[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38301-38302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15719]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0369]


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 July 
27, 2012.

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: 202-395-7285, or emailed to [email protected]. 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: 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: 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--21 CFR Part 1210 (OMB 
Control Number 0910-0212)--Extension

    Under 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 April 20, 2012 (77 FR 23732), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter in response to the 
notice. The letter contained one relevant comment, while additional 
comments were outside the scope of the four collection of information 
topics on which the notice solicits comments and will not be discussed 
in this document.
    (Comment 1) One comment suggested that ``huge bureaucratic expenses 
created by the usa [sic] for 2 forms'' for taxpayers.
    (Response) While FDA appreciates the comment, the commenter did not 
specify which two forms might create an undue expense for taxpayers. 
Each form relating to this information collection request is necessary 
for the proper performance of FDA's functions. FDA has examined each 
form related to this information collection request to assure its 
efficiency.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     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/                      2             200             400             1.5             600
                 Sanitary
                 inspection of
                 dairy farms.
1210.12.......  FDA 1995/                      1               1               1             0.5             0.5
                 Physical
                 examination of
                 cows.
1210.13.......  FDA 1994/                      1               1               1             0.5             0.5
                 Tuberculin test.
1210.14.......  FDA 1997/                      2               1               2               2               4
                 Sanitary
                 inspections of
                 plants.
1210.20.......  FDA 1993/                      2               1               2             0.5               1
                 Application for
                 permit.
1210.23.......  FDA 1815/Permits               2               1               2             0.5               1
                 granted on
                 certificates.
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[[Page 38302]]

 
    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                       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
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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 2 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: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15719 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P