[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