[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
