[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Notices]
[Pages 29738-29739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14297]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0373]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by July 
1, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:  Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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

    European Community (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, 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, and animal casings) 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

[[Page 29739]]

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, 
U.S. 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<SUP>1                                  
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                                                      No. of                                                    
            Products                  No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
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Shell Eggs                             20               1              20               0.25            5       
Dairy                                 100               1             100               0.25           25       
Game Meat and Meat Products            20               1              20               0.25            5       
Animal Casings                         15               1              15               0.25            3.75    
Total                                                                                                  38.75    
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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 volume of exports 
and responses received to date. The estimated number of yearly 
responses has been decreased from the estimate in FDA's previous notice 
seeking comment on this collection of information (61 FR 66671, 
December 18, 1996) because the actual number of responses received has 
been decreasing. Companies do not need to reapply unless they have a 
compliance problem. An estimate for processors that export animal 
casings has also been added because these processors are now being 
included in the listing process. Finally, the operating and maintenance 
cost estimate included in the previous notice has been removed because, 
according to OMB's draft guidance on interpretation of the PRA, the 
costs listed were not operating and maintenance costs. The costs are 
now listed in FDA's supporting statement in the ``Other Non-Labor 
Costs'' category. A copy of the supporting statement may be obtained 
from the contact person listed above.

                      Table 2.--Estimated Annual Reporting Burden (Third Party Disclosure)<SUP>1                     
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                                                      No. of                                                    
           Respondents                No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
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Trade Association                      14               1              14               8             112       
State                                  50               1              50               8             400       
Total                                                                                                 512       
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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 the processors to FDA.

    Dated: May 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14297 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F