[Federal Register Volume 64, Number 157 (Monday, August 16, 1999)]
[Notices]
[Pages 44529-44530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2695]


Agency Emergency Processing Under OMB Review; Survey of 
Biomedical Equipment Manufacturers for Year 2000 Compliance

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, originally approved under OMB control number 0900-0003, 
concerns a survey of manufacturers of biomedical equipment about the 
Year 2000 (Y2K) compliance of their products.

DATES:  Submit written comments on the collection of information by 
August 19, 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:  Thomas B. Shope, Office of Science 
and Technology (HFZ-140), Center for Devices and Radiological Health, 
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 301-443-3314, ext. 132, or FAX 301-443-9101.

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. This collection is needed 
immediately because some manufacturers have not yet provided data on 
their noncompliant products and because other manufacturers have 
provided either incomplete or preliminary, not final, information. 
Health care facilities and others are depending upon the information in 
the FDA-operated Federal Y2K Biomedical Equipment Clearinghouse (the 
Clearinghouse) as they assess the Y2K compliance of the biomedical 
equipment used in their facilities. In order to continue this 
collection activity, it is necessary to extend this activity until 
February 29, 2000. FDA is requesting OMB approval by August 19, 1999.
     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 
Compliance

     The Deputy Secretary of the Department of Health and Human 
Services, on behalf of the governmentwide Biomedical Equipment Subgroup 
of the Chief Information Officer Council's Y2K Subcommittee, is 
surveying manufacturers of biomedical equipment about the Y2K 
compliance of their products. The existence of a Y2K date problem in 
biomedical equipment could pose potentially serious health and safety 
consequences.
     Manufacturers have been asked to post information about 
noncompliant products on a website and link this to a government 
website on biomedical equipment. If all of a manufacturer's products 
are compliant, they may provide a notice of total product compliance. 
Manufacturers have the option to mail the information to the Department 
of Health and Human Services (DHHS) for posting on the government 
website, or they may provide it electronically. All information 
collected is available to the public through the government website.
     FDA, on behalf of DHHS, is continuing to solicit product status 
information from manufacturers that have not responded to this request 
and to seek clarification or expansion of specific information that has 
been received, but is incomplete.
     To be Y2K compliant, a product must be able to accurately process 
date information in the Y2K and between the 20th and 21st centuries, 
including leap year calculations. Medical devices and scientific 
laboratory equipment may experience problems beginning January 1, 2000, 
if the computer systems, software applications, or embedded chips used 
in these devices and equipment contain two-digit fields for year 
representation.
     FDA regulates medical devices and needs information regarding the 
Y2K compliance of these products. Under a previous good manufacturing 
practices regulation and the current quality system regulation, 
effective June 1, 1997, manufacturers must investigate and correct 
problems with medical devices that present a significant risk to public 
health. This includes devices that fail to operate according to their 
specifications because of inaccurate date recording and/or 
calculations. Also, section 518 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360h) requires notification of users or purchasers when 
a device presents an unreasonable risk of substantial harm to public 
health. These regulations, however, do not apply to all biomedical 
equipment, such as scientific laboratory equipment, but only to medical 
devices. Therefore, a proactive collection of Y2K compliance 
information of all biomedical equipment is necessary to prevent a Y2K 
date problem from causing any public health risk in the patient care 
services and health research initiatives of the next century.
    FDA estimates the burden of this collection of information 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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450                                                     1             450               8           3,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 44530]]

    Based on mailing lists and data bases on product approvals, FDA 
believes that approximately 150 manufacturers have not yet provided 
data to the Clearinghouse on Y2K compliance status of their products. 
Based on analysis of data already in the Clearinghouse, approximately 
300 manufacturers have provided information that is either incomplete 
or that requires clarification. FDA estimates that it will take 
manufacturers an average of 8 hours to collect, prepare, and submit the 
requested information.

William K. Hubbard.
    Dated: August 10, 1999
Senior Associate Commissioner for Policy, Planning, and Coordination.

[FR Doc. 99-21082 Filed 8-13-99; 8:45 am]
BILLING CODE 4160-01-F