[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15794-15795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06703]


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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 or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. Under the Paperwork Reduction Act of 1995 (the PRA), 
Federal Agencies must publish a notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, and allow 
60 days for public comment in response to the notice. This notice 
invites comments on the reporting and recordkeeping requirements of our 
regulations implementing the Federal Import Milk Act (FIMA).

DATES: Submit either electronic or written comments on the collection 
of information by May 26, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#3a6a687b694e5b5c5c7a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="336361726047525555735557521d5b5b401d545c45">[email protected]</span></a>.

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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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 (FIMA)--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).
    Our 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.
    We estimate the burden of this collection of information as 
follows:

[[Page 15795]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of                        Average
             21 CFR Section                          Form No.                Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11................................  FDA 1996; Sanitary inspection                 2             200             400             1.5             600
                                          of dairy farms.
1210.12................................  FDA 1995; Physical examination                1               1               1             0.5             0.5
                                          of cows.
1210.13................................  FDA 1994; Tuberculin test......               1               1               1             0.5             0.5
1210.14................................  FDA 1997; Sanitary inspections                2               1               2             2.0             4.0
                                          of plants.
1210.20................................  FDA 1993; Application for                     2               1               2             0.5             1.0
                                          permit.
1210.23................................  FDA 1815; Permits granted on                  2               1               2             0.5             1.0
                                          certificates.
                                                                         -------------------------------------------------------------------------------
    Total..............................  ...............................  ..............  ..............  ..............  ..............             607
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                           21 CFR Section                               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15............................................................               2                1                2             0.05             0.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 our experience with the import milk permit program and the 
average number of import milk permit holders over the past 3 years. We 
estimate that two respondents will submit approximately 200 Form FDA 
1996 reports annually, for a total of 600 responses. We estimate 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 we have not received any Forms FDA 1994 and 1995 
in the last 3 years, the Agency estimates no more than one will be 
submitted annually. We estimate the reporting burden for each to be 0.5 
hours per response for a total burden reporting burden of 0.5 hours 
each.
    We estimate that two respondents will submit one Form FDA 1997 
report annually, for a total of two responses. We estimate the 
reporting burden to be 2.0 hours per response, for a total burden of 4 
hours. We estimate that two respondents will submit one Form FDA 1993 
report annually, for a total of two responses. We estimate the 
reporting burden to be 0.5 hours per response, for a total burden of 1 
hour. We estimate that two respondents will submit one Form FDA 1815 
report annually, for a total of two responses. We estimate the 
reporting burden to be 0.5 hours per response, for a total burden of 1 
hour.
    With regard to records maintenance, we estimate 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 us 
(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 subject to review by the Office of Management and Budget under 
the Paperwork Reduction Act. 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: March 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06703 Filed 3-24-15; 8:45 am]
 BILLING CODE 4164-01-P


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