[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]
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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.
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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,
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:
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Estimated Annual Reporting Burden
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Annual
Form No. 21 CFR No. of Frequency Total Annual Hours per Total Hours
Section Respondents per Response Responses Response
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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
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Estimated Annual Recordkeeping Burden
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Total Annual Hours per
21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Records Recordkeeper Total Hours
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21 CFR 1210.15 1 1 1 .05 0.05
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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
