[Federal Register: April 16, 2004 (Volume 69, Number 74)]
[Page 20630-20631]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 
    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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                                      No. Of Responses  Total Annual    Hours per
            Products              No. of Respondents   per Respondent     Responses     Response     Total Hours
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
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

                           Table 2.--Estimated Annual Reporting Burden; Disclosure\1\
                                                      No. of Responses  Total annual    Hours per
           Respondent             No. of Respondents   per Respondent     Responses     Response     Total Hours
Trade Association                        15                   1              15             8           120
State                                    50                   1              50             8           400
Total                             ..................  ................  ............  ............     520
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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]