[Federal Register Volume 64, Number 207 (Wednesday, October 27, 1999)]
[Notices]
[Pages 57892-57893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4397]


Agency Emergency Processing Request Under OMB Review; Survey of 
Food Manufacturing Facilities 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 concerns a survey of food manufacturing facilities for Year 
2000 compliance.

DATES: Submit written comments on the collection of information by 
November 1, 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: 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. FDA has requested emergency processing of this 
proposed collection of information under the PRA (44 U.S.C. 3507(j) and 
5 CFR 1320.13). FDA is requesting certain information, i.e., 
manufacturer, food products produced, etc., immediately to allow for 
the assessment of their vulnerability to Year 2000 problems and to take 
corrective actions, if necessary, in advance of January 1, 2000. The 
potential existence of Year 2000 problems in the food 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

[[Page 57893]]

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 Food Manufacturing Facilities for Year 2000 
Compliance

    Facilities will be asked to provide a status on their Year 2000 
readiness. They will also be asked if they have contingency plans. The 
survey will also ask if they have tested, verified, and certified their 
systems. The request will also ask for a single point of contact at the 
manufacturer to discuss information.
    The manufacturer will provide paper copy of the information to FDA. 
The provision of information will signify that the information provided 
is true to the best of the manufacturer's knowledge. The information 
will be used for possible FDA inspectional followup, if it indicates 
potential unsafe food manufacturing situations, as well as in the 
preparation of industry and consumer directed material addressing Year 
2000 concerns.
Respondents: Food manufacturers.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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250                                                     1             250               1             250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

     FDA establishment inventory lists were used to determine the 
number of firms who would be subject to this collection. FDA estimates 
that it will take firms an average of 2 hours to collect, prepare, and 
submit the requested information.

    Dated: October 20, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-27977 Filed 10-26-99; 8:45 am]
BILLING CODE 4160-01-F