[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