[Federal Register Volume 66, Number 40 (Wednesday, February 28, 2001)]
[Notices]
[Pages 12802-12803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0069 ]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Information From U.S. 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 the maintenance of lists of 
U.S. processors that export certain animal-derived foods (i.e., shell 
eggs, dairy products, game meat, game meat products, animal casings, 
and gelatin) to the European Community (EC), temporary exemptions from 
certain food labeling requirements for the purpose of conducting 
authorized food labeling experiments, petitions for health claims, and 
petitions for nutrient content claims.

DATES: Submit written or electronic comments on the collection of 
information by April 30, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 Schlosburg, Office of 
Information Resources Management (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: (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.

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

    EC is a group of 15 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 below 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

[[Page 12803]]

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 section 1001 of Title 18, 
United States Code. 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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                                                      Annual
            Products                  No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Shell eggs                             10               1              10               0.25            2.5
Dairy                                 100               1             100               0.25           25
Game meat and meat products            10               1              10               0.25            2.5
Animal casings                         15               1              15               0.25            3.75
Gelatin                                 6               1               6               0.25            1.5
Total                                                                                                  35.25
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated number of respondents is based on the volume of 
exports and responses received to date. The estimated number of yearly 
responses has decreased from the estimate in FDA's previous notice 
seeking comment for this collection of information (63 FR 29738, June 
1, 1998) because the actual number of responses has been decreasing. 
Companies do not need to reapply unless they have a compliance problem. 
An estimate for processors that export gelatin also has been added 
because these processors are now being included in the listing process.

                     Table 2.--Estimated Annual Reporting Burden (Third Party Disclosure)\1\
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                                                      Annual
           Respondents                No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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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.

    The burden estimated for the trade associations assumes the trade 
associations will disseminate FDA's information request through mass 
mailings to their membership or publish it in their trade magazine or 
newsletter. The burden estimated for State authorities assumes 
dissemination of information to the processors or dissemination of 
information about processors to FDA.

    Dated: February 22, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-4851 Filed 2-27-01; 8:45 am]
BILLING CODE 4160-01-F