[Federal Register Volume 61, Number 79 (Tuesday, April 23, 1996)]
[Notices]
[Pages 17900-17901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9869]



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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0066]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Extension

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, 
Federal agencies are required to publish a notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on reporting and recordkeeping requirements 
implementing the Federal Import Milk Act.

DATES: Submit written comments on the collections of information by 
June 24, 1996.

ADDRESSES: Submit written comments on the collections of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (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. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information listed below.
    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.
Part 1210 Regulations Under the Federal Import Milk Act (21 CFR Part 
1210) (OMB Control Number 0910-0212--Extension)
    Under the regulations implementing the Federal Import Milk Act (21 
U.S.C. 141-149), milk or cream may be imported into the United States 
only by the holder of a valid import milk permit. Before such permit is 
issued: (1) All cows from which import milk or cream is produced must 
be physically examined and found healthy; (2) if the milk or cream is 
imported raw, all such cows must pass a tuberculin test; (3) the dairy 
farm and each plant in which the milk or cream is processed or handled 
must be inspected and found to meet certain sanitary requirements; (4) 
bacterial counts of the milk at the time of importation must not exceed 
specified limits; and (5) the temperature of the milk or cream at time 
of importation must not exceed 50  deg.F. In addition, the regulations 
require that dairy farmers and plants maintain pasteurization records 
(Sec. 1210.15) and that each container of milk or cream imported into 
the United States bear a tag with the product type, permit number, and 
shipper's name and address (Sec. 1210.22).
    FDA estimates the burden of complying with the information 
collection provisions of these regulations as follows:

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                        Estimated Annual Reporting Burden                                       
-----------------------------------------------------------------------------------------------------------------
                                                             Annual                                             
          Form No.               21 CFR        No. of       Frequency   Total Annual    Hours per    Total Hours
                                 Section     Respondents  per Response    Responses     Response                
----------------------------------------------------------------------------------------------------------------
FDA 1815/Permits granted on                                                                                     
 certificates                   1210.23          1             1             1             0.5           0.5    
FDA 1993/Application of                                                                                         
 permit                         1210.20          1             1             1             0.5           0.5    
FDA 1994/Tuberculin test        1210.13          0             0             0           N/A             0      
FDA 1995/Physical                                                                                               
 examination of cows            1210.12          0             0             0           N/A             0      
FDA 1996/Sanitary inspection                                                                                    
 of dairy farms                 1210.11          1           300           300             1.5         450      
FDA 1997/Sanitary                                                                                               
 inspections of plants          1210.14          1             1             1             2.0           2.0    
Total                                                                                                  453      
----------------------------------------------------------------------------------------------------------------


                                                                                                                                                        
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Estimated Annual Recordkeeping Burden                                                         
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Total Annual      Hours per                   
  21 CFR Section               No. of Recordkeepers                Annual Frequency per Recordkeeping        Records      Recordkeeper      Total Hours 
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 1210.15      1                                          1                                          1             .05               0.05          
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no capital or operating and maintenance costs associated with this collection.                                                                


[[Page 17901]]


    No burden has been estimated for the tagging requirement in 
Sec. 1210.22 because the information on the tag is either supplied by 
FDA (permit number) or is disclosed to third parties as a usual and 
customary part of the shipper's normal business activities (type of 
product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the 
public disclosure of information originally supplied by the Federal 
government to the recipient for the purpose of disclosure to the public 
is not a collection of information. Under 5 CFR 1320.3(b)(2)), the 
time, effort, and financial resources necessary to comply with a 
collection of information are excluded from the burden estimate if the 
reporting, recordkeeping, or disclosure activities needed to comply are 
usual and customary because they would occur in the normal course of 
activities. No burden has been estimated for Forms FD 1994 and 1995 
because they are not currently being used. The Secretary of Health and 
Human Services has the discretion to allow Form FD 1815, a duly 
certified statement signed by an accredited official of a foreign 
government, to be submitted in lieu of Forms FD 1994 and 1995. To date, 
Form FD-1815 has been submitted in lieu of these forms.

    Dated: April 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-9869 Filed 4-22-96; 8:45 am]
BILLING CODE 4160-01-F