[Federal Register: July 26, 1999 (Volume 64, Number 142)]
[Notices]               
[Page 40379-40380]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy99-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0296]

 
Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Regulations Under the Federal Import Milk Act

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 
August 25, 1999.

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: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy 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.

 Regulations Under the Federal Import Milk Act--21 CFR Part 1210 
(OMB Control Number 0910-021)--Extension

     Under the regulations (part 1210 (21 CFR part 1210)) 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.
     In the Federal Register of April 30, 1999 (64 FR 23333), the 
agency requested comments on the proposed collections of information. 
No comments were received.
     FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1</SUP>
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                                                       Annual
       Form            21 CFR          No. of      Frequency per    Total Annual     Hours per      Total Hours
                      Section       Respondents      Response        Responses       Response
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FDA 1815/Permits     1210.23            4               1               4               0.5             2.0
 granted on
 certificates
FDA 1993/            1210.20            4               4               4               0.5             2.0
 Applicant of
 permit
FDA 1994/            1210.13
 Tuberculin
 test<SUP>2</SUP>
FDA 1995/            1210.12
 Physical
 examination of
 cows<SUP>2</SUP>
FDA 1996/            1210.11            4            200<SUP>3</SUP>             800               1.5          1200.0
 Sanitary
 inspection of
 dairy farms
FDA 1997/            1210.14            4               1               4               2.0             8.0
 Sanitary
 inspection of
 plants
Total                                                                                                1212.0
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\No burden has been estimated for Forms FDA 1994 and 1995 because they are not currently being used.
\3\Due to a clerical error, the reporting burden hours for FDA 1996/Sanitary inspection of daily farms that
  appeared in a notice issued in the Federal Register of April 30, 1999 (64 FR 23333) were incorrect. Table 1 of
  this document contains the correct estimates.


                                Table 2.--Estimated Annual Recordkeeping Burden<SUP>1</SUP>
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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 1210.15                                4               1               4               0.05            0.20
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 40380]]

     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). No burden has been estimated for 
Forms FDA 1994 and 1995 because they are not currently being used. The 
Secretary of Health and Human Services has the discretion to allow Form 
FDA 1815, a duly certified statement signed by an accredited official 
of a foreign Government, to be submitted in lieu of Forms FDA 1994 and 
1995. To date, Form FDA 1815 has been submitted in lieu of these forms.

    Dated: July 19, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-18927 Filed 7-23-99; 8:45 am]
BILLING CODE 4160-01-F