[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
