[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73939-73940]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de08-43]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0453]
Agency Information Collection Activities; Submission for Office
of Management and Budget 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 a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
5, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0212.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: In compliance with 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--(OMB Control Number
0910-0212--Extension)
Under the Federal Import Milk Act (FIMA) (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 (21 U.S.C. 141). 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 (21 U.S.C. 142).
FDA's regulations in part 1210 (21 CFR part 1210) implement the
provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the
sanitary conditions of, respectively, dairy farms and plants producing
milk and/or cream to be shipped to the United States. Section 1210.12
requires reports on the physical examination of herds, while Sec.
1210.13 requires the reporting of tuberculin testing of the herds. In
addition, the regulations in part 1210 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). Section 1210.20 requires that an application for a
permit to ship or transport milk or cream into the United States be
made by the actual shipper. Section 1210.23 allows permits to be
granted based on certificates from accredited officials.
In the Federal Register of August 25, 2008 (73 FR 50031), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section Form No. No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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1210.11 FDA 1996/Sanitary inspection of 8 200 1,600 1.5 2,400
dairy farms
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1210.12 FDA 1995/Physical examination of 1 1 1 0.5 0.5
cows
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[[Page 73940]]
1210.13 FDA 1994/Tuberculin test 1 1 1 0.5 0.5
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1210.14 FDA 1997/Sanitary inspections of 8 1 8 2.0 16.0
plants
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1210.20 FDA 1993/Application for permit 8 1 8 0.5 4.0
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1210.23 FDA 1815/Permits granted on 8 1 8 0.5 4.0
certificates
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Total 2,425.0
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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1210.15 8 1 8 0.05 0.40
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated number of respondents and hours per response are
based on FDA's experience with the import milk permit program and the
average number of import milk permit holders over the past 3 years. FDA
estimates that 8 respondents will submit approximately 200 Form FDA
1996 reports annually, for a total of 1,600 responses. FDA estimates
the reporting burden to be 1.5 hours per response, for a total burden
of 2,400 hours.
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. Because FDA has not received any Forms FDA 1994 and 1995
in the last 3 years, the agency estimates no more than one will be
submitted annually. FDA estimates the reporting burden for each to be
0.5 hours per response for a total burden reporting burden of 0.5 hours
each.
FDA estimates that eight respondents will submit one Form FDA 1997
report annually, for a total of eight responses. FDA estimates the
reporting burden to be 2.0 hours per response, for a total burden of 16
hours. FDA estimates that eight respondents will submit one Form FDA
1993 report annually, for a total of eight responses. FDA estimates the
reporting burden to be 0.5 hours per response, for a total burden of 4
hours. FDA estimates that eight respondents will submit one Form FDA
1815 report annually, for a total of eight responses. FDA estimates the
reporting burden to be 0.5 hours per response, for a total burden of 4
hours.
With regard to records maintenance, FDA estimates that
approximately eight recordkeepers will spend 0.05 hours annually
maintaining the additional pasteurization records required by Sec.
1210.15, for a total of 0.40 hours annually.
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.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28692 Filed 12-3-08; 8:45 am]
BILLING CODE 4160-01-S