[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Notices]
[Pages 29738-29739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14297]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0373]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by July
1, 1998.
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.
FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Request for Information From U.S. Processors that Export to the
European Community (OMB Control Number 0910-0320--Reinstatement)
European Community (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 assurances 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 and State authorities,
FDA requests information from processors that export certain animal-
derived products (e.g., shell eggs, dairy products, game meat, game
meat products, and animal casings) to EC. FDA uses the information to
maintain lists of processors that have demonstrated current compliance
with U.S. requirements and provides the lists to EC quarterly.
Inclusion on the list is voluntary. EC member countries refer to the
lists at ports of entry to verify that products offered for importation
to EC from the United States are from processors that meet U.S.
regulatory requirements. Products processed by firms not on the list
are subject to detention and possible refusal at the port. FDA requests
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 EC and those
intended to be shipped in the next 6 months;
(4) Name and address of manufacturing plants for each product;
(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; and
(6) Assurance that the firm or individual representing the firm and
[[Page 29739]]
submitting a certificate for signature to FDA is aware of and knows
that they are subject to the provisions of section 1001 of Title 18,
U.S. Code. This law provides that it is a criminal offense to knowingly
and willfully make a false statement or alter or counterfeit documents
in a matter within the jurisdiction of a U.S. agency.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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No. of
Products No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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Shell Eggs 20 1 20 0.25 5
Dairy 100 1 100 0.25 25
Game Meat and Meat Products 20 1 20 0.25 5
Animal Casings 15 1 15 0.25 3.75
Total 38.75
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated number of respondents is based on volume of exports
and responses received to date. The estimated number of yearly
responses has been decreased from the estimate in FDA's previous notice
seeking comment on this collection of information (61 FR 66671,
December 18, 1996) because the actual number of responses received has
been decreasing. Companies do not need to reapply unless they have a
compliance problem. An estimate for processors that export animal
casings has also been added because these processors are now being
included in the listing process. Finally, the operating and maintenance
cost estimate included in the previous notice has been removed because,
according to OMB's draft guidance on interpretation of the PRA, the
costs listed were not operating and maintenance costs. The costs are
now listed in FDA's supporting statement in the ``Other Non-Labor
Costs'' category. A copy of the supporting statement may be obtained
from the contact person listed above.
Table 2.--Estimated Annual Reporting Burden (Third Party Disclosure)1
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No. of
Respondents No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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Trade Association 14 1 14 8 112
State 50 1 50 8 400
Total 512
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimated for the trade associations assumes the trade
associations will disseminate FDA's information request through mass
mailings to their membership or publish it in their trade magazine or
newsletter. The burden estimated for State authorities assumes
dissemination of information to the processors or dissemination of
information about the processors to FDA.
Dated: May 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14297 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F
