[Federal Register Volume 62, Number 245 (Monday, December 22, 1997)]
[Notices]
[Page 66869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33310]



[[Page 66869]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

The Office of the Secretary


Information Collection Activity Under Emergency Review by the 
Office of Management and Budget (OMB)

Title: Survey of Biomedical Equipment Manufacturers for Year 2000 
Compliance

Paperwork Reduction Act Requirements

    We are required to solicit public comments under section 
3506(c)(2)(A) of the Paperwork Reduction Act of 1995. Specifically, 
comments are invited on (1) whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information will have practical 
utility; (2) the accuracy of the estimate of the burden of the proposed 
collection of information; (3) ways to enhance the quality, utility, 
and clarity of the information collected; (4) ways to minimize the 
burden of the collection of information on respondents, including the 
use of automated collection techniques or other forms of information 
technology. We are seeking emergency OMB approval for this collection 
of information.

Description

    The Deputy Secretary of the Department of Health and Human 
Services, on behalf of the government-wide Biomedical Equipment 
Subgroup of the CIO Council's Year 2000 Subcommittee, is surveying 
manufacturers of biomedical equipment about the Year 2000 compliance of 
their products. The existence of a Year 2000 date problem in biomedical 
equipment could pose potentially serious health and safety 
consequences.
    Manufacturers are requested to post information about noncompliance 
products on a web site and link this to a government web site on 
biomedical equipment. If all of a manufacturer's products are 
compliant, they are requested to provide notice of total product 
compliance. Manufacturers have the option to mail the information to 
the Department of Health and Human Services for posting on the 
government web site. All information collected will be available to the 
public through the government web site.
    To be Year 2000 compliant, a product must be able to accurately 
process date information in the Year 2000 and between the twentieth and 
twenty-first 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.
    The Food and Drug Administration (FDA) regulates medical devices 
and needs information regarding the Year 2000 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 Food, Drug and Cosmetic Act requires notification of users or 
purchasers when a device presents a reasonable 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 Year 2000 
compliance information of all biomedical equipment is necessary to 
prevent a Year 2000 date problem from causing any public health risk in 
the patient care services and health research initiatives of the next 
century.

Burden Information

    Respondents: Biomedical Equipment Manufacturers.
    Estimated Number of Potentially Noncompliant Products: 20,500.
    Estimated Percentage of Responses Collected Electronically: 75%.
    Estimated Response Time to Post One Noncompliant Product: 5 
minutes.
    Estimated Percentage of Written Responses: 25%.
    Estimated Written Response Time for One Noncompliant Product: 20 
minutes.
    Estimated Total Annual Burden: 2989 hours.

Additional Information

    HHS is requesting that OMB grant a seven day approval under 
procedures for emergency processing.
    Questions about this information collection can be directed to the 
Project Coordinator, Gayle Finch, Director, Office of Information 
Technology Planning and Investment, Humphrey Building, 200 Independent 
Avenue, S.W., Washington, D.C. 20201, phone 202-690-5515 or fax 202-
690-8715.
    Written comments about the information collection described above 
can be directed to Wendy Taylor, OMB Desk Officer, Office of Management 
and Budget, 725 17th Street, N.W., Room 10235, Washington, D.C. 20503, 
or fax 202-395-6974.

    Dated: December 15, 1997.
Tom Joyce,
Reports Clearance Officer.
[FR Doc. 97-33310 Filed 12-19-97; 8:45 am]
BILLING CODE 4150-04-M