[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Notices]
[Pages 51077-51079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20379]
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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
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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
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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 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
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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