[Federal Register: May 31, 2005 (Volume 70, Number 103)]
[Notices]               
[Page 30951-30953]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31my05-41]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0178]

 
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 reporting and recordkeeping 
requirements in implementing the Federal Import Milk Act (FIMA).

DATES: Submit written or electronic comments on the collection of 
information by August 1, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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

[[Page 30952]]

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 the regulations implementing 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. 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 in part 1210 
(21 CFR 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).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
    Form No.          21 CFR          No. of       Frequencyper    Total Annual      Hours per      Total Hours
                      Section       Respondents      Response        Responses       Response
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FDA 1815/Permits         1210.23               8               1               8             0.5             4.0
 granted on
 certificates
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FDA 1993/                1210.20               8               1               8             0.5             4.0
 Application of
 permit
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FDA 1994/                1210.13               1               1               1             0.5             0.5
 Tuberculin test
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FDA 1995/                1210.12               1               1               1             0.5             0.5
 Physical
 examination of
 cows
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FDA 1996/                1210.11               8             200           1,600             1.5           2,400
 Sanitary
 inspection of
 dairy farms
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FDA 1997/                1210.14               8               1               8             2.0            16.0
 Sanitary
 inspections of
 plants
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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 per
              21 CFR Section                    Recordkeepers         Recordkeeping     Total Annual 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.

    These estimates are based on the number of current permit holders 
and the number of inquiries that FDA has received regarding requests 
for applications in the past 3 years. 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. Low burden has been estimated for 
Forms FDA 1994 and 1995 because they are not are not used often.

[[Page 30953]]

 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: May 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10703 Filed 5-27-05; 8:45 am]

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