliant product data base as well as the 
estimated number of Year 2000-vulnerable biomedical products, FDA 
estimates that it will take manufacturers an average of 12 hours to 
collect, prepare, and submit the requested information. These estimates 
include allowance for variance in the number of compliant products to 
be reported by a manufacturer.

    Dated: January 13, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1507 Filed 1-21-99; 8:45 am]
BILLING CODE 4160-01-F