[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
