[Federal Register Volume 72, Number 119 (Thursday, June 21, 2007)]
[Notices]
[Pages 34256-34257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0230]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements in 
implementing the lists of U.S. firms/processors exporting shell eggs, 
dairy products, game meat and game meat products to the European 
Community (the EC).

DATES: Submit written or electronic comments on the collection of 
information by August 20, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of

[[Page 34257]]

information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
extension of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Information From U.S. Processors That Export to the European Community 
(OMB Control Number 0910-0320)--Extension

    The 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 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.
    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                  3
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Dairy                            120                  1                120               0.25                 30
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Game Meat and                      5                  1                  5               0.25                  1
 Meat Products
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Animal Casings                     5                  1                  5               0.25                  1
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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              .................  .................  .................  .................                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: June 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11980 Filed 6-20-07; 8:45 am]
BILLING CODE 4160-01-S