[Federal Register Volume 61, Number 186 (Tuesday, September 24, 1996)]
[Notices]
[Pages 50030-50031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24365]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0283]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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.
DATES: Submit written comments on the collection of information by 
October 24, 1996.

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, Attn: Desk 
Officer for FDA.


[[Page 50031]]


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: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collection of information to OMB for review and 
clearance.

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 Section      No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
FDA 1815/Permits                                                                                                
 granted on                                                                                                     
 certificates        1210.23            1               1               1               0.5             0.5     
FDA 1993/                                                                                                       
 Application for                                                                                                
 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     
----------------------------------------------------------------------------------------------------------------
Totals                                                                                                453       
----------------------------------------------------------------------------------------------------------------
There are no capital or operating and maintenance costs associated with this collection.                        


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

    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: September 10, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-24365 Filed 9-23-96; 8:45 am]
BILLING CODE 4160-01-F