[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Pages 23732-23733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9532]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0369]
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 the reporting and
recordkeeping requirements of FDA's regulations implementing the
Federal Import Milk Act (FIMA).
DATES: Submit either electronic or written comments on the collection
of information by June 19, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, 301-796-5733, [email protected].
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 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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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 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
[[Page 23733]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR Section Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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1210.11.................................. FDA 1996/Sanitary 2 200 400 1.5 600
inspection of dairy farms.
1210.12.................................. FDA 1995/Physical 1 1 1 0.5 0.5
examination of cows.
1210.13.................................. FDA 1994/Tuberculin test... 1 1 1 0.5 0.5
1210.14.................................. FDA 1997/Sanitary 2 1 2 2 4
inspections of plants.
1210.20.................................. FDA 1993/Application for 2 1 2 0.5 1
permit.
1210.23.................................. FDA 1815/Permits granted on 2 1 2 0.5 1
certificates.
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Total................................ ........................... .............. .............. .............. ............... 607
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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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Number of Number of records Total annual Average burden per
21 CFR Section recordkeepers per recordkeeper records recordkeeping Total hours
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1210.15............................................. 2 1 2 0.05 0.10
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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 two respondents will submit approximately 200 Form FDA
1996 reports annually, for a total of 600 responses. FDA estimates the
reporting burden to be 1.5 hours per response, for a total burden of
607 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 two respondents will submit one Form FDA 1997
report annually, for a total of two responses. FDA estimates the
reporting burden to be 2.0 hours per response, for a total burden of 4
hours. FDA estimates that two respondents will submit one Form FDA 1993
report annually, for a total of two responses. FDA estimates the
reporting burden to be 0.5 hours per response, for a total burden of 1
hour. FDA estimates that two respondents will submit one Form FDA 1815
report annually, for a total of two responses. FDA estimates the
reporting burden to be 0.5 hours per response, for a total burden of 1
hour.
With regard to records maintenance, FDA estimates that
approximately two recordkeepers will spend 0.05 hours annually
maintaining the additional pasteurization records required by Sec.
1210.15, for a total of 0.10 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
business activities.
Dated: April 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9532 Filed 4-19-12; 8:45 am]
BILLING CODE 4160-01-P