[Federal Register Volume 64, Number 142 (Monday, July 26, 1999)]
[Notices]
[Pages 40379-40380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18927]
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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 Burden1
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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
test2
FDA 1995/ 1210.12
Physical
examination of
cows2
FDA 1996/ 1210.11 4 2003 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 Burden1
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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
