[Federal Register Volume 61, Number 56 (Thursday, March 21, 1996)]
[Notices]
[Pages 11642-11644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6737]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0084]
Agency Emergency Processing Request Under OMB Review
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 purpose of the proposed collection
of information is to enable FDA to compile lists of U.S. processors
that export certain animal-derived foods to the European Community
(EC). These lists must be completed by May 1, 1996, to meet EC trade
requirements. To meet the EC deadline, FDA is requesting OMB approval
by March 28, 1996.
DATES: Submit written comments by March 28, 1996.
ADDRESSES: Submit written comments 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: Charity B. Smith, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1686.
SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of
this proposed collection of information under section 3507(j) of the
Paperwork Reduction Act of 1995 and 5 CFR 1320.13 because the
information is needed to meet the May 1, 1996, EC deadline; the
information is essential to the agency's mission; and public harm is
reasonably likely to result if normal clearance procedures are
followed.
With respect to the following collection of information, comments
are invited 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 the agency 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
[[Page 11643]]
on respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Request for Information from U.S. Processors that Export Shell Eggs,
Dairy Products, Game Meat and Game Meat Products to the European
Community:
The EC is a group of 15 European countries that have agreed to
harmonize their commodity requirements to facilitate commerce among
member States. EC legislation for intra-EC trade has been extended to
trade with non-EC countries, including the United States. For certain
food products, including those listed below, EC legislation requires
assurance from the responsible authority of the country of origin that
the processor of the food is in compliance with applicable regulatory
requirements.
With the assistance of trade associations, FDA intends to request
information from processors that export certain animal-derived products
(shell eggs, dairy products, game meat and game meat products) to the
EC. FDA will use this information to compile lists of processors that
meet U.S. requirements and will provide the lists to the EC quarterly.
Inclusion on the lists is voluntary. EC member countries will refer to
the lists at ports of entry to verify that products offered for
importation to the EC from the United States are from processors that
meet U.S. regulatory requirements. Products processed by firms not on
the processor list are subject to detention and possible refusal at the
port. FDA intends to request the following information from each
processor:
(1) Business name and address;
(2) Name and telephone number of person designated as business
contact;
(3) Lists of products presently being shipped to the EC and those
intended to be shipped in the next 2 years;
(4) Name and address of manufacturing plants for each product and;
(5) Names and affiliations of any Federal, State, or local
governmental agencies that inspect the plant, government-assigned plant
identifier, such as plant number; and last date of inspection.
FDA estimates the burden of the proposed collection of information
is as follows:
Shell Eggs
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Estimated Annual Reporting Burden
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Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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25 1 25 0.25 6.25
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Dairy Products
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Estimated Annual Reporting Burden
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Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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50 1 50 0.25 12.50
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Game Meat and Game Meat Products
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Estimated Annual Reporting Burden
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Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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25 1 25 0.25 6.25
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There are no capital costs or operating and maintenance costs
associated with this collection.
Third Party Disclosure
The following estimate of the burden on trade associations assumes
that the trade associations will disseminate FDA's information request
through a mass mailing to their membership or publish it in their trade
magazine or newsletter:
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Estimated Annual Reporting Burden
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Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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12 1 12 8 96
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[[Page 11644]]
There are no capital costs or operating and maintenance costs
associated with this collection.
Dated: March 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-6737 Filed 3-18-96; 8:45 am]
BILLING CODE 4160-01-F
