[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]
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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.
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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.
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
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Annual
Form No. 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents 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 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
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Totals 453
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There are no capital or operating and maintenance costs associated with this collection.
Estimated Annual Recordkeeping Burden
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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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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.
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
