[Federal Register: April 30, 1999 (Volume 64, Number 83)]
[Notices]
[Page 23333-23334]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap99-92]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0926]


Agency Information Collection Activities: Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to 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 collection of information by June
29, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (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

[[Page 23334]]

existing collection of information, before submitting the collection to
OMB for approval. 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.

Regulations Under the Federal Import Milk Act--21 CFR Part 1210
(OMB Control Number 0910-0212--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.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1</SUP>
----------------------------------------------------------------------------------------------------------------
                                                      Annual
      Form        21 CFR Section      No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
FDA 1815/Permits     1210.23            4               1               4               0.5             2.0
 granted on
 certificates
FDA 1993/            1210.20            4               1               4               0.5             2.0
 Application of
 permit
FDA 1994/            1210.13            -               -               -               -               -
 Tuberculin
 test\2\
FDA 1995/            1210.12            -               -               -               -               -
 Physical
 examination of
 cows\2\
FDA 1996/            1210.11            4               1             800               1.5          1200.0
 Sanitary
 inspection of
 dairy farms
FDA 1997/            1210.14            4               1               4               2.0             8.0
 Sanitary
 inspections 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.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
----------------------------------------------------------------------------------------------------------------
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.

    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: April 23, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10796 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F