[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31155-31156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14266]


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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 (PRA).

DATES: Fax written comments on the collection of information by August 
2, 2018.

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 Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 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 (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

[[Page 31156]]

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.
    In the Federal Register of April 2, 2018 (83 FR 13992), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
        21 CFR Section                  Form FDA No.            Number of     responses per   Total annual       Average burden per response      Total
                                                               respondents     respondent       responses                                         hours
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1210.11.......................  1996/Sanitary inspection of               2             200             400  1.5...............................      600
                                 dairy farms.
1210.12.......................  1995/Physical examination                 1               1               1  0.5 (30 minutes)..................      0.5
                                 of cows.
1210.13.......................  1994/Tuberculin test.......               1               1               1  0.5 (30 minutes)..................      0.5
1210.14.......................  1997/Sanitary inspections                 2               1               2  2.................................        4
                                 of plants.
1210.20.......................  1993/Application for permit               2               1               2  0.5 (30 minutes)..................        1
1210.23.......................  1815/Permits granted on                   2               1               2  0.5 (30 minutes)..................        1
                                 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
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                                         Number of
   21 CFR Section        Number of      records per    Total annual     Average burden         Total hours
                       recordkeepers   recordkeeper       records     per recordkeeping
----------------------------------------------------------------------------------------------------------------
1210.15.............               2               1               2  0.05 (3 minutes).  0.10 (6 minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Upon review of the information collection, we have retained the 
currently approved estimated burden. 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. Assuming two respondents will submit 
approximately 200 Form FDA 1996 reports annually for a total of 600 
responses, and that each response requires 1.5 hours, we estimate the 
total burden is 600 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 or 1995 in 
the last 3 years, we assume no more than one will be submitted 
annually. We also assume each submission requires 0.5 hour for a total 
of 0.5 burden hour annually.
    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 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 hour 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 hour per response, for a total burden of 1 
hour.
    With regard to records maintenance, we estimate that approximately 
two recordkeepers will spend 0.05 hour annually maintaining the 
additional pasteurization records required by Sec.  1210.15, for a 
total of 0.10 hour 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 OMB under the PRA. 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 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14266 Filed 7-2-18; 8:45 am]
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