80 FR 34670 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

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.

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34670-34672]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14888]


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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

[[Page 34671]]

(OMB) for review and clearance under the Paperwork Reduction Act of 
1995.

DATES: Fax written comments on the collection of information by July 
17, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver 
Spring, MD 20993-0002 [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.
    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[emsp14][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.
    In the Federal Register of March 25, 2015 (80 FR 15794), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    We estimate 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 per      Total hours
                                                                    respondents     respondent       responses           response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (30 minutes)......             0.5
                                      Examination of Cows.
1210.13............................  FDA 1994; Tuberculin Test..               1               1               1  0.5 (30 minutes)......             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 (30 minutes)......               1
                                      Permit.
1210.23............................  FDA 1815; Permits Granted                 2               1               2  0.5 (30 minutes)......               1
                                      on Certificates.
                                    --------------------------------------------------------------------------------------------------------------------
    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                      21 CFR Section                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15..................................................                 2                  1                  2               0.05                0.1
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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 our experience with the import milk permit program and the 
average number of import milk permit holders over the past three 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

[[Page 34672]]

annually, for a total of two responses. We estimate the reporting 
burden to be 2 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: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14888 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P