[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31327-31328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12263]


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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, Agency, or we) 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: Submit written comments (including recommendations) on the 
collection of information by July 12, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0212. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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

    This information collection supports FDA regulations. 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

[[Page 31328]]

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.
    Description of Respondents: Respondents include foreign dairy farms 
and plants engaged in transporting milk and/or cream into the United 
States. Respondents are from the private sector (for-profit 
businesses).
    In the Federal Register of November 4, 2020 (85 FR 70182), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates 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 hours
                                                       respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11..................  1996/Farm Inspection                   1             200             200  1.5................................             300
                            Report.
1210.12..................  1995/Report of Physical                1               1               1  0.5 (30 minutes)...................             0.5
                            Examination of Cows.
1210.13..................  1994/Report of                         1               1               1  0.5 (30 minutes)...................             0.5
                            Tuberculin Tests of
                            Cattle.
1210.14..................  1997/Score Card for                    1               1               1  2..................................               2
                            Sanitation Inspections
                            of Milk Plants.
1210.20..................  1993/Application for                   1               1               1  0.5 (30 minutes)...................             0.5
                            Permit to Ship or
                            Transport Milk and/or
                            Cream into United
                            States.
1210.23..................  1815/Certificate/                      1               1               1  0.5 (30 minutes)...................             0.5
                            Transmittal for an
                            Application.
                                                    ----------------------------------------------------------------------------------------------------
     Total...............  ........................  ..............  ..............  ..............  ...................................             304
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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; activity               Number of      records per    Total annual        Average burden  per recordkeeping        Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15 Pasteurization; Equipment and                      1               1               1  0.05 (3 minutes)..........................            0.05
 Methods.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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. In the past, 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 1 will be submitted 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.
    Based on a review of the information collection since our last OMB 
approval, we have decreased our burden estimate. 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. However, we have not received any 
responses in the last 3 years. Therefore, we estimate that one or fewer 
to be submitted annually. Although we have not received any responses 
in the last 3 years, we believe these information collection provisions 
should be extended to provide for the potential future need for a milk 
importer.

    Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12263 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P