[Federal Register Volume 61, Number 56 (Thursday, March 21, 1996)]
[Notices]
[Pages 11642-11644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6737]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0084]


Agency Emergency Processing Request Under OMB Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995. The purpose of the proposed collection 
of information is to enable FDA to compile lists of U.S. processors 
that export certain animal-derived foods to the European Community 
(EC). These lists must be completed by May 1, 1996, to meet EC trade 
requirements. To meet the EC deadline, FDA is requesting OMB approval 
by March 28, 1996.

DATES: Submit written comments by March 28, 1996.

ADDRESSES: Submit written comments 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. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
Paperwork Reduction Act of 1995 and 5 CFR 1320.13 because the 
information is needed to meet the May 1, 1996, EC deadline; the 
information is essential to the agency's mission; and public harm is 
reasonably likely to result if normal clearance procedures are 
followed.
     With respect to the following collection of information, comments 
are invited 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 the agency 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

[[Page 11643]]
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 Shell Eggs, 
Dairy Products, Game Meat and Game Meat Products to the European 
Community:
    The 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 
assurance 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, FDA intends to request 
information from processors that export certain animal-derived products 
(shell eggs, dairy products, game meat and game meat products) to the 
EC. FDA will use this information to compile lists of processors that 
meet U.S. requirements and will provide the lists to the EC quarterly. 
Inclusion on the lists is voluntary. EC member countries will 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 processor list are subject to detention and possible refusal at the 
port. FDA intends to request 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 the EC and those 
intended to be shipped in the next 2 years;
    (4) Name and address of manufacturing plants for each product and;
    (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.
    FDA estimates the burden of the proposed collection of information 
is as follows:

                               Shell Eggs                               
------------------------------------------------------------------------
                    Estimated Annual Reporting Burden                   
-------------------------------------------------------------------------
                    Annual                                              
    No. of      Frequency per   Total Annual    Hours per    Total Hours
  Respondents      Response      Responses      Response                
------------------------------------------------------------------------
 25             1              25             0.25          6.25        
------------------------------------------------------------------------


                             Dairy Products                             
------------------------------------------------------------------------
                    Estimated Annual Reporting Burden                   
-------------------------------------------------------------------------
                    Annual                                              
    No. of      Frequency per   Total Annual    Hours per    Total Hours
  Respondents      Response      Responses      Response                
------------------------------------------------------------------------
50              1              50             0.25          12.50       
------------------------------------------------------------------------


                    Game Meat and Game Meat Products                    
------------------------------------------------------------------------
                    Estimated Annual Reporting Burden                   
-------------------------------------------------------------------------
                    Annual                                              
    No. of      Frequency per   Total Annual    Hours per    Total Hours
  Respondents      Response      Responses      Response                
------------------------------------------------------------------------
25              1              25             0.25          6.25        
------------------------------------------------------------------------

There are no capital costs or operating and maintenance costs 
associated with this collection.
Third Party Disclosure
    The following estimate of the burden on trade associations assumes 
that the trade associations will disseminate FDA's information request 
through a mass mailing to their membership or publish it in their trade 
magazine or newsletter:

                                                                        
------------------------------------------------------------------------
                    Estimated Annual Reporting Burden                   
-------------------------------------------------------------------------
                    Annual                                              
    No. of      Frequency per   Total Annual    Hours per    Total Hours
  Respondents      Response      Responses      Response                
------------------------------------------------------------------------
12              1              12             8             96          
------------------------------------------------------------------------


[[Page 11644]]


There are no capital costs or operating and maintenance costs 
associated with this collection.

    Dated: March 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-6737 Filed 3-18-96; 8:45 am]
BILLING CODE 4160-01-F