[Federal Register: April 16, 2004 (Volume 69, Number 74)]
[Notices]
[Page 20630-20631]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap04-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0161]
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 European Union Dairy Export List.
DATES: Submit written or electronic comments on the collection of
information by June 15, 2004.
ADDRESSES: Submit electronic comments to: http://www.fda.gov/dockets/ecomments.
Submit written comments 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 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.
[[Page 20631]]
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
(with 10 additional countries joining on May 1, 2004), that have agreed
to harmonize their commodity requirements to facilitate commerce among
member States. EC legislation for intraEC trade has been extended to
trade with nonEC 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.
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
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 18 U.S.C 1001. 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. Of Responses Total Annual Hours per
Products No. of Respondents per Respondent Responses Response Total Hours
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Shell Eggs 10 1 10 0.25 3
Dairy 100 1 100 0.25 25
Game Meat and Meat Products 5 1 5 0.25 1
Animal Casings 5 1 5 0.25 1
Gelatin 3 1 3 0.25 1
Collagen 3 1 3 0.25 1
Total .................. ................ ............ ............ 32
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Reporting Burden; Disclosure\1\
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No. of Responses Total annual Hours per
Respondent No. of Respondents per Respondent Responses Response Total Hours
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Trade Association 15 1 15 8 120
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.
It is estimated that the annual reporting burden would be no more
than 32 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. The number of respondents is a rough estimate based
on volume of exports and responses received to date. No record
retention is required. Therefore, the proposed annual burden for this
information collection is 32 hours.
Dated: April 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8611 Filed 4-15-04; 8:45 am]
BILLING CODE 4160-01-S