[Federal Register Volume 66, Number 108 (Tuesday, June 5, 2001)]
[Notices]
[Pages 30218-30219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0069]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Information From U.S. 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 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.

DATES: Submit written comments on the collection of information by July 
5, 2001.

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: 
Wendy Taylor, Desk Officer for FDA.

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: 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 
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 
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

[[Page 30219]]

    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 section 1001 of Title 18, 
United States 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.
    In the Federal Register of February 28, 2001 (66 FR 12802), the 
agency requested comments on the proposed collection of information. 
One comment was received. In this comment there were two concerns 
regarding burden. The first was that States may incur more than 
``information'' burden. The impact on a few States has been to retrieve 
inspection reports from FDA contracted inspections or from a State 
inspection. The second concern was that FDA ``assumed no operating or 
maintenance costs''. The burden on a company for placement on an EC 
required list is only the initial information asked for in the Federal 
Register notice. A company may inquire about the status during the 
review process for placement on the list but this is of their choosing.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                             No. of       Annual Frequency    Total Annual        Hours per
       Products            Respondents      per Response        Responses         Response         Total Hours
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Shell eggs                    10                 1                10                 0.25              2.5
Dairy                        100                 1               100                 0.25             25
Game meat and meat            10                 1                10                 0.25              2.5
 products
Animal casings                15                 1                15                 0.25              3.75
Gelatin                        6                 1                 6                 0.25              1.5
                                                                                               -----------------
Total                                                                                                 35.25
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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 the volume of 
exports and responses received to date. The estimated number of yearly 
responses has decreased from the estimate in FDA's previous notice 
seeking comment for this collection of information (63 FR 29738, June 
1, 1998) because the actual number of responses has been decreasing. 
Companies do not need to reapply unless they have a compliance problem. 
An estimate for processors that export gelatin also has been added 
because these processors are now being included in the listing process.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                    No. of         Annual Frequency      Total Annual          Hours per
 Respondents     Recordkeepers     of Recordkeeping         Records          Recordkeeper         Total Hours
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Trade                15                   1                  15                   8                 120
 association
State                50                   1                  50                   8                 400
                                                                                             -------------------
Total                                                                                               520
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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 processors to FDA.

    Dated: May 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13985 Filed 6-4-01; 8:45 am]
BILLING CODE 4160-01-S