[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Notices]
[Page 41504-41505]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy04-95]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0161]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Request for
Information From United States Processors That Export to the European
Community
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 review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
9, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with 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)--Extension
The European Community (EC) is a group of 15 European countries
(with 10 additional countries joining on May 1, 2004), that have agreed
to harmonize their commodity requirements to facilitate commerce among
member States. EC legislation for intraEC trade has been extended to
trade with nonEC countries, including the United States. For certain
food products, including those listed in this document, 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, animal casings, and gelatin) 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
submitting a certificate for signature to FDA is aware of and knows
that they are subject to the provisions of 18 U.S.C. 1001. 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.
In the Federal Register of April 16, 2004 (69 FR 20630), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 41505]]
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency
Product Respondents per Respondent Total Annual Responses Hours per Response Total Hours
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Shell eggs 10 1 10 0.25 3
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Dairy 100 1 100 0.25 25
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Game meat 5 1 5 0.25 1
and meat
products
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Animal 5 1 5 0.25 1
casings
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Gelatin 3 1 3 0.25 1
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Collagen 3 1 3 0.25 1
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Total ................. ................. ...................... ................... 32
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Reporting Burden (Disclosure)\1\
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No. of Annual Frequency Total Annual
Product Respondents per Respondent Responses Hours per Response Total Hours
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Trade association 15 1 15 8 120
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State 50 1 50 8 400
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Total ................. ................. ..................... .................... 520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
It is estimated that the annual reporting burden would be no more
than 32 hours. The time to respond to the questions should take
approximately 15 minutes using any of the technologies available to
transmit the information. All of the information asked for should be
readily available. The number of respondents is a rough estimate based
on volume of exports and responses received to date. No record
retention is required. Therefore, the proposed annual burden for this
information collection is 32 hours.
Dated: July 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15661 Filed 7-8-04; 8:45 am]
BILLING CODE 4160-01-S