Document ID: FDA-2010-N-0422-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Information From United States Processors That Export to the European Community
Posted Date: 2010-08-18T04:00Z

[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]               
[Page 51077-51079]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au10-112]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0422]

 
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, game meat products, animal casings, gelatin, 
and collagen to the European Community (the EC).

DATES:  Submit either electronic or written comments on the collection 
of information by October 18, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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:  Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 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

[[Page 51078]]

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:
     Business name and address;
     Name and telephone number of person designated as business 
contact;
     Lists of products presently being shipped to the EC and 
those intended to be shipped in the next 6 months;
     Name and address of manufacturing plants for each product; 
and
     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.
    Description of Respondents: The respondents to this collection of 
information include U.S. producers of shell eggs, dairy products, game 
meat, game meat products, animal casings, gelatin, and collagen.
    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
 Game Meat
 Products
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Animal Casings                    5                  1                  5                0.25                  1
----------------------------------------------------------------------------------------------------------------
Gelatin                           3                  1                  3                0.25                  1
----------------------------------------------------------------------------------------------------------------
Collagen                          3                  1                  3                0.25                  1
----------------------------------------------------------------------------------------------------------------
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 estimates of the number of respondents and total 
annual responses on the submissions that the agency has received in the 
past 3 years for each product type. To calculate the estimate for the 
hours per response values, we assumed that the information requested is 
readily available to the submitter. We expect that submitter will need 
to gather information from appropriate persons in the submitter's 
company and to prepare this information for submission. We believe that 
this effort should take no longer than 15 minutes (0.25 hour) per 
response. FDA estimates that it will receive 1 submission from 10 shell 
egg producers annually, for a total of 10 annual responses. Each 
submission is estimated to take 0.25 hour per response for a total of 
2.5 hours, rounded to 3 hours. FDA estimates that it will receive 1 
submission from 120 dairy product producers annually, for a total of 
120 annual responses. Each submission is estimated to take 0.25 hour 
per response for a total of 30 hours. FDA estimates that it will 
receive 1 submission from 5 game meat and game meat product producers 
annually, for a total of 5 annual responses. Each submission is 
estimated to take 0.25 hour per response for a total of 1.25 hours, 
rounded to 1 hour. FDA estimates that it will receive 1 submission from 
5 animal casings producers annually, for a total of 5 annual responses. 
Each submission is estimated to take 0.25 hour per response for a total 
of 1.25 hours, rounded to 1 hour. FDA estimates that it will receive 1 
submission from 3 gelatin producers annually, for a total of 3 annual 
responses. Each submission is estimated to take 0.25 hour per response 
for a total of 0.75 hour, rounded to 1 hour. FDA estimates that it will 
receive 1 submission from 3 collagen producers annually, for a total of 
3 annual

[[Page 51079]]

responses. Each submission is estimated to take 0.25 hour per response 
for a total of 0.75 hour, rounded to 1 hour.
    Therefore, the proposed annual burden for this information 
collection is 37 hours.

    Dated: August 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20379 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-S