[Federal Register Volume 64, Number 89 (Monday, May 10, 1999)]
[Notices]
[Pages 25045-25046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11734]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-0791]
Agency Emergency Processing Under OMB Review; Survey of Medical
Device Manufacturers for Year 2000 Compliance of Manufacturing Systems
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 medical device manufacturers for Year
2000 compliance of their manufacturing systems. The list of the Year
2000 compliant facilities will be made available to the public via the
World Wide Web.
DATES: Submit written comments on the collection of information by May
17, 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. FDA is requesting certain
information on the Year 2000 compliance status of medical device
manufacturing processes. This information is needed immediately in
order to allow the agency to: (1) Assess the impact of the Year 2000
problem on the continued availability of an adequate supply of safe and
effective medical devices and medical/surgical supplies; (2) properly
advise the health-care industry and the U.S. public regarding the
preparedness of the medical device industry; and (3) assess the need
for additional government actions to address potential supply
disruptions. This information is essential to the mission of the
agency. The potential existence of Year 2000 problems in the medical
device industry could pose potentially serious health and safety
consequences. The use of normal clearance procedures would prolong the
time needed to assess Year 2000 compliance by regulated industry.
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 Medical Device Manufacturers for Year 2000
Compliance of Manufacturing Systems
Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 375(b)) permits the Secretary of Health and Human Services (the
Secretary) to disseminate information regarding food, drugs, devices,
and cosmetics in situations involving, in the opinion of the Secretary,
imminent danger to health, or gross deception of the consumer.
Manufacturers will be asked to provide a status on their Year 2000
readiness and will also be asked if they have contingency plans. The
survey will also ask if they have tested, verified, and certified their
systems. Finally, the request will ask for a single point of contact at
the manufacturer to discuss information.
The manufacturer will be able to provide facsimile, 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 to be able to assess
their vulnerability to Year 2000 problems and to take corrective
actions, if necessary, in advance of January 1, 2000. The posting of
information on compliant facilities is designed to provide health care
facilities with a positive statement as to the status of compliant
firms.
Respondents: Medical Device Manufacturers
FDA estimates the burden of this collection as follows:
[[Page 25046]]
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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13,500 1 13,500 13 175,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA's mailing lists were used to estimate the number of medical
device manufacturers who would be subject to this collection. FDA
estimates that it will take manufacturers an average of 13 hours to
collect, prepare, and submit the requested information. These estimates
include allowance for variance in the number of devices to be reported
by a manufacturer.
Dated: May 5, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-11734 Filed 5-7-99; 8:45 am]
BILLING CODE 4160-01-F
