[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52140-52141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0230]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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 October 
12, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0320. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

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 27 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 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.
    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 the EC. FDA uses 
the information to maintain lists of processors that have demonstrated 
current compliance with U.S. requirements and provides the lists to the 
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 the EC from the United States are from processors 
that meet U.S. regulatory requirements. Products processed by firms not 
on the lists are subject to

[[Page 52141]]

detention and possible refusal at the port. FDA requests the following 
information from each processor seeking to be included on the lists:
    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 6 months;
    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.
    In the Federal Register of June 21, 2007 (72 FR 34256), 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:

                                                     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                 .25                  3
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Dairy                                                                120                     1                120                 .25                 30
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Game Meat and Meat Products                                            5                     1                  5                 .25                  1
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Animal Casings                                                         5                     1                  5                 .25                  1
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Gelatin                                                                3                     1                  3                 .25                  1
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Collagen                                                               3                     1                  3                 .25                  1
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Total                                                                                                                                                37
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate on the responses received over the past 3 
years. We estimate that the annual reporting burden would be 
approximately 37 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. No record retention is required. In previous years, 
FDA estimated that the agency's communication with trade associations 
and states resulted in a reporting burden of 520 hours. FDA no longer 
receives information from trade associations and states under this 
program. Accordingly, the proposed annual burden for this information 
collection has been reduced by 520 hours. Therefore, the proposed 
annual burden for this information collection is 37 hours.

    Dated: September 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18033 Filed 9-11-07; 8:45 am]
BILLING CODE 4160-01-S