[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
----------------------------------------------------------------------------------------------------------------
Shell eggs           10                  1                 10                       0.25                 3
----------------------------------------------------------------------------------------------------------------
Dairy               100                  1                100                       0.25                25
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Game meat             5                  1                  5                       0.25                 1
 and meat
 products
----------------------------------------------------------------------------------------------------------------
Animal                5                  1                  5                       0.25                 1
 casings
----------------------------------------------------------------------------------------------------------------
Gelatin               3                  1                  3                       0.25                 1
----------------------------------------------------------------------------------------------------------------
Collagen              3                  1                  3                       0.25                 1
----------------------------------------------------------------------------------------------------------------
  Total     .................  .................  ......................  ...................           32
----------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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